Trial Outcomes & Findings for A Study of Etigilimab and Nivolumab in Participants With Locally Advanced or Metastatic Tumors (NCT NCT04761198)

Last Updated: 2025-03-17

Results Overview

The ORR was defined as the percentage of participants who achieved a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) per RECIST v1.1. CR: Disappearance of all target or non-target lesions and normalization of tumor marker level. Any pathological lymph node (whether target or non-target) must have reduction in short axis to \<10 millimeters (mm). PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

76 participants

Primary outcome timeframe

From first dose of study drug until the date of first objective response (CR or PR) (maximum exposure: 638 days)

Results posted on

2025-03-17

Participant Flow

Cohort D (Recurrent advanced and/or metastatic gastric or gastroesophageal junction adenocarcinoma) did not enroll any participants due to closure of the cohort by the Sponsor.

Participant milestones

Participant milestones
Measure	Cohort A: Endometrial Cancer CPI (PD-1/PD-L1) Naive Participants with endometrial cancer checkpoint inhibitors (CPI) (programmed death-1 \[PD-1\]/ programmed death ligand-1 \[PD-L1\]) naive received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort B: Head and Neck Squamous Cell Carcinoma Participants with head and neck cell carcinoma received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort C: Cervical Carcinoma Participants with cervical carcinoma received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort E: TMB-H + MSS Solid Tumors Participants with tumour mutational burden-high (TMB-H) and microsatellite stable (MSS) solid tumors received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort F: Rare Tumors (Sarcoma, Uveal Melanoma, Germ Cell) Participants with rare tumors (sarcoma, uveal melanoma, and germ cell) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort G: Endometrial Cancer Post- CPI (PD-1/PD-L1 Treated) Participants with endometrial cancer (PD-1/PD-L1 treated) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort H: Ovarian Cancer Participants with ovarian cancer received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
Overall Study STARTED	11	1	8	9	33	4	10
Overall Study Received at Least 1 Dose of Study Drug	11	1	8	9	33	4	10
Overall Study Response-Evaluable (RE) Analysis Set	10	1	8	9	31	3	10
Overall Study COMPLETED	0	0	0	0	1	0	0
Overall Study NOT COMPLETED	11	1	8	9	32	4	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort A: Endometrial Cancer CPI (PD-1/PD-L1) Naive Participants with endometrial cancer checkpoint inhibitors (CPI) (programmed death-1 \[PD-1\]/ programmed death ligand-1 \[PD-L1\]) naive received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort B: Head and Neck Squamous Cell Carcinoma Participants with head and neck cell carcinoma received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort C: Cervical Carcinoma Participants with cervical carcinoma received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort E: TMB-H + MSS Solid Tumors Participants with tumour mutational burden-high (TMB-H) and microsatellite stable (MSS) solid tumors received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort F: Rare Tumors (Sarcoma, Uveal Melanoma, Germ Cell) Participants with rare tumors (sarcoma, uveal melanoma, and germ cell) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort G: Endometrial Cancer Post- CPI (PD-1/PD-L1 Treated) Participants with endometrial cancer (PD-1/PD-L1 treated) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort H: Ovarian Cancer Participants with ovarian cancer received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
Overall Study Progressive Disease	1	0	0	1	4	1	2
Overall Study Protocol Violation	0	0	0	0	1	0	0
Overall Study Death	2	1	2	5	14	2	5
Overall Study Lost to Follow-up	0	0	0	0	1	0	0
Overall Study Withdrawal by Subject	2	0	1	0	2	0	1
Overall Study Study Terminated by Sponsor	6	0	5	3	10	1	2

Baseline Characteristics

A Study of Etigilimab and Nivolumab in Participants With Locally Advanced or Metastatic Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort A: Endometrial Cancer CPI (PD-1/PD-L1) Naive n=11 Participants Participants with endometrial cancer CPI (PD-1/PD-L1) naive received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort B: Head and Neck Squamous Cell Carcinoma n=1 Participants Participants with head and neck cell carcinoma received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort C: Cervical Carcinoma n=8 Participants Participants with cervical carcinoma received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort E: TMB-H + MSS Solid Tumors n=9 Participants Participants with TMB-H and MSS solid tumors received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort F: Rare Tumors (Sarcoma, Uveal Melanoma, Germ Cell) n=33 Participants Participants with rare tumors (sarcoma, uveal melanoma, and germ cell) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort G: Endometrial Cancer Post- CPI (PD-1/PD-L1 Treated) n=4 Participants Participants with endometrial cancer (PD-1/PD-L1 treated) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort H: Ovarian Cancer n=10 Participants Participants with ovarian cancer received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Total n=76 Participants Total of all reporting groups
Age, Continuous	65.7 years STANDARD_DEVIATION 10.20 • n=5 Participants	69.0 years n=7 Participants	49.1 years STANDARD_DEVIATION 13.53 • n=5 Participants	62.0 years STANDARD_DEVIATION 10.14 • n=4 Participants	55.8 years STANDARD_DEVIATION 13.90 • n=21 Participants	65.3 years STANDARD_DEVIATION 11.79 • n=8 Participants	68.1 years STANDARD_DEVIATION 11.43 • n=8 Participants	59.5 years STANDARD_DEVIATION 13.51 • n=24 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	0 Participants n=7 Participants	8 Participants n=5 Participants	4 Participants n=4 Participants	10 Participants n=21 Participants	4 Participants n=8 Participants	10 Participants n=8 Participants	47 Participants n=24 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants	23 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	29 Participants n=24 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	5 Participants n=24 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	1 Participants n=7 Participants	8 Participants n=5 Participants	8 Participants n=4 Participants	30 Participants n=21 Participants	4 Participants n=8 Participants	10 Participants n=8 Participants	71 Participants n=24 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants	0 Participants n=8 Participants	2 Participants n=24 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	3 Participants n=24 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	1 Participants n=7 Participants	8 Participants n=5 Participants	9 Participants n=4 Participants	31 Participants n=21 Participants	2 Participants n=8 Participants	8 Participants n=8 Participants	69 Participants n=24 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	2 Participants n=8 Participants	2 Participants n=24 Participants

PRIMARY outcome

Timeframe: From first dose of study drug until the date of first objective response (CR or PR) (maximum exposure: 638 days)

Population: RE Analysis Set included all participants with measurable disease at baseline who received study drug and had at least 1 post-baseline response assessment or discontinued treatment due to disease progression (including death due to disease progression) within 16 weeks (+ a 2-week window) of the first dose of study drug. Per planned analysis, the efficacy data for Cohort F were collected and analyzed separately per tumor type.

Outcome measures

Outcome measures
Measure	Cohort A: Endometrial Cancer CPI (PD-1/PD-L1) Naive n=10 Participants Participants with endometrial cancer CPI (PD-1/PD-L1) naive received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort B: Head and Neck Squamous Cell Carcinoma n=1 Participants Participants with head and neck cell carcinoma received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort C: Cervical Carcinoma n=8 Participants Participants with cervical carcinoma received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort E: TMB-H + MSS Solid Tumors n=9 Participants Participants with TMB-H and MSS solid tumors received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort F: Rare Tumors (Uveal) n=8 Participants Participants with rare tumors (uveal) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort F: Rare Tumors (De-diff LPS) n=10 Participants Participants with rare tumors (de-differentiated liposarcoma \[de-diff LPS\]) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort F: Rare Tumors (UPS) n=6 Participants Participants with rare tumors (undifferentiated pleomorphic sarcoma \[UPS\]) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort F: Rare Tumors (Other Sarcoma) n=3 Participants Participants with rare tumors (other sarcoma) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort F: Rare Tumors (GCT) n=4 Participants Participants with rare tumors (germ cell tumours \[GCT\]) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort G: Endometrial Cancer Post- CPI (PD-1/PD-L1 Treated) n=3 Participants Participants with endometrial cancer (PD-1/PD-L1 treated) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort H: Ovarian Cancer n=10 Participants Participants with ovarian cancer received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
Objective Response Rate (ORR) as Assessed Based on Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1)	20.0 percentage of participants Interval 2.52 to 55.61	0 percentage of participants Interval 0.0 to 97.5	37.5 percentage of participants Interval 8.52 to 75.51	0 percentage of participants Interval 0.0 to 33.63	25.0 percentage of participants Interval 3.19 to 65.09	10.0 percentage of participants Interval 0.25 to 44.5	16.7 percentage of participants Interval 0.42 to 64.12	0 percentage of participants Interval 0.0 to 70.76	0 percentage of participants Interval 0.0 to 60.24	0 percentage of participants Interval 0.0 to 70.76	10.0 percentage of participants Interval 0.25 to 44.5

SECONDARY outcome

Timeframe: From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days)

Population: Safety Analysis Set included all participants who received any amount of study drug.

TEAEs were defined as adverse events (AEs) with an onset date on or after the date of first administration of study drug up to 100 days after the last dose of study drug and before starting any subsequent cancer treatment. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AESIs were defined as events (serious or non-serious) which were of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor might be appropriate. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.

Outcome measures

Outcome measures
Measure	Cohort A: Endometrial Cancer CPI (PD-1/PD-L1) Naive n=11 Participants Participants with endometrial cancer CPI (PD-1/PD-L1) naive received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort B: Head and Neck Squamous Cell Carcinoma n=1 Participants Participants with head and neck cell carcinoma received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort C: Cervical Carcinoma n=8 Participants Participants with cervical carcinoma received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort E: TMB-H + MSS Solid Tumors n=9 Participants Participants with TMB-H and MSS solid tumors received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort F: Rare Tumors (Uveal) n=33 Participants Participants with rare tumors (uveal) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort F: Rare Tumors (De-diff LPS) n=4 Participants Participants with rare tumors (de-differentiated liposarcoma \[de-diff LPS\]) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort F: Rare Tumors (UPS) n=10 Participants Participants with rare tumors (undifferentiated pleomorphic sarcoma \[UPS\]) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort F: Rare Tumors (Other Sarcoma) Participants with rare tumors (other sarcoma) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort F: Rare Tumors (GCT) Participants with rare tumors (germ cell tumours \[GCT\]) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort G: Endometrial Cancer Post- CPI (PD-1/PD-L1 Treated) Participants with endometrial cancer (PD-1/PD-L1 treated) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort H: Ovarian Cancer Participants with ovarian cancer received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
Number of Participants WithTreatment-emergent Adverse Events (TEAEs), Any Adverse Events of Special Interests (AESIs), AESI Immune Related AEs, and AESI Infusion Reactions Any TEAEs	11 Participants	1 Participants	8 Participants	8 Participants	33 Participants	4 Participants	9 Participants	—	—	—	—
Number of Participants WithTreatment-emergent Adverse Events (TEAEs), Any Adverse Events of Special Interests (AESIs), AESI Immune Related AEs, and AESI Infusion Reactions Any AESIs	4 Participants	0 Participants	3 Participants	0 Participants	5 Participants	0 Participants	1 Participants	—	—	—	—
Number of Participants WithTreatment-emergent Adverse Events (TEAEs), Any Adverse Events of Special Interests (AESIs), AESI Immune Related AEs, and AESI Infusion Reactions AESI Immune Related AEs	2 Participants	0 Participants	2 Participants	0 Participants	3 Participants	0 Participants	1 Participants	—	—	—	—
Number of Participants WithTreatment-emergent Adverse Events (TEAEs), Any Adverse Events of Special Interests (AESIs), AESI Immune Related AEs, and AESI Infusion Reactions AESI Infusion Reactions	2 Participants	0 Participants	1 Participants	0 Participants	2 Participants	0 Participants	0 Participants	—	—	—	—

SECONDARY outcome

Timeframe: From first dose of study drug until the date of first BOR (CR, PR, or SD) (maximum exposure: 638 days)

The DCR was defined as the percentage of participants who achieved CR, PR, and stable disease (SD). CR: Disappearance of all target or non-target lesions and normalization of tumor marker level. Any pathological lymph node (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. SD: Persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits; and no new lesions.

Outcome measures

Outcome measures
Measure	Cohort A: Endometrial Cancer CPI (PD-1/PD-L1) Naive n=10 Participants Participants with endometrial cancer CPI (PD-1/PD-L1) naive received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort B: Head and Neck Squamous Cell Carcinoma n=1 Participants Participants with head and neck cell carcinoma received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort C: Cervical Carcinoma n=8 Participants Participants with cervical carcinoma received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort E: TMB-H + MSS Solid Tumors n=9 Participants Participants with TMB-H and MSS solid tumors received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort F: Rare Tumors (Uveal) n=8 Participants Participants with rare tumors (uveal) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort F: Rare Tumors (De-diff LPS) n=10 Participants Participants with rare tumors (de-differentiated liposarcoma \[de-diff LPS\]) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort F: Rare Tumors (UPS) n=6 Participants Participants with rare tumors (undifferentiated pleomorphic sarcoma \[UPS\]) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort F: Rare Tumors (Other Sarcoma) n=3 Participants Participants with rare tumors (other sarcoma) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort F: Rare Tumors (GCT) n=4 Participants Participants with rare tumors (germ cell tumours \[GCT\]) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort G: Endometrial Cancer Post- CPI (PD-1/PD-L1 Treated) n=3 Participants Participants with endometrial cancer (PD-1/PD-L1 treated) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort H: Ovarian Cancer n=10 Participants Participants with ovarian cancer received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
Disease Control Rate (DCR) as Assessed Based on RECIST v1.1	50.0 percentage of participants Interval 18.71 to 81.29	0 percentage of participants Interval 0.0 to 97.5	62.5 percentage of participants Interval 24.49 to 91.48	33.3 percentage of participants Interval 7.49 to 70.07	50.0 percentage of participants Interval 15.7 to 84.3	50.0 percentage of participants Interval 18.71 to 81.29	33.3 percentage of participants Interval 4.33 to 77.72	33.3 percentage of participants Interval 0.84 to 90.57	0 percentage of participants Interval 0.0 to 60.24	0 percentage of participants Interval 0.0 to 70.76	60.0 percentage of participants Interval 26.24 to 87.84

SECONDARY outcome

Timeframe: From first dose of study drug until the date of first overall response of PD or date of death due to underlying cancer (maximum exposure: 638 days)

Population: RE Analysis Set: all participants with measurable disease at baseline who received study drug and had at least 1 post-baseline response assessment or discontinued treatment due to disease progression (including death due to disease progression) within 16 weeks of first dose of study drug. Per planned analysis, the efficacy data for Cohort F were collected and analyzed separately per tumor type. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

The DoR was defined as the time, in days, from the first of the 2 assessments required for confirmed PR or CR to the time of the progressive disease (PD) or death due to underlying cancer. CR: Disappearance of all target or non-target lesions and normalization of tumor marker level. Any pathological lymph node (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. PD: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of the existing non-target lesions. The appearance of one or more new lesions was also considered progression.

Outcome measures

Outcome measures
Measure	Cohort A: Endometrial Cancer CPI (PD-1/PD-L1) Naive n=2 Participants Participants with endometrial cancer CPI (PD-1/PD-L1) naive received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort B: Head and Neck Squamous Cell Carcinoma Participants with head and neck cell carcinoma received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort C: Cervical Carcinoma n=3 Participants Participants with cervical carcinoma received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort E: TMB-H + MSS Solid Tumors Participants with TMB-H and MSS solid tumors received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort F: Rare Tumors (Uveal) n=2 Participants Participants with rare tumors (uveal) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort F: Rare Tumors (De-diff LPS) n=1 Participants Participants with rare tumors (de-differentiated liposarcoma \[de-diff LPS\]) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort F: Rare Tumors (UPS) n=1 Participants Participants with rare tumors (undifferentiated pleomorphic sarcoma \[UPS\]) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort F: Rare Tumors (Other Sarcoma) Participants with rare tumors (other sarcoma) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort F: Rare Tumors (GCT) Participants with rare tumors (germ cell tumours \[GCT\]) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort G: Endometrial Cancer Post- CPI (PD-1/PD-L1 Treated) Participants with endometrial cancer (PD-1/PD-L1 treated) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort H: Ovarian Cancer n=1 Participants Participants with ovarian cancer received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
Duration of Response (DoR) as Assessed Based on RECIST v1.1	197.0 days Interval 57.0 to 337.0	—	183.0 days Interval 64.0 to 360.0	—	307.0 days Interval 92.0 to 522.0	464.0 days Interval 464.0 to 464.0	145.0 days Interval 145.0 to 145.0	—	—	—	442.0 days Interval 442.0 to 442.0

SECONDARY outcome

Timeframe: From first dose of study drug until the date of first overall response of PD or date of death due to underlying cancer (up to a maximum of 680 days)

The DoSD was defined as the time, in days, from the first date of treatment until the first date at which PD was experienced or the participant died due to underlying cancer. PD: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of the existing non-target lesions. The appearance of one or more new lesions was also considered progression.

Outcome measures

Outcome measures
Measure	Cohort A: Endometrial Cancer CPI (PD-1/PD-L1) Naive n=10 Participants Participants with endometrial cancer CPI (PD-1/PD-L1) naive received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort B: Head and Neck Squamous Cell Carcinoma n=1 Participants Participants with head and neck cell carcinoma received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort C: Cervical Carcinoma n=8 Participants Participants with cervical carcinoma received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort E: TMB-H + MSS Solid Tumors n=9 Participants Participants with TMB-H and MSS solid tumors received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort F: Rare Tumors (Uveal) n=8 Participants Participants with rare tumors (uveal) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort F: Rare Tumors (De-diff LPS) n=10 Participants Participants with rare tumors (de-differentiated liposarcoma \[de-diff LPS\]) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort F: Rare Tumors (UPS) n=6 Participants Participants with rare tumors (undifferentiated pleomorphic sarcoma \[UPS\]) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort F: Rare Tumors (Other Sarcoma) n=3 Participants Participants with rare tumors (other sarcoma) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort F: Rare Tumors (GCT) n=4 Participants Participants with rare tumors (germ cell tumours \[GCT\]) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort G: Endometrial Cancer Post- CPI (PD-1/PD-L1 Treated) n=3 Participants Participants with endometrial cancer (PD-1/PD-L1 treated) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort H: Ovarian Cancer n=10 Participants Participants with ovarian cancer received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
Duration of Stable Disease (DoSD) as Assessed Based on RECIST v1.1	81.5 days Interval 50.0 to 423.0	45.0 days Interval 45.0 to 45.0	120.0 days Interval 50.0 to 414.0	57.0 days Interval 45.0 to 140.0	109.5 days Interval 52.0 to 680.0	108.0 days Interval 36.0 to 568.0	55.5 days Interval 16.0 to 337.0	53.0 days Interval 52.0 to 60.0	57.5 days Interval 56.0 to 58.0	50.0 days Interval 50.0 to 58.0	70.0 days Interval 37.0 to 547.0

SECONDARY outcome

Timeframe: Pre-infusion and 15 minutes post-infusion on Cycle 1 Day 1 and Cycle 4 Day 43

Population: The pharmacokinetic (PK) analysis set included all participants with sufficient plasma concentration data to allow the characterization of the PK parameters. Per planned analysis, PK data were collected and analyzed combined for all arm groups. 'Number analyzed' = participants evaluable at specified timepoint.

Outcome measures

Outcome measures
Measure	Cohort A: Endometrial Cancer CPI (PD-1/PD-L1) Naive n=30 Participants Participants with endometrial cancer CPI (PD-1/PD-L1) naive received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort B: Head and Neck Squamous Cell Carcinoma Participants with head and neck cell carcinoma received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort C: Cervical Carcinoma Participants with cervical carcinoma received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort E: TMB-H + MSS Solid Tumors Participants with TMB-H and MSS solid tumors received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort F: Rare Tumors (Uveal) Participants with rare tumors (uveal) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort F: Rare Tumors (De-diff LPS) Participants with rare tumors (de-differentiated liposarcoma \[de-diff LPS\]) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort F: Rare Tumors (UPS) Participants with rare tumors (undifferentiated pleomorphic sarcoma \[UPS\]) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort F: Rare Tumors (Other Sarcoma) Participants with rare tumors (other sarcoma) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort F: Rare Tumors (GCT) Participants with rare tumors (germ cell tumours \[GCT\]) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort G: Endometrial Cancer Post- CPI (PD-1/PD-L1 Treated) Participants with endometrial cancer (PD-1/PD-L1 treated) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort H: Ovarian Cancer Participants with ovarian cancer received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
Serum Concentrations of Etigilimab Cycle 1 Day 1 (Pre-infusion)	NA micrograms (μg)/milliliter (mL) Geometric Coefficient of Variation NA Sample below the limit of quantification (0.200 μg/mL).	—	—	—	—	—	—	—	—	—	—
Serum Concentrations of Etigilimab Cycle 1 Day 1 (15 minutes post-infusion)	262 micrograms (μg)/milliliter (mL) Geometric Coefficient of Variation 22	—	—	—	—	—	—	—	—	—	—
Serum Concentrations of Etigilimab Cycle 4 Day 43 (Pre-infusion)	20.1 micrograms (μg)/milliliter (mL) Geometric Coefficient of Variation 82	—	—	—	—	—	—	—	—	—	—
Serum Concentrations of Etigilimab Cycle 4 Day 43 (15 minutes post-infusion)	273 micrograms (μg)/milliliter (mL) Geometric Coefficient of Variation 27	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days)

Population: The immunogenicity analysis set included all participants with at least 1 evaluable post-treatment immunogenicity sample.

Outcome measures

Outcome measures
Measure	Cohort A: Endometrial Cancer CPI (PD-1/PD-L1) Naive Participants with endometrial cancer CPI (PD-1/PD-L1) naive received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort B: Head and Neck Squamous Cell Carcinoma n=1 Participants Participants with head and neck cell carcinoma received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort C: Cervical Carcinoma n=1 Participants Participants with cervical carcinoma received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort E: TMB-H + MSS Solid Tumors Participants with TMB-H and MSS solid tumors received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort F: Rare Tumors (Uveal) n=6 Participants Participants with rare tumors (uveal) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort F: Rare Tumors (De-diff LPS) Participants with rare tumors (de-differentiated liposarcoma \[de-diff LPS\]) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort F: Rare Tumors (UPS) n=1 Participants Participants with rare tumors (undifferentiated pleomorphic sarcoma \[UPS\]) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort F: Rare Tumors (Other Sarcoma) Participants with rare tumors (other sarcoma) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort F: Rare Tumors (GCT) Participants with rare tumors (germ cell tumours \[GCT\]) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort G: Endometrial Cancer Post- CPI (PD-1/PD-L1 Treated) Participants with endometrial cancer (PD-1/PD-L1 treated) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort H: Ovarian Cancer Participants with ovarian cancer received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
Number of Participants With Anti-drug Antibodies (ADA) to Etigilimab	—	0 Participants	0 Participants	—	0 Participants	—	0 Participants	—	—	—	—

Adverse Events

Cohort A: Endometrial Cancer CPI (PD-1/PD-L1) Naive

Serious events: 2 serious events

Other events: 11 other events

Deaths: 2 deaths

Cohort B: Head and Neck Squamous Cell Carcinoma

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

Cohort C: Cervical Carcinoma

Serious events: 2 serious events

Other events: 8 other events

Deaths: 2 deaths

Cohort E: TMB-H + MSS Solid Tumors

Serious events: 5 serious events

Other events: 8 other events

Deaths: 5 deaths

Cohort F: Rare Tumors (Sarcoma, Uveal Melanoma, Germ Cell)

Serious events: 8 serious events

Other events: 33 other events

Deaths: 14 deaths

Cohort G: Endometrial Cancer Post- CPI (PD-1/PD-L1 Treated)

Serious events: 2 serious events

Other events: 4 other events

Deaths: 2 deaths

Cohort H: Ovarian Cancer

Serious events: 3 serious events

Other events: 9 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	Cohort A: Endometrial Cancer CPI (PD-1/PD-L1) Naive n=11 participants at risk Participants with endometrial cancer CPI (PD-1/PD-L1) naive received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort B: Head and Neck Squamous Cell Carcinoma n=1 participants at risk Participants with head and neck cell carcinoma received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort C: Cervical Carcinoma n=8 participants at risk Participants with cervical carcinoma received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort E: TMB-H + MSS Solid Tumors n=9 participants at risk Participants with TMB-H and MSS solid tumors received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort F: Rare Tumors (Sarcoma, Uveal Melanoma, Germ Cell) n=33 participants at risk Participants with rare tumors (sarcoma, uveal melanoma, and germ cell) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort G: Endometrial Cancer Post- CPI (PD-1/PD-L1 Treated) n=4 participants at risk Participants with endometrial cancer (PD-1/PD-L1 treated) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort H: Ovarian Cancer n=10 participants at risk Participants with ovarian cancer received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
Infections and infestations Pneumonia	0.00% 0/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	12.5% 1/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	11.1% 1/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	6.1% 2/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Infections and infestations Sepsis	0.00% 0/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	12.5% 1/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	25.0% 1/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Infections and infestations Abdominal sepsis	0.00% 0/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	3.0% 1/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Infections and infestations Peritonitis	9.1% 1/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Infections and infestations Septic shock	0.00% 0/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	3.0% 1/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Gastrointestinal disorders Abdominal pain	0.00% 0/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	3.0% 1/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Gastrointestinal disorders Ascites	0.00% 0/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	10.0% 1/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Gastrointestinal disorders Immune-mediated gastritis	0.00% 0/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	12.5% 1/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	3.0% 1/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Gastrointestinal disorders Malignant ascites	0.00% 0/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	10.0% 1/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	11.1% 1/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	3.0% 1/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	20.0% 2/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Respiratory, thoracic and mediastinal disorders Chylothorax	0.00% 0/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	10.0% 1/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	3.0% 1/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
General disorders Disease progression	0.00% 0/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	11.1% 1/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	3.0% 1/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
General disorders Fatigue	0.00% 0/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	11.1% 1/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
General disorders Pyrexia	0.00% 0/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	3.0% 1/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	12.5% 1/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	25.0% 1/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Renal and urinary disorders Acute kidney injury	0.00% 0/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	25.0% 1/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Cardiac disorders Atrial fibrillation	0.00% 0/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	10.0% 1/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Cardiac disorders Myocardial infarction	0.00% 0/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	11.1% 1/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	3.0% 1/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	3.0% 1/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	3.0% 1/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Endocrine disorders Adrenal insufficiency	9.1% 1/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	3.0% 1/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Nervous system disorders Hypoaesthesia	0.00% 0/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	11.1% 1/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Reproductive system and breast disorders Pelvic pain	0.00% 0/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	11.1% 1/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.

Other adverse events

Other adverse events
Measure	Cohort A: Endometrial Cancer CPI (PD-1/PD-L1) Naive n=11 participants at risk Participants with endometrial cancer CPI (PD-1/PD-L1) naive received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort B: Head and Neck Squamous Cell Carcinoma n=1 participants at risk Participants with head and neck cell carcinoma received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort C: Cervical Carcinoma n=8 participants at risk Participants with cervical carcinoma received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort E: TMB-H + MSS Solid Tumors n=9 participants at risk Participants with TMB-H and MSS solid tumors received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort F: Rare Tumors (Sarcoma, Uveal Melanoma, Germ Cell) n=33 participants at risk Participants with rare tumors (sarcoma, uveal melanoma, and germ cell) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort G: Endometrial Cancer Post- CPI (PD-1/PD-L1 Treated) n=4 participants at risk Participants with endometrial cancer (PD-1/PD-L1 treated) received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.	Cohort H: Ovarian Cancer n=10 participants at risk Participants with ovarian cancer received etigilimab in combination with nivolumab every 2 weeks and continued treatment until protocol-defined discontinuation criteria were met.
Psychiatric disorders Insomnia	0.00% 0/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	12.1% 4/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Endocrine disorders Hypothyroidism	9.1% 1/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	12.5% 1/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	15.2% 5/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Gastrointestinal disorders Nausea	36.4% 4/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	37.5% 3/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	33.3% 3/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	18.2% 6/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	50.0% 5/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Gastrointestinal disorders Diarrhoea	36.4% 4/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	50.0% 4/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	33.3% 3/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	15.2% 5/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	30.0% 3/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Gastrointestinal disorders Constipation	18.2% 2/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	37.5% 3/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	55.6% 5/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	15.2% 5/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	25.0% 1/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	10.0% 1/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Gastrointestinal disorders Vomiting	36.4% 4/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	25.0% 2/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	22.2% 2/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	18.2% 6/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Gastrointestinal disorders Abdominal pain	9.1% 1/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	25.0% 2/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	33.3% 3/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	3.0% 1/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	10.0% 1/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Skin and subcutaneous tissue disorders Rash	36.4% 4/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	12.5% 1/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	11.1% 1/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	33.3% 11/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	10.0% 1/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Skin and subcutaneous tissue disorders Pruritus	18.2% 2/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	25.0% 2/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	11.1% 1/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	15.2% 5/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	30.0% 3/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Skin and subcutaneous tissue disorders Rash maculo-papular	9.1% 1/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	25.0% 2/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	15.2% 5/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	20.0% 2/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	12.5% 1/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	3.0% 1/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	40.0% 4/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	11.1% 1/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	9.1% 3/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
General disorders Fatigue	27.3% 3/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	25.0% 2/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	33.3% 3/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	42.4% 14/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	25.0% 1/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	50.0% 5/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
General disorders Oedema peripheral	0.00% 0/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	12.5% 1/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	11.1% 1/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	12.1% 4/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	10.0% 1/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
General disorders Chills	18.2% 2/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	11.1% 1/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	9.1% 3/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
General disorders Influenza like illness	18.2% 2/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	3.0% 1/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	20.0% 2/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
General disorders Pyrexia	18.2% 2/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	11.1% 1/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	3.0% 1/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Metabolism and nutrition disorders Decreased appetite	27.3% 3/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	100.0% 1/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	50.0% 4/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	22.2% 2/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	9.1% 3/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	20.0% 2/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Metabolism and nutrition disorders Hyponatraemia	9.1% 1/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	33.3% 3/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	3.0% 1/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	20.0% 2/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Metabolism and nutrition disorders Dehydration	9.1% 1/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	100.0% 1/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	12.5% 1/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	6.1% 2/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	10.0% 1/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	22.2% 2/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	6.1% 2/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	10.0% 1/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	9.1% 1/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	37.5% 3/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	22.2% 2/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	21.2% 7/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	50.0% 2/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	30.0% 3/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Respiratory, thoracic and mediastinal disorders Cough	27.3% 3/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	25.0% 2/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	11.1% 1/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	12.1% 4/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	50.0% 2/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	10.0% 1/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	9.1% 1/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	37.5% 3/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	11.1% 1/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	21.2% 7/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	25.0% 1/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Musculoskeletal and connective tissue disorders Back pain	9.1% 1/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	25.0% 2/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	11.1% 1/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	15.2% 5/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	18.2% 2/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	12.5% 1/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	12.1% 4/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	10.0% 1/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	12.5% 1/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	22.2% 2/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	3.0% 1/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Infections and infestations COVID-19	9.1% 1/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	12.5% 1/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	12.1% 4/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	25.0% 1/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	20.0% 2/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Infections and infestations Upper respiratory tract infection	9.1% 1/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	11.1% 1/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	6.1% 2/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Infections and infestations Urinary tract infection	0.00% 0/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	12.5% 1/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	3.0% 1/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	25.0% 1/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	10.0% 1/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Investigations Aspartate aminotransferase increased	18.2% 2/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	37.5% 3/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	11.1% 1/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	6.1% 2/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	10.0% 1/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Investigations Weight decreased	9.1% 1/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	100.0% 1/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	12.5% 1/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	22.2% 2/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	6.1% 2/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	25.0% 1/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	10.0% 1/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Investigations Alanine aminotransferase increased	9.1% 1/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	12.5% 1/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	11.1% 1/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	6.1% 2/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Investigations Blood creatinine increased	0.00% 0/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	9.1% 3/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	50.0% 2/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Blood and lymphatic system disorders Anaemia	18.2% 2/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	100.0% 1/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	12.5% 1/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	33.3% 3/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	30.3% 10/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	25.0% 1/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	20.0% 2/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Nervous system disorders Dizziness	0.00% 0/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	25.0% 2/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	15.2% 5/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Nervous system disorders Headache	0.00% 0/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	25.0% 2/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	3.0% 1/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	10.0% 1/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Nervous system disorders Paraesthesia	0.00% 0/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	12.5% 1/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	11.1% 1/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	3.0% 1/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	10.0% 1/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Vascular disorders Hypertension	0.00% 0/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	6.1% 2/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	25.0% 1/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	10.0% 1/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Injury, poisoning and procedural complications Infusion related reaction	18.2% 2/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	100.0% 1/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	12.5% 1/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	9.1% 3/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Injury, poisoning and procedural complications Fall	9.1% 1/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	11.1% 1/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	3.0% 1/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	25.0% 1/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.
Psychiatric disorders Anxiety	0.00% 0/11 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/1 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/8 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	11.1% 1/9 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	9.1% 3/33 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/4 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.	0.00% 0/10 • From first dose of study drug until 100 days after the last dose of study drug or the initiation of any subsequent cancer treatment, whichever occurs first (maximum exposure: 638 days) Safety Analysis Set included all participants who received any amount of study drug.

Additional Information

Mereo BioPharma

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Results disclosure agreements

Principal investigator is a sponsor employee All PIs must seek written permission from the sponsor before publication of any trial results.
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Restriction type: OTHER