Trial Outcomes & Findings for Efficacy and Safety Study of Pembrolizumab (MK-3475) in Participants With Advanced Recurrent Ovarian Cancer (MK-3475-100/KEYNOTE-100) (NCT NCT02674061)

NCT ID: NCT02674061

Last Updated: 2022-03-24

Results Overview

ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters \[SOD\] of target lesions) using RECIST 1.1 based on BICR. ORR was analyzed by test of binomial parameter. The percentage of participants who experienced CR or PR per RECIST 1.1 by BICR is reported for all participants in Cohort A and Cohort B.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 376 participants
• Primary outcome timeframe: Up to ~43 months (through database cut-off date of 18-September-2019)
• Results posted on: 2022-03-24

Participant Flow

Seven participants (Cohorts A=5; B = 2) received a second course of pembrolizumab at the investigator's discretion per protocol. Response/progression or adverse events (AEs) that occurred during second course of pembrolizumab were not counted towards efficacy or safety outcome measures.

Per protocol, progression-free survival (PFS) by Blinded Independent Central Review, Overall Survival (OS), adverse events in all participants are from end of trial database (cutoff 18-Mar-2021). Objective Response Rate (ORR), Duration of Response (DOR), Disease Control Rate (DCR), safety outcomes, and sub-group analyses of PFS, OS are from final analysis database (cutoff 18-Sep-2019).

Participant milestones

Measure	Cohort A: Pembrolizumab Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Overall Study STARTED	285	91
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	285	91

Reasons for withdrawal

Measure	Cohort A: Pembrolizumab Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Overall Study Death	229	77
Overall Study Lost to Follow-up	3	3
Overall Study Withdrawal by Subject	9	1
Overall Study Participation in Study Discontinued by Sponsor	44	10

Baseline Characteristics

Efficacy and Safety Study of Pembrolizumab (MK-3475) in Participants With Advanced Recurrent Ovarian Cancer (MK-3475-100/KEYNOTE-100)

Baseline characteristics by cohort

Measure	Cohort A: Pembrolizumab n=285 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=91 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)	Total n=376 Participants Total of all reporting groups
Age, Continuous	60.5 Years STANDARD_DEVIATION 11.3 • n=5 Participants	59.5 Years STANDARD_DEVIATION 9.9 • n=7 Participants	60.3 Years STANDARD_DEVIATION 11.0 • n=5 Participants
Sex: Female, Male Female	285 Participants n=5 Participants	91 Participants n=7 Participants	376 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	258 Participants n=5 Participants	85 Participants n=7 Participants	343 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	21 Participants n=5 Participants	3 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	27 Participants n=5 Participants	3 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	253 Participants n=5 Participants	85 Participants n=7 Participants	338 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to ~43 months (through database cut-off date of 18-September-2019)

Population: All participants in Cohort A and Cohort B who received ≥1 dose of study drug.

ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters [SOD] of target lesions) using RECIST 1.1 based on BICR. ORR was analyzed by test of binomial parameter. The percentage of participants who experienced CR or PR per RECIST 1.1 by BICR is reported for all participants in Cohort A and Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=285 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=91 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in All Cohort A and Cohort B Participants	8.1 Percentage of participants Interval 5.2 to 11.9	9.9 Percentage of participants Interval 4.6 to 17.9

PRIMARY outcome

Timeframe: Up to ~43 months (through database cut-off date of 18-September-2019)

Population: Subgroup of Cohort A and Cohort B participants with CPS ≥10 who received ≥1 dose of study drug.

ORR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or a PR (≥30% decrease in SOD of target lesions) using RECIST 1.1 based on BICR. ORR was analyzed by test of binomial parameter. The percentage of participants who experienced CR or PR per RECIST 1.1 by BICR is reported here as the ORR for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by immunohistochemistry (IHC) as CPS ≥10.

Outcome measures

Measure	Cohort A: Pembrolizumab n=43 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=22 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
ORR Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With Programmed Cell Death Ligand -1 (PD-L1) Combined Positive Score (CPS) ≥10	11.6 Percentage of participants Interval 3.9 to 25.1	18.2 Percentage of participants Interval 5.2 to 40.3

PRIMARY outcome

Timeframe: Up to ~43 months (through database cut-off date of 18-September-2019)

Population: Subgroup of Cohort A and Cohort B participants with CPS ≥1 who received ≥1 dose of study drug.

ORR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or a PR (≥30% decrease in SOD of target lesions) using RECIST 1.1 based on BICR. ORR was analyzed by test of binomial parameter. The percentage of participants who experienced CR or PR per RECIST 1.1 by BICR is reported here as the ORR for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by immunohistochemistry (IHC) as CPS ≥1.

Outcome measures

Measure	Cohort A: Pembrolizumab n=101 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=49 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
ORR Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1	6.9 Percentage of participants Interval 2.8 to 13.8	10.2 Percentage of participants Interval 3.4 to 22.2

SECONDARY outcome

Timeframe: Up to ~43 months (through database cut-off date of 18-September-2019)

Population: All participants in Cohort A and Cohort B who received ≥1 dose of study drug and had CR or PR per RECIST 1.1 by BICR.

For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) per RECIST 1.1 based on BICR, DOR was defined as time from first documented CR or PR until progressive disease (PD) or death, whichever occurs first. DOR for participants who didn't progress or die at time of analysis was censored at last tumor assessment. Per RECIST 1.1 PD is a ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD. DOR analyzed by Kaplan-Meier (KM) method is reported for all participants in Cohort A and Cohort B who had a confirmed CR or PR per RECIST 1.1 by BICR.

Outcome measures

Measure	Cohort A: Pembrolizumab n=23 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=9 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Duration of Response (DOR) Per RECIST 1.1 by BICR in All Cohort A and Cohort B Participants	8.3 Months Interval 3.9 to 35.4	23.6 Months Interval 3.3 to 32.8

SECONDARY outcome

Timeframe: Up to ~43 months (through database cut-off date of 18-September-2019)

Population: Subgroup of Cohort A and Cohort B participants with CPS ≥10 who received ≥1 dose of study drug and had CR or PR per RECIST 1.1 by BICR.

For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) per RECIST 1.1 based on BICR, DOR was defined as time from first documented CR or PR until PD or death, whichever occurs first. DOR for participants who didn't progress or die at time of analysis was censored at last tumor assessment. Per RECIST 1.1 PD was defined as ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD. DOR analyzed by KM method is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10 and had a confirmed CR or PR per RECIST 1.1 by BICR.

Outcome measures

Measure	Cohort A: Pembrolizumab n=5 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=4 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
DOR Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10	11.1 Months Interval 8.3 to 20.5	NA Months Interval 5.9 to NA=Median and upper limit not reached at time of data cutoff due to insufficient number of responding participants with relapse.

SECONDARY outcome

Timeframe: Up to ~43 months (through database cut-off date of 18-September-2019)

Population: Subgroup of Cohort A and Cohort B participants with CPS ≥1 who received ≥1 dose of study drug and had CR or PR per RECIST 1.1 by BICR.

For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) per RECIST 1.1 based on BICR, DOR was defined as time from first documented CR or PR until PD or death, whichever occurs first. DOR for participants who didn't progress or die at time of analysis was censored at last tumor assessment. Per RECIST 1.1 PD was defined as ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD. DOR analyzed by KM method is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1 and had confirmed CR or PR per RECIST 1.1 by BICR.

Outcome measures

Measure	Cohort A: Pembrolizumab n=7 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=5 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
DOR Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1	11.1 Months Interval 8.2 to 35.4	NA Months Interval 5.9 to NA=Median and upper limit not reached at time of data cutoff due to insufficient number of responding participants with relapse.

SECONDARY outcome

Timeframe: Up to ~43 months (through database cut-off date of 18-September-2019)

Population: All participants in Cohort A and Cohort B who received ≥1 dose of study drug.

DCR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) or Stable Disease (SD: Neither sufficient shrinkage for PR nor sufficient increase for PD [at ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD]) or Non-CR/Non-PD (NN: does not qualify for CR or PD) for ≥24 weeks per RECIST 1.1 based on BICR. The percentage of participants who experienced CR, PR, SD or NN per RECIST 1.1 by BICR is reported as the DCR, analyzed by test of binomial parameter, for all participants in Cohort A and Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=285 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=91 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Disease Control Rate (DCR) Per RECIST 1.1 by BICR in All Cohort A and Cohort B Participants	22.1 Percentage of Participants Interval 17.4 to 27.4	22.0 Percentage of Participants Interval 14.0 to 31.9

SECONDARY outcome

Timeframe: Up to ~43 months (through database cut-off date of 18-September-2019)

Population: Subgroup of Cohort A and Cohort B participants with CPS ≥10 who received ≥1 dose of study drug.

DCR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) or SD (Neither sufficient shrinkage for PR nor sufficient increase for PD [at ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD]) or NN (does not qualify for CR or PD) for ≥24 weeks per RECIST 1.1 based on BICR. The percentage of participants who experienced CR, PR, SD or NN per RECIST 1.1 by BICR is reported as the DCR, analyzed by test of binomial parameter, for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10.

Outcome measures

Measure	Cohort A: Pembrolizumab n=43 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=22 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
DCR Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10	25.6 Percentage of Participants Interval 13.5 to 41.2	31.8 Percentage of Participants Interval 13.9 to 54.9

SECONDARY outcome

Timeframe: Up to ~43 months (through database cut-off date of 18-September-2019)

Population: Subgroup of Cohort A and Cohort B participants with CPS ≥1 who received ≥1 dose of study drug.

DCR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) or SD (Neither sufficient shrinkage for PR nor sufficient increase for PD [at ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD]) or NN (does not qualify for CR or PD) for ≥24 weeks per RECIST 1.1 based on BICR. The percentage of participants who experienced CR, PR, SD or NN per RECIST 1.1 by BICR is reported as the DCR, analyzed by test of binomial parameter, for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1.

Outcome measures

Measure	Cohort A: Pembrolizumab n=101 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=49 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
DCR Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1	24.8 Percentage of participants Interval 16.7 to 34.3	22.4 Percentage of participants Interval 11.8 to 36.6

SECONDARY outcome

Timeframe: Up to ~58.8 months (through database cut-off date of 18-March-2021)

Population: All participants in Cohort A and Cohort B who received ≥1 dose of study drug.

PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. PFS was analyzed by KM method. PFS per RECIST 1.1 by BICR is reported for all participants in Cohort A and Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=285 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=91 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Progression Free Survival (PFS) Per RECIST 1.1 by BICR in All Cohort A and Cohort B Participants	2.1 Months Interval 2.1 to 2.2	2.1 Months Interval 2.1 to 2.6

SECONDARY outcome

Timeframe: Month 6

Population: All participants in Cohort A and Cohort B who received ≥1 dose of study drug.

PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 6 per RECIST 1.1 by BICR is reported for all participants in Cohort A and Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=285 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=91 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Percentage of Participants With PFS (PFS Rate) at Month 6 Per RECIST 1.1 by BICR in All Cohort A and Cohort B Participants	23.0 Percentage of Participants Interval 18.1 to 28.1	27.2 Percentage of Participants Interval 18.2 to 36.9

SECONDARY outcome

Timeframe: Month 12

Population: All participants in Cohort A and Cohort B who received ≥1 dose of study drug.

PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 12 per RECIST 1.1 by BICR is reported for all participants in Cohort A and Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=285 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=91 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Percentage of Participants With PFS (PFS Rate) at Month 12 Per RECIST 1.1 by BICR in All Cohort A and Cohort B Participants	10.5 Percentage of Participants Interval 7.0 to 14.8	13.1 Percentage of Participants Interval 6.5 to 22.2

SECONDARY outcome

Timeframe: Month 18

Population: All participants in Cohort A and Cohort B who received ≥1 dose of study drug.

PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 18 per RECIST 1.1 by BICR is reported for all participants in Cohort A and Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=285 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=91 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Percentage of Participants With PFS (PFS Rate) at Month 18 Per RECIST 1.1 by BICR in All Cohort A and Cohort B Participants	5.8 Percentage of Participants Interval 3.2 to 9.5	13.1 Percentage of Participants Interval 6.5 to 22.2

SECONDARY outcome

Timeframe: Up to ~43 months (through database cut-off date of 18-September-2019)

Population: Subgroup of Cohort A and Cohort B participants with CPS ≥10 who received ≥1 dose of study drug.

PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. PFS was analyzed by KM method. PFS per RECIST 1.1 by BICR is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10.

Outcome measures

Measure	Cohort A: Pembrolizumab n=43 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=22 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
PFS Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10	2.1 Months Interval 2.1 to 4.2	2.1 Months Interval 2.0 to 8.3

SECONDARY outcome

Timeframe: Month 6

Population: Subgroup of Cohort A and Cohort B participants with CPS ≥10 who received ≥1 dose of study drug.

PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 6 per RECIST 1.1 by BICR is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10.

Outcome measures

Measure	Cohort A: Pembrolizumab n=43 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=22 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Percentage of Participants With PFS (PFS Rate) at Month 6 Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10	26.9 Percentage of Participants Interval 14.4 to 41.2	36.8 Percentage of Participants Interval 17.0 to 57.0

SECONDARY outcome

Timeframe: Month 12

Population: Subgroup of Cohort A and Cohort B participants with CPS ≥10 who received ≥1 dose of study drug.

PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 12 per RECIST 1.1 by BICR is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10.

Outcome measures

Measure	Cohort A: Pembrolizumab n=43 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=22 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Percentage of Participants With PFS (PFS Rate) at Month 12 Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10	18.2 Percentage of Participants Interval 7.9 to 31.9	16.8 Percentage of Participants Interval 3.5 to 38.7

SECONDARY outcome

Timeframe: Month 18

Population: Subgroup of Cohort A and Cohort B participants with CPS ≥10 who received ≥1 dose of study drug.

PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 18 per RECIST 1.1 by BICR is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10.

Outcome measures

Measure	Cohort A: Pembrolizumab n=43 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=22 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Percentage of Participants With PFS (PFS Rate) at Month 18 Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10	9.1 Percentage of Participants Interval 2.4 to 21.3	16.8 Percentage of Participants Interval 3.5 to 38.7

SECONDARY outcome

Timeframe: Up to ~43 months (through database cut-off date of 18-September-2019)

Population: Subgroup of Cohort A and Cohort B participants with CPS ≥1 who received ≥1 dose of study drug.

PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. PFS was analyzed by KM method. PFS per RECIST 1.1 by BICR is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1.

Outcome measures

Measure	Cohort A: Pembrolizumab n=101 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=49 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
PFS Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1	2.1 Months Interval 2.1 to 2.8	2.1 Months Interval 2.1 to 3.3

SECONDARY outcome

Timeframe: Month 6

Population: Subgroup of Cohort A and Cohort B participants with CPS ≥1 who received ≥1 dose of study drug.

PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 6 per RECIST 1.1 by BICR is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1.

Outcome measures

Measure	Cohort A: Pembrolizumab n=101 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=49 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Percentage of Participants With PFS (PFS Rate) at Month 6 Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1	25.5 Percentage of Participants Interval 17.2 to 34.5	25.6 Percentage of Participants Interval 14.1 to 38.8

SECONDARY outcome

Timeframe: Month 12

Population: Subgroup of Cohort A and Cohort B participants with CPS ≥1 who received ≥1 dose of study drug.

PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 12 per RECIST 1.1 by BICR is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1.

Outcome measures

Measure	Cohort A: Pembrolizumab n=101 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=49 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Percentage of Participants With PFS (PFS Rate) at Month 12 Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1	16.4 Percentage of Participants Interval 9.5 to 25.0	11.6 Percentage of Participants Interval 3.8 to 24.4

SECONDARY outcome

Timeframe: Month 18

Population: Subgroup of Cohort A and Cohort B participants with CPS ≥1 who received ≥1 dose of study drug.

PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 18 per RECIST 1.1 by BICR is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1.

Outcome measures

Measure	Cohort A: Pembrolizumab n=101 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=49 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Percentage of Participants With PFS (PFS Rate) at Month 18 Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1	9.0 Percentage of Participants Interval 3.9 to 16.7	11.6 Percentage of Participants Interval 3.8 to 24.4

SECONDARY outcome

Timeframe: Up to ~43 months (through database cut-off date of 18-September-2019)

Population: All participants in Cohort A and Cohort B who received ≥1 dose of study drug.

ORR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or a PR (≥30% decrease in SOD of target lesions) using RECIST 1.1 based on investigator assessment. ORR was analyzed by test of binomial parameter. The percentage of participants who experienced CR or PR per RECIST 1.1 by investigator is reported as the ORR for all participants in Cohort A and Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=285 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=91 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
ORR Per RECIST 1.1 by Investigator in All Cohort A and Cohort B Participants	7.0 Percentage of participants Interval 4.3 to 10.6	8.8 Percentage of participants Interval 3.9 to 16.6

SECONDARY outcome

Timeframe: Up to ~43 months (through database cut-off date of 18-September-2019)

Population: Subgroup of Cohort A and Cohort B participants with CPS ≥10 who received ≥1 dose of study drug.

ORR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or a PR (≥30% decrease in SOD of target lesions) using RECIST 1.1 based on investigator assessment. ORR was analyzed by test of binomial parameter. The percentage of participants who experienced CR or PR per RECIST 1.1 by investigator is reported as the ORR for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10.

Outcome measures

Measure	Cohort A: Pembrolizumab n=43 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=22 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
ORR Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10	11.6 Percentage of participants Interval 3.9 to 25.1	18.2 Percentage of participants Interval 5.2 to 40.3

SECONDARY outcome

Timeframe: Up to ~43 months (through database cut-off date of 18-September-2019)

Population: Subgroup of Cohort A and Cohort B participants with CPS ≥1 who received ≥1 dose of study drug.

ORR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or a PR (≥30% decrease in SOD of target lesions) using RECIST 1.1 based on investigator assessment. ORR was analyzed by test of binomial parameter. The percentage of participants who experienced CR or PR per RECIST 1.1 by investigator is reported as the ORR for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1.

Outcome measures

Measure	Cohort A: Pembrolizumab n=101 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=49 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
ORR Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1	6.9 Percentage of participants Interval 2.8 to 13.8	12.2 Percentage of participants Interval 4.6 to 24.8

SECONDARY outcome

Timeframe: Up to ~43 months (through database cut-off date of 18-September-2019)

Population: All participants in Cohort A and Cohort B who received ≥1 dose of study drug and had CR or PR per RECIST 1.1 by investigator.

For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) per RECIST 1.1 by investigator assessment, DOR was defined as time from first documented CR or PR until PD or death, whichever occurs first. DOR for participants who didn't progress or die at time of analysis was censored at last tumor assessment. Per RECIST 1.1 PD is a ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD. DOR analyzed by KM method is reported for all participants in Cohort A and Cohort B who had a confirmed CR or PR per RECIST 1.1 by investigator.

Outcome measures

Measure	Cohort A: Pembrolizumab n=20 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=8 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
DOR Per RECIST 1.1 by Investigator in All Cohort A and Cohort B Participants	9.1 Months Interval 4.0 to 35.4	7.5 Months Interval 4.2 to 32.9

SECONDARY outcome

Timeframe: Up to ~43 months (through database cut-off date of 18-September-2019)

Population: Subgroup of Cohort A and Cohort B participants with CPS ≥10 who received ≥1 dose of study drug and had CR or PR per RECIST 1.1 by investigator.

For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) per RECIST 1.1 by investigator assessment, DOR was defined as time from first documented CR or PR until PD or death, whichever occurs first. DOR for participants who didn't progress or die at time of analysis was censored at last tumor assessment. Per RECIST 1.1 PD was defined as ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD. DOR analyzed by KM method is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10 and had a confirmed CR or PR per RECIST 1.1 by investigator.

Outcome measures

Measure	Cohort A: Pembrolizumab n=5 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=4 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
DOR Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10	9.8 Months Interval 4.0 to 22.6	7.3 Months Interval 4.2 to 32.9

SECONDARY outcome

Timeframe: Up to ~43 months (through database cut-off date of 18-September-2019)

Population: Subgroup of Cohort A and Cohort B participants with CPS ≥1 who received ≥1 dose of study drug and had CR or PR per RECIST 1.1 by investigator.

For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) per RECIST 1.1 by investigator assessment, DOR was defined as time from first documented CR or PR until PD or death, whichever occurs first. DOR for participants who didn't progress or die at time of analysis was censored at last tumor assessment. Per RECIST 1.1 PD was defined as ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD. DOR analyzed by KM method is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1 and had confirmed CR or PR per RECIST 1.1 by investigator.

Outcome measures

Measure	Cohort A: Pembrolizumab n=7 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=6 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
DOR Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1	9.8 Months Interval 4.0 to 35.4	7.5 Months Interval 4.2 to 32.9

SECONDARY outcome

Timeframe: Up to ~43 months (through database cut-off date of 18-September-2019)

Population: All participants in Cohort A and Cohort B who received ≥1 dose of study drug.

DCR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) or SD (Neither sufficient shrinkage for PR nor sufficient increase for PD [at ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD]) or NN (does not qualify for CR or PD) for ≥24 weeks per RECIST 1.1 by investigator assessment. The percentage of participants who experienced CR, PR, SD or NN per RECIST 1.1 by investigator is reported as the DCR, analyzed by test of binomial parameter, for all participants in Cohort A and Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=285 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=91 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
DCR Per RECIST 1.1 by Investigator in All Cohort A and Cohort B Participants	24.9 Percentage of Participants Interval 20.0 to 30.4	17.6 Percentage of Participants Interval 10.4 to 27.0

SECONDARY outcome

Timeframe: Up to ~43 months (through database cut-off date of 18-September-2019)

Population: Subgroup of Cohort A and Cohort B participants with CPS ≥10 who received ≥1 dose of study drug.

DCR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) or SD (Neither sufficient shrinkage for PR nor sufficient increase for PD [at ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD]) or NN (does not qualify for CR or PD) for ≥24 weeks per RECIST 1.1 by investigator assessment. The percentage of participants who experienced CR, PR, SD or NN per RECIST 1.1 by investigator is reported as the DCR, analyzed by test of binomial parameter, for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10.

Outcome measures

Measure	Cohort A: Pembrolizumab n=43 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=22 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
DCR Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10	25.6 Percentage of Participants Interval 13.5 to 41.2	27.3 Percentage of Participants Interval 10.7 to 50.2

SECONDARY outcome

Timeframe: Up to ~43 months (through database cut-off date of 18-September-2019)

Population: Subgroup of Cohort A and Cohort B participants with CPS ≥1 who received ≥1 dose of study drug.

DCR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) or SD (Neither sufficient shrinkage for PR nor sufficient increase for PD [at ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD]) or NN (does not qualify for CR or PD) for ≥24 weeks per RECIST 1.1 by investigator assessment. The percentage of participants who experienced CR, PR, SD or NN per RECIST 1.1 by investigator is reported as the DCR, analyzed by test of binomial parameter, for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1.

Outcome measures

Measure	Cohort A: Pembrolizumab n=101 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=49 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
DCR Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1	24.8 Percentage of participants Interval 16.7 to 34.3	20.4 Percentage of participants Interval 10.2 to 34.3

SECONDARY outcome

Timeframe: Up to ~43 months (through database cut-off date of 18-September-2019)

Population: All participants in Cohort A and Cohort B who received ≥1 dose of study drug.

PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. PFS was analyzed by KM method. PFS per RECIST 1.1 by investigator is reported for all participants in Cohort A and Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=285 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=91 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
PFS Per RECIST 1.1 by Investigator in All Cohort A and Cohort B Participants	2.1 Months Interval 2.1 to 2.1	2.1 Months Interval 2.1 to 2.3

SECONDARY outcome

Timeframe: Month 6

Population: All participants in Cohort A and Cohort B who received ≥1 dose of study drug.

PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 6 per RECIST 1.1 by investigator is reported for all participants in Cohort A and Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=285 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=91 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Percentage of Participants With PFS (PFS Rate) at Month 6 Per RECIST 1.1 by Investigator in All Cohort A and Cohort B Participants	24.0 Percentage of Participants Interval 19.2 to 29.1	17.8 Percentage of Participants Interval 10.7 to 26.3

SECONDARY outcome

Timeframe: Month 12

Population: All participants in Cohort A and Cohort B who received ≥1 dose of study drug.

PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 12 per RECIST 1.1 by investigator is reported for all participants in Cohort A and Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=285 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=91 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Percentage of Participants With PFS (PFS Rate) at Month 12 Per RECIST 1.1 by Investigator in All Cohort A and Cohort B Participants	7.7 Percentage of Participants Interval 4.9 to 11.3	6.7 Percentage of Participants Interval 2.7 to 13.1

SECONDARY outcome

Timeframe: Month 18

Population: All participants in Cohort A and Cohort B who received ≥1 dose of study drug.

PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 18 per RECIST 1.1 by investigator is reported for all participants in Cohort A and Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=285 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=91 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Percentage of Participants With PFS (PFS Rate) at Month 18 Per RECIST 1.1 by Investigator in All Cohort A and Cohort B Participants	5.0 Percentage of Participants Interval 2.8 to 8.3	4.4 Percentage of Participants Interval 1.4 to 10.1

SECONDARY outcome

Timeframe: Up to ~43 months (through database cut-off date of 18-September-2019)

Population: Subgroup of Cohort A and Cohort B participants with CPS ≥10 who received ≥1 dose of study drug.

PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. PFS was analyzed by KM method. PFS per RECIST 1.1 by investigator is reported here for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10.

Per protocol PFS per RECIST 1.1 by investigator was analyzed in the subgroup of Cohort A and Cohort B participants with CPS ≥10.

Outcome measures

Measure	Cohort A: Pembrolizumab n=43 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=22 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
PFS Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10	2.1 Months Interval 2.1 to 4.1	2.2 Months Interval 2.0 to 4.8

SECONDARY outcome

Timeframe: Month 6

Population: Subgroup of Cohort A and Cohort B participants with CPS ≥10 who received ≥1 dose of study drug.

PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 6 per RECIST 1.1 by investigator is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10.

Outcome measures

Measure	Cohort A: Pembrolizumab n=43 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=22 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Percentage of Participants With PFS (PFS Rate) at Month 6 Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10	24.2 Percentage of Participants Interval 12.5 to 38.1	27.3 Percentage of Participants Interval 11.1 to 46.4

SECONDARY outcome

Timeframe: Month 12

Population: Subgroup of Cohort A and Cohort B participants with CPS ≥10 who received ≥1 dose of study drug.

PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 12 per RECIST 1.1 by investigator is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10.

Outcome measures

Measure	Cohort A: Pembrolizumab n=43 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=22 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Percentage of Participants With PFS (PFS Rate) at Month 12 Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10	10.8 Percentage of Participants Interval 3.5 to 22.8	13.6 Percentage of Participants Interval 3.4 to 30.9

SECONDARY outcome

Timeframe: Month 18

Population: Subgroup of Cohort A and Cohort B participants with CPS ≥10 who received ≥1 dose of study drug.

PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS rate) at Month 18 per RECIST 1.1 by investigator is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10.

Outcome measures

Measure	Cohort A: Pembrolizumab n=43 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=22 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Percentage of Participants With PFS (PFS Rate) at Month 18 Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10	5.4 Percentage of Participants Interval 1.0 to 15.8	9.1 Percentage of Participants Interval 1.6 to 25.1

SECONDARY outcome

Timeframe: Up to ~43 months (through database cut-off date of 18-September-2019)

Population: Subgroup of Cohort A and Cohort B participants with CPS ≥1 who received ≥1 dose of study drug.

PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. PFS was analyzed by KM method. PFS per RECIST 1.1 by investigator is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1.

Outcome measures

Measure	Cohort A: Pembrolizumab n=101 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=49 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
PFS Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1	2.1 Months Interval 2.1 to 2.2	2.1 Months Interval 2.1 to 2.2

SECONDARY outcome

Timeframe: Month 6

Population: Subgroup of Cohort A and Cohort B participants with CPS ≥1 who received ≥1 dose of study drug.

PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS Rate) at Month 6 per RECIST 1.1 by investigator is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1.

Outcome measures

Measure	Cohort A: Pembrolizumab n=101 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=49 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Percentage of Participants With PFS (PFS Rate) at Month 6 Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1	24.1 Percentage of Participants Interval 16.2 to 32.9	20.4 Percentage of Participants Interval 10.5 to 32.6

SECONDARY outcome

Timeframe: Month 12

Population: Subgroup of Cohort A and Cohort B participants with CPS ≥1 who received ≥1 dose of study drug.

PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS Rate) at Month 12 per RECIST 1.1 by investigator is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1.

Outcome measures

Measure	Cohort A: Pembrolizumab n=101 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=49 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Percentage of Participants With PFS (PFS Rate) at Month 12 Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1	11.0 Percentage of Participants Interval 5.7 to 18.2	10.2 Percentage of Participants Interval 3.7 to 20.5

SECONDARY outcome

Timeframe: Month 18

Population: Subgroup of Cohort A and Cohort B participants with CPS ≥1 who received ≥1 dose of study drug.

PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. The percentage of participants with PFS (PFS Rate) at Month 18 per RECIST 1.1 by investigator is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1.

Outcome measures

Measure	Cohort A: Pembrolizumab n=101 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=49 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Percentage of Participants With PFS (PFS Rate) at Month 18 Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1	5.6 Percentage of Participants Interval 1.9 to 12.3	6.1 Percentage of Participants Interval 1.6 to 15.2

SECONDARY outcome

Timeframe: Up to ~43 months (through database cut-off date of 18-September-2019)

Population: Subgroup of Cohort A participants with PFI/TFI ≥3-6 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup ORR analysis.

ORR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or a PR (≥30% decrease in SOD of target lesions) using RECIST 1.1 based on BICR. ORR was analyzed by test of binomial parameter. Per protocol the percentage of participants who experienced CR or PR per RECIST 1.1 by BICR is reported as the ORR for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months. Per protocol PFI/TFI >3-6 months subgroup analysis of ORR per RECIST 1.1 by BICR was not planned or executed in Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=127 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
ORR Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With Platinum-Free Interval (PFI)/Treatment-Free Interval (TFI) ≥3-6 Months	7.9 Percentage of participants Interval 3.8 to 14.0	—

SECONDARY outcome

Timeframe: Up to ~43 months (through database cut-off date of 18-September-2019)

Population: Subgroup of Cohort A participants with PFI/TFI \>6-12 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup ORR analysis.

ORR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or a PR (≥30% decrease in SOD of target lesions) using RECIST 1.1 based on BICR. ORR was analyzed by test of binomial parameter. Per protocol the percentage of participants who experienced CR or PR per RECIST 1.1 by BICR is reported as the ORR for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months. Per protocol PFI/TFI >6-12 months subgroup analysis of ORR per RECIST 1.1 by BICR was not planned or executed in Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=115 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
ORR Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/ TFI >6-12 Months	8.7 Percentage of Participants Interval 4.2 to 15.4	—

SECONDARY outcome

Timeframe: Up to ~43 months (through database cut-off date of 18-September-2019)

Population: Subgroup of Cohort A participants with PFI/TFI ≥3-6 months who received ≥1 dose of study drug and had CR or PR per RECIST 1.1 by BICR. Per protocol Cohort B was excluded from PFI/TFI subgroup DOR analysis.

For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) per RECIST 1.1 based on BICR, DOR was defined as time from first documented CR or PR until PD or death, whichever occurs first. DOR for participants who didn't progress or die at time of analysis was censored at last tumor assessment. Per RECIST 1.1 PD is a ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD. Per protocol DOR analyzed by KM method is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months who had a CR or PR per RECIST 1.1 by BICR. Per protocol PFI/TFI ≥3-6 months subgroup analysis of DOR per RECIST 1.1 by BICR was not planned or executed in Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=10 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
DOR Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months	8.3 Months Interval 4.1 to 14.5	—

SECONDARY outcome

Timeframe: Up to ~43 months (through database cut-off date of 18-September-2019)

Population: Subgroup of Cohort A participants with PFI/TFI \>6-12 months who received ≥1 dose of study drug and had CR or PR per RECIST 1.1 by BICR. Per protocol Cohort B was excluded from PFI/TFI subgroup DOR analysis.

For participants who demonstrated confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) per RECIST 1.1 based on BICR, DOR was defined as time from first documented CR or PR until PD or death, whichever occurs first. DOR for participants who didn't progress or die at time of analysis was censored at last tumor assessment. Per RECIST 1.1 PD is a ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD. Per protocol DOR analyzed by KM method is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months who had a CR or PR per RECIST 1.1 by BICR. Per protocol PFI/TFI >6-12 months subgroup analysis of DOR per RECIST 1.1 by BICR was not planned or executed in Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=10 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
DOR Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months	4.7 Months Interval 3.9 to 34.6	—

SECONDARY outcome

Timeframe: Up to ~43 months (through database cut-off date of 18-September-2019)

Population: Subgroup of Cohort A participants with PFI/TFI ≥3-6 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup DCR analysis.

DCR was defined as the percentage of participants in the analysis population who have a CR (Disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) or SD (Neither sufficient shrinkage for PR nor sufficient increase for PD [at ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD]) or NN (does not qualify for CR or PD) for ≥24 weeks per RECIST 1.1 based on BICR. Per protocol the percentage of participants who experienced CR, PR, SD or NN per RECIST 1.1 by BICR is reported as the DCR, analyzed by test of binomial parameter, for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months. Per protocol PFI/TFI ≥3-6 months subgroup analysis of DCR per RECIST 1.1 by BICR was not planned or executed in Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=127 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
DCR Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months	18.9 Percentage of participants Interval 12.5 to 26.8	—

SECONDARY outcome

Timeframe: Up to ~43 months (through database cut-off date of 18-September-2019)

Population: Subgroup of Cohort A participants with PFI/TFI \>6-12 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup DCR analysis.

DCR was defined as the percentage of participants in the analysis population who have a CR (Disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) or SD (Neither sufficient shrinkage to for PR nor sufficient increase for PD [at ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD]) or NN (does not qualify for CR or PD) for ≥24 weeks per RECIST 1.1 based on BICR. Per protocol the percentage of participants who experienced CR, PR, SD or NN per RECIST 1.1 by BICR is reported as the DCR, analyzed by test of binomial parameter, for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months. Per protocol PFI/TFI >6-12 months subgroup analysis of DCR per RECIST 1.1 by BICR was not planned or executed in Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=115 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
DCR Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months	21.7 Percentage of Participants Interval 14.6 to 30.4	—

SECONDARY outcome

Timeframe: Up to ~43 months (through database cut-off date of 18-September-2019)

Population: Subgroup of Cohort A participants with PFI/TFI ≥3-6 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup PFS analysis.

PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. PFS was analyzed by KM method. Per protocol PFS per RECIST 1.1 by BICR is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months. Per protocol PFI/TFI ≥3-6 months subgroup analysis of PFS per RECIST 1.1 by BICR was not planned or executed in Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=127 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
PFS Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months	2.1 Months Interval 2.1 to 2.1	—

SECONDARY outcome

Timeframe: Month 6

Population: Subgroup of Cohort A participants with PFI/TFI ≥3-6 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup PFS rate analysis at Month 6.

PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. Per protocol the percentage of participants with PFS (PFS rate) at Month 6 per RECIST 1.1 by BICR is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months. Per protocol PFI/TFI ≥3-6 months subgroup analysis of PFS rate at Month 6 per RECIST 1.1 by BICR was not planned or executed in Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=127 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Percentage of Participants With PFS (PFS Rate) at Month 6 Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months	18.2 Percentage of Participants Interval 11.9 to 25.5	—

SECONDARY outcome

Timeframe: Month 12

Population: Subgroup of Cohort A participants with PFI/TFI ≥3-6 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup PFS rate analysis at Month 12.

PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. Per protocol the percentage of participants with PFS (PFS rate) at Month 12 per RECIST 1.1 by BICR is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months. Per protocol PFI/TFI ≥3-6 months subgroup analysis of PFS rate at Month 12 per RECIST 1.1 by BICR was not planned or executed in Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=127 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Percentage of Participants With PFS (PFS Rate) at Month 12 Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months	6.4 Percentage of Participants Interval 2.8 to 11.9	—

SECONDARY outcome

Timeframe: Month 18

Population: Subgroup of Cohort A participants with PFI/TFI ≥3-6 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup PFS rate analysis at Month 18.

PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. Per protocol the percentage of participants with PFS (PFS rate) at Month 18 per RECIST 1.1 by BICR is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months. Per protocol PFI/TFI ≥3-6 months subgroup analysis of PFS rate at Month 18 per RECIST 1.1 by BICR was not planned or conducted in Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=127 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Percentage of Participants With PFS (PFS Rate) at Month 18 Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months	1.1 Percentage of Participants Interval 0.1 to 5.2	—

SECONDARY outcome

Timeframe: Up to ~43 months (through database cut-off date of 18-September-2019)

Population: Subgroup of Cohort A participants with PFI/TFI \>6-12 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup PFS analysis.

PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. PFS was analyzed by KM method. Per protocol PFS per RECIST 1.1 by BICR is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months. Per protocol PFI/TFI >6-12 months subgroup analysis of PFS per RECIST 1.1 by BICR was not planned or executed in Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=115 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
PFS Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months	2.1 Months Interval 2.1 to 2.2	—

SECONDARY outcome

Timeframe: Month 6

Population: Subgroup of Cohort A participants with PFI/TFI \>6-12 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup PFS rate analysis at Month 6.

PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. Per protocol the percentage of participants with PFS (PFS rate) at Month 6 per RECIST 1.1 by BICR is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months. Per protocol PFI/TFI >6-12 months subgroup analysis of PFS rate at Month 6 per RECIST 1.1 by BICR was not planned or executed in Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=115 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Percentage of Participants With PFS (PFS Rate) at Month 6 Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months	23.1 Percentage of Participants Interval 15.7 to 31.4	—

SECONDARY outcome

Timeframe: Month 12

Population: Subgroup of Cohort A participants with PFI/TFI \>6-12 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup PFS rate analysis at Month 12.

PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. Per protocol the percentage of participants with PFS (PFS rate) at Month 12 per RECIST 1.1 by BICR is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months. Per protocol PFI/TFI >6-12 months subgroup analysis of PFS rate at Month 12 per RECIST 1.1 by BICR was not planned or executed in Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=115 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Percentage of Participants With PFS (PFS Rate) at Month 12 Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months	12.0 Percentage of Participants Interval 6.4 to 19.4	—

SECONDARY outcome

Timeframe: Month 18

Population: Subgroup of Cohort A participants with PFI/TFI \>6-12 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup PFS rate analysis at Month 18.

PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. Per protocol the percentage of participants with PFS (PFS rate) at Month 18 per RECIST 1.1 by BICR is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months. Per protocol PFI/TFI >6-12 months subgroup analysis of PFS rate at Month 18 per RECIST 1.1 by BICR was not planned or executed in Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=115 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Percentage of Participants With PFS (PFS Rate) at Month 18 Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months	8.0 Percentage of Participants Interval 3.5 to 14.9	—

SECONDARY outcome

Timeframe: Up to ~43 months (through database cut-off date of 18-September-2019)

Population: Subgroup of Cohort A participants with PFI/TFI ≥3-6 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup ORR analysis.

ORR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or a PR (≥30% decrease in SOD of target lesions) using RECIST 1.1 based on investigator assessment. ORR was analyzed by test of binomial parameter. Per protocol the percentage of participants who experienced CR or PR per RECIST 1.1 by investigator is reported as the ORR for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months. Per protocol PFI/TFI ≥3-6 months subgroup analysis of ORR per RECIST 1.1 by investigator was not planned or executed in Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=127 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
ORR Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/ TFI ≥3-6 Months	8.7 Percentage of participants Interval 4.4 to 15.0	—

SECONDARY outcome

Timeframe: Up to ~43 months (through database cut-off date of 18-September-2019)

Population: Subgroup of Cohort A participants with PFI/TFI \>6-12 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup ORR analysis.

ORR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or a PR (≥30% decrease in SOD of target lesions) using RECIST 1.1 based on investigator assessment. ORR was analyzed by test of binomial parameter. Per protocol the percentage of participants who experienced CR or PR per RECIST 1.1 by investigator is reported as the ORR for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months. Per protocol PFI/TFI >6-12 months subgroup analysis of ORR per RECIST 1.1 by investigator was not planned or executed in Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=115 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
ORR Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/ TFI >6-12 Months	5.2 Percentage of Participants Interval 1.9 to 11.0	—

SECONDARY outcome

Timeframe: Up to ~43 months (through database cut-off date of 18-September-2019)

Population: Subgroup of Cohort A participants with PFI/TFI ≥3-6 months who received ≥1 dose of study drug and had CR or PR per RECIST 1.1 by investigator. Per protocol Cohort B was excluded from PFI/TFI subgroup DOR analysis.

For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) per RECIST 1.1 by investigator assessment, DOR was defined as time from first documented CR or PR until PD or death, whichever occurs first. DOR for participants who didn't progress or die at time of analysis was censored at last tumor assessment. Per RECIST 1.1 PD is ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD. Per protocol DOR analyzed by KM method is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months who had a CR or PR per RECIST 1.1 by investigator. Per protocol PFI/TFI ≥3-6 months subgroup analysis of DOR per RECIST 1.1 by investigator was not planned or executed in Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=11 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
DOR Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months	8.4 Months Interval 5.0 to 17.2	—

SECONDARY outcome

Timeframe: Up to ~43 months (through database cut-off date of 18-September-2019)

Population: Subgroup of Cohort A participants with PFI/TFI \>6-12 months who received ≥1 dose of study drug and had CR or PR per RECIST 1.1 by investigator. Per protocol Cohort B was excluded from PFI/TFI subgroup DOR analysis. DOR for all Cohort B participants was analyzed separately and not reported here.

For participants who demonstrated confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) per RECIST 1.1 by investigator assessment, DOR was defined as time from first documented CR or PR until PD or death, whichever occurs first. DOR for participants who didn't progress or die at time of analysis was censored at last tumor assessment. Per RECIST 1.1 PD is ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD. Per protocol DOR analyzed by KM method is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months who had a CR or PR per RECIST 1.1 by investigator. Per protocol PFI/TFI >6-12 months subgroup analysis of DOR per RECIST 1.1 by investigator was not planned or executed in Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=6 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
DOR Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months	9.7 Months Interval 4.0 to 34.6	—

SECONDARY outcome

Timeframe: Up to ~43 months (through database cut-off date of 18-September-2019)

Population: Subgroup of Cohort A participants with PFI/TFI ≥3-6 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup DCR analysis.

DCR was defined as the percentage of participants in the analysis population who have CR (Disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) or SD (Neither sufficient shrinkage for PR nor sufficient increase for PD [at ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD]) or NN (doesn't qualify for CR or PD) for ≥24 weeks per RECIST 1.1 by investigator assessment. Per protocol percentage of participants who experienced CR, PR, SD or NN per RECIST 1.1 by investigator is reported as DCR, analyzed by test of binomial parameter, for subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months. Per protocol PFI/TFI ≥3-6 months subgroup analysis of DCR per RECIST 1.1 by investigator was not planned or executed in Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=127 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
DCR Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months	21.3 Percentage of participants Interval 14.5 to 29.4	—

SECONDARY outcome

Timeframe: Up to ~43 months (through database cut-off date of 18-September-2019)

Population: Subgroup of Cohort A participants with PFI/TFI \>6-12 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup DCR analysis. DCR for all Cohort B participants was analyzed separately and not reported here.

DCR was defined as the percentage of participants in the analysis population who have CR (Disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) or SD (Neither sufficient shrinkage for PR nor sufficient increase for PD [at ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm. Appearance of ≥1 new lesion is also PD]) or NN (doesn't qualify for CR or PD) for ≥24 weeks per RECIST 1.1 by investigator assessment. Per protocol percentage of participants who experienced CR, PR, SD or NN per RECIST 1.1 by investigator is reported as DCR, analyzed by test of binomial parameter, for subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months. Per protocol PFI/TFI>6-12 months subgroup analysis of DCR per RECIST 1.1 by investigator was not planned or executed in Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=115 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
DCR Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months	23.5 Percentage of participants Interval 16.1 to 32.3	—

SECONDARY outcome

Timeframe: Up to ~43 months (through database cut-off date of 18-September-2019)

Population: Subgroup of Cohort A participants with PFI/TFI ≥3-6 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup PFS analysis.

PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. PFS was analyzed by KM method. Per protocol PFS per RECIST 1.1 by investigator is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months. Per protocol PFI/TFI ≥3-6 months subgroup analysis of PFS per RECIST 1.1 by investigator was not planned or executed in Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=127 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
PFS Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months	2.1 Months Interval 2.1 to 2.1	—

SECONDARY outcome

Timeframe: Month 6

Population: Subgroup of Cohort A participants with PFI/TFI ≥3-6 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup PFS rate analysis at Month 6.

PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. Per protocol the percentage of participants with PFS (PFS rate) at Month 6 per RECIST 1.1 by investigator is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months. Per protocol PFI/TFI ≥3-6 months subgroup analysis of PFS rate at Month 6 per RECIST 1.1 by investigator was not planned or executed in Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=127 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Percentage of Participants With PFS (PFS Rate) at Month 6 Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months	20.5 Percentage of Participants Interval 13.9 to 27.9	—

SECONDARY outcome

Timeframe: Month 12

Population: Subgroup of Cohort A participants with PFI/TFI ≥3-6 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup PFS rate analysis at Month 12.

PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. Per protocol the percentage of participants with PFS (PFS rate) at Month 12 per RECIST 1.1 by investigator is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months. Per protocol PFI/TFI ≥3-6 months subgroup analysis of PFS rate at Month 12 per RECIST 1.1 by investigator was not planned or executed in Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=127 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Percentage of Participants With PFS (PFS Rate) at Month 12 Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months	6.8 Percentage of Participants Interval 3.2 to 12.3	—

SECONDARY outcome

Timeframe: Month 18

Population: Subgroup of Cohort A participants with PFI/TFI ≥3-6 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup PFS rate analysis at Month 18.

PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. Per protocol the percentage of participants with PFS (PFS rate) at Month 18 per RECIST 1.1 by investigator is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months. Per protocol PFI/TFI ≥3-6 months subgroup analysis of PFS rate at Month 18 per RECIST 1.1 by investigator was not planned or executed in Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=127 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Percentage of Participants With PFS (PFS Rate) at Month 18 Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months	4.0 Percentage of Participants Interval 1.4 to 8.8	—

SECONDARY outcome

Timeframe: Up to ~43 months (through database cut-off date of 18-September-2019)

Population: Subgroup of Cohort A participants with PFI/TFI \>6-12 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup PFS analysis.

PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. PFS was analyzed by KM method. Per protocol PFS per RECIST 1.1 by investigator is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months. Per protocol PFI/TFI >6-12 months subgroup analysis of PFS per RECIST 1.1 by investigator was not planned or executed in Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=115 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
PFS Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months	2.1 Months Interval 2.1 to 2.1	—

SECONDARY outcome

Timeframe: Month 6

Population: Subgroup of Cohort A participants with PFI/TFI \>6-12 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup PFS rate analysis at Month 6.

PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. Per protocol the percentage of participants with PFS (PFS rate) at Month 6 per RECIST 1.1 by investigator is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months. Per protocol PFI/TFI >6-12 months subgroup analysis of PFS rate at Month 6 per RECIST 1.1 by investigator was not planned or executed in Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=115 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Percentage of Participants With PFS (PFS Rate) at Month 6 Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months	22.6 Percentage of Participants Interval 15.5 to 30.6	—

SECONDARY outcome

Timeframe: Month 12

Population: Subgroup of Cohort A participants with PFI/TFI \>6-12 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup PFS rate analysis at Month 12.

PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. Per protocol the percentage of participants with PFS (PFS rate) at Month 12 per RECIST 1.1 by investigator is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months. Per protocol PFI/TFI >6-12 months subgroup analysis of PFS rate at Month 12 per RECIST 1.1 by investigator was not planned or executed in Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=115 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Percentage of Participants With PFS (PFS Rate) at Month 12 Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months	5.6 Percentage of Participants Interval 2.3 to 10.9	—

SECONDARY outcome

Timeframe: Month 18

Population: Subgroup of Cohort A participants with PFI/TFI \>6-12 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup PFS rate analysis at Month 18.

PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. Per protocol the percentage of participants with PFS (PFS rate) at Month 18 per RECIST 1.1 by investigator is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months. Per protocol PFI/TFI >6-12 months subgroup analysis of PFS rate at Month 18 per RECIST 1.1 by investigator was not planned or executed in Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=115 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Percentage of Participants With PFS (PFS Rate) at Month 18 Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months	3.7 Percentage of Participants Interval 1.2 to 8.5	—

SECONDARY outcome

Timeframe: Up to ~58.8 months (through database cut-off date of 18-March-2021)

Population: All participants in Cohort A and Cohort B who received ≥1 dose of study drug.

OS was defined as the time from the first dose of study drug to death due to any cause. OS analyzed by KM method is reported for all participants in Cohort A and Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=285 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=91 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Overall Survival (OS) in All Cohort A and Cohort B Participants	18.7 Months Interval 17.0 to 22.4	17.6 Months Interval 13.3 to 24.4

SECONDARY outcome

Timeframe: Month 6

Population: All participants in Cohort A and Cohort B who received ≥1 dose of study drug.

OS was defined as the time from the first dose of study drug to death due to any cause. The percentage of participants with OS (OS rate) at Month 6 is reported for all participants in Cohort A and Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=285 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=91 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Percentage of Participants With OS (OS Rate) at Month 6 in All Cohort A and Cohort B Participants	82.5 Percentage of Participants Interval 77.5 to 86.4	79.0 Percentage of Participants Interval 69.0 to 86.0

SECONDARY outcome

Timeframe: Month 12

Population: All participants in Cohort A and Cohort B who received ≥1 dose of study drug.

OS was defined as the time from the first dose of study drug to death due to any cause. The percentage of participants with OS (OS rate) at Month 12 is reported for all participants in Cohort A and Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=285 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=91 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Percentage of Participants With OS (OS Rate) at Month 12 in All Cohort A and Cohort B Participants	66.0 Percentage of Participants Interval 60.1 to 71.1	66.6 Percentage of Participants Interval 55.8 to 75.3

SECONDARY outcome

Timeframe: Month 18

Population: All participants in Cohort A and Cohort B who received ≥1 dose of study drug.

OS was defined as the time from the first dose of study drug to death due to any cause. The percentage of participants with OS (OS rate) at Month 18 is reported for all participants in Cohort A and Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=285 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=91 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Percentage of Participants With OS (OS Rate) at Month 18 in All Cohort A and Cohort B Participants	51.3 Percentage of Participants Interval 45.4 to 57.0	48.5 Percentage of Participants Interval 37.8 to 58.4

SECONDARY outcome

Timeframe: Month 24

Population: All participants in Cohort A and Cohort B who received ≥1 dose of study drug.

OS was defined as the time from the first dose of study drug to death due to any cause. The percentage of participants with OS (OS rate) at Month 24 is reported for all participants in Cohort A and Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=285 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=91 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Percentage of Participants With OS (OS Rate) at Month 24 in All Cohort A and Cohort B Participants	40.5 Percentage of Participants Interval 34.7 to 46.1	40.6 Percentage of Participants Interval 30.4 to 50.6

SECONDARY outcome

Timeframe: Up to ~43 months (through database cut-off date of 18-September-2019)

Population: Subgroup of Cohort A and Cohort B participants with CPS ≥10 who received ≥1 dose of study drug.

OS was defined as the time from the first dose of study drug to death due to any cause. OS analyzed by KM method is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10.

Outcome measures

Measure	Cohort A: Pembrolizumab n=43 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=22 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
OS in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10	21.9 Months Interval 12.9 to 26.8	24.0 Months Interval 14.5 to Based on the statistical model used for data analysis, upper 95% CI limit was not reached by the data cut-off date.

SECONDARY outcome

Timeframe: Month 6

Population: Subgroup of Cohort A and Cohort B participants with CPS ≥10 who received ≥1 dose of study drug.

OS was defined as the time from the first dose of study drug to death due to any cause. The percentage of participants with OS (OS rate) at Month 6 is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10.

Outcome measures

Measure	Cohort A: Pembrolizumab n=43 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=22 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Percentage of Participants With OS (OS Rate) at Month 6 in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10	81.0 Percentage of Participants Interval 65.6 to 90.0	95.5 Percentage of Participants Interval 71.9 to 99.3

SECONDARY outcome

Timeframe: Month 12

Population: Subgroup of Cohort A and Cohort B participants with CPS ≥10 who received ≥1 dose of study drug.

OS was defined as the time from the first dose of study drug to death due to any cause. The percentage of participants with OS (OS rate) at Month 12 is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10.

Outcome measures

Measure	Cohort A: Pembrolizumab n=43 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=22 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Percentage of Participants With OS (OS Rate) at Month 12 in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10	69.1 Percentage of Participants Interval 52.8 to 80.7	86.4 Percentage of Participants Interval 63.4 to 95.4

SECONDARY outcome

Timeframe: Month 18

Population: Subgroup of Cohort A and Cohort B participants with CPS ≥10 who received ≥1 dose of study drug.

OS was defined as the time from the first dose of study drug to death due to any cause. The percentage of participants with OS (OS rate) at Month 18 is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥10.

Outcome measures

Measure	Cohort A: Pembrolizumab n=43 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=22 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Percentage of Participants With OS (OS Rate) at Month 18 in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10	54.3 Percentage of Participants Interval 38.1 to 67.9	59.1 Percentage of Participants Interval 36.1 to 76.2

SECONDARY outcome

Timeframe: Up to ~43 months (through database cut-off date of 18-September-2019)

Population: Subgroup of Cohort A and Cohort B participants with CPS ≥1 who received ≥1 dose of study drug.

OS was defined as the time from the first dose of study drug to death due to any cause. OS analyzed by KM method is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1.

Outcome measures

Measure	Cohort A: Pembrolizumab n=101 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=49 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
OS in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1	20.6 Months Interval 15.2 to 23.2	20.7 Months Interval 13.6 to 27.4

SECONDARY outcome

Timeframe: Month 6

Population: Subgroup of Cohort A and Cohort B participants with CPS ≥1 who received ≥1 dose of study drug.

OS was defined as the time from the first dose of study drug to death due to any cause. The percentage of participants with OS (OS rate) at Month 6 is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1.

Outcome measures

Measure	Cohort A: Pembrolizumab n=101 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=49 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Percentage of Participants With OS (OS Rate) at Month 6 in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1	80.0 Percentage of Participants Interval 70.8 to 86.6	87.8 Percentage of Participants Interval 74.8 to 94.3

SECONDARY outcome

Timeframe: Month 12

Population: Subgroup of Cohort A and Cohort B participants with CPS ≥1 who received ≥1 dose of study drug.

OS was defined as the time from the first dose of study drug to death due to any cause. The percentage of participants with OS (OS rate) at Month 12 is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1.

Outcome measures

Measure	Cohort A: Pembrolizumab n=101 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=49 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Percentage of Participants With OS (OS Rate) at Month 12 in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1	65.0 Percentage of Participants Interval 54.8 to 73.5	75.5 Percentage of Participants Interval 60.9 to 85.3

SECONDARY outcome

Timeframe: Month 18

Population: Subgroup of Cohort A and Cohort B participants with CPS ≥1 who received ≥1 dose of study drug.

OS was defined as the time from the first dose of study drug to death due to any cause. The percentage of participants with OS (OS rate) at Month 18 is reported for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by IHC as CPS ≥1.

Outcome measures

Measure	Cohort A: Pembrolizumab n=101 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=49 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Percentage of Participants With OS (OS Rate) at Month 18 in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1	52.6 Percentage of Participants Interval 42.4 to 61.9	53.1 Percentage of Participants Interval 38.3 to 65.8

SECONDARY outcome

Timeframe: Up to ~43 months (through database cut-off date of 18-September-2019)

Population: Subgroup of Cohort A participants with PFI/TFI ≥3-6 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup OS analysis.

OS was defined as the time from the first dose of study drug to death due to any cause. Per protocol OS analyzed by KM method is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months. Per protocol PFI/TFI ≥3-6 months subgroup analysis of OS was not planned or executed in Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=127 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
OS in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months	17.2 Months Interval 14.0 to 20.6	—

SECONDARY outcome

Timeframe: Month 6

Population: Subgroup of Cohort A participants with PFI/TFI ≥3-6 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup OS rate analysis at Month 6.

OS was defined as the time from the first dose of study drug to death due to any cause. Per protocol the percentage of participants with OS (OS rate) at Month 6 is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months. Per protocol PFI/TFI ≥3-6 months subgroup analysis of OS rate at Month 6 was not planned or executed in Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=127 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Percentage of Participants With OS (OS Rate) at Month 6 in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months	77.7 Percentage of Participants Interval 69.4 to 84.1	—

SECONDARY outcome

Timeframe: Month 12

Population: Subgroup of Cohort A participants with PFI/TFI ≥3-6 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup OS rate analysis at Month 12.

OS was defined as the time from the first dose of study drug to death due to any cause. Per protocol the percentage of participants with OS (OS rate) at Month 12 is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months. Per protocol PFI/TFI ≥3-6 months subgroup analysis of OS rate at Month 12 was not planned or executed in Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=127 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Percentage of Participants With OS (OS Rate) at Month 12 in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months	62.5 Percentage of Participants Interval 53.4 to 70.3	—

SECONDARY outcome

Timeframe: Month 18

Population: Subgroup of Cohort A participants with PFI/TFI ≥3-6 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup OS rate analysis at Month 18.

OS was defined as the time from the first dose of study drug to death due to any cause. Per protocol the percentage of participants with OS (OS rate) at Month 18 is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) ≥3-6 months. Per protocol PFI/TFI ≥3-6 months subgroup analysis of OS rate at Month 18 was not planned or executed in Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=127 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Percentage of Participants With OS (OS Rate) at Month 18 in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months	45.2 Percentage of Participants Interval 36.3 to 53.8	—

SECONDARY outcome

Timeframe: Up to ~43 months (through database cut-off date of 18-September-2019)

Population: Subgroup of Cohort A participants with PFI/TFI \>6-12 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup OS analysis.

OS was defined as the time from the first dose of study drug to death due to any cause. Per protocol OS analyzed by KM method is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months. Per protocol PFI/TFI >6-12 months subgroup analysis of OS was not planned or executed in Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=115 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
OS in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months	22.1 Months Interval 15.2 to 27.9	—

SECONDARY outcome

Timeframe: Month 6

Population: Subgroup of Cohort A participants with PFI/TFI \>6-12 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup OS rate analysis at Month 6.

OS was defined as the time from the first dose of study drug to death due to any cause. Per protocol the percentage of participants with OS (OS rate) at Month 6 is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months. Per protocol PFI/TFI >6-12 months subgroup analysis of OS rate at Month 6 was not planned or executed in Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=115 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Percentage of Participants With OS (OS Rate) at Month 6 in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months	86.1 Percentage of Participants Interval 78.3 to 91.2	—

SECONDARY outcome

Timeframe: Month 12

Population: Subgroup of Cohort A participants with PFI/TFI \>6-12 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup OS rate analysis at Month 12.

OS was defined as the time from the first dose of study drug to death due to any cause. Per protocol the percentage of participants with OS (OS rate) at Month 12 is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months. Per protocol PFI/TFI >6-12 months subgroup analysis of OS rate at Month 12 was not planned or executed in Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=115 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Percentage of Participants With OS (OS Rate) at Month 12 in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months	68.7 Percentage of Participants Interval 59.3 to 76.3	—

SECONDARY outcome

Timeframe: Month 18

Population: Subgroup of Cohort A participants with PFI/TFI \>6-12 months who received ≥1 dose of study drug. Per protocol Cohort B was excluded from PFI/TFI subgroup OS rate analysis at Month 18.

OS was defined as the time from the first dose of study drug to death due to any cause. Per protocol the percentage of participants with OS (OS rate) at Month 18 is reported for the subgroup of Cohort A participants with PFI/TFI (duration from end of treatment to disease recurrence) >6-12 months. Per protocol PFI/TFI >6-12 months subgroup analysis of OS rate at Month 18 was not planned or executed in Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=115 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Percentage of Participants With OS (OS Rate) at Month 18 in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months	54.6 Percentage of Participants Interval 45.0 to 63.2	—

SECONDARY outcome

Timeframe: Up to ~58.8 months (through database cut-off date of 18-March-2021)

Population: All participants in Cohort A and Cohort B who received ≥1 dose of study drug.

An AE was defined as any untoward medical occurrence in a pharmaceutical product which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. As specified by the protocol, the number of participants who experienced at least one AE is reported here for all participants in Cohort A and Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=285 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=91 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Number of Participants Who Experienced an Adverse Event (AE)	274 Participants	85 Participants

SECONDARY outcome

Timeframe: Up to ~58.8 months (through database cut-off date of 18-March-2021)

Population: All participants in Cohort A and Cohort B who received ≥1 dose of study drug.

An AE was defined as any untoward medical occurrence in a pharmaceutical product which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. As specified by the protocol, the number of participants who discontinued study treatment due to an AE is reported here for all participants in Cohort A and Cohort B.

Outcome measures

Measure	Cohort A: Pembrolizumab n=285 Participants Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=91 Participants Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year)
Number of Participants Who Discontinued Study Treatment Due to an AE	23 Participants	4 Participants

Adverse Events

Cohort A: Pembrolizumab

Serious events: 91 serious events

Other events: 260 other events

Deaths: 233 deaths

Cohort B: Pembrolizumab

Serious events: 26 serious events

Other events: 82 other events

Deaths: 77 deaths

Cohort A: Second Course Pembrolizumab

Serious events: 1 serious events

Other events: 5 other events

Deaths: 1 deaths

Cohort B: Second Course Pembrolizumab

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cohort A: Pembrolizumab n=285 participants at risk Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=91 participants at risk Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort A: Second Course Pembrolizumab n=5 participants at risk Eligible participants in Cohort A who stopped pembrolizumab with stable disease (SD) or better but progressed after stopping study treatment initiated a second course of pembrolizumab at the investigator's discretion at the same dose and schedule (200 mg Q3W) for up to 17 cycles (up to approximately 1 additional year).	Cohort B: Second Course Pembrolizumab n=2 participants at risk Eligible participants in Cohort B who stopped pembrolizumab with SD or better but progressed after stopping study treatment initiated a second course of pembrolizumab at the investigator's discretion at the same dose and schedule (200 mg Q3W) for up to 17 cycles (up to approximately 1 additional year).
Blood and lymphatic system disorders Splenic haematoma	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Gastrointestinal disorders Colonic fistula	0.00% 0/285 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	1.1% 1/91 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Endocrine disorders Addison's disease	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Endocrine disorders Adrenal insufficiency	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Endocrine disorders Hypoaldosteronism	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Endocrine disorders Hypophysitis	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Endocrine disorders Hypothyroidism	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Endocrine disorders Lymphocytic hypophysitis	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Gastrointestinal disorders Abdominal pain	0.35% 1/285 • Number of events 3 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Gastrointestinal disorders Ascites	3.2% 9/285 • Number of events 12 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	2.2% 2/91 • Number of events 2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Gastrointestinal disorders Autoimmune colitis	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Gastrointestinal disorders Colitis	1.1% 3/285 • Number of events 3 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	2.2% 2/91 • Number of events 2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Gastrointestinal disorders Constipation	0.70% 2/285 • Number of events 4 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Gastrointestinal disorders Diarrhoea	1.1% 3/285 • Number of events 3 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	1.1% 1/91 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Gastrointestinal disorders Duodenal ulcer	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Gastrointestinal disorders Enteritis	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	1.1% 1/91 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Gastrointestinal disorders Gastrointestinal disorder	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Gastrointestinal disorders Gastrointestinal perforation	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Gastrointestinal disorders Haematemesis	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Gastrointestinal disorders Ileus	1.8% 5/285 • Number of events 5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	1.1% 1/91 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Gastrointestinal disorders Intestinal obstruction	1.4% 4/285 • Number of events 6 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Gastrointestinal disorders Intussusception	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Gastrointestinal disorders Large intestinal haemorrhage	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Gastrointestinal disorders Large intestinal obstruction	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Gastrointestinal disorders Large intestine perforation	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Gastrointestinal disorders Oesophageal ulcer	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Gastrointestinal disorders Proctalgia	0.00% 0/285 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	1.1% 1/91 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Gastrointestinal disorders Rectal haemorrhage	0.70% 2/285 • Number of events 2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Gastrointestinal disorders Small intestinal obstruction	3.5% 10/285 • Number of events 14 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	1.1% 1/91 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Gastrointestinal disorders Subileus	0.70% 2/285 • Number of events 2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	2.2% 2/91 • Number of events 2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Gastrointestinal disorders Vomiting	1.1% 3/285 • Number of events 3 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	1.1% 1/91 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
General disorders Death	0.70% 2/285 • Number of events 2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
General disorders General physical health deterioration	0.70% 2/285 • Number of events 2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
General disorders Incarcerated hernia	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
General disorders Pyrexia	0.35% 1/285 • Number of events 2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	1.1% 1/91 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Hepatobiliary disorders Biliary obstruction	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Hepatobiliary disorders Budd-Chiari syndrome	0.00% 0/285 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	1.1% 1/91 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Hepatobiliary disorders Hepatotoxicity	0.00% 0/285 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	1.1% 1/91 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Hepatobiliary disorders Portal vein thrombosis	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Immune system disorders Drug hypersensitivity	0.70% 2/285 • Number of events 2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Immune system disorders Sarcoidosis	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Infections and infestations Acinetobacter infection	0.00% 0/285 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	1.1% 1/91 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Infections and infestations Bacterial sepsis	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	1.1% 1/91 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Infections and infestations Cellulitis	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Infections and infestations Clostridium difficile colitis	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Infections and infestations Clostridium difficile infection	0.00% 0/285 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	1.1% 1/91 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Infections and infestations Gastroenteritis	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Infections and infestations Herpes virus infection	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Infections and infestations Herpes zoster	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Infections and infestations Influenza	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Infections and infestations Laryngitis	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Infections and infestations Peritonitis	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	1.1% 1/91 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Infections and infestations Pharyngitis streptococcal	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Infections and infestations Pleural infection bacterial	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Infections and infestations Pneumonia	1.4% 4/285 • Number of events 5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	1.1% 1/91 • Number of events 2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	20.0% 1/5 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Infections and infestations Post procedural infection	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Infections and infestations Pyelonephritis acute	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Infections and infestations Sepsis	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	1.1% 1/91 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Infections and infestations Sepsis syndrome	0.00% 0/285 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	1.1% 1/91 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Infections and infestations Urinary tract infection	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	2.2% 2/91 • Number of events 2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Injury, poisoning and procedural complications Gastrointestinal injury	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Injury, poisoning and procedural complications Incisional hernia	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Injury, poisoning and procedural complications Tibia fracture	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Investigations Blood bilirubin increased	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Investigations Blood sodium decreased	0.35% 1/285 • Number of events 2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Investigations Neutrophil count decreased	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Metabolism and nutrition disorders Dehydration	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	1.1% 1/91 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Metabolism and nutrition disorders Diabetes mellitus	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Metabolism and nutrition disorders Hypercalcaemia	1.1% 3/285 • Number of events 3 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Metabolism and nutrition disorders Hyponatraemia	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	1.1% 1/91 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.70% 2/285 • Number of events 2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Infected neoplasm	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant ascites	0.35% 1/285 • Number of events 2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Paraneoplastic syndrome	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour associated fever	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Nervous system disorders Cerebral infarction	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Nervous system disorders Intercostal neuralgia	0.00% 0/285 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	1.1% 1/91 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Nervous system disorders Myasthenic syndrome	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Product Issues Device malfunction	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Psychiatric disorders Anxiety	0.00% 0/285 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	1.1% 1/91 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Psychiatric disorders Suicide attempt	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Renal and urinary disorders Acute kidney injury	0.70% 2/285 • Number of events 2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	2.2% 2/91 • Number of events 2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Renal and urinary disorders Hydronephrosis	0.00% 0/285 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	1.1% 1/91 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Renal and urinary disorders Hydroureter	0.00% 0/285 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	1.1% 1/91 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Renal and urinary disorders Renal failure	0.35% 1/285 • Number of events 2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Renal and urinary disorders Tubulointerstitial nephritis	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Reproductive system and breast disorders Female genital tract fistula	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	1.1% 1/91 • Number of events 2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.1% 3/285 • Number of events 3 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Respiratory, thoracic and mediastinal disorders Dyspnoea at rest	0.00% 0/285 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	20.0% 1/5 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.5% 7/285 • Number of events 8 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.70% 2/285 • Number of events 2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.1% 3/285 • Number of events 5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	1.1% 1/91 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Skin and subcutaneous tissue disorders Dermatitis	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Skin and subcutaneous tissue disorders Perivascular dermatitis	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Skin and subcutaneous tissue disorders Rash	0.00% 0/285 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	1.1% 1/91 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Skin and subcutaneous tissue disorders Stevens-Johnson syndrome	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Vascular disorders Circulatory collapse	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Vascular disorders Deep vein thrombosis	0.70% 2/285 • Number of events 2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Vascular disorders Embolism	0.00% 0/285 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	1.1% 1/91 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Vascular disorders Hypotension	0.00% 0/285 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	1.1% 1/91 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Vascular disorders Vena cava embolism	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Vascular disorders Vena cava thrombosis	0.35% 1/285 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.

Other adverse events

Measure	Cohort A: Pembrolizumab n=285 participants at risk Participants in Cohort A received 0-2 prior lines of treatment for recurrent ovarian cancer (ROC; 1-3 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort B: Pembrolizumab n=91 participants at risk Participants in Cohort B received 3-5 prior lines of treatment for ROC (4-6 total prior lines including front-line treatment) and were administered pembrolizumab at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle for up to 35 cycles (up to \~2 years). Qualified participants who complete 35 administrations of pembrolizumab but progress after discontinuation can initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to \~1 additional year).	Cohort A: Second Course Pembrolizumab n=5 participants at risk Eligible participants in Cohort A who stopped pembrolizumab with stable disease (SD) or better but progressed after stopping study treatment initiated a second course of pembrolizumab at the investigator's discretion at the same dose and schedule (200 mg Q3W) for up to 17 cycles (up to approximately 1 additional year).	Cohort B: Second Course Pembrolizumab n=2 participants at risk Eligible participants in Cohort B who stopped pembrolizumab with SD or better but progressed after stopping study treatment initiated a second course of pembrolizumab at the investigator's discretion at the same dose and schedule (200 mg Q3W) for up to 17 cycles (up to approximately 1 additional year).
Blood and lymphatic system disorders Anaemia	14.0% 40/285 • Number of events 58 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	14.3% 13/91 • Number of events 18 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Blood and lymphatic system disorders Lymph node pain	0.00% 0/285 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	20.0% 1/5 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Endocrine disorders Hyperthyroidism	6.7% 19/285 • Number of events 20 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	7.7% 7/91 • Number of events 7 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Endocrine disorders Hypothyroidism	11.6% 33/285 • Number of events 33 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	12.1% 11/91 • Number of events 14 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Eye disorders Eyelid rash	0.00% 0/285 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	20.0% 1/5 • Number of events 3 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Eye disorders Eyelids pruritus	0.00% 0/285 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	20.0% 1/5 • Number of events 3 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Gastrointestinal disorders Abdominal distension	7.0% 20/285 • Number of events 24 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	5.5% 5/91 • Number of events 5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	20.0% 1/5 • Number of events 2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Gastrointestinal disorders Abdominal pain	26.7% 76/285 • Number of events 90 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	22.0% 20/91 • Number of events 26 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Gastrointestinal disorders Abdominal pain upper	6.0% 17/285 • Number of events 19 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	8.8% 8/91 • Number of events 9 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Gastrointestinal disorders Ascites	10.9% 31/285 • Number of events 47 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	7.7% 7/91 • Number of events 7 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Gastrointestinal disorders Constipation	20.7% 59/285 • Number of events 63 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	24.2% 22/91 • Number of events 25 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Gastrointestinal disorders Diarrhoea	19.6% 56/285 • Number of events 85 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	22.0% 20/91 • Number of events 30 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	40.0% 2/5 • Number of events 2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Gastrointestinal disorders Dry mouth	5.3% 15/285 • Number of events 15 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	2.2% 2/91 • Number of events 2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Gastrointestinal disorders Dyspepsia	6.3% 18/285 • Number of events 19 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	1.1% 1/91 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Gastrointestinal disorders Nausea	33.3% 95/285 • Number of events 123 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	26.4% 24/91 • Number of events 30 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	20.0% 1/5 • Number of events 2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Gastrointestinal disorders Stomatitis	4.9% 14/285 • Number of events 15 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	5.5% 5/91 • Number of events 5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Gastrointestinal disorders Vomiting	21.4% 61/285 • Number of events 78 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	19.8% 18/91 • Number of events 24 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
General disorders Asthenia	15.8% 45/285 • Number of events 52 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	28.6% 26/91 • Number of events 29 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
General disorders Fatigue	33.7% 96/285 • Number of events 118 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	24.2% 22/91 • Number of events 27 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	20.0% 1/5 • Number of events 2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
General disorders Hernia	0.00% 0/285 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	1.1% 1/91 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	50.0% 1/2 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
General disorders Oedema peripheral	7.7% 22/285 • Number of events 30 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	4.4% 4/91 • Number of events 4 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
General disorders Pain	0.70% 2/285 • Number of events 2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	5.5% 5/91 • Number of events 5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
General disorders Pyrexia	10.9% 31/285 • Number of events 37 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	9.9% 9/91 • Number of events 11 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
General disorders Suprapubic pain	0.00% 0/285 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	20.0% 1/5 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Infections and infestations COVID-19	0.00% 0/285 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	50.0% 1/2 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Infections and infestations Nasopharyngitis	5.6% 16/285 • Number of events 20 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	5.5% 5/91 • Number of events 6 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Infections and infestations Sinusitis	1.4% 4/285 • Number of events 4 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	2.2% 2/91 • Number of events 2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	20.0% 1/5 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Infections and infestations Upper respiratory tract infection	3.9% 11/285 • Number of events 12 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	20.0% 1/5 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Infections and infestations Urinary tract infection	7.4% 21/285 • Number of events 26 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	11.0% 10/91 • Number of events 13 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Injury, poisoning and procedural complications Bone contusion	0.00% 0/285 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	20.0% 1/5 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Injury, poisoning and procedural complications Incision site complication	0.00% 0/285 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	20.0% 1/5 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/285 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	20.0% 1/5 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Investigations Alanine aminotransferase increased	6.0% 17/285 • Number of events 19 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	1.1% 1/91 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	20.0% 1/5 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Investigations Aspartate aminotransferase increased	6.7% 19/285 • Number of events 21 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	2.2% 2/91 • Number of events 2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Investigations Blood alkaline phosphatase increased	6.7% 19/285 • Number of events 23 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	3.3% 3/91 • Number of events 3 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	20.0% 1/5 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Investigations Blood bicarbonate increased	0.00% 0/285 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	20.0% 1/5 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Investigations Blood lactate dehydrogenase increased	2.5% 7/285 • Number of events 7 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	1.1% 1/91 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	20.0% 1/5 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Investigations PCO2 increased	0.00% 0/285 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	20.0% 1/5 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Investigations Weight decreased	6.0% 17/285 • Number of events 17 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	6.6% 6/91 • Number of events 6 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Investigations White blood cells urine positive	0.00% 0/285 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	20.0% 1/5 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Metabolism and nutrition disorders Decreased appetite	26.7% 76/285 • Number of events 84 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	15.4% 14/91 • Number of events 16 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Metabolism and nutrition disorders Hypomagnesaemia	2.5% 7/285 • Number of events 7 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	6.6% 6/91 • Number of events 8 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Metabolism and nutrition disorders Hyponatraemia	3.5% 10/285 • Number of events 11 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	20.0% 1/5 • Number of events 4 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Metabolism and nutrition disorders Hypophosphataemia	1.4% 4/285 • Number of events 5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	2.2% 2/91 • Number of events 6 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	20.0% 1/5 • Number of events 2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Musculoskeletal and connective tissue disorders Arthralgia	10.5% 30/285 • Number of events 33 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	15.4% 14/91 • Number of events 23 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	20.0% 1/5 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Musculoskeletal and connective tissue disorders Back pain	8.8% 25/285 • Number of events 28 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	11.0% 10/91 • Number of events 14 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Musculoskeletal and connective tissue disorders Groin pain	1.1% 3/285 • Number of events 3 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	20.0% 1/5 • Number of events 2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Musculoskeletal and connective tissue disorders Muscle spasms	2.8% 8/285 • Number of events 9 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	5.5% 5/91 • Number of events 5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Musculoskeletal and connective tissue disorders Muscular weakness	1.1% 3/285 • Number of events 3 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	20.0% 1/5 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Musculoskeletal and connective tissue disorders Myalgia	6.7% 19/285 • Number of events 20 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	5.5% 5/91 • Number of events 5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Musculoskeletal and connective tissue disorders Pain in extremity	4.9% 14/285 • Number of events 19 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	7.7% 7/91 • Number of events 8 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Nervous system disorders Dizziness	7.4% 21/285 • Number of events 22 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	6.6% 6/91 • Number of events 6 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Nervous system disorders Headache	8.8% 25/285 • Number of events 32 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	9.9% 9/91 • Number of events 11 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	20.0% 1/5 • Number of events 2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Psychiatric disorders Insomnia	6.0% 17/285 • Number of events 19 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	3.3% 3/91 • Number of events 4 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	20.0% 1/5 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Renal and urinary disorders Dysuria	1.8% 5/285 • Number of events 5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	5.5% 5/91 • Number of events 5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Respiratory, thoracic and mediastinal disorders Cough	13.3% 38/285 • Number of events 44 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	14.3% 13/91 • Number of events 14 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Respiratory, thoracic and mediastinal disorders Dyspnoea	14.0% 40/285 • Number of events 49 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	6.6% 6/91 • Number of events 8 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	50.0% 1/2 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/285 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	20.0% 1/5 • Number of events 2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Respiratory, thoracic and mediastinal disorders Productive cough	2.5% 7/285 • Number of events 8 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	1.1% 1/91 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	20.0% 1/5 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Respiratory, thoracic and mediastinal disorders Sputum discoloured	0.00% 0/285 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	20.0% 1/5 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Skin and subcutaneous tissue disorders Dry skin	5.3% 15/285 • Number of events 15 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	3.3% 3/91 • Number of events 3 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Skin and subcutaneous tissue disorders Pruritus	10.9% 31/285 • Number of events 35 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	13.2% 12/91 • Number of events 16 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Skin and subcutaneous tissue disorders Rash	9.5% 27/285 • Number of events 32 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	8.8% 8/91 • Number of events 11 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/5 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Skin and subcutaneous tissue disorders Rash maculo-papular	3.5% 10/285 • Number of events 13 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	20.0% 1/5 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.
Vascular disorders Aortic aneurysm	0.00% 0/285 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/91 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	20.0% 1/5 • Number of events 1 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.	0.00% 0/2 • Up to ~58.8 months (through database cut-off date of 18-March-2021) Adverse events in all participants who received ≥1 dose of study drug. Per protocol, disease progression was not considered an AE unless considered related to study drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression (NP)", "Malignant NP" and "Disease progression" not related to study drug are excluded as AEs. Seven participants received a second course of pembrolizumab per protocol and were monitored for AEs and are presented separately.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
• Publication restrictions are in place

Restriction type: OTHER