Trial Outcomes & Findings for A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Melanoma (Morpheus-Melanoma) (NCT NCT05116202)

Last Updated: 2025-07-18

Results Overview

pRR was defined as the percentage of participants with pathologic complete response (pCR), pathologic near complete response (pnCR), and pathologic partial response (pPR) as determined by an independent pathologic review. pCR was defined as a complete absence of viable tumor cells, pnCR as \> 0 to ≤ 10% of viable tumor cells, and pPR was defined as \> 10 to ≤ 50% of viable tumor cells in the dissected lymph node. Participants with missing or no pathologic response assessment, including participants who did not proceed to complete lymph node dissection (CLND), were classified as non-responders. pRR was calculated for each arm along with 95% confidence intervals (CIs) using Clopper-Pearson method. The difference in pRR between the experimental arms and the control arm was calculated, along with 95% CIs using the Wald method with continuity correction.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

110 participants

Primary outcome timeframe

Time of surgery (scheduled at Week 7)

Results posted on

2025-07-18

Participant Flow

Participants took part in the study across 14 investigative sites in 5 countries: the United States, Italy, France, Spain, and Australia. The study is considered "Completed" because all the pre-planned study activities and analyses have been performed.

A total of 110 participants with resectable Stage III melanoma and Stage IV melanoma took part in Cohort 1 and Cohort 2, respectively. A total of 6 treatment arms were planned in Cohort 1 and 102 participants were enrolled in only 4 arms. The study was closed before the Cohort 1 arms tobemstomig 600 milligrams (mg), and tobemstomig 600 mg + tiragolumab were opened. 8 participants were enrolled in 1 arm in Cohort 2.

Participant milestones

Participant milestones
Measure	Cohort 1: Nivolumab + Ipilimumab (Control) Participants received nivolumab 3 milligrams/kilograms (mg/kg) intravenously (IV) and ipilimumab 1 mg/kg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Tobemstomig 2100 mg Participants received a fixed dose of tobemstomig 2100 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Atezolizumab + Tiragolumab Participants received atezolizumab 1200 mg IV and tiragolumab 600 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Tobemstomig + Tiragolumab Participants received tobemstomig 2100 mg IV and tiragolumab 600 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 2: Tobemstomig + Tiragolumab Participants received tobemstomig 2100 mg IV and tiragolumab 600 mg IV on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status.
Overall Study STARTED	22	40	20	20	8
Overall Study COMPLETED	0	0	0	0	0
Overall Study NOT COMPLETED	22	40	20	20	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1: Nivolumab + Ipilimumab (Control) Participants received nivolumab 3 milligrams/kilograms (mg/kg) intravenously (IV) and ipilimumab 1 mg/kg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Tobemstomig 2100 mg Participants received a fixed dose of tobemstomig 2100 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Atezolizumab + Tiragolumab Participants received atezolizumab 1200 mg IV and tiragolumab 600 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Tobemstomig + Tiragolumab Participants received tobemstomig 2100 mg IV and tiragolumab 600 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 2: Tobemstomig + Tiragolumab Participants received tobemstomig 2100 mg IV and tiragolumab 600 mg IV on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status.
Overall Study Study Terminated by Sponsor	21	38	17	18	0
Overall Study Withdrawal by Subject	0	1	1	1	1
Overall Study Lost to Follow-up	0	0	0	0	2
Overall Study Death	1	1	2	1	5

Baseline Characteristics

A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Melanoma (Morpheus-Melanoma)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: Nivolumab + Ipilimumab (Control) n=22 Participants Participants received nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Tobemstomig 2100 mg n=40 Participants Participants received a fixed dose of tobemstomig 2100 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Atezolizumab + Tiragolumab n=20 Participants Participants received atezolizumab 1200 mg IV and tiragolumab 600 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Tobemstomig + Tiragolumab n=20 Participants Participants received tobemstomig 2100 mg IV and tiragolumab 600 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 2: Tobemstomig + Tiragolumab n=8 Participants Participants received tobemstomig 2100 mg IV and tiragolumab 600 mg IV on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status.	Total n=110 Participants Total of all reporting groups
Age, Continuous	55.05 years STANDARD_DEVIATION 16.03 • n=5 Participants	64.10 years STANDARD_DEVIATION 10.97 • n=7 Participants	58.90 years STANDARD_DEVIATION 14.10 • n=5 Participants	59.15 years STANDARD_DEVIATION 10.69 • n=4 Participants	52.63 years STANDARD_DEVIATION 14.22 • n=21 Participants	59.6 years STANDARD_DEVIATION 13.3 • n=10 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	9 Participants n=7 Participants	8 Participants n=5 Participants	6 Participants n=4 Participants	3 Participants n=21 Participants	37 Participants n=10 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	31 Participants n=7 Participants	12 Participants n=5 Participants	14 Participants n=4 Participants	5 Participants n=21 Participants	73 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants	29 Participants n=7 Participants	10 Participants n=5 Participants	16 Participants n=4 Participants	8 Participants n=21 Participants	76 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants	11 Participants n=7 Participants	10 Participants n=5 Participants	4 Participants n=4 Participants	0 Participants n=21 Participants	33 Participants n=10 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=10 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 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=10 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	35 Participants n=7 Participants	14 Participants n=5 Participants	14 Participants n=4 Participants	8 Participants n=21 Participants	86 Participants n=10 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=10 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	4 Participants n=4 Participants	0 Participants n=21 Participants	22 Participants n=10 Participants

PRIMARY outcome

Timeframe: Time of surgery (scheduled at Week 7)

Population: Efficacy-evaluable population included all participants in Cohort 1 who received at least one dose of each drug for their assigned treatment regimen.

Outcome measures

Outcome measures
Measure	Cohort 1: Nivolumab + Ipilimumab (Control) n=22 Participants Participants received nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Tobemstomig 2100 mg n=40 Participants Participants received a fixed dose of tobemstomig 2100 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Atezolizumab + Tiragolumab n=20 Participants Participants received atezolizumab 1200 mg IV and tiragolumab 600 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Tobemstomig + Tiragolumab n=20 Participants Participants received tobemstomig 2100 mg IV and tiragolumab 600 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.
Pathologic Response Rate (pRR) for Cohort 1 as Determined by Independent Pathologic Review	77.3 percentage of participants Interval 54.63 to 92.18	80.0 percentage of participants Interval 64.35 to 90.95	45.0 percentage of participants Interval 23.06 to 68.47	60.0 percentage of participants Interval 36.05 to 80.88

PRIMARY outcome

Timeframe: From randomization up to approximately 3.6 months

Population: Efficacy-evaluable population included all participants in Cohort 2 who received at least one dose of each drug for their assigned treatment regimen.

ORR was defined as the percentage of participants with a complete response (CR) or partial response (PR) on two consecutive occasions ≥4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in the short axis to \<10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. Participants with missing or no response assessments were classified as non-responders. ORR was calculated for each arm, along with 95% CIs using Clopper-Pearson method.

Outcome measures

Outcome measures
Measure	Cohort 1: Nivolumab + Ipilimumab (Control) n=8 Participants Participants received nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Tobemstomig 2100 mg Participants received a fixed dose of tobemstomig 2100 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Atezolizumab + Tiragolumab Participants received atezolizumab 1200 mg IV and tiragolumab 600 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Tobemstomig + Tiragolumab Participants received tobemstomig 2100 mg IV and tiragolumab 600 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.
Objective Response Rate (ORR) for Cohort 2 as Determined by the Investigator	0 percentage of participants Interval 0.0 to 36.94	—	—	—

SECONDARY outcome

Timeframe: Time of surgery ( scheduled at Week 7)

Population: Efficacy-evaluable population included all participants in Cohort 1 who received at least one dose of each drug for their assigned treatment regimen.

pRR was defined as the percentage of participants with pCR, pnCR, and pPR as determined by a local pathologic review. pCR was defined as a complete absence of viable tumor cells, pnCR as \> 0 to ≤ 10% of viable tumor cells, and pPR was defined as \> 10 to ≤ 50% of viable tumor cells in the dissected lymph node. Participants with missing or no pathologic response assessment, including participants who did not proceed to CLND, were classified as non-responders. pRR was calculated for each arm along with 95% CIs using Clopper-Pearson method. The difference in pRR between the experimental arms and the control arm was calculated, along with 95% CIs using the Wald method with continuity correction.

Outcome measures

Outcome measures
Measure	Cohort 1: Nivolumab + Ipilimumab (Control) n=22 Participants Participants received nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Tobemstomig 2100 mg n=40 Participants Participants received a fixed dose of tobemstomig 2100 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Atezolizumab + Tiragolumab n=20 Participants Participants received atezolizumab 1200 mg IV and tiragolumab 600 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Tobemstomig + Tiragolumab n=20 Participants Participants received tobemstomig 2100 mg IV and tiragolumab 600 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.
pRR for Cohort 1 as Determined by Local Pathologic Assessment	81.8 percentage of participants Interval 59.72 to 94.81	75.0 percentage of participants Interval 58.8 to 87.31	50.0 percentage of participants Interval 27.2 to 72.8	60.0 percentage of participants Interval 36.05 to 80.88

SECONDARY outcome

Timeframe: From randomization to disease progression, disease recurrence or death or last tumor assessment (up to 22.51 months)

Population: Efficacy-evaluable population included all participants in Cohort 1 who received at least one dose of each drug for their assigned treatment regimen.

EFS was defined as the time from randomization to any of the following events (whichever occurs first): documented disease progression (PD) that precludes surgery, as assessed by investigator per RECIST v1.1, local, regional, or distant disease recurrence, or death from any cause. PD = as at least a 20% increase in smallest sum of diameter (SOD) of target lesions, taking as reference the smallest SOD on study (including baseline). Local recurrence was defined as tumor regrowth within 2 cm of the primary lesion's tumor bed; regional recurrence as any nodal or non-nodal tumor lesions that are \> 2 cm from the primary lesion but not beyond the regional nodal basin; distant recurrence as any non-local/non-regional recurrence. Participants without disease recurrence, progression, or death at the time of analysis were censored at the time of the last tumor assessment. Kaplan-Meier method was used to estimate the median for EFS, and 95% CIs was constructed using Brookmeyer and Crowley method.

Outcome measures

Outcome measures
Measure	Cohort 1: Nivolumab + Ipilimumab (Control) n=22 Participants Participants received nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Tobemstomig 2100 mg n=40 Participants Participants received a fixed dose of tobemstomig 2100 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Atezolizumab + Tiragolumab n=20 Participants Participants received atezolizumab 1200 mg IV and tiragolumab 600 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Tobemstomig + Tiragolumab n=20 Participants Participants received tobemstomig 2100 mg IV and tiragolumab 600 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.
Event-free Survival (EFS) for Cohort 1	19.55 months Interval 19.55 to The upper limit of the 95% CI was not estimable due to insufficient number of participants with events.	NA months Interval 14.09 to The median and upper limit of the 95% CI was not estimable due to insufficient number of participants with events.	22.51 months Interval 6.08 to The upper limit of the 95% CI was not estimable due to insufficient number of participants with events.	NA months Interval 6.51 to The median and upper limit of the 95% CI was not estimable due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: From surgery (scheduled at Week 7) to first documented disease recurrence or death or last tumor assessment (up to 20.9 months)

Population: Adjuvant evaluable population included participants in Cohort 1 who had completed surgery (CLND).

RFS was defined as the time from surgery to the first documented recurrence of disease or death from any cause. Recurrent disease includes local, regional, or distant recurrence: local recurrence was defined as tumor regrowth within 2 cm of the primary lesion's tumor bed; regional recurrence as any nodal or non-nodal tumor lesions that are more than 2 cm from the primary lesion but are not beyond the regional nodal basin; distant recurrence as any non-local/non-regional recurrence. Participants without disease recurrence or death at the time of analysis were censored at the last tumor assessment. Kaplan-Meier method was used to estimate the median for RFS, and 95% CIs were constructed using the Brookmeyer and Crowley method.

Outcome measures

Outcome measures
Measure	Cohort 1: Nivolumab + Ipilimumab (Control) n=22 Participants Participants received nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Tobemstomig 2100 mg n=38 Participants Participants received a fixed dose of tobemstomig 2100 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Atezolizumab + Tiragolumab n=18 Participants Participants received atezolizumab 1200 mg IV and tiragolumab 600 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Tobemstomig + Tiragolumab n=19 Participants Participants received tobemstomig 2100 mg IV and tiragolumab 600 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.
Relapse-free Survival (RFS) for Cohort 1	17.91 months Interval 17.91 to The upper limit of the 95% CI was not estimable due to insufficient number of participants with events.	17.08 months Interval 11.79 to The upper limit of the 95% CI was not estimable due to insufficient number of participants with events.	20.90 months Interval 4.4 to The upper limit of the 95% CI was not estimable due to insufficient number of participants with events.	NA months The median and 95% CI was not estimable due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: From randomization to death from any cause or last known to be alive (Up to 25 months)

Population: Efficacy-evaluable population included all participants in Cohort 1 who received at least one dose of each drug for their assigned treatment regimen.

OS was defined as the time from randomization to death from any cause. Participants who were still alive at the time of OS analysis were censored at the last date they were known to be alive. Kaplan-Meier method was used to estimate the median for OS, 95% CIs were constructed using the Brookmeyer and Crowley method.

Outcome measures

Outcome measures
Measure	Cohort 1: Nivolumab + Ipilimumab (Control) n=22 Participants Participants received nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Tobemstomig 2100 mg n=40 Participants Participants received a fixed dose of tobemstomig 2100 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Atezolizumab + Tiragolumab n=20 Participants Participants received atezolizumab 1200 mg IV and tiragolumab 600 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Tobemstomig + Tiragolumab n=20 Participants Participants received tobemstomig 2100 mg IV and tiragolumab 600 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.
Overall Survival (OS) for Cohort 1	NA months The median and 95% CI was not estimable due to insufficient number of participants with events.	NA months The median and 95% CI was not estimable due to insufficient number of participants with events.	NA months The median and 95% CI was not estimable due to insufficient number of participants with events.	NA months The median and 95% CI was not estimable due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: Prior to surgery (up to Week 6)

Population: Efficacy-evaluable population included all participants in Cohort 1 who received at least one dose of each drug for their assigned treatment regimen.

ORR was defined as the percentage of participants with a CR or PR, as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. Participants with missing or no response assessments were classified as non-responders. ORR was calculated for each arm, along with 95% CIs using the Clopper-Pearson method. The difference in ORR between the experimental arms and the control arm was calculated, along with 95% CIs using the Wald method with continuity correction.

Outcome measures

Outcome measures
Measure	Cohort 1: Nivolumab + Ipilimumab (Control) n=22 Participants Participants received nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Tobemstomig 2100 mg n=40 Participants Participants received a fixed dose of tobemstomig 2100 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Atezolizumab + Tiragolumab n=20 Participants Participants received atezolizumab 1200 mg IV and tiragolumab 600 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Tobemstomig + Tiragolumab n=20 Participants Participants received tobemstomig 2100 mg IV and tiragolumab 600 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.
ORR for Cohort 1	59.1 percentage of participants Interval 36.35 to 79.29	37.5 percentage of participants Interval 22.73 to 54.2	35.0 percentage of participants Interval 15.39 to 59.22	60.0 percentage of participants Interval 36.05 to 80.88

SECONDARY outcome

Timeframe: From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months)

Population: Safety-evaluable population included all randomized participants in Cohort 1 who received any amount of study treatment. All AEs were reported until 30 days after final dose or until initiation of new systemic anti-cancer therapy (whichever occurs first). Serious AEs and AEs of special interest (AESIs) and treatment-related non-serious AEs that lead to surgery delay were reported until 135 days after final dose or until initiation of new systemic anti-cancer therapy (whichever occurs first).

An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. Severity was determined per NCI CTCAE v5.0 Grade 1: Mild; asymptomatic or mild symptoms; clinical/diagnostic observations only; or intervention not indicated; Grade 2:Moderate; minimal, local/non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living (ADL); Grade 3: Severe or medically significant, but not immediately life-threatening: hospitalization or prolongation of hospitalization indicated; disabling or limiting self-care ADL; Grade 4: Life-threatening consequences or urgent intervention indicated; Grade 5: Death related to AE. Multiple occurrences of AEs in the same category at the worst (highest) NCIC-CTCAE grade for an individual are counted only once.

Outcome measures

Outcome measures
Measure	Cohort 1: Nivolumab + Ipilimumab (Control) n=22 Participants Participants received nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Tobemstomig 2100 mg n=40 Participants Participants received a fixed dose of tobemstomig 2100 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Atezolizumab + Tiragolumab n=20 Participants Participants received atezolizumab 1200 mg IV and tiragolumab 600 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Tobemstomig + Tiragolumab n=20 Participants Participants received tobemstomig 2100 mg IV and tiragolumab 600 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.
Number of Participants With Adverse Events (AEs) and Severity of AEs Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0) for Cohort 1 AE, Any Grade	19 Participants	36 Participants	19 Participants	18 Participants
Number of Participants With Adverse Events (AEs) and Severity of AEs Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0) for Cohort 1 Worst Grade, Grade 1 AE	4 Participants	13 Participants	9 Participants	4 Participants
Number of Participants With Adverse Events (AEs) and Severity of AEs Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0) for Cohort 1 Worst Grade, Grade 2 AE	9 Participants	15 Participants	9 Participants	8 Participants
Number of Participants With Adverse Events (AEs) and Severity of AEs Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0) for Cohort 1 Worst Grade, Grade 3 AE	4 Participants	5 Participants	1 Participants	6 Participants
Number of Participants With Adverse Events (AEs) and Severity of AEs Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0) for Cohort 1 Worst Grade, Grade 4 AE	2 Participants	3 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events (AEs) and Severity of AEs Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0) for Cohort 1 Worst Grade, Grade 5 AE	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From initiation of study treatment up to 135 days after the final dose of study treatment (Up to 5.6 months)

Population: Safety-evaluable population included all randomized participants in Cohort 1 who received any amount of the study treatment.

An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product. Participants with immune-related adverse events Grade ≥ 3 were reported.

Outcome measures

Outcome measures
Measure	Cohort 1: Nivolumab + Ipilimumab (Control) n=22 Participants Participants received nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Tobemstomig 2100 mg n=40 Participants Participants received a fixed dose of tobemstomig 2100 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Atezolizumab + Tiragolumab n=20 Participants Participants received atezolizumab 1200 mg IV and tiragolumab 600 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Tobemstomig + Tiragolumab n=20 Participants Participants received tobemstomig 2100 mg IV and tiragolumab 600 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.
Number of Participants With Immune-related AEs Grade ≥ 3 for Cohort 1	5 Participants	1 Participants	0 Participants	3 Participants

SECONDARY outcome

Timeframe: Time of surgery (scheduled at Week 7) up to 40.1 weeks

Population: Safety-evaluable population included all randomized participants in Cohort 1 who received any amount of the study treatment.

Rate of delayed surgery due to treatment related AEs was defined as the percentage of participants for whom surgery was delayed due to treatment-related AEs for more than 2 weeks. An AE was any untoward medical occurrence in a clinical investigation participants administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with the use of the investigational product, whether considered related to the investigational product.

Outcome measures

Outcome measures
Measure	Cohort 1: Nivolumab + Ipilimumab (Control) n=22 Participants Participants received nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Tobemstomig 2100 mg n=40 Participants Participants received a fixed dose of tobemstomig 2100 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Atezolizumab + Tiragolumab n=20 Participants Participants received atezolizumab 1200 mg IV and tiragolumab 600 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Tobemstomig + Tiragolumab n=20 Participants Participants received tobemstomig 2100 mg IV and tiragolumab 600 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.
Rate of Delayed Surgery Due to Treatment-related AEs	13.6 percentage of participants	2.5 percentage of participants	0 percentage of participants	5.0 percentage of participants

SECONDARY outcome

Timeframe: Time of surgery (scheduled at Week 7) up to 40.1 weeks

Population: Safety-evaluable population included all randomized participants in Cohort 1 who received any amount of the study treatment. Participants with a surgery delay of more than 2 weeks due to treatment-related AE were analyzed.

Duration of surgery delay due to treatment related AEs was calculated on the participants for whom surgery was delayed due to treatment-related AEs for more than 2 weeks. An AE was any untoward medical occurrence in a clinical investigation participants administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with the use of the investigational product, whether considered related to the investigational product.

Outcome measures

Outcome measures
Measure	Cohort 1: Nivolumab + Ipilimumab (Control) n=3 Participants Participants received nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Tobemstomig 2100 mg n=1 Participants Participants received a fixed dose of tobemstomig 2100 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Atezolizumab + Tiragolumab Participants received atezolizumab 1200 mg IV and tiragolumab 600 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Tobemstomig + Tiragolumab n=1 Participants Participants received tobemstomig 2100 mg IV and tiragolumab 600 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.
Duration of Surgery Delay Due to Treatment-related AEs	17.0 weeks Standard Deviation 14.8	5.1 weeks Standard Deviation NA The Standard Deviation (SD) was not estimable due to insufficient number of participants with events.	—	3.0 weeks Standard Deviation NA The SD was not estimable due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: At treatment discontinuation visit (Week 13) and Surgery Follow-Up (6 months after surgery)

Population: Safety-evaluable population included all randomized participants in Cohort 1 who received any amount of the study treatment. Overall number analyzed is the number of participants who underwent surgery. Number analyzed is the number of participants with surgical complication.

Surgical complications were scored according to the Clavien-Dindo surgical classification. Complication rates for every grade were reported and scored for participants who underwent CLND. The Surgical complications according to Clavien-Dindo can be classified into the following grades: Grade I: Any complication that does not need pharmacological treatment or surgical, endoscopic, and radiological interventions. Grade II: Complications that require pharmacological treatment with drugs or blood transfusions and total parenteral nutrition. Grade III: Complications that require surgical, endoscopic, or radiological intervention with (Grade IIIb) or without (Grade IIIa) general anesthesia. Grade IV: Life-threatening complications requiring intensive care unit (ICU) management, which may be single organ (Grade IVa) or multiorgan (Grade IVb) dysfunction. Grade V: Complications that might cause the death of a participant. Values have been rounded off to 2 decimal digits.

Outcome measures

Outcome measures
Measure	Cohort 1: Nivolumab + Ipilimumab (Control) n=22 Participants Participants received nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Tobemstomig 2100 mg n=38 Participants Participants received a fixed dose of tobemstomig 2100 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Atezolizumab + Tiragolumab n=18 Participants Participants received atezolizumab 1200 mg IV and tiragolumab 600 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Tobemstomig + Tiragolumab n=19 Participants Participants received tobemstomig 2100 mg IV and tiragolumab 600 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.
Surgical Complication Rates for Cohort 1 Treatment Discontinuation Visit: Grade 0	0 percentage of participants	0 percentage of participants	5.55 percentage of participants	5.26 percentage of participants
Surgical Complication Rates for Cohort 1 Treatment Discontinuation Visit: Grade I	18.18 percentage of participants	5.26 percentage of participants	22.22 percentage of participants	0 percentage of participants
Surgical Complication Rates for Cohort 1 Treatment Discontinuation Visit: Grade II	13.63 percentage of participants	18.42 percentage of participants	16.66 percentage of participants	10.52 percentage of participants
Surgical Complication Rates for Cohort 1 Treatment Discontinuation Visit: Grade IIIa	0 percentage of participants	7.89 percentage of participants	0 percentage of participants	5.26 percentage of participants
Surgical Complication Rates for Cohort 1 Treatment Discontinuation Visit: Grade IIIb	0 percentage of participants	2.63 percentage of participants	0 percentage of participants	10.52 percentage of participants
Surgical Complication Rates for Cohort 1 Treatment Discontinuation Visit: Grade IVa	0 percentage of participants	2.63 percentage of participants	0 percentage of participants	0 percentage of participants
Surgical Complication Rates for Cohort 1 Long-term Follow-up Month 6: Grade 0	0 percentage of participants	0 percentage of participants	5.88 percentage of participants	0 percentage of participants
Surgical Complication Rates for Cohort 1 Long-term Follow-up Month 6: Grade I	13.63 percentage of participants	8.11 percentage of participants	17.64 percentage of participants	0 percentage of participants
Surgical Complication Rates for Cohort 1 Long-term Follow-up Month 6: Grade II	4.54 percentage of participants	10.81 percentage of participants	5.88 percentage of participants	0 percentage of participants
Surgical Complication Rates for Cohort 1 Long-term Follow-up Month 6: Grade IIIa	0 percentage of participants	13.51 percentage of participants	5.88 percentage of participants	0 percentage of participants
Surgical Complication Rates for Cohort 1 Long-term Follow-up Month 6: Grade IIIb	0 percentage of participants	0 percentage of participants	0 percentage of participants	11.76 percentage of participants
Surgical Complication Rates for Cohort 1 Long-term Follow-up Month 6: Grade IVa	0 percentage of participants	2.7 percentage of participants	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: From randomization/enrollment to first documented disease progression or death or last tumor assessment (up to 3.6 months)

Population: Efficacy-evaluable population included all participants in Cohort 2 who received at least one dose of each drug for their assigned treatment regimen.

PFS after randomization/enrollment was defined as the time from randomization/enrollment to the first occurrence of disease progression or death from any cause (whichever occurred first), as determined by the investigator according to RECIST v1.1. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on the study (including baseline) and/or unequivocal progression of a non-target lesion and/or any new lesion. Participants without documented disease progression or death at the time of analysis were censored at the day of the last tumor assessment. Kaplan-Meier method was used to estimate the median for PFS, with 95% CIs constructed by using the Brookmeyer and Crowley method.

Outcome measures

Outcome measures
Measure	Cohort 1: Nivolumab + Ipilimumab (Control) n=8 Participants Participants received nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Tobemstomig 2100 mg Participants received a fixed dose of tobemstomig 2100 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Atezolizumab + Tiragolumab Participants received atezolizumab 1200 mg IV and tiragolumab 600 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Tobemstomig + Tiragolumab Participants received tobemstomig 2100 mg IV and tiragolumab 600 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.
Progression-Free Survival (PFS) for Cohort 2	2.07 months Interval 1.68 to 2.37	—	—	—

SECONDARY outcome

Timeframe: From randomization/enrollment to death from any cause or last known to be alive (Up to 24.2 months)

Population: Efficacy-evaluable population included all participants in Cohort 2 who received at least one dose of each drug for their assigned treatment regimen.

OS was defined as the time from randomization to death from any cause. Participants who were still alive at the time of OS analysis were censored at the last date they were known to be alive. Kaplan-Meier method was used to estimate the median for OS, with 95% CIs constructed by using the Brookmeyer and Crowley method.

Outcome measures

Outcome measures
Measure	Cohort 1: Nivolumab + Ipilimumab (Control) n=8 Participants Participants received nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Tobemstomig 2100 mg Participants received a fixed dose of tobemstomig 2100 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Atezolizumab + Tiragolumab Participants received atezolizumab 1200 mg IV and tiragolumab 600 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Tobemstomig + Tiragolumab Participants received tobemstomig 2100 mg IV and tiragolumab 600 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.
OS for Cohort 2	8.94 months Interval 4.17 to The upper limit of the 95% CI was not estimable due to insufficient number of participants with events.	—	—	—

SECONDARY outcome

Timeframe: Months 3, 6 and 12

Population: Efficacy-evaluable population included all participants in Cohort 2 who received at least one dose of each drug for their assigned treatment regimen. Number analyzed per timepoint are unique number of participants out of all the assessed participants who remain at risk for an OS event at that timepoint. Different participants may have contributed data for each timepoint.

OS was defined as the time from randomization to death from any cause. OS rate is percentage of participants who were event free for OS. Participants who were still alive at the time of OS analysis were censored at the last date they were known to be alive. OS rate at specific time points were estimated using the Kaplan-Meier method, with 95% CIs calculated based on Greenwood's estimate for the variance.

Outcome measures

Outcome measures
Measure	Cohort 1: Nivolumab + Ipilimumab (Control) n=8 Participants Participants received nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Tobemstomig 2100 mg Participants received a fixed dose of tobemstomig 2100 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Atezolizumab + Tiragolumab Participants received atezolizumab 1200 mg IV and tiragolumab 600 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Tobemstomig + Tiragolumab Participants received tobemstomig 2100 mg IV and tiragolumab 600 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.
OS Rates at Specific Timepoints for Cohort 2 6 months	71.43 percentage of participants Interval 37.96 to 100.0	—	—	—
OS Rates at Specific Timepoints for Cohort 2 3 months	100.0 percentage of participants Interval 100.0 to 100.0	—	—	—
OS Rates at Specific Timepoints for Cohort 2 12 months	47.62 percentage of participants Interval 3.47 to 91.77	—	—	—

SECONDARY outcome

Timeframe: Time from the first occurrence of a documented OR to disease progression or death from any cause (up to 3.6 months)

Population: Efficacy-evaluable population included all participants in Cohort 2 who received at least one dose of each drug for their assigned treatment regimen. DOR was only evaluated in participants who achieved an OR (CR or PR).

DOR was defined as the time from the first occurrence of a documented objective response (OR) to disease progression or death from any cause (whichever occurred first), as determined by the investigator according to RECIST v1.1. OR was defined as a CR or PR on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to RECIST v1.1. CR = disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to \<10 mm. PR = at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on the study (including baseline). Participants without PD or death at time of analysis were censored at time of last tumor assessment. Kaplan-Meier method was used to estimate median for DOR, with 95% CIs constructed using Brookmeyer \& Crowley method.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From randomization up to 3.6 months

Population: Efficacy-evaluable population included all participants in Cohort 2 who received at least one dose of each drug for their assigned treatment regimen.

DCR was defined as the percentage of participants with stable disease for ≥ 12 weeks or a CR or PR, as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. Stable disease was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on the study (including baseline). DCR was calculated for each treatment arm, with 95% CIs estimated through use of Clopper-Pearson's exact method.

Outcome measures

Outcome measures
Measure	Cohort 1: Nivolumab + Ipilimumab (Control) n=8 Participants Participants received nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Tobemstomig 2100 mg Participants received a fixed dose of tobemstomig 2100 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Atezolizumab + Tiragolumab Participants received atezolizumab 1200 mg IV and tiragolumab 600 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Tobemstomig + Tiragolumab Participants received tobemstomig 2100 mg IV and tiragolumab 600 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.
Disease Control Rate (DCR) for Cohort 2	0 percentage of participants Interval 0.0 to 36.94	—	—	—

SECONDARY outcome

Population: Safety-evaluable population included all randomized participants in Cohort 2 who received any amount of the study treatment. All AEs were reported until 30 days after the final dose or until initiation of new systemic anti-cancer therapy (whichever occurs first). Serious AEs and AESIs were reported until 135 days after the final dose or until initiation of new systemic anti-cancer therapy (whichever occurs first).

An AE=any untoward medical occurrence in clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. AE can therefore be any unfavorable \& unintended sign, symptom/disease temporally associated with using an investigational product, whether or not considered related to the investigational product. Severity was determined per NCI CTCAE v5.0 Grade 1: Mild; asymptomatic/mild symptoms; clinical/diagnostic observations only; or intervention not indicated; Grade 2: Moderate; minimal, local/non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living (ADL); Grade 3: Severe/medically significant, but not immediately life-threatening: hospitalization/prolongation of hospitalization indicated; disabling/limiting self-care ADL; Grade 4: Life-threatening consequences/urgent intervention indicated; Grade 5: Death related to AE. Multiple occurrences of AEs in 1 individual are counted once at highest grade.

Outcome measures

Outcome measures
Measure	Cohort 1: Nivolumab + Ipilimumab (Control) n=8 Participants Participants received nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Tobemstomig 2100 mg Participants received a fixed dose of tobemstomig 2100 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Atezolizumab + Tiragolumab Participants received atezolizumab 1200 mg IV and tiragolumab 600 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Tobemstomig + Tiragolumab Participants received tobemstomig 2100 mg IV and tiragolumab 600 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.
Number of Participants With AEs and Severity of AEs Determined According to NCI CTCAE v5.0 for Cohort 2 AE, Any Grade	7 Participants	—	—	—
Number of Participants With AEs and Severity of AEs Determined According to NCI CTCAE v5.0 for Cohort 2 Worst Grade, Grade 1 AE	0 Participants	—	—	—
Number of Participants With AEs and Severity of AEs Determined According to NCI CTCAE v5.0 for Cohort 2 Worst Grade, Grade 2 AE	6 Participants	—	—	—
Number of Participants With AEs and Severity of AEs Determined According to NCI CTCAE v5.0 for Cohort 2 Worst Grade, Grade 3 AE	1 Participants	—	—	—
Number of Participants With AEs and Severity of AEs Determined According to NCI CTCAE v5.0 for Cohort 2 Worst Grade, Grade 4 AE	0 Participants	—	—	—
Number of Participants With AEs and Severity of AEs Determined According to NCI CTCAE v5.0 for Cohort 2 Worst Grade, Grade 5 AE	0 Participants	—	—	—

Adverse Events

Cohort 1: Nivolumab + Ipilimumab (Control)

Serious events: 4 serious events

Other events: 18 other events

Deaths: 1 deaths

Cohort 1: Tobemstomig 2100 mg

Serious events: 9 serious events

Other events: 34 other events

Deaths: 1 deaths

Cohort 1: Atezolizumab + Tiragolumab

Serious events: 3 serious events

Other events: 18 other events

Deaths: 2 deaths

Cohort 1: Tobemstomig + Tiragolumab

Serious events: 6 serious events

Other events: 18 other events

Deaths: 1 deaths

Cohort 2: Tobemstomig + Tiragolumab

Serious events: 1 serious events

Other events: 7 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1: Nivolumab + Ipilimumab (Control) n=22 participants at risk Participants received nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Tobemstomig 2100 mg n=40 participants at risk Participants received a fixed dose of tobemstomig 2100 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Atezolizumab + Tiragolumab n=20 participants at risk Participants received atezolizumab 1200 mg IV and tiragolumab 600 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Tobemstomig + Tiragolumab n=20 participants at risk Participants received tobemstomig 2100 mg IV and tiragolumab 600 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 2: Tobemstomig + Tiragolumab n=8 participants at risk Participants received tobemstomig 2100 mg IV and tiragolumab 600 mg IV on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status.
Infections and infestations Meningitis aseptic	4.5% 1/22 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Infections and infestations Pneumonia	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	2.5% 1/40 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Infections and infestations Postoperative wound infection	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Injury, poisoning and procedural complications Post procedural haematoma	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	2.5% 1/40 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Injury, poisoning and procedural complications Wound dehiscence	4.5% 1/22 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	2.5% 1/40 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Investigations Heart rate irregular	4.5% 1/22 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Investigations Troponin increased	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Metabolism and nutrition disorders Hyperlipasaemia	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	2.5% 1/40 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	2.5% 1/40 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Respiratory, thoracic and mediastinal disorders Immune-mediated lung disease	4.5% 1/22 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Respiratory, thoracic and mediastinal disorders Pneumonitis	4.5% 1/22 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Surgical and medical procedures Scar excision	4.5% 1/22 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Vascular disorders Haematoma	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Vascular disorders Hypotension	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	2.5% 1/40 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Vascular disorders Lymphatic fistula	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Cardiac disorders Myocardial ischaemia	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	2.5% 1/40 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Cardiac disorders Myocarditis	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Cardiac disorders Ventricular fibrillation	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	2.5% 1/40 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Gastrointestinal disorders Colitis	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	2.5% 1/40 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Gastrointestinal disorders Enteritis	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	12.5% 1/8 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Hepatobiliary disorders Immune-mediated hepatitis	4.5% 1/22 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Infections and infestations Catheter site infection	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	2.5% 1/40 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Infections and infestations Cellulitis	4.5% 1/22 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	2.5% 1/40 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Infections and infestations Infected seroma	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	2.5% 1/40 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.

Other adverse events

Other adverse events
Measure	Cohort 1: Nivolumab + Ipilimumab (Control) n=22 participants at risk Participants received nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Tobemstomig 2100 mg n=40 participants at risk Participants received a fixed dose of tobemstomig 2100 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Atezolizumab + Tiragolumab n=20 participants at risk Participants received atezolizumab 1200 mg IV and tiragolumab 600 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 1: Tobemstomig + Tiragolumab n=20 participants at risk Participants received tobemstomig 2100 mg IV and tiragolumab 600 mg IV on Day 1 of each 21-day cycle for 2 cycles (6 weeks) until surgery (Week 7) or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. Post-surgery at the discretion of the investigator, participants started either adjuvant therapy or an observation phase from Week 13.	Cohort 2: Tobemstomig + Tiragolumab n=8 participants at risk Participants received tobemstomig 2100 mg IV and tiragolumab 600 mg IV on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status.
Blood and lymphatic system disorders Anaemia	4.5% 1/22 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 2/40 • Number of events 2 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	25.0% 2/8 • Number of events 3 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Cardiac disorders Sinus bradycardia	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Endocrine disorders Hyperthyroidism	18.2% 4/22 • Number of events 4 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	17.5% 7/40 • Number of events 7 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	15.0% 3/20 • Number of events 3 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	30.0% 6/20 • Number of events 6 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	12.5% 1/8 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Endocrine disorders Hypophysitis	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Endocrine disorders Hypothyroidism	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	7.5% 3/40 • Number of events 3 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Endocrine disorders Thyroiditis	4.5% 1/22 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 2/40 • Number of events 2 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Eye disorders Dry eye	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 2/40 • Number of events 2 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Eye disorders Eyelid ptosis	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Eye disorders Retinal detachment	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Gastrointestinal disorders Abdominal pain	4.5% 1/22 • Number of events 2 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	2.5% 1/40 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	25.0% 2/8 • Number of events 3 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Gastrointestinal disorders Abdominal tenderness	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	12.5% 1/8 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Gastrointestinal disorders Constipation	9.1% 2/22 • Number of events 2 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	7.5% 3/40 • Number of events 3 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	10.0% 2/20 • Number of events 2 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	12.5% 1/8 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Gastrointestinal disorders Diarrhoea	9.1% 2/22 • Number of events 2 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	7.5% 3/40 • Number of events 3 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	15.0% 3/20 • Number of events 5 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	37.5% 3/8 • Number of events 3 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Gastrointestinal disorders Dry mouth	9.1% 2/22 • Number of events 2 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	7.5% 3/40 • Number of events 3 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	20.0% 4/20 • Number of events 4 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Gastrointestinal disorders Nausea	18.2% 4/22 • Number of events 4 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	2.5% 1/40 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	15.0% 3/20 • Number of events 3 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	12.5% 1/8 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Gastrointestinal disorders Vomiting	4.5% 1/22 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
General disorders Asthenia	9.1% 2/22 • Number of events 2 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 2/40 • Number of events 2 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	20.0% 4/20 • Number of events 4 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
General disorders Chest pain	4.5% 1/22 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	12.5% 1/8 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
General disorders Chills	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	2.5% 1/40 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	20.0% 4/20 • Number of events 4 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
General disorders Extravasation	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
General disorders Fatigue	31.8% 7/22 • Number of events 7 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	37.5% 15/40 • Number of events 15 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	15.0% 3/20 • Number of events 4 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	30.0% 6/20 • Number of events 6 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	50.0% 4/8 • Number of events 4 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
General disorders Hyperthermia	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
General disorders Influenza like illness	4.5% 1/22 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	2.5% 1/40 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	12.5% 1/8 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
General disorders Oedema peripheral	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 2/40 • Number of events 2 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	12.5% 1/8 • Number of events 2 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
General disorders Pain	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	2.5% 1/40 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	10.0% 2/20 • Number of events 2 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
General disorders Peripheral swelling	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	12.5% 1/8 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
General disorders Pyrexia	4.5% 1/22 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	10.0% 2/20 • Number of events 2 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	25.0% 2/8 • Number of events 4 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
General disorders Xerosis	9.1% 2/22 • Number of events 2 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Hepatobiliary disorders Hepatitis	9.1% 2/22 • Number of events 2 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 2/40 • Number of events 2 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Hepatobiliary disorders Hypertransaminasaemia	4.5% 1/22 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 2/40 • Number of events 2 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	10.0% 2/20 • Number of events 2 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Immune system disorders Contrast media allergy	9.1% 2/22 • Number of events 2 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Infections and infestations COVID-19	4.5% 1/22 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	25.0% 2/8 • Number of events 2 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Infections and infestations Cystitis	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Infections and infestations Device related infection	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Infections and infestations Pharyngitis	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Injury, poisoning and procedural complications Infusion related reaction	9.1% 2/22 • Number of events 2 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	15.0% 6/40 • Number of events 8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Injury, poisoning and procedural complications Joint injury	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Injury, poisoning and procedural complications Post procedural constipation	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	2.5% 1/40 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Injury, poisoning and procedural complications Procedural nausea	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 2/40 • Number of events 2 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Injury, poisoning and procedural complications Procedural pain	9.1% 2/22 • Number of events 2 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	20.0% 8/40 • Number of events 8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	20.0% 4/20 • Number of events 4 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	15.0% 3/20 • Number of events 3 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Injury, poisoning and procedural complications Seroma	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	2.5% 1/40 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	12.5% 1/8 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Investigations Alanine aminotransferase increased	13.6% 3/22 • Number of events 3 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 2/40 • Number of events 2 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Investigations Amylase increased	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	7.5% 3/40 • Number of events 3 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Investigations Aspartate aminotransferase increased	4.5% 1/22 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 2/40 • Number of events 2 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Investigations Blood creatinine increased	4.5% 1/22 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 2/40 • Number of events 2 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Investigations International normalised ratio decreased	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Investigations Lipase increased	9.1% 2/22 • Number of events 2 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	7.5% 3/40 • Number of events 4 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	12.5% 1/8 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Investigations SARS-CoV-2 test positive	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	2.5% 1/40 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	12.5% 1/8 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Investigations Serum ferritin decreased	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	12.5% 1/8 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Investigations Troponin increased	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Investigations Weight decreased	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 2/40 • Number of events 2 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Metabolism and nutrition disorders Hyperamylasaemia	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Musculoskeletal and connective tissue disorders Arthralgia	13.6% 3/22 • Number of events 3 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 2/40 • Number of events 3 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	10.0% 2/20 • Number of events 2 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Musculoskeletal and connective tissue disorders Joint stiffness	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	2.5% 1/40 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 2 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Musculoskeletal and connective tissue disorders Myalgia	4.5% 1/22 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	2.5% 1/40 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	10.0% 2/20 • Number of events 2 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Musculoskeletal and connective tissue disorders Myositis	4.5% 1/22 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	2.5% 1/40 • Number of events 2 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	10.0% 2/20 • Number of events 2 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	12.5% 1/8 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 3 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Nervous system disorders Dizziness	9.1% 2/22 • Number of events 2 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	2.5% 1/40 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Nervous system disorders Dysgeusia	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Nervous system disorders Headache	9.1% 2/22 • Number of events 2 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	2.5% 1/40 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 2 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	25.0% 2/8 • Number of events 2 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Nervous system disorders Hypoaesthesia	9.1% 2/22 • Number of events 2 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	2.5% 1/40 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Nervous system disorders Lethargy	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	12.5% 1/8 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Nervous system disorders Paraesthesia	4.5% 1/22 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Nervous system disorders Sensory disturbance	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Psychiatric disorders Confusional state	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Psychiatric disorders Insomnia	4.5% 1/22 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	2.5% 1/40 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	10.0% 2/20 • Number of events 2 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Psychiatric disorders Sleep disorder	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Renal and urinary disorders Renal impairment	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Respiratory, thoracic and mediastinal disorders Cough	9.1% 2/22 • Number of events 2 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 2/40 • Number of events 2 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	10.0% 2/20 • Number of events 2 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	25.0% 2/8 • Number of events 2 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	9.1% 2/22 • Number of events 2 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	2.5% 1/40 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	12.5% 1/8 • Number of events 2 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	2.5% 1/40 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	2.5% 1/40 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	10.0% 2/20 • Number of events 2 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	12.5% 1/8 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Skin and subcutaneous tissue disorders Eczema	4.5% 1/22 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	12.5% 1/8 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Skin and subcutaneous tissue disorders Lichenoid keratosis	9.1% 2/22 • Number of events 3 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 2/40 • Number of events 4 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Skin and subcutaneous tissue disorders Pruritus	36.4% 8/22 • Number of events 8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	15.0% 6/40 • Number of events 6 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	10.0% 2/20 • Number of events 2 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	25.0% 5/20 • Number of events 5 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	25.0% 2/8 • Number of events 3 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Skin and subcutaneous tissue disorders Rash	27.3% 6/22 • Number of events 7 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	17.5% 7/40 • Number of events 8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	15.0% 3/20 • Number of events 3 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	25.0% 2/8 • Number of events 2 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Skin and subcutaneous tissue disorders Rash maculo-papular	4.5% 1/22 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	7.5% 3/40 • Number of events 3 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	10.0% 2/20 • Number of events 2 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	10.0% 2/20 • Number of events 2 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Vascular disorders Haematoma	0.00% 0/22 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.
Vascular disorders Lymphoedema	4.5% 1/22 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/40 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/20 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	5.0% 1/20 • Number of events 1 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.	0.00% 0/8 • From initiation of study treatment up to 135 days (Serious AEs and AESI) or 30 days (all other AEs) after the final dose of study treatment or until initiation of new systemic anti-cancer therapy (Up to 5.6 months for Cohort 1 and 10 months for Cohort 2); All-cause Mortality: Randomization up to the end of long-term follow-up (Up to approximately 25 months for Cohort 1 and 24.2 months for Cohort 2) Safety evaluable population included all randomized participants who received at least one dose of the study drug.

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Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsorâ€™s intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER