Trial Outcomes & Findings for GSK3359609 Plus Tremelimumab for the Treatment of Advanced Solid Tumors (NCT NCT03693612)

Last Updated: 2024-08-28

Results Overview

A DLT is considered by the investigator to be clinically relevant, attributed event within first 28 days of intervention meeting the following criteria of toxicity, Hematologic: Febrile neutropenia, Grade 4 neutropenia of greater than (\>) 7 days in duration or requiring Granulocyte- Colony stimulating factor (G-CSF), Grade 4 anemia and Grade 3 thrombocytopenia with bleeding or Grade 4 thrombocytopenia; Non-hematologic: Grade 4 toxicity, Grade 3 pneumonitis, any greater than or equal to (≥) Grade 2 pneumonitis that does not resolve to less than or equal to (≤ ) Grade 1 within 3 days of the initiation of maximal supportive care, Grade 3 toxicity that does not resolve to Grade 1 or baseline within 3 days despite optimal supportive care and any Grade 2 ocular toxicity requiring systemic steroids, or any ≥ Grade 3 ocular toxicity.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

26 participants

Primary outcome timeframe

Up to 28 days

Results posted on

2024-08-28

Participant Flow

The study was conducted in United States and Canada.

The results presented are for Part 1 of the study. Part 2 was not initiated due to Sponsor decision to not proceed based on scientific and portfolio priority reasons and lack of adequate efficacy and not due to safety reasons in Part 1. A total of 26 participants were enrolled in this study.

Participant milestones

Participant milestones
Measure	Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 milligram (mg) Feladilimab first as a 30-minute intravenous (IV) infusion once every 3 weeks (Q3W) in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once every 12 weeks (Q12W).	Part 1: Feladilimab 24 mg + Tremelimumab 75 mg In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 8 mg + Tremelimumab 225 mg In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 80 mg + Tremelimumab 75 mg In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 80 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 24 mg + Tremelimumab 225 mg In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.
Overall Study STARTED	1	1	5	3	16
Overall Study COMPLETED	1	0	4	3	10
Overall Study NOT COMPLETED	0	1	1	0	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1: Feladilimab 24 mg + Tremelimumab 75 mg In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 8 mg + Tremelimumab 225 mg In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 24 mg + Tremelimumab 225 mg In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.
Overall Study Lost to Follow-up	0	0	1
Overall Study Withdrawal by Subject	0	1	2
Overall Study Study Terminated by Sponsor	1	0	3

Baseline Characteristics

GSK3359609 Plus Tremelimumab for the Treatment of Advanced Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg n=1 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 24 mg + Tremelimumab 75 mg n=1 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 8 mg + Tremelimumab 225 mg n=5 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 80 mg + Tremelimumab 75 mg n=3 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 80 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 24 mg + Tremelimumab 225 mg n=16 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 2: Feladilimab + Tremelimumab In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/ PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with Feladilimab and Tremelimumab as an IV infusion after the RP2D determination.	Part 2: Standard of Care (SOC) In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with a single agent SOC therapy of either paclitaxel (as an IV infusion once weekly at a dose of 80 mg/m\^2), docetaxel (as an IV infusion once every 3 weeks at a dose of 75 mg/m\^2) or cetuximab (at a loading dose of 400 mg/m\^2 followed by 250 mg/m\^2 once weekly) as per the investigator's choice.	Total n=26 Participants Total of all reporting groups
Age, Continuous	51.0 YEARS STANDARD_DEVIATION 0 • n=5 Participants	51.0 YEARS STANDARD_DEVIATION 0 • n=7 Participants	58.2 YEARS STANDARD_DEVIATION 11.73 • n=5 Participants	69.0 YEARS STANDARD_DEVIATION 12.77 • n=4 Participants	66.8 YEARS STANDARD_DEVIATION 11.51 • n=21 Participants	—	—	64.2 YEARS STANDARD_DEVIATION 11.95 • n=24 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	9 Participants n=24 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	12 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	17 Participants n=24 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=24 Participants
Race/Ethnicity, Customized Multiple	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=24 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	1 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants	3 Participants n=4 Participants	14 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	24 Participants n=24 Participants

PRIMARY outcome

Timeframe: Up to 28 days

Population: All Treated Population includes all participants who received at least 1 dose of Tremelimumab or Feladilimab.

Outcome measures

Outcome measures
Measure	Part 2: Feladilimab + Tremelimumab n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/ PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with Feladilimab and Tremelimumab as an IV infusion after the RP2D determination.	Part 2: Standard of Care (SOC) n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with a single agent SOC therapy of either paclitaxel (as an IV infusion once weekly at a dose of 80 mg/m\^2), docetaxel (as an IV infusion once every 3 weeks at a dose of 75 mg/m\^2) or cetuximab (at a loading dose of 400 mg/m\^2 followed by 250 mg/m\^2 once weekly) as per the investigator's choice.	Part 1: Feladilimab 8 mg + Tremelimumab 225 mg n=5 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 80 mg + Tremelimumab 75 mg n=3 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 80 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 24 mg + Tremelimumab 225 mg n=16 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.
Number of Participants With Dose Limiting Toxicities (DLTs)-Part 1	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Up to 28 days

Population: All Treated Population

The severity of all toxicities were graded using the National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 5.0. Grade 1: Mild reaction; infusion interruption not indicated; intervention not indicated; Grade 2: Requires therapy or infusion interruption but responds promptly to symptomatic treatment or prophylactic medications indicated for ≤24 hours; Grade 3: Prolonged (i.e., not rapidly responsive to symptomatic medication and/or brief interruption of infusion) or recurrence of symptoms following initial improvement; hospitalization indicated for other clinical sequelae; Grade 4: Life-threatening; pressor or ventilatory support indicated; Grade 5: Death related to AE.

Outcome measures

Outcome measures
Measure	Part 2: Feladilimab + Tremelimumab n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/ PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with Feladilimab and Tremelimumab as an IV infusion after the RP2D determination.	Part 2: Standard of Care (SOC) n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with a single agent SOC therapy of either paclitaxel (as an IV infusion once weekly at a dose of 80 mg/m\^2), docetaxel (as an IV infusion once every 3 weeks at a dose of 75 mg/m\^2) or cetuximab (at a loading dose of 400 mg/m\^2 followed by 250 mg/m\^2 once weekly) as per the investigator's choice.	Part 1: Feladilimab 8 mg + Tremelimumab 225 mg n=5 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 80 mg + Tremelimumab 75 mg n=3 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 80 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 24 mg + Tremelimumab 225 mg n=16 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.
Number of Participants With DLTs According to Severity-Part 1 Grade 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With DLTs According to Severity-Part 1 Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With DLTs According to Severity-Part 1 Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With DLTs According to Severity-Part 1 Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With DLTs According to Severity-Part 1 Grade 5	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 4 years

Population: All Treated Population

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect and important medical events may jeopardize the subject or may require medical or surgical intervention/SOC to prevent one of the other outcomes mentioned before. AESIs are defined as events of potential immunologic etiology, including immune related AEs.

Outcome measures

Outcome measures
Measure	Part 2: Feladilimab + Tremelimumab n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/ PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with Feladilimab and Tremelimumab as an IV infusion after the RP2D determination.	Part 2: Standard of Care (SOC) n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with a single agent SOC therapy of either paclitaxel (as an IV infusion once weekly at a dose of 80 mg/m\^2), docetaxel (as an IV infusion once every 3 weeks at a dose of 75 mg/m\^2) or cetuximab (at a loading dose of 400 mg/m\^2 followed by 250 mg/m\^2 once weekly) as per the investigator's choice.	Part 1: Feladilimab 8 mg + Tremelimumab 225 mg n=5 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 80 mg + Tremelimumab 75 mg n=3 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 80 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 24 mg + Tremelimumab 225 mg n=16 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)-Part 1 AEs	1 Participants	1 Participants	5 Participants	3 Participants	16 Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)-Part 1 SAEs	0 Participants	0 Participants	3 Participants	3 Participants	6 Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)-Part 1 AESIs	0 Participants	0 Participants	2 Participants	0 Participants	7 Participants

PRIMARY outcome

Timeframe: Up to 4 years

Population: All Treated Population

The number of participants with AE/SAE/DLTs leading to dose modifications/delays/withdrawals were summarized.

Outcome measures

Outcome measures
Measure	Part 2: Feladilimab + Tremelimumab n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/ PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with Feladilimab and Tremelimumab as an IV infusion after the RP2D determination.	Part 2: Standard of Care (SOC) n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with a single agent SOC therapy of either paclitaxel (as an IV infusion once weekly at a dose of 80 mg/m\^2), docetaxel (as an IV infusion once every 3 weeks at a dose of 75 mg/m\^2) or cetuximab (at a loading dose of 400 mg/m\^2 followed by 250 mg/m\^2 once weekly) as per the investigator's choice.	Part 1: Feladilimab 8 mg + Tremelimumab 225 mg n=5 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 80 mg + Tremelimumab 75 mg n=3 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 80 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 24 mg + Tremelimumab 225 mg n=16 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.
Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 Any Aes-Dose Modification	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 Any Aes-Dose Delay	0 Participants	0 Participants	3 Participants	0 Participants	4 Participants
Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 Any Aes-Dose Withdrawal	0 Participants	0 Participants	1 Participants	0 Participants	3 Participants
Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 Any SAEs-Dose Modification	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 Any SAEs-Dose Delay	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 Any SAEs-Dose Withdrawal	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants
Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 Any DLTs-Dose Modification	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 Any DLTs-Dose Delay	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 Any DLTs-Dose Withdrawal	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Up to 4 years

Population: All Treated Population

Outcome measures

Outcome measures
Measure	Part 2: Feladilimab + Tremelimumab n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/ PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with Feladilimab and Tremelimumab as an IV infusion after the RP2D determination.	Part 2: Standard of Care (SOC) n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with a single agent SOC therapy of either paclitaxel (as an IV infusion once weekly at a dose of 80 mg/m\^2), docetaxel (as an IV infusion once every 3 weeks at a dose of 75 mg/m\^2) or cetuximab (at a loading dose of 400 mg/m\^2 followed by 250 mg/m\^2 once weekly) as per the investigator's choice.	Part 1: Feladilimab 8 mg + Tremelimumab 225 mg n=5 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 80 mg + Tremelimumab 75 mg n=3 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 80 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 24 mg + Tremelimumab 225 mg n=16 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.
Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 Grade 4: AEs	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 Grade 1: AEs	0 Participants	0 Participants	0 Participants	0 Participants	4 Participants
Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 Grade 2: AEs	1 Participants	1 Participants	1 Participants	0 Participants	4 Participants
Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 Grade 3: AEs	0 Participants	0 Participants	3 Participants	3 Participants	6 Participants
Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 Grade 1: AESI	0 Participants	0 Participants	0 Participants	0 Participants	3 Participants
Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 Grade 2: AESI	0 Participants	0 Participants	2 Participants	0 Participants	2 Participants
Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 Grade 3: AESI	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 Grade 4: AESI	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 Grade 5: AESI	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 Grade 5: AEs	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 Grade 1: SAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 Grade 2: SAEs	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 Grade 3: SAEs	0 Participants	0 Participants	2 Participants	3 Participants	3 Participants
Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 Grade 4: SAEs	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 Grade 5: SAEs	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Up to 4 years

Population: All Treated Population

The number of participants with severe- AE/SAE/DLTs leading to dose modifications/delays/withdrawals were summarized.

Outcome measures

Outcome measures
Measure	Part 2: Feladilimab + Tremelimumab n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/ PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with Feladilimab and Tremelimumab as an IV infusion after the RP2D determination.	Part 2: Standard of Care (SOC) n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with a single agent SOC therapy of either paclitaxel (as an IV infusion once weekly at a dose of 80 mg/m\^2), docetaxel (as an IV infusion once every 3 weeks at a dose of 75 mg/m\^2) or cetuximab (at a loading dose of 400 mg/m\^2 followed by 250 mg/m\^2 once weekly) as per the investigator's choice.	Part 1: Feladilimab 8 mg + Tremelimumab 225 mg n=5 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 80 mg + Tremelimumab 75 mg n=3 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 80 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 24 mg + Tremelimumab 225 mg n=16 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.
Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 Any Severe Aes-Dose Modification	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 Any Severe Aes-Dose Delay	0 Participants	0 Participants	3 Participants	0 Participants	4 Participants
Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 Any Severe Aes-Dose Withdrawal	0 Participants	0 Participants	1 Participants	0 Participants	3 Participants
Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 Any Severe SAEs-Dose Modification	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 Any Severe SAEs-Dose Delay	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 Any Severe SAEs-Dose Withdrawal	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants
Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 Any Severe DLTs-Dose Modification	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 Any Severe DLTs-Dose Delay	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 Any Severe DLTs-Dose Withdrawal	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) and Week 4

Population: All Treated Population. Only those participants with data available at the specified data points were analyzed.

SBP and DBP were measured after 5 minutes of rest for the participant.

Outcome measures

Outcome measures
Measure	Part 2: Feladilimab + Tremelimumab n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/ PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with Feladilimab and Tremelimumab as an IV infusion after the RP2D determination.	Part 2: Standard of Care (SOC) n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with a single agent SOC therapy of either paclitaxel (as an IV infusion once weekly at a dose of 80 mg/m\^2), docetaxel (as an IV infusion once every 3 weeks at a dose of 75 mg/m\^2) or cetuximab (at a loading dose of 400 mg/m\^2 followed by 250 mg/m\^2 once weekly) as per the investigator's choice.	Part 1: Feladilimab 8 mg + Tremelimumab 225 mg n=5 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 80 mg + Tremelimumab 75 mg n=3 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 80 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 24 mg + Tremelimumab 225 mg n=16 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)-Part 1 SBP, Baseline (Day 1)	104 Millimeters of mercury (mmHg)	128 Millimeters of mercury (mmHg)	128 Millimeters of mercury (mmHg) Standard Deviation 14.967	133.67 Millimeters of mercury (mmHg) Standard Deviation 11.676	127.5 Millimeters of mercury (mmHg) Standard Deviation 16.415
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)-Part 1 SBP, Week 4	16 Millimeters of mercury (mmHg)	-12 Millimeters of mercury (mmHg)	-10 Millimeters of mercury (mmHg) Standard Deviation 11.726	-12 Millimeters of mercury (mmHg) Standard Deviation 11.533	-0.27 Millimeters of mercury (mmHg) Standard Deviation 19.568
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)-Part 1 DBP, Baseline (Day 1)	73 Millimeters of mercury (mmHg)	79 Millimeters of mercury (mmHg)	83.4 Millimeters of mercury (mmHg) Standard Deviation 8.081	74.67 Millimeters of mercury (mmHg) Standard Deviation 4.041	76.25 Millimeters of mercury (mmHg) Standard Deviation 9.015
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)-Part 1 DBP, Week 4	4 Millimeters of mercury (mmHg)	-3 Millimeters of mercury (mmHg)	-5 Millimeters of mercury (mmHg) Standard Deviation 3.162	-4 Millimeters of mercury (mmHg) Standard Deviation 6.557	-2.8 Millimeters of mercury (mmHg) Standard Deviation 7.552

PRIMARY outcome

Timeframe: Baseline (Day 1) and Week 4

Population: All Treated Population. Only those participants with data available at the specified data points were analyzed.

Temperature was measured after 5 minutes of rest for the participant.

Outcome measures

Outcome measures
Measure	Part 2: Feladilimab + Tremelimumab n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/ PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with Feladilimab and Tremelimumab as an IV infusion after the RP2D determination.	Part 2: Standard of Care (SOC) n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with a single agent SOC therapy of either paclitaxel (as an IV infusion once weekly at a dose of 80 mg/m\^2), docetaxel (as an IV infusion once every 3 weeks at a dose of 75 mg/m\^2) or cetuximab (at a loading dose of 400 mg/m\^2 followed by 250 mg/m\^2 once weekly) as per the investigator's choice.	Part 1: Feladilimab 8 mg + Tremelimumab 225 mg n=5 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 80 mg + Tremelimumab 75 mg n=3 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 80 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 24 mg + Tremelimumab 225 mg n=16 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.
Change From Baseline in Temperature-Part 1 Baseline (Day 1)	36.5 Celsius (C)	36.9 Celsius (C)	36.8 Celsius (C) Standard Deviation 0.212	36.6 Celsius (C) Standard Deviation 0.173	36.64 Celsius (C) Standard Deviation 0.479
Change From Baseline in Temperature-Part 1 Week 4	0 Celsius (C)	-0.3 Celsius (C)	0.04 Celsius (C) Standard Deviation 0.321	0.2 Celsius (C) Standard Deviation 0.1	0.04 Celsius (C) Standard Deviation 0.378

PRIMARY outcome

Timeframe: Baseline (Day 1) and Week 4

Population: All Treated Population. Only those participants with data available at the specified data points were analyzed.

Pulse rate was measured after 5 minutes of rest for the participant.

Outcome measures

Outcome measures
Measure	Part 2: Feladilimab + Tremelimumab n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/ PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with Feladilimab and Tremelimumab as an IV infusion after the RP2D determination.	Part 2: Standard of Care (SOC) n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with a single agent SOC therapy of either paclitaxel (as an IV infusion once weekly at a dose of 80 mg/m\^2), docetaxel (as an IV infusion once every 3 weeks at a dose of 75 mg/m\^2) or cetuximab (at a loading dose of 400 mg/m\^2 followed by 250 mg/m\^2 once weekly) as per the investigator's choice.	Part 1: Feladilimab 8 mg + Tremelimumab 225 mg n=5 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 80 mg + Tremelimumab 75 mg n=3 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 80 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 24 mg + Tremelimumab 225 mg n=16 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.
Change From Baseline in Pulse Rate-Part 1 Baseline (Day 1)	81 beats/minute	83 beats/minute	91.6 beats/minute Standard Deviation 29.771	79.67 beats/minute Standard Deviation 9.074	76.56 beats/minute Standard Deviation 14.724
Change From Baseline in Pulse Rate-Part 1 Week 4	1 beats/minute	0 beats/minute	-2.4 beats/minute Standard Deviation 20.732	5 beats/minute Standard Deviation 15.716	8.07 beats/minute Standard Deviation 10.747

PRIMARY outcome

Timeframe: Baseline (Day 1) and Week 4

Population: All Treated Population. Only those participants with data available at the specified data points were analyzed.

Respiratory rate was measured after 5 minutes of rest for the participant.

Outcome measures

Outcome measures
Measure	Part 2: Feladilimab + Tremelimumab n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/ PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with Feladilimab and Tremelimumab as an IV infusion after the RP2D determination.	Part 2: Standard of Care (SOC) n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with a single agent SOC therapy of either paclitaxel (as an IV infusion once weekly at a dose of 80 mg/m\^2), docetaxel (as an IV infusion once every 3 weeks at a dose of 75 mg/m\^2) or cetuximab (at a loading dose of 400 mg/m\^2 followed by 250 mg/m\^2 once weekly) as per the investigator's choice.	Part 1: Feladilimab 8 mg + Tremelimumab 225 mg n=5 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 80 mg + Tremelimumab 75 mg n=3 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 80 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 24 mg + Tremelimumab 225 mg n=16 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.
Change From Baseline in Respiratory Rate-Part 1 Baseline (Day 1)	18 breaths/ minute	18 breaths/ minute	17.6 breaths/ minute Standard Deviation 0.894	16 breaths/ minute Standard Deviation 0	16.75 breaths/ minute Standard Deviation 1.065
Change From Baseline in Respiratory Rate-Part 1 Week 4	0 breaths/ minute	-2 breaths/ minute	0 breaths/ minute Standard Deviation 1.414	2 breaths/ minute Standard Deviation 0	0.07 breaths/ minute Standard Deviation 1.668

PRIMARY outcome

Timeframe: Baseline (Day 1) and Week 4

Population: All Treated Population. Only those participants with data available at the specified data points were analyzed.

Oxygen saturation was measured using pulse oximeter after 5 minutes of rest for the participant.

Outcome measures

Outcome measures
Measure	Part 2: Feladilimab + Tremelimumab n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/ PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with Feladilimab and Tremelimumab as an IV infusion after the RP2D determination.	Part 2: Standard of Care (SOC) n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with a single agent SOC therapy of either paclitaxel (as an IV infusion once weekly at a dose of 80 mg/m\^2), docetaxel (as an IV infusion once every 3 weeks at a dose of 75 mg/m\^2) or cetuximab (at a loading dose of 400 mg/m\^2 followed by 250 mg/m\^2 once weekly) as per the investigator's choice.	Part 1: Feladilimab 8 mg + Tremelimumab 225 mg n=5 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 80 mg + Tremelimumab 75 mg n=3 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 80 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 24 mg + Tremelimumab 225 mg n=16 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.
Change From Baseline in Oxygen Saturation-Part 1 Baseline (Day 1)	96 Percentage (%) of Oxygen	95 Percentage (%) of Oxygen	95.6 Percentage (%) of Oxygen Standard Deviation 2.881	96 Percentage (%) of Oxygen Standard Deviation 1.00	97.63 Percentage (%) of Oxygen Standard Deviation 1.586
Change From Baseline in Oxygen Saturation-Part 1 Week 4	2 Percentage (%) of Oxygen	5 Percentage (%) of Oxygen	0.8 Percentage (%) of Oxygen Standard Deviation 1.304	0 Percentage (%) of Oxygen Standard Deviation 2.00	-0.2 Percentage (%) of Oxygen Standard Deviation 2.007

PRIMARY outcome

Timeframe: Baseline (Pre dose, Day 1) and up to 4 Years

Population: All Treated Population. Only those participants with data available at the specified data points were analyzed.

Single 12-lead ECG was obtained using an automated ECG machine. ECG findings were categorized as: normal, abnormal - clinically significant (CS), or abnormal - not clinically significant (NCS), as determined by the investigator.

Outcome measures

Outcome measures
Measure	Part 2: Feladilimab + Tremelimumab n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/ PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with Feladilimab and Tremelimumab as an IV infusion after the RP2D determination.	Part 2: Standard of Care (SOC) n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with a single agent SOC therapy of either paclitaxel (as an IV infusion once weekly at a dose of 80 mg/m\^2), docetaxel (as an IV infusion once every 3 weeks at a dose of 75 mg/m\^2) or cetuximab (at a loading dose of 400 mg/m\^2 followed by 250 mg/m\^2 once weekly) as per the investigator's choice.	Part 1: Feladilimab 8 mg + Tremelimumab 225 mg n=5 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 80 mg + Tremelimumab 75 mg n=3 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 80 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 24 mg + Tremelimumab 225 mg n=16 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.
Number of Participants With Electrocardiogram (ECG) Findings Worst case Post-Baseline · Normal	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Findings Worst case Post-Baseline · Abnormal CS	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Findings Worst case Post-Baseline · Abnormal NCS	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants
Number of Participants With Electrocardiogram (ECG) Findings Baseline (Pre dose, Day 1) · Normal	1 Participants	1 Participants	1 Participants	1 Participants	6 Participants
Number of Participants With Electrocardiogram (ECG) Findings Baseline (Pre dose, Day 1) · Abnormal CS	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Findings Baseline (Pre dose, Day 1) · Abnormal NCS	0 Participants	0 Participants	3 Participants	2 Participants	10 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) and Week 4

Population: All Treated Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected to assess change from Baseline in neutrophil, lymphocyte, monocyte, eosinophil, basophil and platelet counts.

Outcome measures

Outcome measures
Measure	Part 2: Feladilimab + Tremelimumab n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/ PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with Feladilimab and Tremelimumab as an IV infusion after the RP2D determination.	Part 2: Standard of Care (SOC) n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with a single agent SOC therapy of either paclitaxel (as an IV infusion once weekly at a dose of 80 mg/m\^2), docetaxel (as an IV infusion once every 3 weeks at a dose of 75 mg/m\^2) or cetuximab (at a loading dose of 400 mg/m\^2 followed by 250 mg/m\^2 once weekly) as per the investigator's choice.	Part 1: Feladilimab 8 mg + Tremelimumab 225 mg n=5 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 80 mg + Tremelimumab 75 mg n=3 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 80 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 24 mg + Tremelimumab 225 mg n=16 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 Basophils, Baseline (Day 1)	0.00 10^9 cells/liter	0.00 10^9 cells/liter	0.05 10^9 cells/liter Standard Deviation 0.0577	0.01 10^9 cells/liter Standard Deviation 0.0141	0.039 10^9 cells/liter Standard Deviation 0.048
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 Basophils, Week 4	0.00 10^9 cells/liter	—	0 10^9 cells/liter Standard Deviation 0	0.005 10^9 cells/liter Standard Deviation 0.0071	0.007 10^9 cells/liter Standard Deviation 0.0344
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 Eosinophils, Baseline (Day 1)	0.3 10^9 cells/liter	0.1 10^9 cells/liter	0.35 10^9 cells/liter Standard Deviation 0.173	0.08 10^9 cells/liter Standard Deviation 0.113	0.2 10^9 cells/liter Standard Deviation 0.217
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 Eosinophils, Week 4	0.4 10^9 cells/liter	—	0.03 10^9 cells/liter Standard Deviation 0.15	0.06 10^9 cells/liter Standard Deviation 0.064	0.07 10^9 cells/liter Standard Deviation 0.169
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 Lymphocytes, Baseline (Day 1)	1 10^9 cells/liter	1.5 10^9 cells/liter	0.9 10^9 cells/liter Standard Deviation 0.216	1.25 10^9 cells/liter Standard Deviation 0.212	0.92 10^9 cells/liter Standard Deviation 0.223
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 Lymphocytes, Week 4	0.4 10^9 cells/liter	—	0.23 10^9 cells/liter Standard Deviation 0.15	-0.38 10^9 cells/liter Standard Deviation 0.46	0.01 10^9 cells/liter Standard Deviation 0.185
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 Monocytes, Baseline (Day 1)	0.4 10^9 cells/liter	0.3 10^9 cells/liter	0.8 10^9 cells/liter Standard Deviation 0.2944	1.255 10^9 cells/liter Standard Deviation 0.9122	0.738 10^9 cells/liter Standard Deviation 0.3004
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 Monocytes, Week 4	0 10^9 cells/liter	—	0.05 10^9 cells/liter Standard Deviation 0.1732	-0.215 10^9 cells/liter Standard Deviation 0.1202	0.038 10^9 cells/liter Standard Deviation 0.2598
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 Neutrophils, Baseline (Day 1)	4 10^9 cells/liter	3.9 10^9 cells/liter	4.38 10^9 cells/liter Standard Deviation 1.548	6.2 10^9 cells/liter Standard Deviation 2.97	11.32 10^9 cells/liter Standard Deviation 21.379
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 Neutrophils, Week 4	0.3 10^9 cells/liter	—	0.93 10^9 cells/liter Standard Deviation 0.512	-0.9 10^9 cells/liter Standard Deviation 0.7	-8.95 10^9 cells/liter Standard Deviation 26.151
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 Platelets, Baseline (Day 1)	196 10^9 cells/liter	325 10^9 cells/liter	250.6 10^9 cells/liter Standard Deviation 103.5	229.7 10^9 cells/liter Standard Deviation 147.06	266.3 10^9 cells/liter Standard Deviation 90.28
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 Platelets, Week 4	-1 10^9 cells/liter	—	8.6 10^9 cells/liter Standard Deviation 34.93	-8.7 10^9 cells/liter Standard Deviation 16.65	31.3 10^9 cells/liter Standard Deviation 42.72

PRIMARY outcome

Timeframe: Baseline (Day 1) and Week 4

Population: All Treated Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected to assess change from baseline in hemoglobin level.

Outcome measures

Outcome measures
Measure	Part 2: Feladilimab + Tremelimumab n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/ PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with Feladilimab and Tremelimumab as an IV infusion after the RP2D determination.	Part 2: Standard of Care (SOC) n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with a single agent SOC therapy of either paclitaxel (as an IV infusion once weekly at a dose of 80 mg/m\^2), docetaxel (as an IV infusion once every 3 weeks at a dose of 75 mg/m\^2) or cetuximab (at a loading dose of 400 mg/m\^2 followed by 250 mg/m\^2 once weekly) as per the investigator's choice.	Part 1: Feladilimab 8 mg + Tremelimumab 225 mg n=5 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 80 mg + Tremelimumab 75 mg n=3 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 80 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 24 mg + Tremelimumab 225 mg n=16 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.
Change From Baseline in Hemoglobin Level-Part 1 Baseline (Day 1)	125 grams/liter	134 grams/liter	123.4 grams/liter Standard Deviation 32.61	125 grams/liter Standard Deviation 23.07	111.5 grams/liter Standard Deviation 12.74
Change From Baseline in Hemoglobin Level-Part 1 Week 4	5 grams/liter	—	-5.8 grams/liter Standard Deviation 4.21	0.3 grams/liter Standard Deviation 2.89	-0.7 grams/liter Standard Deviation 10.78

PRIMARY outcome

Timeframe: Baseline (Day 1) and Week 4

Population: All Treated Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected to assess change from baseline in hematocrit level.

Outcome measures

Outcome measures
Measure	Part 2: Feladilimab + Tremelimumab n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/ PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with Feladilimab and Tremelimumab as an IV infusion after the RP2D determination.	Part 2: Standard of Care (SOC) n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with a single agent SOC therapy of either paclitaxel (as an IV infusion once weekly at a dose of 80 mg/m\^2), docetaxel (as an IV infusion once every 3 weeks at a dose of 75 mg/m\^2) or cetuximab (at a loading dose of 400 mg/m\^2 followed by 250 mg/m\^2 once weekly) as per the investigator's choice.	Part 1: Feladilimab 8 mg + Tremelimumab 225 mg n=5 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 80 mg + Tremelimumab 75 mg n=3 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 80 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 24 mg + Tremelimumab 225 mg n=16 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.
Change From Baseline in Hematocrit Level-Part 1 Baseline (Day 1)	0.38 fraction of 1	0.4 fraction of 1	0.385 fraction of 1 Standard Deviation 0.10999	0.3937 fraction of 1 Standard Deviation 0.0647	0.3421 fraction of 1 Standard Deviation 0.03603
Change From Baseline in Hematocrit Level-Part 1 Week 4	0 fraction of 1	—	-0.0202 fraction of 1 Standard Deviation 0.01494	-0.0017 fraction of 1 Standard Deviation 0.01102	-0.0039 fraction of 1 Standard Deviation 0.03413

PRIMARY outcome

Timeframe: Baseline (Day 1) and Week 4

Population: All Treated Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected to assess change from baseline in Erythrocytes count.

Outcome measures

Outcome measures
Measure	Part 2: Feladilimab + Tremelimumab n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/ PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with Feladilimab and Tremelimumab as an IV infusion after the RP2D determination.	Part 2: Standard of Care (SOC) n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with a single agent SOC therapy of either paclitaxel (as an IV infusion once weekly at a dose of 80 mg/m\^2), docetaxel (as an IV infusion once every 3 weeks at a dose of 75 mg/m\^2) or cetuximab (at a loading dose of 400 mg/m\^2 followed by 250 mg/m\^2 once weekly) as per the investigator's choice.	Part 1: Feladilimab 8 mg + Tremelimumab 225 mg n=5 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 80 mg + Tremelimumab 75 mg n=3 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 80 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 24 mg + Tremelimumab 225 mg n=16 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.
Change From Baseline in Erythrocytes Count-Part 1 Baseline (Day 1)	4.2 10^12 cells/liter	4.65 10^12 cells/liter	4.328 10^12 cells/liter Standard Deviation 1.2592	4.673 10^12 cells/liter Standard Deviation 0.4885	3.76 10^12 cells/liter Standard Deviation 0.526
Change From Baseline in Erythrocytes Count-Part 1 Week 4	0.13 10^12 cells/liter	—	-0.216 10^12 cells/liter Standard Deviation 0.2131	0.04 10^12 cells/liter Standard Deviation 0.1652	0.016 10^12 cells/liter Standard Deviation 0.3913

PRIMARY outcome

Timeframe: Baseline (Day 1) and Week 4

Population: All Treated Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected to assess change from Baseline in albumin and total protein levels.

Outcome measures

Outcome measures
Measure	Part 2: Feladilimab + Tremelimumab n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/ PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with Feladilimab and Tremelimumab as an IV infusion after the RP2D determination.	Part 2: Standard of Care (SOC) n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with a single agent SOC therapy of either paclitaxel (as an IV infusion once weekly at a dose of 80 mg/m\^2), docetaxel (as an IV infusion once every 3 weeks at a dose of 75 mg/m\^2) or cetuximab (at a loading dose of 400 mg/m\^2 followed by 250 mg/m\^2 once weekly) as per the investigator's choice.	Part 1: Feladilimab 8 mg + Tremelimumab 225 mg n=5 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 80 mg + Tremelimumab 75 mg n=3 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 80 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 24 mg + Tremelimumab 225 mg n=16 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.
Change From Baseline in Albumin and Total Protein Levels-Part 1 Albumin, Baseline (Day 1)	41 grams/Liter	40 grams/Liter	36 grams/Liter Standard Deviation 7.18	36.7 grams/Liter Standard Deviation 9.24	37.9 grams/Liter Standard Deviation 2.79
Change From Baseline in Albumin and Total Protein Levels-Part 1 Albumin, Week 4	0 grams/Liter	—	0 grams/Liter Standard Deviation 3.81	-0.7 grams/Liter Standard Deviation 2.31	-2.1 grams/Liter Standard Deviation 2.81
Change From Baseline in Albumin and Total Protein Levels-Part 1 Protein, Baseline (Day 1)	71 grams/Liter	—	66.7 grams/Liter Standard Deviation 7.02	73 grams/Liter Standard Deviation 3.61	72.1 grams/Liter Standard Deviation 6.51
Change From Baseline in Albumin and Total Protein Levels-Part 1 Protein, Week 4	—	—	3.3 grams/Liter Standard Deviation 2.89	0 grams/Liter Standard Deviation 4.36	1.4 grams/Liter Standard Deviation 4.31

PRIMARY outcome

Timeframe: Baseline (Day 1) and Week 4

Population: All Treated Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected to assess change from baseline in creatinine and bilirubin levels.

Outcome measures

Outcome measures
Measure	Part 2: Feladilimab + Tremelimumab n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/ PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with Feladilimab and Tremelimumab as an IV infusion after the RP2D determination.	Part 2: Standard of Care (SOC) n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with a single agent SOC therapy of either paclitaxel (as an IV infusion once weekly at a dose of 80 mg/m\^2), docetaxel (as an IV infusion once every 3 weeks at a dose of 75 mg/m\^2) or cetuximab (at a loading dose of 400 mg/m\^2 followed by 250 mg/m\^2 once weekly) as per the investigator's choice.	Part 1: Feladilimab 8 mg + Tremelimumab 225 mg n=5 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 80 mg + Tremelimumab 75 mg n=3 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 80 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 24 mg + Tremelimumab 225 mg n=16 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.
Change From Baseline in Creatinine and Bilirubin Levels-Part 1 Bilirubin, Baseline (Day 1)	5 micromoles/ Liter	7 micromoles/ Liter	6.1 micromoles/ Liter Standard Deviation 2.44	6.1 micromoles/ Liter Standard Deviation 2.84	6.5 micromoles/ Liter Standard Deviation 4.23
Change From Baseline in Creatinine and Bilirubin Levels-Part 1 Bilirubin, Week 4	-1 micromoles/ Liter	—	2.2 micromoles/ Liter Standard Deviation 2.48	-1.1 micromoles/ Liter Standard Deviation 1.97	-0.4 micromoles/ Liter Standard Deviation 1.52
Change From Baseline in Creatinine and Bilirubin Levels-Part 1 Creatinine, Baseline (Day 1)	59000 micromoles/ Liter	63000 micromoles/ Liter	31636.7 micromoles/ Liter Standard Deviation 43702.44	73.5 micromoles/ Liter Standard Deviation 33.52	93 micromoles/ Liter Standard Deviation 44.72
Change From Baseline in Creatinine and Bilirubin Levels-Part 1 Creatinine, Week 4	1000 micromoles/ Liter	—	-1798.9 micromoles/ Liter Standard Deviation 3493.56	3.1 micromoles/ Liter Standard Deviation 4.29	-2.9 micromoles/ Liter Standard Deviation 9.53

PRIMARY outcome

Timeframe: Baseline (Day 1) and Week 4

Population: All Treated Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected to assess change from baseline in ALT, AST ALP, LDH levels.

Outcome measures

Outcome measures
Measure	Part 2: Feladilimab + Tremelimumab n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/ PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with Feladilimab and Tremelimumab as an IV infusion after the RP2D determination.	Part 2: Standard of Care (SOC) n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with a single agent SOC therapy of either paclitaxel (as an IV infusion once weekly at a dose of 80 mg/m\^2), docetaxel (as an IV infusion once every 3 weeks at a dose of 75 mg/m\^2) or cetuximab (at a loading dose of 400 mg/m\^2 followed by 250 mg/m\^2 once weekly) as per the investigator's choice.	Part 1: Feladilimab 8 mg + Tremelimumab 225 mg n=5 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 80 mg + Tremelimumab 75 mg n=3 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 80 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 24 mg + Tremelimumab 225 mg n=16 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.
Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Lactate Dehydrogenase (LDH) Levels-Part 1 ALP, Baseline (Day 1)	53 International Units/milliliter	68 International Units/milliliter	307.4 International Units/milliliter Standard Deviation 416.93	121.5 International Units/milliliter Standard Deviation 82.73	120.2 International Units/milliliter Standard Deviation 60.54
Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Lactate Dehydrogenase (LDH) Levels-Part 1 ALP, Week 4	2 International Units/milliliter	—	55.8 International Units/milliliter Standard Deviation 101.74	-18 International Units/milliliter Standard Deviation 25.46	36.2 International Units/milliliter Standard Deviation 75.58
Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Lactate Dehydrogenase (LDH) Levels-Part 1 ALT, Baseline (Day 1)	18 International Units/milliliter	25 International Units/milliliter	24 International Units/milliliter Standard Deviation 14.18	26.7 International Units/milliliter Standard Deviation 24.79	18.2 International Units/milliliter Standard Deviation 13.49
Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Lactate Dehydrogenase (LDH) Levels-Part 1 ALT, Week 4	-2 International Units/milliliter	—	8.2 International Units/milliliter Standard Deviation 13.05	-4.7 International Units/milliliter Standard Deviation 15.14	7.4 International Units/milliliter Standard Deviation 26.46
Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Lactate Dehydrogenase (LDH) Levels-Part 1 AST, Baseline (Day 1)	32 International Units/milliliter	44 International Units/milliliter	24.6 International Units/milliliter Standard Deviation 9.91	23.7 International Units/milliliter Standard Deviation 15.89	21.9 International Units/milliliter Standard Deviation 8.23
Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Lactate Dehydrogenase (LDH) Levels-Part 1 AST, Week 4	0 International Units/milliliter	—	10 International Units/milliliter Standard Deviation 14.2	-7 International Units/milliliter Standard Deviation 14.73	12.9 International Units/milliliter Standard Deviation 35.1
Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Lactate Dehydrogenase (LDH) Levels-Part 1 LDH, Baseline (Day 1)	325 International Units/milliliter	382 International Units/milliliter	228.8 International Units/milliliter Standard Deviation 20.69	168 International Units/milliliter Standard Deviation 104.23	239.9 International Units/milliliter Standard Deviation 139.36
Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Lactate Dehydrogenase (LDH) Levels-Part 1 LDH, Week 4	127 International Units/milliliter	—	11.4 International Units/milliliter Standard Deviation 42.76	31.3 International Units/milliliter Standard Deviation 53.3	42.9 International Units/milliliter Standard Deviation 85.66

PRIMARY outcome

Timeframe: Baseline (Day 1) and week 4

Population: All Treated Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected to assess change from baseline in amylase and lipase levels.

Outcome measures

Outcome measures
Measure	Part 2: Feladilimab + Tremelimumab n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/ PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with Feladilimab and Tremelimumab as an IV infusion after the RP2D determination.	Part 2: Standard of Care (SOC) n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with a single agent SOC therapy of either paclitaxel (as an IV infusion once weekly at a dose of 80 mg/m\^2), docetaxel (as an IV infusion once every 3 weeks at a dose of 75 mg/m\^2) or cetuximab (at a loading dose of 400 mg/m\^2 followed by 250 mg/m\^2 once weekly) as per the investigator's choice.	Part 1: Feladilimab 8 mg + Tremelimumab 225 mg n=5 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 80 mg + Tremelimumab 75 mg n=3 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 80 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 24 mg + Tremelimumab 225 mg n=16 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.
Change From Baseline in Amylase and Lipase Levels-Part 1 Amylase, Baseline (Day 1)	48 Units/milliliter	50 Units/milliliter	50.2 Units/milliliter Standard Deviation 34.85	40 Units/milliliter Standard Deviation 15.62	51.5 Units/milliliter Standard Deviation 26.72
Change From Baseline in Amylase and Lipase Levels-Part 1 Amylase, Week 4	-2 Units/milliliter	—	-5.3 Units/milliliter Standard Deviation 7.23	-5 Units/milliliter Standard Deviation 1	-3.5 Units/milliliter Standard Deviation 9.64
Change From Baseline in Amylase and Lipase Levels-Part 1 Lipase, Baseline (Day 1)	28 Units/milliliter	23 Units/milliliter	50.8 Units/milliliter Standard Deviation 55.65	54.7 Units/milliliter Standard Deviation 48.99	34.6 Units/milliliter Standard Deviation 27.8
Change From Baseline in Amylase and Lipase Levels-Part 1 Lipase, Week 4	0 Units/milliliter	—	1.5 Units/milliliter Standard Deviation 4.65	-13 Units/milliliter Standard Deviation 23.81	6.1 Units/milliliter Standard Deviation 35.96

PRIMARY outcome

Timeframe: Baseline (Day 1) and Week 4

Population: All Treated Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected to assess change in levels of urea, glucose, potassium, sodium and calcium from baseline.

Outcome measures

Outcome measures
Measure	Part 2: Feladilimab + Tremelimumab n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/ PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with Feladilimab and Tremelimumab as an IV infusion after the RP2D determination.	Part 2: Standard of Care (SOC) n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with a single agent SOC therapy of either paclitaxel (as an IV infusion once weekly at a dose of 80 mg/m\^2), docetaxel (as an IV infusion once every 3 weeks at a dose of 75 mg/m\^2) or cetuximab (at a loading dose of 400 mg/m\^2 followed by 250 mg/m\^2 once weekly) as per the investigator's choice.	Part 1: Feladilimab 8 mg + Tremelimumab 225 mg n=5 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 80 mg + Tremelimumab 75 mg n=3 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 80 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 24 mg + Tremelimumab 225 mg n=16 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.
Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 Urea, Baseline (Day 1)	3.4 millimoles/Liter	3.3 millimoles/Liter	6.36 millimoles/Liter Standard Deviation 1.226	7.36 millimoles/Liter Standard Deviation 0.75	6.92 millimoles/Liter Standard Deviation 3.495
Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 Glucose, Baseline (Day 1)	6.7 millimoles/Liter	7.3 millimoles/Liter	6.09 millimoles/Liter Standard Deviation 1.6994	5.897 millimoles/Liter Standard Deviation 0.2754	6.397 millimoles/Liter Standard Deviation 1.5963
Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 Glucose, Week 4	-0.3 millimoles/Liter	—	-0.365 millimoles/Liter Standard Deviation 1.3225	-0.848 millimoles/Liter Standard Deviation 0.4949	-0.11 millimoles/Liter Standard Deviation 1.0164
Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 Calcium, Baseline (Day 1)	2.37 millimoles/Liter	2.24 millimoles/Liter	2.325 millimoles/Liter Standard Deviation 0.1221	2.397 millimoles/Liter Standard Deviation 0.1475	2.33 millimoles/Liter Standard Deviation 0.0886
Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 Calcium, Week 4	0.15 millimoles/Liter	—	0.137 millimoles/Liter Standard Deviation 0.1385	0.05 millimoles/Liter Standard Deviation 0.1322	-0.028 millimoles/Liter Standard Deviation 0.0878
Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 Potassium, Baseline (Day 1)	4.3 millimoles/Liter	4 millimoles/Liter	4.18 millimoles/Liter Standard Deviation 0.606	4.3 millimoles/Liter Standard Deviation 0.173	4.22 millimoles/Liter Standard Deviation 0.391
Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 Potassium, Week 4	-0.3 millimoles/Liter	—	0.04 millimoles/Liter Standard Deviation 0.586	-0.03 millimoles/Liter Standard Deviation 0.306	-0.01 millimoles/Liter Standard Deviation 0.328
Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 Sodium, Baseline (Day 1)	138 millimoles/Liter	140 millimoles/Liter	137.2 millimoles/Liter Standard Deviation 4.49	137.3 millimoles/Liter Standard Deviation 3.21	137.1 millimoles/Liter Standard Deviation 3.52
Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 Sodium, Week 4	-1 millimoles/Liter	—	0.2 millimoles/Liter Standard Deviation 1.3	0.7 millimoles/Liter Standard Deviation 0.58	-1 millimoles/Liter Standard Deviation 2.65
Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 Urea, Week 4	1.5 millimoles/Liter	—	-1.37 millimoles/Liter Standard Deviation 1.09	1.08 millimoles/Liter Standard Deviation 0.357	-0.51 millimoles/Liter Standard Deviation 1.633

PRIMARY outcome

Timeframe: Baseline (Day 1) and Week 4

Population: All Treated Population. Only those participants with data available at the specified data points were analyzed.

Urine samples were collected to assess change from baseline in specific gravity of urine.

Outcome measures

Outcome measures
Measure	Part 2: Feladilimab + Tremelimumab n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/ PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with Feladilimab and Tremelimumab as an IV infusion after the RP2D determination.	Part 2: Standard of Care (SOC) n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with a single agent SOC therapy of either paclitaxel (as an IV infusion once weekly at a dose of 80 mg/m\^2), docetaxel (as an IV infusion once every 3 weeks at a dose of 75 mg/m\^2) or cetuximab (at a loading dose of 400 mg/m\^2 followed by 250 mg/m\^2 once weekly) as per the investigator's choice.	Part 1: Feladilimab 8 mg + Tremelimumab 225 mg n=5 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 80 mg + Tremelimumab 75 mg n=3 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 80 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 24 mg + Tremelimumab 225 mg n=16 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.
Change From Baseline in Specific Gravity of Urine-Part 1 Baseline (Day 1)	1.015 Ratio	1.02 Ratio	1.0204 Ratio Standard Deviation 0.00856	1.021 Ratio Standard Deviation 0.01015	1.0159 Ratio Standard Deviation 0.00605
Change From Baseline in Specific Gravity of Urine-Part 1 Week 4	0.005 Ratio	—	-0.0055 Ratio Standard Deviation 0.00666	0.0013 Ratio Standard Deviation 0.00115	-0.0005 Ratio Standard Deviation 0.006

PRIMARY outcome

Timeframe: Baseline (Day 1) and Week 4

Population: All Treated Population. Only those participants with data available at the specified data points were analyzed.

Urine samples were collected to assess change from baseline in pH of urine.

Outcome measures

Outcome measures
Measure	Part 2: Feladilimab + Tremelimumab n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/ PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with Feladilimab and Tremelimumab as an IV infusion after the RP2D determination.	Part 2: Standard of Care (SOC) n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with a single agent SOC therapy of either paclitaxel (as an IV infusion once weekly at a dose of 80 mg/m\^2), docetaxel (as an IV infusion once every 3 weeks at a dose of 75 mg/m\^2) or cetuximab (at a loading dose of 400 mg/m\^2 followed by 250 mg/m\^2 once weekly) as per the investigator's choice.	Part 1: Feladilimab 8 mg + Tremelimumab 225 mg n=5 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 80 mg + Tremelimumab 75 mg n=3 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 80 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 24 mg + Tremelimumab 225 mg n=16 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.
Change From Baseline in Potential of Hydrogen (pH) of Urine-Part 1 Baseline (Day 1)	6.5 pH	7 pH	6 pH Standard Deviation 1.173	5.33 pH Standard Deviation 0.289	6.16 pH Standard Deviation 0.826
Change From Baseline in Potential of Hydrogen (pH) of Urine-Part 1 Week 4	-0.5 pH	—	0.5 pH Standard Deviation 0.707	-0.33 pH Standard Deviation 0.289	-0.24 pH Standard Deviation 0.918

PRIMARY outcome

Timeframe: Week 4

Population: All Treated Population. Only those participants with data available at the specified data points were analyzed.

The dipstick test gives positive or negative results for protein, ketones, occult blood and glucose in urine. Positive test results were considered as abnormal. Number of participants with positive test results have been summarized.

Outcome measures

Outcome measures
Measure	Part 2: Feladilimab + Tremelimumab n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/ PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with Feladilimab and Tremelimumab as an IV infusion after the RP2D determination.	Part 2: Standard of Care (SOC) In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with a single agent SOC therapy of either paclitaxel (as an IV infusion once weekly at a dose of 80 mg/m\^2), docetaxel (as an IV infusion once every 3 weeks at a dose of 75 mg/m\^2) or cetuximab (at a loading dose of 400 mg/m\^2 followed by 250 mg/m\^2 once weekly) as per the investigator's choice.	Part 1: Feladilimab 8 mg + Tremelimumab 225 mg n=5 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 80 mg + Tremelimumab 75 mg n=3 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 80 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 24 mg + Tremelimumab 225 mg n=16 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.
Number of Participants With Abnormal Urinalysis Parameters-Part 1 Dip stick test for Glucose	0 Participants	—	1 Participants	0 Participants	2 Participants
Number of Participants With Abnormal Urinalysis Parameters-Part 1 Dip stick test for Protein	0 Participants	—	1 Participants	0 Participants	6 Participants
Number of Participants With Abnormal Urinalysis Parameters-Part 1 Dip stick test for Occult Blood	1 Participants	—	2 Participants	1 Participants	5 Participants
Number of Participants With Abnormal Urinalysis Parameters-Part 1 Dip stick test for Ketones	0 Participants	—	4 Participants	0 Participants	3 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) and Week 4

Population: All Treated Population. Only those participants with data available at specified time points were analyzed.

Blood samples were collected to assess change from Baseline in TSH.

Outcome measures

Outcome measures
Measure	Part 2: Feladilimab + Tremelimumab n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/ PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with Feladilimab and Tremelimumab as an IV infusion after the RP2D determination.	Part 2: Standard of Care (SOC) n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with a single agent SOC therapy of either paclitaxel (as an IV infusion once weekly at a dose of 80 mg/m\^2), docetaxel (as an IV infusion once every 3 weeks at a dose of 75 mg/m\^2) or cetuximab (at a loading dose of 400 mg/m\^2 followed by 250 mg/m\^2 once weekly) as per the investigator's choice.	Part 1: Feladilimab 8 mg + Tremelimumab 225 mg n=5 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 80 mg + Tremelimumab 75 mg n=3 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 80 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 24 mg + Tremelimumab 225 mg n=16 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.
Change From Baseline in Thyroid Stimulating Hormone (TSH) or Thyrotropin-Part 1 Baseline (Day 1)	0.79 milliUnits/Liter	1.22 milliUnits/Liter	1.856 milliUnits/Liter Standard Deviation 1.6061	1.463 milliUnits/Liter Standard Deviation 1.2079	2.211 milliUnits/Liter Standard Deviation 1.7527
Change From Baseline in Thyroid Stimulating Hormone (TSH) or Thyrotropin-Part 1 Week 4	—	—	—	-0.87 milliUnits/Liter	—

PRIMARY outcome

Timeframe: Baseline (Day 1) and Week 4

Population: All Treated Population. Only those participants with data available at specified time points were analyzed.

Blood samples were collected to assess change from Baseline in free T3.

Outcome measures

Outcome measures
Measure	Part 2: Feladilimab + Tremelimumab n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/ PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with Feladilimab and Tremelimumab as an IV infusion after the RP2D determination.	Part 2: Standard of Care (SOC) n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with a single agent SOC therapy of either paclitaxel (as an IV infusion once weekly at a dose of 80 mg/m\^2), docetaxel (as an IV infusion once every 3 weeks at a dose of 75 mg/m\^2) or cetuximab (at a loading dose of 400 mg/m\^2 followed by 250 mg/m\^2 once weekly) as per the investigator's choice.	Part 1: Feladilimab 8 mg + Tremelimumab 225 mg n=5 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 80 mg + Tremelimumab 75 mg n=3 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 80 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 24 mg + Tremelimumab 225 mg n=16 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.
Change From Baseline in Free Triiodothyronine (T3)-Part 1 Baseline (Day 1)	3.5 Picomoles per liter	3.6 Picomoles per liter	2.75 Picomoles per liter Standard Deviation 0.212	4.47 Picomoles per liter	3.88 Picomoles per liter Standard Deviation 0.665

PRIMARY outcome

Timeframe: Baseline (Day 1) and Week 4

Population: All Treated Population. Only those participants with data available at specified time points were analyzed.

Blood samples were collected to assess change from baseline in free T4.

Outcome measures

Outcome measures
Measure	Part 2: Feladilimab + Tremelimumab n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/ PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with Feladilimab and Tremelimumab as an IV infusion after the RP2D determination.	Part 2: Standard of Care (SOC) n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with a single agent SOC therapy of either paclitaxel (as an IV infusion once weekly at a dose of 80 mg/m\^2), docetaxel (as an IV infusion once every 3 weeks at a dose of 75 mg/m\^2) or cetuximab (at a loading dose of 400 mg/m\^2 followed by 250 mg/m\^2 once weekly) as per the investigator's choice.	Part 1: Feladilimab 8 mg + Tremelimumab 225 mg n=5 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 80 mg + Tremelimumab 75 mg n=3 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 80 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 24 mg + Tremelimumab 225 mg n=16 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.
Change From Baseline in Free Thyroxine (T4)-Part 1 Baseline (Day 1)	10 Picomoles per liter	11 Picomoles per liter	12.43 Picomoles per liter Standard Deviation 3.128	13.84 Picomoles per liter Standard Deviation 2.296	15.98 Picomoles per liter Standard Deviation 3.144
Change From Baseline in Free Thyroxine (T4)-Part 1 Week 4	—	—	—	2.57 Picomoles per liter	—

PRIMARY outcome

Timeframe: Up to 4 years

Population: Intent-To-Treat population includes all participants in Part 2 who were planned to be randomized in the trial. Part 1 participants that were dosed at the dose level chosen for expansion in Part 2 were planned to be excluded from the Part 2 ITT. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled.

For participants in Part 2, overall survival is defined as time from the date of randomization to the date of death due to any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 4 years

Population: All Treated Population

Overall response rate is defined as percentage of participants with confirmed complete response (Disappearance of all target lesions. Any pathological lymph nodes \[whether target or non-target\] must have reduction in short axis to \<10 millimeter \[mm\]) or partial response (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) at any time as per response evaluation criteria in solid tumors (RECIST) version 1.1.

Outcome measures

Outcome measures
Measure	Part 2: Feladilimab + Tremelimumab n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/ PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with Feladilimab and Tremelimumab as an IV infusion after the RP2D determination.	Part 2: Standard of Care (SOC) n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with a single agent SOC therapy of either paclitaxel (as an IV infusion once weekly at a dose of 80 mg/m\^2), docetaxel (as an IV infusion once every 3 weeks at a dose of 75 mg/m\^2) or cetuximab (at a loading dose of 400 mg/m\^2 followed by 250 mg/m\^2 once weekly) as per the investigator's choice.	Part 1: Feladilimab 8 mg + Tremelimumab 225 mg n=5 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 80 mg + Tremelimumab 75 mg n=3 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 80 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 24 mg + Tremelimumab 225 mg n=16 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.
Overall Response Rate-Part 1	0 Percentage of Participants Interval 0.0 to 97.5	0 Percentage of Participants Interval 0.0 to 97.5	0 Percentage of Participants Interval 0.0 to 52.2	0 Percentage of Participants Interval 0.0 to 70.8	6.3 Percentage of Participants Interval 0.2 to 30.2

SECONDARY outcome

Timeframe: Up to 4 years

Population: Intent-To-Treat Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled.

Overall response rate is defined as percentage of participants with confirmed complete response (Disappearance of all target lesions. Any pathological lymph nodes \[whether target or non-target\] must have reduction in short axis to \<10 mm) or partial response (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) at any time as per RECIST version 1.1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 4 years

Population: All Treated Population

Disease control rate is defined as percentage of subjects with confirmed complete response (Disappearance of all target lesions. Any pathological lymph nodes \[whether target or non-target\] must have reduction in short axis to \<10 mm) or partial response (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) or at least 18 weeks of stable disease (Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD) as per RECIST version 1.1.

Outcome measures

Outcome measures
Measure	Part 2: Feladilimab + Tremelimumab n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/ PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with Feladilimab and Tremelimumab as an IV infusion after the RP2D determination.	Part 2: Standard of Care (SOC) n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with a single agent SOC therapy of either paclitaxel (as an IV infusion once weekly at a dose of 80 mg/m\^2), docetaxel (as an IV infusion once every 3 weeks at a dose of 75 mg/m\^2) or cetuximab (at a loading dose of 400 mg/m\^2 followed by 250 mg/m\^2 once weekly) as per the investigator's choice.	Part 1: Feladilimab 8 mg + Tremelimumab 225 mg n=5 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 80 mg + Tremelimumab 75 mg n=3 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 80 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 24 mg + Tremelimumab 225 mg n=16 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.
Disease Control Rate-Part 1	0 Percentage of Participants Interval 0.0 to 97.5	0 Percentage of Participants Interval 0.0 to 97.5	0 Percentage of Participants Interval 0.0 to 52.2	33.3 Percentage of Participants Interval 0.8 to 90.6	12.5 Percentage of Participants Interval 1.6 to 38.3

SECONDARY outcome

Timeframe: Up to 4 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 4 years

For Part 2, progression free survival duration is defined as the time from the date of randomization to first documented evidence of disease progression (At least a 20% increase in the sum of diameters of target lesions and In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm) or death (regardless of cause of death), whichever comes first as per RECIST version 1.1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 4 years

Time to response is defined as the time from the first dose to the first documented evidence of complete response (Disappearance of all target lesions. Any pathological lymph nodes \[whether target or non-target\] must have reduction in short axis to \<10 mm) or partial response (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) for participants with a confirmed CR or PR as per RECIST version 1.1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 4 years

Duration of response is defined as time from the first documented evidence of response until the first documented sign of disease progression or death among participants who achieve a response (CR \[Disappearance of all target lesions. Any pathological lymph nodes {whether target or non-target} must have reduction in short axis to \<10 mm or PR \[At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters\] as per RECIST version 1.1).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose, end of infusion and 4 hours post dose at Day 1

Population: Pharmacokinetic (PK) Population includes all participants from the All Treated population for whom at least one PK sample was obtained, analysed and measurable.

Blood samples were collected at indicated time points for pharmacokinetic assessment.

Outcome measures

Outcome measures
Measure	Part 2: Feladilimab + Tremelimumab n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/ PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with Feladilimab and Tremelimumab as an IV infusion after the RP2D determination.	Part 2: Standard of Care (SOC) n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with a single agent SOC therapy of either paclitaxel (as an IV infusion once weekly at a dose of 80 mg/m\^2), docetaxel (as an IV infusion once every 3 weeks at a dose of 75 mg/m\^2) or cetuximab (at a loading dose of 400 mg/m\^2 followed by 250 mg/m\^2 once weekly) as per the investigator's choice.	Part 1: Feladilimab 8 mg + Tremelimumab 225 mg n=5 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 80 mg + Tremelimumab 75 mg n=3 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 80 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 24 mg + Tremelimumab 225 mg n=16 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.
Maximum Observed Plasma Concentration (Cmax) of Feladilimab-Part 1	2758 nanograms/milliliter	5965 nanograms/milliliter	2686.6 nanograms/milliliter Geometric Coefficient of Variation 25.7	28340.9 nanograms/milliliter Geometric Coefficient of Variation 12.3	6098.3 nanograms/milliliter Geometric Coefficient of Variation 25.3

SECONDARY outcome

Timeframe: Pre-dose, end of infusion and 4 hours post dose at Day 1

Population: Pharmacokinetic Population. Only those participants with data available at specified time points were analyzed.

Blood samples were collected at indicated time points for pharmacokinetic assessment.

Outcome measures

Outcome measures
Measure	Part 2: Feladilimab + Tremelimumab n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/ PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with Feladilimab and Tremelimumab as an IV infusion after the RP2D determination.	Part 2: Standard of Care (SOC) n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with a single agent SOC therapy of either paclitaxel (as an IV infusion once weekly at a dose of 80 mg/m\^2), docetaxel (as an IV infusion once every 3 weeks at a dose of 75 mg/m\^2) or cetuximab (at a loading dose of 400 mg/m\^2 followed by 250 mg/m\^2 once weekly) as per the investigator's choice.	Part 1: Feladilimab 8 mg + Tremelimumab 225 mg n=5 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 80 mg + Tremelimumab 75 mg In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 80 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 24 mg + Tremelimumab 225 mg n=16 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.
Cmax of Tremelimumab-Part 1	0 nanograms/milliliter	0 nanograms/milliliter	112312.1 nanograms/milliliter Geometric Coefficient of Variation 8.2	—	93206.7 nanograms/milliliter Geometric Coefficient of Variation 24.8

SECONDARY outcome

Timeframe: Pre-dose at Weeks 1, 2, 4, 7, 10, 13, 16, 19, 25, then every 12 weeks for 2 years; end of infusion at Weeks 1, 19 and 25; and 4 hours post-infusion at Week 1

Population: Pharmacokinetic Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled.

Blood samples were planned to be collected at indicated time points for pharmacokinetic assessment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose at Weeks 1, 2, 4, 7, 10, 13, 16, 19, 25, then every 12 weeks for 2 years; end of infusion at Weeks 1, 19 and 25; and 4 hours post-infusion at Week 1

Blood samples were planned to be collected at indicated time points for pharmacokinetic assessment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose, end of infusion and 4 hours post dose at Day 1

Population: Pharmacokinetic Population. Only those participants with data available at specified time points were analyzed.

Blood samples were collected at indicated time points for pharmacokinetic assessment.

Outcome measures

Outcome measures
Measure	Part 2: Feladilimab + Tremelimumab n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/ PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with Feladilimab and Tremelimumab as an IV infusion after the RP2D determination.	Part 2: Standard of Care (SOC) In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with a single agent SOC therapy of either paclitaxel (as an IV infusion once weekly at a dose of 80 mg/m\^2), docetaxel (as an IV infusion once every 3 weeks at a dose of 75 mg/m\^2) or cetuximab (at a loading dose of 400 mg/m\^2 followed by 250 mg/m\^2 once weekly) as per the investigator's choice.	Part 1: Feladilimab 8 mg + Tremelimumab 225 mg n=5 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 80 mg + Tremelimumab 75 mg n=3 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 80 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 24 mg + Tremelimumab 225 mg n=16 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.
Minimum Observed Plasma Concentration (Cmin) of Feladilimab-Part 1	462 nanograms/ milliliter	—	348 nanograms/ milliliter Geometric Coefficient of Variation 14.2	3197 nanograms/ milliliter Geometric Coefficient of Variation 31	856.4 nanograms/ milliliter Geometric Coefficient of Variation 35.9

SECONDARY outcome

Timeframe: Pre-dose, end of infusion and 4 hours post dose at Day 1

Population: Pharmacokinetic Population. Only those participants with data available at specified time points were analyzed.

Blood samples were collected at indicated time points for pharmacokinetic assessment.

Outcome measures

Outcome measures
Measure	Part 2: Feladilimab + Tremelimumab n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/ PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with Feladilimab and Tremelimumab as an IV infusion after the RP2D determination.	Part 2: Standard of Care (SOC) In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with a single agent SOC therapy of either paclitaxel (as an IV infusion once weekly at a dose of 80 mg/m\^2), docetaxel (as an IV infusion once every 3 weeks at a dose of 75 mg/m\^2) or cetuximab (at a loading dose of 400 mg/m\^2 followed by 250 mg/m\^2 once weekly) as per the investigator's choice.	Part 1: Feladilimab 8 mg + Tremelimumab 225 mg n=5 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 80 mg + Tremelimumab 75 mg n=3 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 80 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 24 mg + Tremelimumab 225 mg n=16 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.
Cmin of Tremelimumab-Part 1	6467 nanograms/ milliliter	—	22466.3 nanograms/ milliliter Geometric Coefficient of Variation 58.4	5715.6 nanograms/ milliliter Geometric Coefficient of Variation 43.9	15084.9 nanograms/ milliliter Geometric Coefficient of Variation 48.4

SECONDARY outcome

Timeframe: Pre-dose at Weeks 1, 2, 4, 7, 10, 13, 16, then every 12 weeks for 2 years; end of infusion; and 4 hours post-infusion at Week 1

Blood samples were planned to be collected at indicated time points for pharmacokinetic assessment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose at Weeks 1, 2, 4, 7, 10, 13, 16, then every 12 weeks for 2 years; end of infusion; and 4 hours post-infusion at Week 1

Blood samples were planned to be collected at indicated time points for pharmacokinetic assessment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose, end of infusion and 4 hours post dose at Day 1

Population: Pharmacokinetic Population. Only those participants with data available at specified time points has been analyzed.

Blood samples were collected at indicated time points for pharmacokinetic assessment.

Outcome measures

Outcome measures
Measure	Part 2: Feladilimab + Tremelimumab n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/ PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with Feladilimab and Tremelimumab as an IV infusion after the RP2D determination.	Part 2: Standard of Care (SOC) In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with a single agent SOC therapy of either paclitaxel (as an IV infusion once weekly at a dose of 80 mg/m\^2), docetaxel (as an IV infusion once every 3 weeks at a dose of 75 mg/m\^2) or cetuximab (at a loading dose of 400 mg/m\^2 followed by 250 mg/m\^2 once weekly) as per the investigator's choice.	Part 1: Feladilimab 8 mg + Tremelimumab 225 mg n=5 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 80 mg + Tremelimumab 75 mg n=3 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 80 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 24 mg + Tremelimumab 225 mg n=16 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.
Area Under the Plasma Concentration-time Curve (AUC[0-t]) of Feladilimab-Part 1	545097.4 nanograms*hours/milliLiter	—	453561.5 nanograms*hours/milliLiter Geometric Coefficient of Variation 11.7	4552653.1 nanograms*hours/milliLiter Geometric Coefficient of Variation 18.5	1055659.5 nanograms*hours/milliLiter Geometric Coefficient of Variation 23.5

SECONDARY outcome

Timeframe: Pre-dose, end of infusion and 4 hours post dose at Day 1

Population: Pharmacokinetic Population. Only those participants with data available at specified time points has been analyzed.

Blood samples were collected at indicated time points for pharmacokinetic assessment.

Outcome measures

Outcome measures
Measure	Part 2: Feladilimab + Tremelimumab In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/ PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with Feladilimab and Tremelimumab as an IV infusion after the RP2D determination.	Part 2: Standard of Care (SOC) In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with a single agent SOC therapy of either paclitaxel (as an IV infusion once weekly at a dose of 80 mg/m\^2), docetaxel (as an IV infusion once every 3 weeks at a dose of 75 mg/m\^2) or cetuximab (at a loading dose of 400 mg/m\^2 followed by 250 mg/m\^2 once weekly) as per the investigator's choice.	Part 1: Feladilimab 8 mg + Tremelimumab 225 mg In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 80 mg + Tremelimumab 75 mg In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 80 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 24 mg + Tremelimumab 225 mg n=9 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.
AUC(0-t) of Tremelimumab-Part 1	—	—	—	—	18160725.7 nanograms*hours/milliLiter Geometric Coefficient of Variation 23.4

SECONDARY outcome

Timeframe: Pre-dose at Weeks 1, 2, 4, 7, 10, 13, 16, 19, 25, then every 12 weeks for 2 years; end of infusion at Weeks 1, 19 and 25, and 4 hours post-infusion at Week 1

Blood samples were planned to be collected at indicated time points for pharmacokinetic assessment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose at Weeks 1, 2, 4, 7, 10, 13, 16, then every 12 weeks for 2 years; end of infusion; and 4 hours post-infusion at Week 1

Blood samples were planned to be collected at indicated time points for pharmacokinetic assessment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose at Week 4, 7, 10 and 13

Population: All Treated population. Only those participants with data available at specified time points has been analyzed. Number of participants analyzed refers to the analysis population. Number analyzed at each time point refers to the participants for whom screening assays were conducted.

Serum samples were collected and tested for the presence of antibodies to feladilimab.

Outcome measures

Outcome measures
Measure	Part 2: Feladilimab + Tremelimumab n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/ PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with Feladilimab and Tremelimumab as an IV infusion after the RP2D determination.	Part 2: Standard of Care (SOC) n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with a single agent SOC therapy of either paclitaxel (as an IV infusion once weekly at a dose of 80 mg/m\^2), docetaxel (as an IV infusion once every 3 weeks at a dose of 75 mg/m\^2) or cetuximab (at a loading dose of 400 mg/m\^2 followed by 250 mg/m\^2 once weekly) as per the investigator's choice.	Part 1: Feladilimab 8 mg + Tremelimumab 225 mg n=5 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 80 mg + Tremelimumab 75 mg n=3 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 80 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 24 mg + Tremelimumab 225 mg n=16 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.
Number of Participants With Anti-drug Antibodies Against Feladilimab-Part 1 Week 4	0 Participants	0 Participants	1 Participants	0 Participants	5 Participants
Number of Participants With Anti-drug Antibodies Against Feladilimab-Part 1 Week 7	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants
Number of Participants With Anti-drug Antibodies Against Feladilimab-Part 1 Week 10	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Anti-drug Antibodies Against Feladilimab-Part 1 Week 13	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Pre-dose at Week 1, 4, 7, 10 and 13

Serum samples were collected and tested for the presence of antibodies to tremelimumab.

Outcome measures

Outcome measures
Measure	Part 2: Feladilimab + Tremelimumab n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/ PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with Feladilimab and Tremelimumab as an IV infusion after the RP2D determination.	Part 2: Standard of Care (SOC) n=1 Participants In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with a single agent SOC therapy of either paclitaxel (as an IV infusion once weekly at a dose of 80 mg/m\^2), docetaxel (as an IV infusion once every 3 weeks at a dose of 75 mg/m\^2) or cetuximab (at a loading dose of 400 mg/m\^2 followed by 250 mg/m\^2 once weekly) as per the investigator's choice.	Part 1: Feladilimab 8 mg + Tremelimumab 225 mg n=5 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 80 mg + Tremelimumab 75 mg n=3 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 80 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 24 mg + Tremelimumab 225 mg n=16 Participants In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.
Number of Participants With Anti-drug Antibodies Against Tremelimumab-Part 1 Week 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Anti-drug Antibodies Against Tremelimumab-Part 1 Week 4	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants
Number of Participants With Anti-drug Antibodies Against Tremelimumab-Part 1 Week 7	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Anti-drug Antibodies Against Tremelimumab-Part 1 Week 10	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Anti-drug Antibodies Against Tremelimumab-Part 1 Week 13	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 2.5 years

Population: ITT Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled.

Serum samples will be collected and tested for the presence of antibodies to feladilimab.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to 2 years

Population: All Treated Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled.

Blood samples will be collected to assess change from baseline in free T4.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2.5 years

Serum samples will be collected and tested for the presence of antibodies to tremelimumab.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 4 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 4 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 4 years

The number of participants with severe- AE/SAE/DLTs leading to dose modifications/delays/withdrawals were planned to be summarized.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to 2 years

SBP and DBP will be measured after 5 minutes of rest for the participant.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to 2 years

Temperature will be measured after 5 minutes of rest for the participant.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to 2 years

Pulse rate will be measured after 5 minutes of rest for the participant.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to 2 years

Respiratory rate will be measured after 5 minutes of rest for the participant.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to 2 years

Oxygen saturation will be measured using pulse oximetry after 5 minutes of rest for the participant.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (Pre-dose) up to 2 years

Single 12-lead ECG will be obtained using an automated ECG machine.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to 2 years

Blood samples will be collected to assess change from baseline in neutrophil, lymphocyte, monocyte, eosinophil, basophil and platelet count.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to 2 years

Blood samples will be collected to assess change from baseline in hemoglobin level.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to 2 years

Blood samples will be collected to assess change from baseline in hematocrit level.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to 2 years

Blood samples will be collected to assess change from Baseline in erythrocytes count.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to 2 years

Blood samples will be collected to assess change from baseline in albumin and total protein levels.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to 2 years

Blood samples will be collected to assess change from baseline in creatinine and bilirubin levels.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to 2 years

Blood samples will be collected to assess change from baseline in ALT, AST ALP, LDH, amylase and lipase levels.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to 2 years

Blood samples were collected to assess change from baseline in amylase and lipase levels.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to 2 years

Blood samples will be collected to assess change in levels of urea, glucose, potassium, sodium and calcium from baseline.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to 2 years

Urine samples will be collected to assess change from Baseline in specific gravity of urine.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to 2 years

Urine samples will be collected to assess change from baseline in pH of urine.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

The dipstick test gives positive or negative results for protein, ketones, occult blood and glucose. Positive test results were considered as abnormal. Number of participants with positive test results were planned to be summarized.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to 2 years

Blood samples will be collected to assess change from Baseline in TSH.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to 2 years

Blood samples will be collected to assess change from baseline in free T3.

Outcome measures

Outcome data not reported

Adverse Events

Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 1: Feladilimab 24 mg + Tremelimumab 75 mg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 1: Feladilimab 8 mg + Tremelimumab 225 mg

Serious events: 3 serious events

Other events: 5 other events

Deaths: 0 deaths

Part 1: Feladilimab 80 mg + Tremelimumab 75 mg

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 1: Feladilimab 24 mg + Tremelimumab 225 mg

Serious events: 6 serious events

Other events: 16 other events

Deaths: 1 deaths

Part 2: Feladilimab + Tremelimumab

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part 2: Standard of Care (SOC)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg n=1 participants at risk In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 24 mg + Tremelimumab 75 mg n=1 participants at risk In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 8 mg + Tremelimumab 225 mg n=5 participants at risk In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 80 mg + Tremelimumab 75 mg n=3 participants at risk In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 80 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 24 mg + Tremelimumab 225 mg n=16 participants at risk In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 2: Feladilimab + Tremelimumab In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/ PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with Feladilimab and Tremelimumab as an IV infusion after the RP2D determination.	Part 2: Standard of Care (SOC) In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with a single agent SOC therapy of either paclitaxel (as an IV infusion once weekly at a dose of 80 mg/m\^2), docetaxel (as an IV infusion once every 3 weeks at a dose of 75 mg/m\^2) or cetuximab (at a loading dose of 400 mg/m\^2 followed by 250 mg/m\^2 once weekly) as per the investigator's choice.
Cardiac disorders Cardiac tamponade	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	20.0% 1/5 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Gastrointestinal disorders Colitis	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Gastrointestinal disorders Diarrhoea	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
General disorders Death	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Infections and infestations Abscess neck	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Infections and infestations Bacteraemia	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	20.0% 1/5 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Infections and infestations Pneumonia	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	33.3% 1/3 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Investigations Blood creatinine increased	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Metabolism and nutrition disorders Dehydration	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	20.0% 1/5 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	33.3% 1/3 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pericardial effusion malignant	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	20.0% 1/5 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Nervous system disorders Hydrocephalus	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Renal and urinary disorders Acute kidney injury	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Renal and urinary disorders Chronic kidney disease	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	20.0% 1/5 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	33.3% 1/3 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Vascular disorders Embolism	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	20.0% 1/5 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	33.3% 1/3 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Vascular disorders Hypotension	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.

Other adverse events

Other adverse events
Measure	Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg n=1 participants at risk In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 24 mg + Tremelimumab 75 mg n=1 participants at risk In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 8 mg + Tremelimumab 225 mg n=5 participants at risk In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 80 mg + Tremelimumab 75 mg n=3 participants at risk In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 80 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 1: Feladilimab 24 mg + Tremelimumab 225 mg n=16 participants at risk In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W.	Part 2: Feladilimab + Tremelimumab In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/ PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with Feladilimab and Tremelimumab as an IV infusion after the RP2D determination.	Part 2: Standard of Care (SOC) In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with a single agent SOC therapy of either paclitaxel (as an IV infusion once weekly at a dose of 80 mg/m\^2), docetaxel (as an IV infusion once every 3 weeks at a dose of 75 mg/m\^2) or cetuximab (at a loading dose of 400 mg/m\^2 followed by 250 mg/m\^2 once weekly) as per the investigator's choice.
Blood and lymphatic system disorders Anaemia	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	40.0% 2/5 • Number of events 3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	33.3% 1/3 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	31.2% 5/16 • Number of events 5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Cardiac disorders Atrial flutter	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Cardiac disorders Sinus bradycardia	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	20.0% 1/5 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Cardiac disorders Sinus tachycardia	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	20.0% 1/5 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Cardiac disorders Tachycardia	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	12.5% 2/16 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Endocrine disorders Hypothyroidism	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Eye disorders Conjunctival haemorrhage	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Eye disorders Visual impairment	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Gastrointestinal disorders Abdominal distension	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Gastrointestinal disorders Abdominal pain	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	25.0% 4/16 • Number of events 4 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Gastrointestinal disorders Colitis	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	20.0% 1/5 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Gastrointestinal disorders Constipation	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	20.0% 1/5 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	33.3% 1/3 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	18.8% 3/16 • Number of events 3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Gastrointestinal disorders Diarrhoea	100.0% 1/1 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	20.0% 1/5 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	50.0% 8/16 • Number of events 11 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Gastrointestinal disorders Dyspepsia	100.0% 1/1 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	20.0% 1/5 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Gastrointestinal disorders Flatulence	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	12.5% 2/16 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Gastrointestinal disorders Haemorrhoids	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Gastrointestinal disorders Hyperchlorhydria	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	12.5% 2/16 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Gastrointestinal disorders Ileus	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Gastrointestinal disorders Nausea	100.0% 1/1 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	20.0% 1/5 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	33.3% 1/3 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	37.5% 6/16 • Number of events 7 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Gastrointestinal disorders Oesophagitis	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Gastrointestinal disorders Salivary duct inflammation	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Gastrointestinal disorders Stomatitis	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	20.0% 1/5 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Gastrointestinal disorders Swollen tongue	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Gastrointestinal disorders Vomiting	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	20.0% 1/5 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	25.0% 4/16 • Number of events 7 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
General disorders Asthenia	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
General disorders Chest pain	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	33.3% 1/3 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
General disorders Chills	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	20.0% 1/5 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
General disorders Fatigue	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	20.0% 1/5 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	33.3% 1/3 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	62.5% 10/16 • Number of events 10 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
General disorders Malaise	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
General disorders Non-cardiac chest pain	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	33.3% 1/3 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
General disorders Oedema peripheral	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	20.0% 1/5 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	18.8% 3/16 • Number of events 3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
General disorders Pain	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
General disorders Physical deconditioning	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
General disorders Pyrexia	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	20.0% 1/5 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Hepatobiliary disorders Hepatitis	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	20.0% 1/5 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Infections and infestations Bacterial infection	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	20.0% 1/5 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Infections and infestations Bronchitis	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Infections and infestations Catheter site infection	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Infections and infestations Eye infection	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	12.5% 2/16 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Infections and infestations Fungal infection	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	12.5% 2/16 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Infections and infestations Infection	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Infections and infestations Oesophageal candidiasis	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Infections and infestations Oral candidiasis	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Infections and infestations Oral herpes	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Infections and infestations Pyelonephritis	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Infections and infestations Rash pustular	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Infections and infestations Sinusitis	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	33.3% 1/3 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Infections and infestations Urinary tract infection	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	12.5% 2/16 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Investigations Alanine aminotransferase increased	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	20.0% 1/5 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	12.5% 2/16 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Investigations Aspartate aminotransferase increased	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	18.8% 3/16 • Number of events 4 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Investigations Blood alkaline phosphatase increased	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	20.0% 1/5 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	33.3% 1/3 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	12.5% 2/16 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Investigations Blood creatinine increased	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	20.0% 1/5 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	33.3% 1/3 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Investigations Blood lactate dehydrogenase increased	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	20.0% 1/5 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Investigations Blood thyroid stimulating hormone increased	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Investigations International normalised ratio increased	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Investigations Lymphocyte count decreased	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	20.0% 1/5 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Investigations Platelet count decreased	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	33.3% 1/3 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Investigations Weight decreased	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	20.0% 1/5 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Metabolism and nutrition disorders Acidosis	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	20.0% 1/5 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	33.3% 1/3 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	37.5% 6/16 • Number of events 7 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Metabolism and nutrition disorders Dehydration	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	20.0% 1/5 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	33.3% 1/3 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	20.0% 1/5 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	33.3% 1/3 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	20.0% 1/5 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	33.3% 1/3 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	31.2% 5/16 • Number of events 5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	12.5% 2/16 • Number of events 3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	20.0% 1/5 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	33.3% 1/3 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	25.0% 4/16 • Number of events 4 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	20.0% 1/5 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	20.0% 1/5 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	100.0% 1/1 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Nervous system disorders Dizziness	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	18.8% 3/16 • Number of events 3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Nervous system disorders Dysgeusia	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	20.0% 1/5 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Nervous system disorders Headache	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Nervous system disorders Neuralgia	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	33.3% 1/3 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Nervous system disorders Syncope	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Psychiatric disorders Delirium	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Psychiatric disorders Insomnia	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	12.5% 2/16 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Psychiatric disorders Restlessness	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Renal and urinary disorders Acute kidney injury	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Renal and urinary disorders Chronic kidney disease	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Reproductive system and breast disorders Pelvic pain	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	33.3% 1/3 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	20.0% 1/5 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	12.5% 2/16 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	40.0% 2/5 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	66.7% 2/3 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	12.5% 2/16 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	100.0% 1/1 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	20.0% 1/5 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	100.0% 1/1 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	20.0% 1/5 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	20.0% 1/5 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	20.0% 1/5 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	20.0% 1/5 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	12.5% 2/16 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Skin and subcutaneous tissue disorders Rash	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Skin and subcutaneous tissue disorders Skin irritation	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	33.3% 1/3 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Skin and subcutaneous tissue disorders Vitiligo	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Vascular disorders Embolism	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	6.2% 1/16 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Vascular disorders Haematoma	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/5 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	33.3% 1/3 • Number of events 1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
Vascular disorders Hypertension	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/1 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	20.0% 1/5 • Number of events 2 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/3 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	0.00% 0/16 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.	— 0/0 • Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
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