Trial Outcomes & Findings for Enoblituzumab Plus Retifanlimab or Tebotelimab in Head and Neck Cancer (NCT NCT04634825)

Last Updated: 2023-12-20

Results Overview

Investigator-assessed ORR. defined as the percentage of patients in the response evaluable population who achieve the best overall response of complete response (CR) or partial response (PR),per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 criteria.. CR is defined as disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease from baseline in the sum of diameters of target lesions

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

62 participants

Primary outcome timeframe

Tumor assessment is conducted 6 weeks after the first dose, then every 9 weeks until disease progression, up to 16.5 months.

Results posted on

2023-12-20

Participant Flow

Participant milestones

Participant milestones
Measure	Retifanlimab Cohort Enoblituzumab 15 mg/kg every 3 weeks plus retifanlimab 375 mg every 3 weeks for up to 35 cycles	Tebotelimab Cohort Enoblituzumab 15 mg/kg every 3 weeks plus tebotelimab 600 mg every 3 weeks for up to 35 cycles
Overall Study STARTED	48	14
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	48	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Retifanlimab Cohort Enoblituzumab 15 mg/kg every 3 weeks plus retifanlimab 375 mg every 3 weeks for up to 35 cycles	Tebotelimab Cohort Enoblituzumab 15 mg/kg every 3 weeks plus tebotelimab 600 mg every 3 weeks for up to 35 cycles
Overall Study Death	10	3
Overall Study Lost to Follow-up	1	0
Overall Study Study terminated by sponsor	35	11
Overall Study Withdrawal by Subject	2	0

Baseline Characteristics

Enoblituzumab Plus Retifanlimab or Tebotelimab in Head and Neck Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Retifanlimab Cohort n=48 Participants Enoblituzumab 15 mg/kg every 3 weeks plus retifanlimab 375 mg every 3 weeks	Tebotelimab Cohort n=14 Participants Enoblituzumab 15 mg/kg every 3 weeks plus tebotelimab 600 mg every 3 weeks	Total n=62 Participants Total of all reporting groups
Age, Continuous	61.2 years STANDARD_DEVIATION 11.31 • n=93 Participants	65.1 years STANDARD_DEVIATION 6.80 • n=4 Participants	62.0 years STANDARD_DEVIATION 10.54 • n=27 Participants
Sex: Female, Male Female	10 Participants n=93 Participants	3 Participants n=4 Participants	13 Participants n=27 Participants
Sex: Female, Male Male	38 Participants n=93 Participants	11 Participants n=4 Participants	49 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	47 Participants n=93 Participants	12 Participants n=4 Participants	59 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Asian	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	3 Participants n=93 Participants	0 Participants n=4 Participants	3 Participants n=27 Participants
Race (NIH/OMB) White	42 Participants n=93 Participants	14 Participants n=4 Participants	56 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment Hungary	3 participants n=93 Participants	1 participants n=4 Participants	4 participants n=27 Participants
Region of Enrollment United States	12 participants n=93 Participants	1 participants n=4 Participants	13 participants n=27 Participants
Region of Enrollment Ukraine	12 participants n=93 Participants	2 participants n=4 Participants	14 participants n=27 Participants
Region of Enrollment Poland	6 participants n=93 Participants	1 participants n=4 Participants	7 participants n=27 Participants
Region of Enrollment Bulgaria	0 participants n=93 Participants	2 participants n=4 Participants	2 participants n=27 Participants
Region of Enrollment Australia	6 participants n=93 Participants	1 participants n=4 Participants	7 participants n=27 Participants
Region of Enrollment Spain	9 participants n=93 Participants	6 participants n=4 Participants	15 participants n=27 Participants

PRIMARY outcome

Timeframe: Tumor assessment is conducted 6 weeks after the first dose, then every 9 weeks until disease progression, up to 16.5 months.

Outcome measures

Outcome measures
Measure	Retifanlimab Cohort n=48 Participants Enoblituzumab 15 mg/kg every 3 weeks plus retifanlimab 375 mg every 3 weeks	Tebotelimab Cohort Enoblituzumab 15 mg/kg every 3 weeks plus tebotelimab 600 mg every 3 weeks
Overall Response Rate (ORR) of Enoblituzumab Plus Retifanlimab	3 Participants	—

PRIMARY outcome

Timeframe: Throughout the study, up to 16.5 months.

Outcome measures

Outcome measures
Measure	Retifanlimab Cohort n=14 Participants Enoblituzumab 15 mg/kg every 3 weeks plus retifanlimab 375 mg every 3 weeks	Tebotelimab Cohort Enoblituzumab 15 mg/kg every 3 weeks plus tebotelimab 600 mg every 3 weeks
Number of Patients With Adverse Events (AEs) Receiving Enoblituzumab Plus Tebotelimab	12 Participants	—

PRIMARY outcome

Timeframe: Tumor assessment is conducted 6 weeks after the first dose, then every 9 weeks until disease progression, up to 16.5 months

Investigator-assessed ORR. ORR, defined as the percentage of patients in the response evaluable population who achieve the a best overall response of complete response (CR) or partial response (PR), per RECIST, version 1.1 criteria. CR is defined as disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease from baseline in the sum of diameters of target lesions

Outcome measures

Outcome measures
Measure	Retifanlimab Cohort n=14 Participants Enoblituzumab 15 mg/kg every 3 weeks plus retifanlimab 375 mg every 3 weeks	Tebotelimab Cohort Enoblituzumab 15 mg/kg every 3 weeks plus tebotelimab 600 mg every 3 weeks
ORR of Enoblituzumab Plus Tebotelimab	2 Participants	—

SECONDARY outcome

Timeframe: Tumor assessment is conducted 6 weeks after the first dose, then every 9 weeks until disease progression, up to 16.5 months

Time from the first dose date to the date of first documented progression or death from any cause, whichever occurs first, evaluated by cohort

Outcome measures

Outcome measures
Measure	Retifanlimab Cohort n=48 Participants Enoblituzumab 15 mg/kg every 3 weeks plus retifanlimab 375 mg every 3 weeks	Tebotelimab Cohort n=14 Participants Enoblituzumab 15 mg/kg every 3 weeks plus tebotelimab 600 mg every 3 weeks
Progression-free Survival (PFS)	NA months There was an insufficient number of events to calculate PFS.	NA months There was an insufficient number of events to calculate PFS.

SECONDARY outcome

Timeframe: Tumor assessment is conducted 6 weeks after the first dose, then every 9 weeks until disease progression, up to 16.5 months

Percentage of response-evaluable patients with CR, PR, or stable disease (SD) for at least 3 months, evaluated by cohort

Outcome measures

Outcome measures
Measure	Retifanlimab Cohort n=48 Participants Enoblituzumab 15 mg/kg every 3 weeks plus retifanlimab 375 mg every 3 weeks	Tebotelimab Cohort n=14 Participants Enoblituzumab 15 mg/kg every 3 weeks plus tebotelimab 600 mg every 3 weeks
Disease-control Rate (DCR)	19 Participants	5 Participants

SECONDARY outcome

Timeframe: Tumor assessment is conducted 6 weeks after the first dose, then every 9 weeks until disease progression, up to 16.5 months

Time from the date of initial response (CR or PR) to the date of first documented progression or death from any cause, whichever occurs first, evaluated by cohort

Outcome measures

Outcome measures
Measure	Retifanlimab Cohort n=48 Participants Enoblituzumab 15 mg/kg every 3 weeks plus retifanlimab 375 mg every 3 weeks	Tebotelimab Cohort n=14 Participants Enoblituzumab 15 mg/kg every 3 weeks plus tebotelimab 600 mg every 3 weeks
Duration of Response	NA months Standard Deviation NA There were an insufficient number of progression events in the analysis population to calculate duration of response.	NA months Standard Deviation NA There were an insufficient number of progression events in the analysis population to calculate duration of response.

SECONDARY outcome

Timeframe: up to 16.5 months

Time from the first dose date to the date of death from any cause, evaluated by cohort

Outcome measures

Outcome measures
Measure	Retifanlimab Cohort n=48 Participants Enoblituzumab 15 mg/kg every 3 weeks plus retifanlimab 375 mg every 3 weeks	Tebotelimab Cohort n=14 Participants Enoblituzumab 15 mg/kg every 3 weeks plus tebotelimab 600 mg every 3 weeks
Overall Survival	NA months There were an insufficient number of death events in the analysis population to calculate overall survival.	NA months There were an insufficient number of death events in the analysis population to calculate overall survival.

SECONDARY outcome

Timeframe: Tumor assessment is conducted 6 weeks after first dose, then every 9 weeks until disease progression, up to 16.5 months

The participants best response to treatment during their study participation. Responses are categorized as CR, PR, stable disease (SD), progressive disease (PD), or not evaluated (NE), per RECIST 1.1 criteria CR is defined as disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease from baseline in the sum of diameters of target lesions, and non-PD in non-target lesions PD is defined as at least a 20% increase from nadir in the sum of diameters of target lesions or unequivocal progression in non-target lesions SD is defined as non-PD in target and non-target lesions

Outcome measures

Outcome measures
Measure	Retifanlimab Cohort n=48 Participants Enoblituzumab 15 mg/kg every 3 weeks plus retifanlimab 375 mg every 3 weeks	Tebotelimab Cohort n=14 Participants Enoblituzumab 15 mg/kg every 3 weeks plus tebotelimab 600 mg every 3 weeks
Best Overall Response (BOR) Complete Response	0 Participants	0 Participants
Best Overall Response (BOR) Partial Response	3 Participants	2 Participants
Best Overall Response (BOR) Stable Disease	20 Participants	5 Participants
Best Overall Response (BOR) Progressive Disease	15 Participants	2 Participants
Best Overall Response (BOR) Not Evaluable	10 Participants	5 Participants

SECONDARY outcome

Timeframe: Throughout the study, up to 16.5 months.

Outcome measures

Outcome measures
Measure	Retifanlimab Cohort n=48 Participants Enoblituzumab 15 mg/kg every 3 weeks plus retifanlimab 375 mg every 3 weeks	Tebotelimab Cohort Enoblituzumab 15 mg/kg every 3 weeks plus tebotelimab 600 mg every 3 weeks
Number of Patients With AEs Receiving Enoblituzumab Plus Retifanlimab	40 Participants	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1: Pre-infusion, end of infusion (EOI [2 hours]), 4 hours after EOI; Cycle 1 Days 2, 3, 8 and 15 at any time; On Day 1 of Cycles 2, 3, 4, 5 and 6: Pre-infusion and EOI (each cycle is 21 days)

Population: Participants who received Enoblituzumab and had at least 1 end of infusion PK sample. As pre-specified in the PK analysis plan, Enoblituzumab PK data from both arms of the study were combined for analysis since Enoblituzumab dose was schedule were consistent across both arms.

The highest measured concentration of enoblituzumab in the bloodstream.

Outcome measures

Outcome measures
Measure	Retifanlimab Cohort n=62 Participants Enoblituzumab 15 mg/kg every 3 weeks plus retifanlimab 375 mg every 3 weeks	Tebotelimab Cohort Enoblituzumab 15 mg/kg every 3 weeks plus tebotelimab 600 mg every 3 weeks
Maximum Drug Concentration or Drug Concentration of Enoblituzumab at the End of Infusion of Enoblituzumab (Cmax)	505.3 mcg/mL Standard Deviation 130.5	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1: Pre-infusion, end of infusion (EOI [1 hour]), 4 hours after EOI; Cycle 1 Days 2, 3, 8 and 15 at any time; On Day 1 of Cycles 2, 3, 4, 5 and 6: Pre-infusion and EOI (each cycle is 21 days)

Population: Participants who received tebotelimab and had at least 1 End of Infusion PK sample

The highest measured concentration of tebotelimab in the bloodstream.

Outcome measures

Outcome measures
Measure	Retifanlimab Cohort n=14 Participants Enoblituzumab 15 mg/kg every 3 weeks plus retifanlimab 375 mg every 3 weeks	Tebotelimab Cohort Enoblituzumab 15 mg/kg every 3 weeks plus tebotelimab 600 mg every 3 weeks
Maximum Drug Concentration or Drug Concentration of Tebotelimab at the End of Infusion of Tebotelimab (Cmax)	196.5 mcg/mL Standard Deviation 74.8	—

SECONDARY outcome

Population: Participants who received retifanlimab and had at least 1 end of infusion PK sample.

The highest measured concentration of retifanlimab in the bloodstream.

Outcome measures

Outcome measures
Measure	Retifanlimab Cohort n=47 Participants Enoblituzumab 15 mg/kg every 3 weeks plus retifanlimab 375 mg every 3 weeks	Tebotelimab Cohort Enoblituzumab 15 mg/kg every 3 weeks plus tebotelimab 600 mg every 3 weeks
Maximum Drug Concentration or Drug Concentration of Retifanlimab at the End of Infusion of Enoblituzumab (Cmax)	113.1 mcg/mL Standard Deviation 26.9	—

SECONDARY outcome

Population: Participants who received enoblituzumab and had at least 1 pre-infusion PK sample. As pre-specified in the PK analysis plan, enoblituzumab PK data from both arms of the study were combined for analysis since enoblituzumab dose and schedule were consistent across both arms.

The amount of enoblituzumab left in the bloodstream before the next dose is given.

Outcome measures

Outcome measures
Measure	Retifanlimab Cohort n=62 Participants Enoblituzumab 15 mg/kg every 3 weeks plus retifanlimab 375 mg every 3 weeks	Tebotelimab Cohort Enoblituzumab 15 mg/kg every 3 weeks plus tebotelimab 600 mg every 3 weeks
Trough Concentration of Enoblituzumab (Ctrough or Cmin)	165.7 mcg/mL Standard Deviation 88.8	—

SECONDARY outcome

Population: Participants who received tebotelimab and had at least 1 pre-infusion PK sample.

The amount of tebotelimab left in the bloodstream before the next dose is given.

Outcome measures

Outcome measures
Measure	Retifanlimab Cohort n=12 Participants Enoblituzumab 15 mg/kg every 3 weeks plus retifanlimab 375 mg every 3 weeks	Tebotelimab Cohort Enoblituzumab 15 mg/kg every 3 weeks plus tebotelimab 600 mg every 3 weeks
Trough Concentration of Tebotelimab (Ctrough or Cmin)	20.1 mcg/mL Standard Deviation 6.1	—

SECONDARY outcome

Population: Participants who received retifanlimab and had at least 1 pre-infusion PK sample.

The amount of retifanlimab left in the bloodstream before the next dose is given.

Outcome measures

Outcome measures
Measure	Retifanlimab Cohort n=33 Participants Enoblituzumab 15 mg/kg every 3 weeks plus retifanlimab 375 mg every 3 weeks	Tebotelimab Cohort Enoblituzumab 15 mg/kg every 3 weeks plus tebotelimab 600 mg every 3 weeks
Trough Concentration of Retifanlimab (Ctrough or Cmin)	31.2 mcg/mL Standard Deviation 15.5	—

SECONDARY outcome

Timeframe: Prior to treatment (baseline) and at the beginning of every 3-week cycle of treatment (post baseline) up to 16.5 months

Population: As pre-specified in the PK analysis plan, enoblituzumab ADA data from both arms of the study were combined for analysis since enoblituzumab dose and schedule were consistent across both arms.

Outcome measures

Outcome measures
Measure	Retifanlimab Cohort n=62 Participants Enoblituzumab 15 mg/kg every 3 weeks plus retifanlimab 375 mg every 3 weeks	Tebotelimab Cohort Enoblituzumab 15 mg/kg every 3 weeks plus tebotelimab 600 mg every 3 weeks
Number of Patients Who Develop Antidrug Antibodies (ADA) to Enoblituzumab. Not done at baseline, negative post baseline	3 Participants	—
Number of Patients Who Develop Antidrug Antibodies (ADA) to Enoblituzumab. Not done at baseline, positive at least once post baseline	1 Participants	—
Number of Patients Who Develop Antidrug Antibodies (ADA) to Enoblituzumab. negative at baseline, not done post baseline	6 Participants	—
Number of Patients Who Develop Antidrug Antibodies (ADA) to Enoblituzumab. negative at baseline, negative post baseline	37 Participants	—
Number of Patients Who Develop Antidrug Antibodies (ADA) to Enoblituzumab. negative at baseline, positive at least once post baseline	5 Participants	—
Number of Patients Who Develop Antidrug Antibodies (ADA) to Enoblituzumab. positive at baseline, not done post baseline	4 Participants	—
Number of Patients Who Develop Antidrug Antibodies (ADA) to Enoblituzumab. positive at baseline, negative post baseline	4 Participants	—
Number of Patients Who Develop Antidrug Antibodies (ADA) to Enoblituzumab. positive at baseline, positive at least once post baseline	2 Participants	—

SECONDARY outcome

Timeframe: Prior to treatment (baseline) and at the beginning of every 3-week cycle of treatment (post baseline) up to 16.5 months

Population: Only participants receiving tebotelimab were analyzed for the presence of tebotelimab ADA.

Outcome measures

Outcome measures
Measure	Retifanlimab Cohort n=14 Participants Enoblituzumab 15 mg/kg every 3 weeks plus retifanlimab 375 mg every 3 weeks	Tebotelimab Cohort Enoblituzumab 15 mg/kg every 3 weeks plus tebotelimab 600 mg every 3 weeks
Number of Patients Who Develop ADA to Tebotelimab negative at baseline, not done post baseline	2 Participants	—
Number of Patients Who Develop ADA to Tebotelimab not done at baseline, positive at least once post baseline	1 Participants	—
Number of Patients Who Develop ADA to Tebotelimab negative at baseline, negative post baseline	7 Participants	—
Number of Patients Who Develop ADA to Tebotelimab negative at baseline, positive at least once post baseline	3 Participants	—
Number of Patients Who Develop ADA to Tebotelimab positive at baseline, negative post baseline	1 Participants	—

SECONDARY outcome

Timeframe: Prior to treatment (baseline) and at the beginning of every 3-week cycle of treatment (post baseline) up to 16.5 months

Population: Only participants receiving retifanlimab were analyzed for the presence of retifanlimab ADA.

Outcome measures

Outcome measures
Measure	Retifanlimab Cohort n=48 Participants Enoblituzumab 15 mg/kg every 3 weeks plus retifanlimab 375 mg every 3 weeks	Tebotelimab Cohort Enoblituzumab 15 mg/kg every 3 weeks plus tebotelimab 600 mg every 3 weeks
Number of Patients Who ADA to Retifanlimab Not done at baseline, negative post baseline	3 Participants	—
Number of Patients Who ADA to Retifanlimab negative at baseline, not done post baseline	8 Participants	—
Number of Patients Who ADA to Retifanlimab negative at baseline, negative post baseline	37 Participants	—

Adverse Events

Retifanlimab Cohort

Serious events: 14 serious events

Other events: 40 other events

Deaths: 10 deaths

Tebotelimab Cohort

Serious events: 6 serious events

Other events: 12 other events

Deaths: 3 deaths

Serious adverse events

Other adverse events

Additional Information

Chief Medical Officer

MacroGenics, Inc.

Phone: 301-251-5172

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Serious adverse events
Measure	Retifanlimab Cohort n=48 participants at risk Enoblituzumab 15 mg/kg every 3 weeks plus retifanlimab 375 mg every 3 weeks	Tebotelimab Cohort n=14 participants at risk Enoblituzumab 15 mg/kg every 3 weeks plus tebotelimab 600 mg every 3 weeks
Blood and lymphatic system disorders Blood loss anaemia	2.1% 1/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Cardiac disorders Atrial fibrillation	2.1% 1/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Cardiac disorders Cardiotoxicity	2.1% 1/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Cardiac disorders Immune-mediated myocarditis	2.1% 1/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Congenital, familial and genetic disorders Tracheo-oesophageal fistula	0.00% 0/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	7.1% 1/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Endocrine disorders Immune-mediated endocrinopathy	2.1% 1/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Gastrointestinal disorders Diarrhoea	2.1% 1/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Gastrointestinal disorders Dysphagia	0.00% 0/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	7.1% 1/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Gastrointestinal disorders Immune-mediated enterocolitis	2.1% 1/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	2.1% 1/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Gastrointestinal disorders Vomiting	2.1% 1/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Infections and infestations Pneumonia	2.1% 1/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	7.1% 1/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Infections and infestations Cytomegalovirus gastritis	0.00% 0/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	7.1% 1/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Infections and infestations Lower respiratory tract infection	0.00% 0/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	7.1% 1/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Infections and infestations Pneumonia aspiration	2.1% 1/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Infections and infestations Wound infection	2.1% 1/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	6.2% 3/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	7.1% 1/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	4.2% 2/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Respiratory, thoracic and mediastinal disorders Haemoptysis	2.1% 1/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.1% 1/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.00% 0/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	7.1% 1/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Respiratory, thoracic and mediastinal disorders Respiratory tract haemorrhage	2.1% 1/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Skin and subcutaneous tissue disorders Fungating wound	2.1% 1/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Surgical and medical procedures Gastrostomy	2.1% 1/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Vascular disorders Shock haemorrhagic	2.1% 1/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.

Other adverse events
Measure	Retifanlimab Cohort n=48 participants at risk Enoblituzumab 15 mg/kg every 3 weeks plus retifanlimab 375 mg every 3 weeks	Tebotelimab Cohort n=14 participants at risk Enoblituzumab 15 mg/kg every 3 weeks plus tebotelimab 600 mg every 3 weeks
Blood and lymphatic system disorders Anaemia	6.2% 3/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Blood and lymphatic system disorders Eosinophilia	2.1% 1/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	7.1% 1/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	7.1% 1/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Cardiac disorders Cardiac failure	2.1% 1/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Cardiac disorders Palpitations	2.1% 1/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Cardiac disorders Sinus bradycardia	2.1% 1/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Endocrine disorders Hypothyroidism	12.5% 6/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Endocrine disorders Hyperthyroidism	2.1% 1/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Gastrointestinal disorders Constipation	8.3% 4/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	7.1% 1/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Gastrointestinal disorders Diarrhoea	4.2% 2/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	7.1% 1/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Gastrointestinal disorders Dysphagia	4.2% 2/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	7.1% 1/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Gastrointestinal disorders Abdominal pain upper	2.1% 1/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	7.1% 1/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Gastrointestinal disorders Mouth haemorrhage	2.1% 1/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	7.1% 1/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Gastrointestinal disorders Oral pain	4.2% 2/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Gastrointestinal disorders Stomatitis	4.2% 2/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Gastrointestinal disorders Abdominal pain	2.1% 1/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Gastrointestinal disorders Flatulence	0.00% 0/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	7.1% 1/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Gastrointestinal disorders Gastrooesophageal reflux disease	2.1% 1/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Gastrointestinal disorders Nausea	0.00% 0/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	7.1% 1/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Gastrointestinal disorders Odynophagia	0.00% 0/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	7.1% 1/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Gastrointestinal disorders Salivary hypersecretion	0.00% 0/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	7.1% 1/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Gastrointestinal disorders Swollen tongue	2.1% 1/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Gastrointestinal disorders Vomiting	2.1% 1/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
General disorders Fatigue	12.5% 6/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	7.1% 1/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
General disorders Oedema peripheral	6.2% 3/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	7.1% 1/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
General disorders Pyrexia	4.2% 2/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	7.1% 1/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
General disorders Asthenia	0.00% 0/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	14.3% 2/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
General disorders Axillary pain	2.1% 1/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
General disorders Chest discomfort	2.1% 1/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
General disorders Inadequate analgesia	2.1% 1/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
General disorders Swelling face	2.1% 1/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Immune system disorders Cytokine release syndrome	0.00% 0/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	7.1% 1/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Infections and infestations COVID-19	6.2% 3/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	7.1% 1/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Infections and infestations Oral candidiasis	6.2% 3/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Infections and infestations Breakthrough COVID-19	4.2% 2/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Infections and infestations Respiratory tract infection	4.2% 2/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Infections and infestations Urinary tract infection	4.2% 2/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	0.00% 0/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Infections and infestations Candida infection	0.00% 0/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	7.1% 1/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.
Infections and infestations Cellulitis	0.00% 0/48 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.	7.1% 1/14 • Throughout the study, up to 16.5 months AEs are based on physical exam, participant reports and significant abnormal laboratory values. AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator.. Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.