Trial Outcomes & Findings for Relative Bioavailability Study of Subcutaneous Injection Versus Intravenous Infusion of Pembrolizumab (MK-3475) in Participants With Advanced Melanoma (MK-3475-555/KEYNOTE-555) (NCT NCT03665597)

Last Updated: 2025-02-10

Results Overview

AUC was defined as a measure of pembrolizumab exposure that was calculated as the product of plasma drug concentration and time. Blood samples were collected at designated time points and a pharmacokinetic (PK) model based on historical intravenous pembrolizumab PK data were used for the determination of the AUC of pembrolizumab. Geometric least-square mean (GM) and 95% confidence intervals were derived from mixed-effects model performed on natural log-transformed values. Data were reported by treatment received.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

138 participants

Primary outcome timeframe

Cycles 1-3: Day 1 Predose and Days 2, 5, 10 and 15; Cycle 4: Day 1 Predose. Samples were also collected after IV infusion on Cycles 1-3: Day 1 ~0.5 hours after infusion and after SC injection on Days 3, 4, 6, and 7. Each cycle was 21 days.

Results posted on

2025-02-10

Participant Flow

138 participants were randomized and 137 participants received at least one dose of study intervention.

Participant milestones

Participant milestones
Measure	Cohort A Pembrolizumab Treatment Sequence 1 Participants received a single dose of pembrolizumab in each 21-day cycle in the following sequence: Cycle 1 Day 1: pembrolizumab 165 mg/mL subcutaneously (SC); Cycle 2 Day 1: pembrolizumab 200 mg intravenously (IV); Cycle 3 Day 1: pembrolizumab 130 mg/mL SC; Cycle 4 Day 1 and every cycle thereafter, up to a total of 35 cycles (up to approximately 2 years), Day 1: pembrolizumab 200 mg IV.	Cohort A Pembrolizumab Treatment Sequence 2 Participants received a single dose of pembrolizumab in each 21-day cycle in the following sequence: Cycle 1 Day 1: pembrolizumab 165 mg/mL SC; Cycle 2 Day 1: pembrolizumab 130 mg/mL SC; Cycle 3 Day 1: pembrolizumab 200 mg IV; Cycle 4 Day 1 and every cycle thereafter, up to a total of 35 cycles (up to approximately 2 years), Day 1: pembrolizumab 200 mg IV.	Cohort A Pembrolizumab Treatment Sequence 3 Participants received a single dose of pembrolizumab in each 21-day cycle in the following sequence: Cycle 1 Day 1: pembrolizumab 130 mg/mL SC; Cycle 2 Day 1: pembrolizumab 165 mg/mL SC; Cycle 3 Day 1: pembrolizumab 200 mg IV; Cycle 4 Day 1 and every cycle thereafter, up to a total of 35 cycles (up to approximately 2 years), Day 1: pembrolizumab 200 mg IV.	Cohort A Pembrolizumab Treatment Sequence 4 Participants received a single dose of pembrolizumab in each 21-day cycle in the following sequence: Cycle 1 Day 1: pembrolizumab 200 mg SC; Cycle 2 Day 1: pembrolizumab 200 mg IV; Cycle 3 Day 1: pembrolizumab 130 mg/mL SC; Cycle 4 Day 1 and every cycle thereafter, up to a total of 35 cycles (up to approximately 2 years), Day 1: pembrolizumab Dose 200 mg IV.	Cohort A Pembrolizumab Treatment Sequence 5 Participants received a single dose of pembrolizumab in each 21-day cycle in the following sequence: Cycle 1 Day 1: pembrolizumab 200 mg IV; Cycle 2 Day 1: pembrolizumab 130 mg/mL SC; Cycle 3 Day 1: pembrolizumab 165 mg/mL SC: Cycle 4 Day 1 and every cycle thereafter, up to a total of 35 cycles (up to approximately 2 years), Day 1: pembrolizumab 200 mg IV.	Cohort A Pembrolizumab Treatment Sequence 6 Participants received a single dose of pembrolizumab in each 21-day cycle in the following sequence: Cycle 1 Day 1: pembrolizumab 200 mg IV; Cycle 2 Day 1: pembrolizumab 165 mg/mL SC; Cycle 3 Day 1: pembrolizumab 130 mg/mL SC; Cycle 4 Day 1 and every cycle thereafter, up to a total of 35 cycles (up to approximately 2 years), Day 1: pembrolizumab 200 mg IV.	Cohort B Pembrolizumab 400 mg IV Participants received a single dose of pembrolizumab 400 mg IV on Day 1 of each 42-day cycle (every 6 weeks; Q6W) for up to 18 cycles (up to approximately 2 years).
Period 1 STARTED	7	6	6	6	5	7	101
Period 1 Treated	7	6	6	5	5	7	101
Period 1 COMPLETED	6	6	6	4	5	7	51
Period 1 NOT COMPLETED	1	0	0	2	0	0	50
Period 2 STARTED	6	6	6	4	5	7	0
Period 2 Treated	6	6	6	4	4	7	0
Period 2 COMPLETED	6	6	6	4	5	6	0
Period 2 NOT COMPLETED	0	0	0	0	0	1	0
Period 3 STARTED	6	6	6	4	5	6	0
Period 3 Treated	6	6	6	4	4	6	0
Period 3 COMPLETED	6	5	6	4	4	6	0
Period 3 NOT COMPLETED	0	1	0	0	1	0	0
Period 4 STARTED	6	5	6	4	4	6	0
Period 4 Treated	6	5	6	4	3	6	0
Period 4 COMPLETED	3	1	2	2	3	6	0
Period 4 NOT COMPLETED	3	4	4	2	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort A Pembrolizumab Treatment Sequence 1 Participants received a single dose of pembrolizumab in each 21-day cycle in the following sequence: Cycle 1 Day 1: pembrolizumab 165 mg/mL subcutaneously (SC); Cycle 2 Day 1: pembrolizumab 200 mg intravenously (IV); Cycle 3 Day 1: pembrolizumab 130 mg/mL SC; Cycle 4 Day 1 and every cycle thereafter, up to a total of 35 cycles (up to approximately 2 years), Day 1: pembrolizumab 200 mg IV.	Cohort A Pembrolizumab Treatment Sequence 2 Participants received a single dose of pembrolizumab in each 21-day cycle in the following sequence: Cycle 1 Day 1: pembrolizumab 165 mg/mL SC; Cycle 2 Day 1: pembrolizumab 130 mg/mL SC; Cycle 3 Day 1: pembrolizumab 200 mg IV; Cycle 4 Day 1 and every cycle thereafter, up to a total of 35 cycles (up to approximately 2 years), Day 1: pembrolizumab 200 mg IV.	Cohort A Pembrolizumab Treatment Sequence 3 Participants received a single dose of pembrolizumab in each 21-day cycle in the following sequence: Cycle 1 Day 1: pembrolizumab 130 mg/mL SC; Cycle 2 Day 1: pembrolizumab 165 mg/mL SC; Cycle 3 Day 1: pembrolizumab 200 mg IV; Cycle 4 Day 1 and every cycle thereafter, up to a total of 35 cycles (up to approximately 2 years), Day 1: pembrolizumab 200 mg IV.	Cohort A Pembrolizumab Treatment Sequence 4 Participants received a single dose of pembrolizumab in each 21-day cycle in the following sequence: Cycle 1 Day 1: pembrolizumab 200 mg SC; Cycle 2 Day 1: pembrolizumab 200 mg IV; Cycle 3 Day 1: pembrolizumab 130 mg/mL SC; Cycle 4 Day 1 and every cycle thereafter, up to a total of 35 cycles (up to approximately 2 years), Day 1: pembrolizumab Dose 200 mg IV.	Cohort A Pembrolizumab Treatment Sequence 5 Participants received a single dose of pembrolizumab in each 21-day cycle in the following sequence: Cycle 1 Day 1: pembrolizumab 200 mg IV; Cycle 2 Day 1: pembrolizumab 130 mg/mL SC; Cycle 3 Day 1: pembrolizumab 165 mg/mL SC: Cycle 4 Day 1 and every cycle thereafter, up to a total of 35 cycles (up to approximately 2 years), Day 1: pembrolizumab 200 mg IV.	Cohort A Pembrolizumab Treatment Sequence 6 Participants received a single dose of pembrolizumab in each 21-day cycle in the following sequence: Cycle 1 Day 1: pembrolizumab 200 mg IV; Cycle 2 Day 1: pembrolizumab 165 mg/mL SC; Cycle 3 Day 1: pembrolizumab 130 mg/mL SC; Cycle 4 Day 1 and every cycle thereafter, up to a total of 35 cycles (up to approximately 2 years), Day 1: pembrolizumab 200 mg IV.	Cohort B Pembrolizumab 400 mg IV Participants received a single dose of pembrolizumab 400 mg IV on Day 1 of each 42-day cycle (every 6 weeks; Q6W) for up to 18 cycles (up to approximately 2 years).
Period 1 Adverse Event	1	0	0	1	0	0	0
Period 1 Screen Failure	0	0	0	1	0	0	0
Period 1 Death	0	0	0	0	0	0	45
Period 1 Withdrawal by Subject	0	0	0	0	0	0	5
Period 2 Adverse Event	0	0	0	0	0	1	0
Period 3 Adverse Event	0	1	0	0	0	0	0
Period 3 Death	0	0	0	0	1	0	0
Period 4 Adverse Event	2	2	2	2	1	0	0
Period 4 Death	0	0	2	0	0	0	0
Period 4 Physician Decision	1	2	0	0	0	0	0

Baseline Characteristics

Relative Bioavailability Study of Subcutaneous Injection Versus Intravenous Infusion of Pembrolizumab (MK-3475) in Participants With Advanced Melanoma (MK-3475-555/KEYNOTE-555)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort A Pembrolizumab Treatment Sequence 1 n=7 Participants Participants received a single dose of pembrolizumab in each 21-day cycle in the following sequence: Cycle 1 Day 1: pembrolizumab 165 mg/mL subcutaneously (SC); Cycle 2 Day 1: pembrolizumab 200 mg intravenously (IV); Cycle 3 Day 1: pembrolizumab 130 mg/mL SC; Cycle 4 Day 1 and every cycle thereafter, up to a total of 35 cycles (up to approximately 2 years), Day 1: pembrolizumab 200 mg IV.	Cohort A Pembrolizumab Treatment Sequence 2 n=6 Participants Participants received a single dose of pembrolizumab in each 21-day cycle in the following sequence: Cycle 1 Day 1: pembrolizumab 165 mg/mL SC; Cycle 2 Day 1: pembrolizumab 130 mg/mL SC; Cycle 3 Day 1: pembrolizumab 200 mg IV; Cycle 4 Day 1 and every cycle thereafter, up to a total of 35 cycles (up to approximately 2 years), Day 1: pembrolizumab 200 mg IV.	Cohort A Pembrolizumab Treatment Sequence 3 n=6 Participants Participants received a single dose of pembrolizumab in each 21-day cycle in the following sequence: Cycle 1 Day 1: pembrolizumab 130 mg/mL SC; Cycle 2 Day 1: pembrolizumab 165 mg/mL SC; Cycle 3 Day 1: pembrolizumab 200 mg IV; Cycle 4 Day 1 and every cycle thereafter, up to a total of 35 cycles (up to approximately 2 years), Day 1: pembrolizumab 200 mg IV.	Cohort A Pembrolizumab Treatment Sequence 4 n=6 Participants Participants received a single dose of pembrolizumab in each 21-day cycle in the following sequence: Cycle 1 Day 1: pembrolizumab 200 mg SC; Cycle 2 Day 1: pembrolizumab 200 mg IV; Cycle 3 Day 1: pembrolizumab 130 mg/mL SC; Cycle 4 Day 1 and every cycle thereafter, up to a total of 35 cycles (up to approximately 2 years), Day 1: pembrolizumab Dose 200 mg IV.	Cohort A Pembrolizumab Treatment Sequence 5 n=5 Participants Participants received a single dose of pembrolizumab in each 21-day cycle in the following sequence: Cycle 1 Day 1: pembrolizumab 200 mg IV; Cycle 2 Day 1: pembrolizumab 130 mg/mL SC; Cycle 3 Day 1: pembrolizumab 165 mg/mL SC: Cycle 4 Day 1 and every cycle thereafter, up to a total of 35 cycles (up to approximately 2 years), Day 1: pembrolizumab 200 mg IV.	Cohort A Pembrolizumab Treatment Sequence 6 n=7 Participants Participants received a single dose of pembrolizumab in each 21-day cycle in the following sequence: Cycle 1 Day 1: pembrolizumab 200 mg IV; Cycle 2 Day 1: pembrolizumab 165 mg/mL SC; Cycle 3 Day 1: pembrolizumab 130 mg/mL SC; Cycle 4 Day 1 and every cycle thereafter, up to a total of 35 cycles (up to approximately 2 years), Day 1: pembrolizumab 200 mg IV.	Cohort B Pembrolizumab 400 mg IV n=101 Participants Participants received a single dose of pembrolizumab 400 mg IV on Day 1 of each 42-day cycle (every 6 weeks; Q6W) for up to 18 cycles (up to approximately 2 years).	Total n=138 Participants Total of all reporting groups
Age, Continuous	60.9 Years STANDARD_DEVIATION 14.9 • n=5 Participants	54.0 Years STANDARD_DEVIATION 20.1 • n=7 Participants	58.2 Years STANDARD_DEVIATION 12.4 • n=5 Participants	49.8 Years STANDARD_DEVIATION 16.7 • n=4 Participants	59.8 Years STANDARD_DEVIATION 18.0 • n=21 Participants	63.0 Years STANDARD_DEVIATION 22.5 • n=8 Participants	62.1 Years STANDARD_DEVIATION 13.9 • n=8 Participants	60.9 Years STANDARD_DEVIATION 14.9 • n=24 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=8 Participants	36 Participants n=8 Participants	45 Participants n=24 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	3 Participants n=4 Participants	4 Participants n=21 Participants	5 Participants n=8 Participants	65 Participants n=8 Participants	93 Participants n=24 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	4 Participants n=4 Participants	3 Participants n=21 Participants	5 Participants n=8 Participants	93 Participants n=8 Participants	120 Participants n=24 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=8 Participants	8 Participants n=8 Participants	18 Participants n=24 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	1 Participants n=24 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	8 Participants n=8 Participants	8 Participants n=24 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	5 Participants n=21 Participants	7 Participants n=8 Participants	87 Participants n=8 Participants	124 Participants n=24 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	4 Participants n=8 Participants	4 Participants n=24 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	1 Participants n=24 Participants

PRIMARY outcome

Timeframe: Cycles 1-3: Day 1 Predose and Days 2, 5, 10 and 15; Cycle 4: Day 1 Predose. Samples were also collected after IV infusion on Cycles 1-3: Day 1 ~0.5 hours after infusion and after SC injection on Days 3, 4, 6, and 7. Each cycle was 21 days.

Population: All participants in Cohort A who were complaint with the study procedures and had available data from IV treatment and at least one SC treatment cycle were analyzed per protocol by treatment. Per protocol, participants in Cohort B were analyzed separately.

Outcome measures

Outcome measures
Measure	Cohort A Pembrolizumab 130 mg/mL SC n=32 Participants Participants received pembrolizumab 130 mg/mL via subcutaneous injection on Day 1 of a 21-day cycle.	Cohort A Pembrolizumab 165 mg/mL SC n=32 Participants Participants received pembrolizumab 165 mg/mL via subcutaneous injection on Day 1 of a 21-day cycle.	Cohort A Pembrolizumab 200 mg IV n=32 Participants Participants received pembrolizumab 200 mg via intravenous injection on Day 1 of a 21-day cycle.	Combined Cohort A On Day 1 of Cycle 1 through Cycle 4, participants received one dose of the following: pembrolizumab 130 mg/mL via subcutaneous injection, pembrolizumab 165 mg/mL via subcutaneous injection, or pembrolizumab 200 mg via intravenous injection, depending on randomized treatment sequence. Each cycle was 21 days.
Area Under the Concentration-Time Curve (AUC) of Pembrolizumab - Cohort A	507 mg*day/L Interval 440.0 to 585.0	480 mg*day/L Interval 418.0 to 551.0	695 mg*day/L Interval 631.0 to 766.0	—

PRIMARY outcome

Cmax was defined as the maximum concentration of pembrolizumab observed in plasma following a single dose. Blood samples were collected at designated time points and a PK model based on historical intravenous pembrolizumab PK data were used for the determination of the AUC of pembrolizumab. GM and 95% confidence intervals were derived from mixed-effects model performed on natural log-transformed values. Data were reported by treatment received.

Outcome measures

Outcome measures
Measure	Cohort A Pembrolizumab 130 mg/mL SC n=32 Participants Participants received pembrolizumab 130 mg/mL via subcutaneous injection on Day 1 of a 21-day cycle.	Cohort A Pembrolizumab 165 mg/mL SC n=32 Participants Participants received pembrolizumab 165 mg/mL via subcutaneous injection on Day 1 of a 21-day cycle.	Cohort A Pembrolizumab 200 mg IV n=32 Participants Participants received pembrolizumab 200 mg via intravenous injection on Day 1 of a 21-day cycle.	Combined Cohort A On Day 1 of Cycle 1 through Cycle 4, participants received one dose of the following: pembrolizumab 130 mg/mL via subcutaneous injection, pembrolizumab 165 mg/mL via subcutaneous injection, or pembrolizumab 200 mg via intravenous injection, depending on randomized treatment sequence. Each cycle was 21 days.
Maximum Plasma Concentration (Cmax) of Pembrolizumab - Cohort A	28.6 mg/L Interval 24.7 to 33.1	26.8 mg/L Interval 23.2 to 30.9	71.3 mg/L Interval 65.6 to 77.5	—

PRIMARY outcome

Population: All participants in Cohort A who were compliant with the study procedure and had available data from IV treatment and at least one SC treatment cycle were analyzed. Per protocol, data were pre-specified to be combined for participants in Cohort A; therefore data by individual dose were not analyzed. Participants in Cohort B weren't analyzed, per protocol.

Blood samples were collected at designated time points and a population PK model based on historical intravenous pembrolizumab PK data was used for the determination of the F of pembrolizumab. Per protocol, an integrated population PK analysis was performed and combined data for Cohort A was reported.

Outcome measures

Outcome measures
Measure	Cohort A Pembrolizumab 130 mg/mL SC Participants received pembrolizumab 130 mg/mL via subcutaneous injection on Day 1 of a 21-day cycle.	Cohort A Pembrolizumab 165 mg/mL SC Participants received pembrolizumab 165 mg/mL via subcutaneous injection on Day 1 of a 21-day cycle.	Cohort A Pembrolizumab 200 mg IV Participants received pembrolizumab 200 mg via intravenous injection on Day 1 of a 21-day cycle.	Combined Cohort A n=32 Participants On Day 1 of Cycle 1 through Cycle 4, participants received one dose of the following: pembrolizumab 130 mg/mL via subcutaneous injection, pembrolizumab 165 mg/mL via subcutaneous injection, or pembrolizumab 200 mg via intravenous injection, depending on randomized treatment sequence. Each cycle was 21 days.
Bioavailability (F) of Pembrolizumab - Cohort A	—	—	—	66 Percent Interval 58.0 to 74.0

PRIMARY outcome

Blood samples were collected at designated time points and a population PK model based on historical intravenous pembrolizumab PK data was used for the determination of the Ka of pembrolizumab. Per protocol, an integrated population PK analysis was performed and combined data for Cohort A was reported. Participants in Cohort B weren't analyzed, per protocol.

Outcome measures

Outcome measures
Measure	Cohort A Pembrolizumab 130 mg/mL SC Participants received pembrolizumab 130 mg/mL via subcutaneous injection on Day 1 of a 21-day cycle.	Cohort A Pembrolizumab 165 mg/mL SC Participants received pembrolizumab 165 mg/mL via subcutaneous injection on Day 1 of a 21-day cycle.	Cohort A Pembrolizumab 200 mg IV Participants received pembrolizumab 200 mg via intravenous injection on Day 1 of a 21-day cycle.	Combined Cohort A n=32 Participants On Day 1 of Cycle 1 through Cycle 4, participants received one dose of the following: pembrolizumab 130 mg/mL via subcutaneous injection, pembrolizumab 165 mg/mL via subcutaneous injection, or pembrolizumab 200 mg via intravenous injection, depending on randomized treatment sequence. Each cycle was 21 days.
Absorption Rate Constant (Ka) of Pembrolizumab - Cohort A	—	—	—	0.191 1/day Standard Error 13.1

PRIMARY outcome

Blood samples were collected at designated time points for the determination of the Tmax of pembrolizumab.

Outcome measures

Outcome measures
Measure	Cohort A Pembrolizumab 130 mg/mL SC n=32 Participants Participants received pembrolizumab 130 mg/mL via subcutaneous injection on Day 1 of a 21-day cycle.	Cohort A Pembrolizumab 165 mg/mL SC n=32 Participants Participants received pembrolizumab 165 mg/mL via subcutaneous injection on Day 1 of a 21-day cycle.	Cohort A Pembrolizumab 200 mg IV n=32 Participants Participants received pembrolizumab 200 mg via intravenous injection on Day 1 of a 21-day cycle.	Combined Cohort A On Day 1 of Cycle 1 through Cycle 4, participants received one dose of the following: pembrolizumab 130 mg/mL via subcutaneous injection, pembrolizumab 165 mg/mL via subcutaneous injection, or pembrolizumab 200 mg via intravenous injection, depending on randomized treatment sequence. Each cycle was 21 days.
Time of Maximum Plasma Concentration (Tmax) of Pembrolizumab - Cohort A	6.55 Days Interval 3.7 to 21.0	8.35 Days Interval 3.0 to 21.0	0.02 Days Interval 0.02 to 0.02	—

PRIMARY outcome

Population: All participants who were complaint with the study procedures and had available data from IV treatment and at least one SC treatment cycle were analyzed. Per protocol, data were pre-specified to be combined for participants in Cohort A; therefore data by individual dose were not analyzed. Participants in Cohort B weren't analyzed, per protocol.

Blood samples were collected at designated time points and a population PK model based on historical intravenous pembrolizumab PK data was used for the determination of the CL of pembrolizumab. Per protocol, an integrated population PK analysis was performed and combined data for Cohort A was reported.

Outcome measures

Outcome measures
Measure	Cohort A Pembrolizumab 130 mg/mL SC Participants received pembrolizumab 130 mg/mL via subcutaneous injection on Day 1 of a 21-day cycle.	Cohort A Pembrolizumab 165 mg/mL SC Participants received pembrolizumab 165 mg/mL via subcutaneous injection on Day 1 of a 21-day cycle.	Cohort A Pembrolizumab 200 mg IV Participants received pembrolizumab 200 mg via intravenous injection on Day 1 of a 21-day cycle.	Combined Cohort A n=32 Participants On Day 1 of Cycle 1 through Cycle 4, participants received one dose of the following: pembrolizumab 130 mg/mL via subcutaneous injection, pembrolizumab 165 mg/mL via subcutaneous injection, or pembrolizumab 200 mg via intravenous injection, depending on randomized treatment sequence. Each cycle was 21 days.
Clearance (CL) of Pembrolizumab - Cohort A	—	—	—	0.25 Liters/day Standard Error 6.28

PRIMARY outcome

Population: All participants in Cohort A who were complaint with the study procedures and had available data from IV treatment and at least one SC treatment cycle were analyzed. Per protocol, data were pre-specified to be combined for participants in Cohort A; therefore data by individual dose were not analyzed. Participants in Cohort B weren't analyzed, per protocol.

Blood samples were collected at designated time points and a population PK model based on historical intravenous pembrolizumab PK data was used for the determination of the Vc of pembrolizumab. Per protocol, an integrated population PK analysis was performed and combined data for Cohort A was reported.

Outcome measures

Outcome measures
Measure	Cohort A Pembrolizumab 130 mg/mL SC Participants received pembrolizumab 130 mg/mL via subcutaneous injection on Day 1 of a 21-day cycle.	Cohort A Pembrolizumab 165 mg/mL SC Participants received pembrolizumab 165 mg/mL via subcutaneous injection on Day 1 of a 21-day cycle.	Cohort A Pembrolizumab 200 mg IV Participants received pembrolizumab 200 mg via intravenous injection on Day 1 of a 21-day cycle.	Combined Cohort A n=32 Participants On Day 1 of Cycle 1 through Cycle 4, participants received one dose of the following: pembrolizumab 130 mg/mL via subcutaneous injection, pembrolizumab 165 mg/mL via subcutaneous injection, or pembrolizumab 200 mg via intravenous injection, depending on randomized treatment sequence. Each cycle was 21 days.
Central Volume of Distribution (Vc) of Pembrolizumab - Cohort A	—	—	—	3.39 Liters Standard Error 5.68

PRIMARY outcome

Timeframe: Up to approximately 54 months

Population: All randomized participants in Cohort B who received at least one dose of study intervention were analyzed. Per protocol, participants in Cohort A were not analyzed.

ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions). Responses were based upon blinded independent central review (BICR) per RECIST 1.1. ORR was reported for participants in Cohort B.

Outcome measures

Outcome measures
Measure	Cohort A Pembrolizumab 130 mg/mL SC n=101 Participants Participants received pembrolizumab 130 mg/mL via subcutaneous injection on Day 1 of a 21-day cycle.	Cohort A Pembrolizumab 165 mg/mL SC Participants received pembrolizumab 165 mg/mL via subcutaneous injection on Day 1 of a 21-day cycle.	Cohort A Pembrolizumab 200 mg IV Participants received pembrolizumab 200 mg via intravenous injection on Day 1 of a 21-day cycle.	Combined Cohort A On Day 1 of Cycle 1 through Cycle 4, participants received one dose of the following: pembrolizumab 130 mg/mL via subcutaneous injection, pembrolizumab 165 mg/mL via subcutaneous injection, or pembrolizumab 200 mg via intravenous injection, depending on randomized treatment sequence. Each cycle was 21 days.
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Cohort B	53.5 Percentage of Participants Interval 43.3 to 63.5	—	—	—

SECONDARY outcome

Timeframe: Cycles 1-4 Day 1: Predose. Each cycle is 21 days. (Up to approximately 64 days)

Population: All randomized participants in Cohort A who had at least one, conclusive ADA sample available after treatment with pembrolizumab in Cycles 1 through Cycle 4 were analyzed. Participants in Cohort B weren't analyzed, per protocol.

Blood samples were collected at designated time points for the determination of the presence or absence of pembrolizumab anti-drug antibodies. The number of participants who develop anti-pembrolizumab antibodies were assessed in Cycles 1 through Cycle 4. Per ADA immunogenicity analysis report, data from participants in Cohort A were reported combined across treatment cycles 1-4.

Outcome measures

Outcome measures
Measure	Cohort A Pembrolizumab 130 mg/mL SC Participants received pembrolizumab 130 mg/mL via subcutaneous injection on Day 1 of a 21-day cycle.	Cohort A Pembrolizumab 165 mg/mL SC Participants received pembrolizumab 165 mg/mL via subcutaneous injection on Day 1 of a 21-day cycle.	Cohort A Pembrolizumab 200 mg IV Participants received pembrolizumab 200 mg via intravenous injection on Day 1 of a 21-day cycle.	Combined Cohort A n=25 Participants On Day 1 of Cycle 1 through Cycle 4, participants received one dose of the following: pembrolizumab 130 mg/mL via subcutaneous injection, pembrolizumab 165 mg/mL via subcutaneous injection, or pembrolizumab 200 mg via intravenous injection, depending on randomized treatment sequence. Each cycle was 21 days.
Number of Participants Positive for Pembrolizumab Anti-Drug Antibody (ADA) Formation - Cohort A	—	—	—	0 Participants

SECONDARY outcome

Timeframe: Up to approximately 27 months

Population: All randomized participants in Cohort A who received at least one dose of study intervention were analyzed. Per protocol, AEs from Cycles 4-35 were reported separately and participants in Cohort B were analyzed separately.

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experienced one or more AEs in Cohort A was reported. Per protocol, data were reported by treatment received and AEs from Cycles 4-35 were reported separately.

Outcome measures

Outcome measures
Measure	Cohort A Pembrolizumab 130 mg/mL SC n=33 Participants Participants received pembrolizumab 130 mg/mL via subcutaneous injection on Day 1 of a 21-day cycle.	Cohort A Pembrolizumab 165 mg/mL SC n=34 Participants Participants received pembrolizumab 165 mg/mL via subcutaneous injection on Day 1 of a 21-day cycle.	Cohort A Pembrolizumab 200 mg IV n=34 Participants Participants received pembrolizumab 200 mg via intravenous injection on Day 1 of a 21-day cycle.	Combined Cohort A n=30 Participants On Day 1 of Cycle 1 through Cycle 4, participants received one dose of the following: pembrolizumab 130 mg/mL via subcutaneous injection, pembrolizumab 165 mg/mL via subcutaneous injection, or pembrolizumab 200 mg via intravenous injection, depending on randomized treatment sequence. Each cycle was 21 days.
Number of Participants Who Experienced One or More Adverse Event (AEs) - Cohort A	18 Participants	18 Participants	14 Participants	29 Participants

SECONDARY outcome

Timeframe: Up to approximately 23 months

Population: All participants in Cohort A who received at least one dose of study intervention were analyzed. All randomized participants in Cohort A who received at least one dose of study intervention were analyzed. Per protocol, data from Cycles 4-35 were reported separately and participants in Cohort B were analyzed separately.

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinued due to an AE in Cohort A were reported. Per protocol, data were reported by treatment received and data from Cycles 4-35 were reported separately.

Outcome measures

Outcome measures
Measure	Cohort A Pembrolizumab 130 mg/mL SC n=33 Participants Participants received pembrolizumab 130 mg/mL via subcutaneous injection on Day 1 of a 21-day cycle.	Cohort A Pembrolizumab 165 mg/mL SC n=34 Participants Participants received pembrolizumab 165 mg/mL via subcutaneous injection on Day 1 of a 21-day cycle.	Cohort A Pembrolizumab 200 mg IV n=34 Participants Participants received pembrolizumab 200 mg via intravenous injection on Day 1 of a 21-day cycle.	Combined Cohort A n=30 Participants On Day 1 of Cycle 1 through Cycle 4, participants received one dose of the following: pembrolizumab 130 mg/mL via subcutaneous injection, pembrolizumab 165 mg/mL via subcutaneous injection, or pembrolizumab 200 mg via intravenous injection, depending on randomized treatment sequence. Each cycle was 21 days.
Number of Participants Who Discontinued Study Treatment Due to an AE - Cohort A	1 Participants	0 Participants	1 Participants	5 Participants

SECONDARY outcome

Timeframe: Cycles 1-3 Day 1: Up to 60 minutes postdose. Each cycle is 21 days. (Up to approximately 43 days)

Population: Per protocol, participants in Cohort A who received a subcutaneous dose of pembrolizumab were analyzed by treatment received. Therefore, data were not analyzed in participants who received IV infusion. Participants in Cohort B were not analyzed, per protocol.

Participants completed the Injection Site Signs and Symptoms Questionnaire, within 60 minutes after each pembrolizumab SC injection during Cycles 1-3. Participants rated any pain, itching, swelling and redness they experienced at the pembrolizumab SC injection site from "None" to "Severe". The number of participants who experienced an injection site sign or symptom was reported.

Outcome measures

Outcome measures
Measure	Cohort A Pembrolizumab 130 mg/mL SC n=33 Participants Participants received pembrolizumab 130 mg/mL via subcutaneous injection on Day 1 of a 21-day cycle.	Cohort A Pembrolizumab 165 mg/mL SC n=34 Participants Participants received pembrolizumab 165 mg/mL via subcutaneous injection on Day 1 of a 21-day cycle.	Cohort A Pembrolizumab 200 mg IV Participants received pembrolizumab 200 mg via intravenous injection on Day 1 of a 21-day cycle.	Combined Cohort A On Day 1 of Cycle 1 through Cycle 4, participants received one dose of the following: pembrolizumab 130 mg/mL via subcutaneous injection, pembrolizumab 165 mg/mL via subcutaneous injection, or pembrolizumab 200 mg via intravenous injection, depending on randomized treatment sequence. Each cycle was 21 days.
Number of Participants With One or More Injection Site Signs and Symptoms After Subcutaneous Pembrolizumab Injection in Cycles 1-3 - Cohort A	3 Participants	2 Participants	—	—

SECONDARY outcome

Timeframe: Up to approximately 54 months

Population: All randomized participants in Cohort B who received at least one dose of study intervention and demonstrated a confirmed CR or PR response were analyzed. Per protocol, participants in Cohort A were not analyzed.

For participants who demonstrated a CR (disappearance of all target lesions) or PR (At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions as well as an absolute increase of at least a 5 mm in the sum of diameters. The appearance of one or more new lesions was also considered PD. DOR was calculated for RECIST 1.1 based on BICR. DOR for Cohort B was reported.

Outcome measures

Outcome measures
Measure	Cohort A Pembrolizumab 130 mg/mL SC n=54 Participants Participants received pembrolizumab 130 mg/mL via subcutaneous injection on Day 1 of a 21-day cycle.	Cohort A Pembrolizumab 165 mg/mL SC Participants received pembrolizumab 165 mg/mL via subcutaneous injection on Day 1 of a 21-day cycle.	Cohort A Pembrolizumab 200 mg IV Participants received pembrolizumab 200 mg via intravenous injection on Day 1 of a 21-day cycle.	Combined Cohort A On Day 1 of Cycle 1 through Cycle 4, participants received one dose of the following: pembrolizumab 130 mg/mL via subcutaneous injection, pembrolizumab 165 mg/mL via subcutaneous injection, or pembrolizumab 200 mg via intravenous injection, depending on randomized treatment sequence. Each cycle was 21 days.
Duration of Response (DOR) Per RECIST 1.1 - Cohort B	NA Months NA = Median, upper limit, and lower limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.	—	—	—

SECONDARY outcome

Timeframe: Up to approximately 54 months

Population: All randomized participants in Cohort B who received at least one dose of study intervention were analyzed. Per protocol, participants in Cohort A were not analyzed.

PFS was defined as the time from the first dose of study treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. Although RECIST 1.1 was modified to allow for a maximum of 10 target lesions in total and 5 per organ. Per protocol, PFS as assessed by BICR for participants in Cohort B was reported.

Outcome measures

Outcome measures
Measure	Cohort A Pembrolizumab 130 mg/mL SC n=101 Participants Participants received pembrolizumab 130 mg/mL via subcutaneous injection on Day 1 of a 21-day cycle.	Cohort A Pembrolizumab 165 mg/mL SC Participants received pembrolizumab 165 mg/mL via subcutaneous injection on Day 1 of a 21-day cycle.	Cohort A Pembrolizumab 200 mg IV Participants received pembrolizumab 200 mg via intravenous injection on Day 1 of a 21-day cycle.	Combined Cohort A On Day 1 of Cycle 1 through Cycle 4, participants received one dose of the following: pembrolizumab 130 mg/mL via subcutaneous injection, pembrolizumab 165 mg/mL via subcutaneous injection, or pembrolizumab 200 mg via intravenous injection, depending on randomized treatment sequence. Each cycle was 21 days.
Progression-free Survival (PFS) Per to RECIST v1.1 Modified to Follow a Maximum of 10 Target Lesions and a Maximum of 5 Target Lesions Per Organ - Cohort B	13.8 Months Interval 5.3 to 41.4	—	—	—

SECONDARY outcome

Timeframe: Up to approximately 54 months

Population: All randomized participants in Cohort B who received at least one dose of study intervention were analyzed. Per protocol, participants in Cohort A were not analyzed.

OS was defined as the time from the first dose of study treatment to death due to any cause. Per protocol, OS for participants in Cohort B was reported.

Outcome measures

Outcome measures
Measure	Cohort A Pembrolizumab 130 mg/mL SC n=101 Participants Participants received pembrolizumab 130 mg/mL via subcutaneous injection on Day 1 of a 21-day cycle.	Cohort A Pembrolizumab 165 mg/mL SC Participants received pembrolizumab 165 mg/mL via subcutaneous injection on Day 1 of a 21-day cycle.	Cohort A Pembrolizumab 200 mg IV Participants received pembrolizumab 200 mg via intravenous injection on Day 1 of a 21-day cycle.	Combined Cohort A On Day 1 of Cycle 1 through Cycle 4, participants received one dose of the following: pembrolizumab 130 mg/mL via subcutaneous injection, pembrolizumab 165 mg/mL via subcutaneous injection, or pembrolizumab 200 mg via intravenous injection, depending on randomized treatment sequence. Each cycle was 21 days.
Overall Survival (OS) - Cohort B	NA Months Interval 27.1 to NA = Median and upper limit not reached at time of data cut-off due to insufficient number of participants with an event.	—	—	—

SECONDARY outcome

Timeframe: Cycle 1: Day 1 Predose and ~5 minutes post infusion and Day 22; Cycle 2: Predose. A Cycle was 42 days. (Up to approximately 6 weeks)

Population: All randomized participants in Cohort B who were compliant with the study procedures and had available data at the specified time point were analyzed. Per protocol, participants in Cohort A were analyzed separately.

AUC was defined as a measure of pembrolizumab exposure that was calculated as the product of plasma drug concentration and time. Blood samples were collected at designated time points for the determination of the pembrolizumab AUC in participants in Cohort B during Cycle 1 (early cycle). Blood samples were also collected predose on Day 1 of Cycle 2 just prior to the next dose as the last sample (trough concentration) of Cycle 1. A cycle was 42 days.

Outcome measures

Outcome measures
Measure	Cohort A Pembrolizumab 130 mg/mL SC n=101 Participants Participants received pembrolizumab 130 mg/mL via subcutaneous injection on Day 1 of a 21-day cycle.	Cohort A Pembrolizumab 165 mg/mL SC Participants received pembrolizumab 165 mg/mL via subcutaneous injection on Day 1 of a 21-day cycle.	Cohort A Pembrolizumab 200 mg IV Participants received pembrolizumab 200 mg via intravenous injection on Day 1 of a 21-day cycle.	Combined Cohort A On Day 1 of Cycle 1 through Cycle 4, participants received one dose of the following: pembrolizumab 130 mg/mL via subcutaneous injection, pembrolizumab 165 mg/mL via subcutaneous injection, or pembrolizumab 200 mg via intravenous injection, depending on randomized treatment sequence. Each cycle was 21 days.
Early Cycle AUC of Pembrolizumab - Cohort B	NA μg/ml AUC was determined by trapezoidal methods using interpolation between data points. Thus, at least 3 data points in the terminal phase excluding Tmax (i.e., end of infusion) were required to determine AUC. Due to sparse PK sampling schedule, per participant data could not be calculated.	—	—	—

SECONDARY outcome

Timeframe: Cycle 4: Day 1 Predose and ~5 minutes post infusion and Day 22; Cycle 5: Predose. A Cycle was 42 days. (Up to approximately 6 weeks)

AUC was defined as a measure of pembrolizumab exposure that was calculated as the product of plasma drug concentration and time. Blood samples were collected at designated time points for the determination of the pembrolizumab AUC in participants in Cohort B during Cycle 4 (steady state). Blood samples were also collected predose on Day 1 of Cycle 5 just prior to the next dose as the last samples (trough concentration) of Cycle 4. Each cycle was 42 days.

Outcome measures

Outcome measures
Measure	Cohort A Pembrolizumab 130 mg/mL SC n=73 Participants Participants received pembrolizumab 130 mg/mL via subcutaneous injection on Day 1 of a 21-day cycle.	Cohort A Pembrolizumab 165 mg/mL SC Participants received pembrolizumab 165 mg/mL via subcutaneous injection on Day 1 of a 21-day cycle.	Cohort A Pembrolizumab 200 mg IV Participants received pembrolizumab 200 mg via intravenous injection on Day 1 of a 21-day cycle.	Combined Cohort A On Day 1 of Cycle 1 through Cycle 4, participants received one dose of the following: pembrolizumab 130 mg/mL via subcutaneous injection, pembrolizumab 165 mg/mL via subcutaneous injection, or pembrolizumab 200 mg via intravenous injection, depending on randomized treatment sequence. Each cycle was 21 days.
Steady State AUC of Pembrolizumab - Cohort B	NA μg/ml AUC was determined by trapezoidal methods using interpolation between data points. Thus, at least 3 data points in the terminal phase excluding Tmax (i.e., end of infusion) were required to determine AUC. Due to sparse PK sampling schedule, per participant data could not be calculated.	—	—	—

SECONDARY outcome

Timeframe: Cycle 1: Day 1 Predose and ~5 minutes post infusion and Day 22; Cycle 2: Predose. A Cycle was 42 days. (Up to approximately 6 weeks)

Cmax was defined as the maximum concentration of pembrolizumab observed in plasma following a single dose. Blood samples were collected at designated time points for the determination of the pembrolizumab Cmax in participants in Cohort B during Cycle 1 (early cycle). Blood samples were also collected predose on Day 1 of Cycle 2 just prior to the next dose as the last sample (trough concentration) of Cycle 1. Each cycle was 42 days.

Outcome measures

Outcome measures
Measure	Cohort A Pembrolizumab 130 mg/mL SC n=99 Participants Participants received pembrolizumab 130 mg/mL via subcutaneous injection on Day 1 of a 21-day cycle.	Cohort A Pembrolizumab 165 mg/mL SC Participants received pembrolizumab 165 mg/mL via subcutaneous injection on Day 1 of a 21-day cycle.	Cohort A Pembrolizumab 200 mg IV Participants received pembrolizumab 200 mg via intravenous injection on Day 1 of a 21-day cycle.	Combined Cohort A On Day 1 of Cycle 1 through Cycle 4, participants received one dose of the following: pembrolizumab 130 mg/mL via subcutaneous injection, pembrolizumab 165 mg/mL via subcutaneous injection, or pembrolizumab 200 mg via intravenous injection, depending on randomized treatment sequence. Each cycle was 21 days.
Early Cycle Cmax of Pembrolizumab - Cohort B	127.0 μg/ml Interval 121.3 to 132.7	—	—	—

SECONDARY outcome

Timeframe: Cycle 4: Day 1 Predose and ~5 minutes post infusion and Day 22; Cycle 5: Predose. A Cycle was 42 days. (Up to approximately 6 weeks)

Cmax was defined as the maximum concentration of pembrolizumab observed in plasma following a single dose. Blood samples were collected at designated time points for the determination of the pembrolizumab Cmax in participants in Cohort B during Cycle 4 (steady state). Blood samples were also collected predose on Day 1 of Cycle 5 just prior to the next dose as the last sample (trough concentration) of Cycle 4. Each cycle was 42 days.

Outcome measures

Outcome measures
Measure	Cohort A Pembrolizumab 130 mg/mL SC n=72 Participants Participants received pembrolizumab 130 mg/mL via subcutaneous injection on Day 1 of a 21-day cycle.	Cohort A Pembrolizumab 165 mg/mL SC Participants received pembrolizumab 165 mg/mL via subcutaneous injection on Day 1 of a 21-day cycle.	Cohort A Pembrolizumab 200 mg IV Participants received pembrolizumab 200 mg via intravenous injection on Day 1 of a 21-day cycle.	Combined Cohort A On Day 1 of Cycle 1 through Cycle 4, participants received one dose of the following: pembrolizumab 130 mg/mL via subcutaneous injection, pembrolizumab 165 mg/mL via subcutaneous injection, or pembrolizumab 200 mg via intravenous injection, depending on randomized treatment sequence. Each cycle was 21 days.
Steady State Cmax of Pembrolizumab - Cohort B	150.0 μg/ml Interval 141.9 to 158.3	—	—	—

SECONDARY outcome

Timeframe: Cycle 1: Day 1 Predose and ~5 minutes post infusion and Day 22; Cycle 2: Predose. A Cycle was 42 days. (Up to approximately 6 weeks)

Cmin was defined as the minimum concentration of pembrolizumab observed in plasma following a single dose. Blood samples were collected at designated time points for the determination of the pembrolizumab Cmin in participants in Cohort B during Cycle 1 (early cycle). Blood samples were also collected predose on Day 1 of Cycle 2 just prior to the next dose as the last sample (trough concentration) of Cycle 1. Each cycle was 42 days.

Outcome measures

Outcome measures
Measure	Cohort A Pembrolizumab 130 mg/mL SC n=87 Participants Participants received pembrolizumab 130 mg/mL via subcutaneous injection on Day 1 of a 21-day cycle.	Cohort A Pembrolizumab 165 mg/mL SC Participants received pembrolizumab 165 mg/mL via subcutaneous injection on Day 1 of a 21-day cycle.	Cohort A Pembrolizumab 200 mg IV Participants received pembrolizumab 200 mg via intravenous injection on Day 1 of a 21-day cycle.	Combined Cohort A On Day 1 of Cycle 1 through Cycle 4, participants received one dose of the following: pembrolizumab 130 mg/mL via subcutaneous injection, pembrolizumab 165 mg/mL via subcutaneous injection, or pembrolizumab 200 mg via intravenous injection, depending on randomized treatment sequence. Each cycle was 21 days.
Early Cycle Minimum Plasma Concentration (Cmin) of Pembrolizumab - Cohort B	15.1 μg/ml Interval 13.5 to 16.9	—	—	—

SECONDARY outcome

Timeframe: Cycle 4: Day 1 Predose and ~5 minutes post infusion and Day 22; Cycle 5: Predose. Each Cycle was 42 days. (Up to approximately 6 weeks)

Cmin was defined as the minimum concentration of pembrolizumab observed in plasma following a single dose. Blood samples were collected at designated time points for the determination of the pembrolizumab Cmin in participants in Cohort B during Cycle 4 (steady state). Blood samples were also collected predose on Day 1 of Cycle 5 just prior to the next dose as the last sample (trough concentration) of Cycle 4. Each cycle was 42 days.

Outcome measures

Outcome measures
Measure	Cohort A Pembrolizumab 130 mg/mL SC n=69 Participants Participants received pembrolizumab 130 mg/mL via subcutaneous injection on Day 1 of a 21-day cycle.	Cohort A Pembrolizumab 165 mg/mL SC Participants received pembrolizumab 165 mg/mL via subcutaneous injection on Day 1 of a 21-day cycle.	Cohort A Pembrolizumab 200 mg IV Participants received pembrolizumab 200 mg via intravenous injection on Day 1 of a 21-day cycle.	Combined Cohort A On Day 1 of Cycle 1 through Cycle 4, participants received one dose of the following: pembrolizumab 130 mg/mL via subcutaneous injection, pembrolizumab 165 mg/mL via subcutaneous injection, or pembrolizumab 200 mg via intravenous injection, depending on randomized treatment sequence. Each cycle was 21 days.
Steady State Cmin of Pembrolizumab - Cohort B	24.0 μg/ml Interval 20.6 to 27.9	—	—	—

SECONDARY outcome

Timeframe: Up to approximately 54 months

Population: All randomized participants in Cohort B who received at least one dose of study intervention were analyzed. Per protocol, participants in Cohort A were analyzed separately.

Outcome measures

Outcome measures
Measure	Cohort A Pembrolizumab 130 mg/mL SC n=101 Participants Participants received pembrolizumab 130 mg/mL via subcutaneous injection on Day 1 of a 21-day cycle.	Cohort A Pembrolizumab 165 mg/mL SC Participants received pembrolizumab 165 mg/mL via subcutaneous injection on Day 1 of a 21-day cycle.	Cohort A Pembrolizumab 200 mg IV Participants received pembrolizumab 200 mg via intravenous injection on Day 1 of a 21-day cycle.	Combined Cohort A On Day 1 of Cycle 1 through Cycle 4, participants received one dose of the following: pembrolizumab 130 mg/mL via subcutaneous injection, pembrolizumab 165 mg/mL via subcutaneous injection, or pembrolizumab 200 mg via intravenous injection, depending on randomized treatment sequence. Each cycle was 21 days.
Number of Participants Who Experienced One or More AEs - Cohort B	101 Participants	—	—	—

SECONDARY outcome

Timeframe: Up to approximately 26 months

Population: All randomized participants in Cohort B who received at least one dose of study intervention. Per protocol, participants in Cohort A were analyzed separately.

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinued due to an AE in Cohort B were reported.

Outcome measures

Outcome measures
Measure	Cohort A Pembrolizumab 130 mg/mL SC n=101 Participants Participants received pembrolizumab 130 mg/mL via subcutaneous injection on Day 1 of a 21-day cycle.	Cohort A Pembrolizumab 165 mg/mL SC Participants received pembrolizumab 165 mg/mL via subcutaneous injection on Day 1 of a 21-day cycle.	Cohort A Pembrolizumab 200 mg IV Participants received pembrolizumab 200 mg via intravenous injection on Day 1 of a 21-day cycle.	Combined Cohort A On Day 1 of Cycle 1 through Cycle 4, participants received one dose of the following: pembrolizumab 130 mg/mL via subcutaneous injection, pembrolizumab 165 mg/mL via subcutaneous injection, or pembrolizumab 200 mg via intravenous injection, depending on randomized treatment sequence. Each cycle was 21 days.
Number of Participants Who Discontinued Study Treatment Due to an AE - Cohort B	8 Participants	—	—	—

Adverse Events

Cohort A Pembrolizumab 130 mg/mL SC

Serious events: 1 serious events

Other events: 15 other events

Deaths: 1 deaths

Cohort A Pembrolizumab 165 mg/mL SC

Serious events: 2 serious events

Other events: 15 other events

Deaths: 3 deaths

Cohort A Pembrolizumab 200 mg IV (Cycle 1 - Cycle 3)

Serious events: 2 serious events

Other events: 8 other events

Deaths: 1 deaths

Cohort A Pembrolizumab 200 mg IV (Cycle 4 - Cycle 35)

Serious events: 9 serious events

Other events: 27 other events

Deaths: 4 deaths

Cohort B Pembrolizumab 400 mg IV

Serious events: 31 serious events

Other events: 93 other events

Deaths: 45 deaths

Serious adverse events

Serious adverse events
Measure	Cohort A Pembrolizumab 130 mg/mL SC n=33 participants at risk Participants received pembrolizumab 130 mg/mL via subcutaneous injection on Day 1 of a 21-day cycle.	Cohort A Pembrolizumab 165 mg/mL SC n=34 participants at risk Participants received pembrolizumab 165 mg/mL via subcutaneous injection on Day 1 of a 21-day cycle.	Cohort A Pembrolizumab 200 mg IV (Cycle 1 - Cycle 3) n=34 participants at risk Participants received pembrolizumab 200 mg via intravenous injection on Day 1 of a 21-day cycle.	Cohort A Pembrolizumab 200 mg IV (Cycle 4 - Cycle 35) n=30 participants at risk In Cycle 4 through Cycle 35, participants received pembrolizumab 200 mg via intravenous injection on Day 1 of each 21-day cycle.	Cohort B Pembrolizumab 400 mg IV n=101 participants at risk Participants received a single dose of pembrolizumab 400 mg IV on Day 1 of each 42-day cycle (every 6 weeks; Q6W) for up to 18 cycles (up to approximately 2 years).
Blood and lymphatic system disorders Anaemia	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	2.9% 1/34 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	3.3% 1/30 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	2.0% 2/101 • Number of events 2 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Cardiac disorders Angina unstable	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/30 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.99% 1/101 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Cardiac disorders Atrial fibrillation	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/30 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.99% 1/101 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Cardiac disorders Cardiac failure	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/30 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.99% 1/101 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Cardiac disorders Cardiac failure congestive	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/30 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.99% 1/101 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Cardiac disorders Myocarditis	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	2.9% 1/34 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/30 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/101 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Endocrine disorders Adrenal insufficiency	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	3.3% 1/30 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/101 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Gastrointestinal disorders Ascites	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/30 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.99% 1/101 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Gastrointestinal disorders Colitis	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/30 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.99% 1/101 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Gastrointestinal disorders Intestinal obstruction	3.0% 1/33 • Number of events 2 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	3.3% 1/30 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/101 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
General disorders Asthenia	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/30 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.99% 1/101 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
General disorders Chest pain	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/30 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.99% 1/101 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
General disorders Pyrexia	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/30 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.99% 1/101 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Hepatobiliary disorders Hepatitis acute	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	3.3% 1/30 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/101 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Immune system disorders Drug hypersensitivity	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/30 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.99% 1/101 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Immune system disorders Immune-mediated adverse reaction	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/30 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.99% 1/101 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Infections and infestations Atypical pneumonia	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/30 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.99% 1/101 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Infections and infestations COVID-19	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/30 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.99% 1/101 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Infections and infestations COVID-19 pneumonia	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/30 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	3.0% 3/101 • Number of events 3 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Infections and infestations Cellulitis	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	10.0% 3/30 • Number of events 4 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.99% 1/101 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Infections and infestations Infection	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	3.3% 1/30 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/101 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Infections and infestations Pneumonia	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/30 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	4.0% 4/101 • Number of events 4 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Infections and infestations Pneumonia fungal	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/30 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.99% 1/101 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Infections and infestations Sepsis	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/30 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	3.0% 3/101 • Number of events 3 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Infections and infestations Skin infection	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/30 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.99% 1/101 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Infections and infestations Urinary tract infection	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/30 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	2.0% 2/101 • Number of events 2 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	2.9% 1/34 • Number of events 2 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/30 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/101 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/30 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.99% 1/101 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/30 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.99% 1/101 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/30 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.99% 1/101 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Musculoskeletal and connective tissue disorders Soft tissue necrosis	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/30 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.99% 1/101 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/30 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.99% 1/101 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/30 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.99% 1/101 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/30 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.99% 1/101 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour compression	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	3.3% 1/30 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/101 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/30 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	2.0% 2/101 • Number of events 3 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Nervous system disorders Seizure	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	3.3% 1/30 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/101 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Nervous system disorders Spinal cord compression	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/30 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.99% 1/101 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Psychiatric disorders Confusional state	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/30 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.99% 1/101 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Renal and urinary disorders Renal failure	3.0% 1/33 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/30 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/101 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Renal and urinary disorders Tubulointerstitial nephritis	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/30 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.99% 1/101 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Renal and urinary disorders Ureterolithiasis	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/30 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.99% 1/101 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Reproductive system and breast disorders Prostatitis	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/30 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.99% 1/101 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/30 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.99% 1/101 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Respiratory, thoracic and mediastinal disorders Pleural disorder	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	3.3% 1/30 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/101 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/30 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.99% 1/101 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	2.9% 1/34 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	3.3% 1/30 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/101 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/30 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.99% 1/101 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/30 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.99% 1/101 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Vascular disorders Deep vein thrombosis	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/30 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.99% 1/101 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.

Other adverse events

Other adverse events
Measure	Cohort A Pembrolizumab 130 mg/mL SC n=33 participants at risk Participants received pembrolizumab 130 mg/mL via subcutaneous injection on Day 1 of a 21-day cycle.	Cohort A Pembrolizumab 165 mg/mL SC n=34 participants at risk Participants received pembrolizumab 165 mg/mL via subcutaneous injection on Day 1 of a 21-day cycle.	Cohort A Pembrolizumab 200 mg IV (Cycle 1 - Cycle 3) n=34 participants at risk Participants received pembrolizumab 200 mg via intravenous injection on Day 1 of a 21-day cycle.	Cohort A Pembrolizumab 200 mg IV (Cycle 4 - Cycle 35) n=30 participants at risk In Cycle 4 through Cycle 35, participants received pembrolizumab 200 mg via intravenous injection on Day 1 of each 21-day cycle.	Cohort B Pembrolizumab 400 mg IV n=101 participants at risk Participants received a single dose of pembrolizumab 400 mg IV on Day 1 of each 42-day cycle (every 6 weeks; Q6W) for up to 18 cycles (up to approximately 2 years).
Blood and lymphatic system disorders Anaemia	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	2.9% 1/34 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/30 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	15.8% 16/101 • Number of events 33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	2.9% 1/34 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/30 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	6.9% 7/101 • Number of events 17 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	2.9% 1/34 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	3.3% 1/30 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	5.9% 6/101 • Number of events 8 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Endocrine disorders Hyperthyroidism	3.0% 1/33 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	3.3% 1/30 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	7.9% 8/101 • Number of events 8 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Endocrine disorders Hypothyroidism	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	3.3% 1/30 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	7.9% 8/101 • Number of events 9 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Gastrointestinal disorders Abdominal pain	3.0% 1/33 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	6.7% 2/30 • Number of events 2 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	6.9% 7/101 • Number of events 10 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Gastrointestinal disorders Constipation	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	5.9% 2/34 • Number of events 2 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	10.0% 3/30 • Number of events 4 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	5.9% 6/101 • Number of events 9 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Gastrointestinal disorders Diarrhoea	6.1% 2/33 • Number of events 2 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	2.9% 1/34 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	16.7% 5/30 • Number of events 7 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	19.8% 20/101 • Number of events 33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Gastrointestinal disorders Dry mouth	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	5.9% 2/34 • Number of events 2 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	2.9% 1/34 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/30 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	5.9% 6/101 • Number of events 9 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Gastrointestinal disorders Dyspepsia	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	6.7% 2/30 • Number of events 2 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	2.0% 2/101 • Number of events 2 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Gastrointestinal disorders Nausea	3.0% 1/33 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	5.9% 2/34 • Number of events 2 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	20.0% 6/30 • Number of events 7 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	16.8% 17/101 • Number of events 21 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Gastrointestinal disorders Stomatitis	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	6.7% 2/30 • Number of events 2 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	2.0% 2/101 • Number of events 2 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Gastrointestinal disorders Vomiting	6.1% 2/33 • Number of events 2 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/30 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	4.0% 4/101 • Number of events 6 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
General disorders Asthenia	3.0% 1/33 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	2.9% 1/34 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	2.9% 1/34 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/30 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	10.9% 11/101 • Number of events 13 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
General disorders Fatigue	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	2.9% 1/34 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	23.3% 7/30 • Number of events 8 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	28.7% 29/101 • Number of events 34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
General disorders Oedema peripheral	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	2.9% 1/34 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/30 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	5.9% 6/101 • Number of events 6 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
General disorders Peripheral swelling	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	3.3% 1/30 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	5.9% 6/101 • Number of events 6 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Infections and infestations Folliculitis	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	6.7% 2/30 • Number of events 3 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	2.0% 2/101 • Number of events 2 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Infections and infestations Influenza	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	2.9% 1/34 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	10.0% 3/30 • Number of events 3 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	3.0% 3/101 • Number of events 3 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Infections and infestations Sinusitis	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	10.0% 3/30 • Number of events 3 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	5.9% 6/101 • Number of events 6 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Infections and infestations Tooth abscess	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	6.7% 2/30 • Number of events 2 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	2.0% 2/101 • Number of events 2 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Infections and infestations Upper respiratory tract infection	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	2.9% 1/34 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	2.9% 1/34 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	10.0% 3/30 • Number of events 4 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	9.9% 10/101 • Number of events 10 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Infections and infestations Urinary tract infection	6.1% 2/33 • Number of events 2 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	2.9% 1/34 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	13.3% 4/30 • Number of events 6 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	7.9% 8/101 • Number of events 11 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Investigations Alanine aminotransferase increased	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	2.9% 1/34 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	26.7% 8/30 • Number of events 13 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	13.9% 14/101 • Number of events 26 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Investigations Aspartate aminotransferase increased	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	2.9% 1/34 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	13.3% 4/30 • Number of events 7 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	12.9% 13/101 • Number of events 17 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Investigations Blood alkaline phosphatase increased	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	3.3% 1/30 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	12.9% 13/101 • Number of events 18 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Investigations Blood bilirubin increased	3.0% 1/33 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	5.9% 2/34 • Number of events 2 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	3.3% 1/30 • Number of events 3 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	5.9% 6/101 • Number of events 18 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Investigations Blood creatinine increased	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/30 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	8.9% 9/101 • Number of events 13 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Investigations Blood phosphorus increased	3.0% 1/33 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	6.7% 2/30 • Number of events 4 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	3.0% 3/101 • Number of events 3 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Investigations Blood thyroid stimulating hormone decreased	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	2.9% 1/34 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/30 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	5.9% 6/101 • Number of events 9 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Investigations Blood thyroid stimulating hormone increased	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	6.7% 2/30 • Number of events 4 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	5.9% 6/101 • Number of events 13 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Investigations Blood urea increased	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/30 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	12.9% 13/101 • Number of events 25 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Investigations Weight decreased	6.1% 2/33 • Number of events 2 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	6.7% 2/30 • Number of events 2 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	13.9% 14/101 • Number of events 14 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Metabolism and nutrition disorders Decreased appetite	3.0% 1/33 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	5.9% 2/34 • Number of events 2 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/30 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	6.9% 7/101 • Number of events 7 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	3.3% 1/30 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	5.9% 6/101 • Number of events 14 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/30 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	7.9% 8/101 • Number of events 11 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Musculoskeletal and connective tissue disorders Arthralgia	9.1% 3/33 • Number of events 3 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	5.9% 2/34 • Number of events 2 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	23.3% 7/30 • Number of events 9 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	31.7% 32/101 • Number of events 57 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	2.9% 1/34 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	6.7% 2/30 • Number of events 2 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	5.9% 6/101 • Number of events 6 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Musculoskeletal and connective tissue disorders Back pain	3.0% 1/33 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	8.8% 3/34 • Number of events 3 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	6.7% 2/30 • Number of events 2 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	10.9% 11/101 • Number of events 17 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	10.0% 3/30 • Number of events 3 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	11.9% 12/101 • Number of events 14 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Nervous system disorders Dizziness	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	10.0% 3/30 • Number of events 3 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	5.9% 6/101 • Number of events 7 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Nervous system disorders Headache	3.0% 1/33 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	2.9% 1/34 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	2.9% 1/34 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	10.0% 3/30 • Number of events 4 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	8.9% 9/101 • Number of events 12 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Nervous system disorders Paraesthesia	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	6.7% 2/30 • Number of events 4 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.99% 1/101 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Psychiatric disorders Depression	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	6.7% 2/30 • Number of events 2 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	5.9% 6/101 • Number of events 7 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Psychiatric disorders Insomnia	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	10.0% 3/30 • Number of events 3 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	5.9% 6/101 • Number of events 6 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Renal and urinary disorders Haematuria	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	2.9% 1/34 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	3.3% 1/30 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	8.9% 9/101 • Number of events 12 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Renal and urinary disorders Proteinuria	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	3.3% 1/30 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	7.9% 8/101 • Number of events 13 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	6.7% 2/30 • Number of events 3 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	10.9% 11/101 • Number of events 11 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Skin and subcutaneous tissue disorders Pruritus	3.0% 1/33 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	2.9% 1/34 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	2.9% 1/34 • Number of events 2 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	20.0% 6/30 • Number of events 7 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	19.8% 20/101 • Number of events 29 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Skin and subcutaneous tissue disorders Rash	6.1% 2/33 • Number of events 2 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	2.9% 1/34 • Number of events 1 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	16.7% 5/30 • Number of events 10 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	21.8% 22/101 • Number of events 31 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Skin and subcutaneous tissue disorders Vitiligo	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	26.7% 8/30 • Number of events 10 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	24.8% 25/101 • Number of events 25 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.
Vascular disorders Hypertension	0.00% 0/33 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/34 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	0.00% 0/30 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.	7.9% 8/101 • Number of events 10 • Up to approximately 54 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, data are reported by treatment received \& data for Cohort A Cycles 4-35 was reported separately.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. In this case, a coordinating investigator will be designated by mutual agreement. If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
Publication restrictions are in place

Restriction type: OTHER