Trial Outcomes & Findings for Study of Pembrolizumab (MK-3475) in Platinum Pre-treated Recurrent/Metastatic Nasopharyngeal Cancer (MK-3475-122/KEYNOTE-122) (NCT NCT02611960)

NCT ID: NCT02611960

Last Updated: 2023-07-13

Results Overview

Overall Survival was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last known contact. OS was reported for each treatment arm. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

233 participants

Primary outcome timeframe

Up to approximately 53 months (through analysis cut-off date of 30-Nov-2020)

Results posted on

2023-07-13

Participant Flow

Five participants randomized to the Pembrolizumab arm received a second course of pembrolizumab at the investigator's discretion as specified by the protocol. Per protocol, response/progression or adverse events (AEs) that occurred during a non-randomized second course of pembrolizumab were not counted towards efficacy or safety outcome measures, respectively. These results are for randomized treatment only.

Participant milestones

Participant milestones
Measure	Pembrolizumab Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) until progressive disease (PD) or unacceptable toxicity for a maximum of up to 35 cycles (up to approximately 2 years). Eligible participants who stopped pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab 200 mg Q3W for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.	Standard Treatment Participants received capecitabine 1000 mg/m\^2 orally (PO) twice each day (BID) on Days 1-14 of each 3-week cycle, or gemcitabine 1250 mg/m\^2 IV on Days 1 and 8 of each 3-week cycle, or docetaxel 75 mg/m\^2 IV on Day 1 of each 3-week cycle until PD or unacceptable toxicity.
Overall Study STARTED	117	116
Overall Study Discontinued	117	116
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	117	116

Reasons for withdrawal

Reasons for withdrawal
Measure	Pembrolizumab Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) until progressive disease (PD) or unacceptable toxicity for a maximum of up to 35 cycles (up to approximately 2 years). Eligible participants who stopped pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab 200 mg Q3W for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.	Standard Treatment Participants received capecitabine 1000 mg/m\^2 orally (PO) twice each day (BID) on Days 1-14 of each 3-week cycle, or gemcitabine 1250 mg/m\^2 IV on Days 1 and 8 of each 3-week cycle, or docetaxel 75 mg/m\^2 IV on Day 1 of each 3-week cycle until PD or unacceptable toxicity.
Overall Study Adverse Event	7	8
Overall Study Death	98	92
Overall Study Withdrawal by Subject	1	5
Overall Study Sponsor Decision	11	11

Baseline Characteristics

Study of Pembrolizumab (MK-3475) in Platinum Pre-treated Recurrent/Metastatic Nasopharyngeal Cancer (MK-3475-122/KEYNOTE-122)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pembrolizumab n=117 Participants Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) until progressive disease (PD) or unacceptable toxicity for a maximum of up to 35 cycles (up to approximately 2 years). Eligible participants who stopped pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab 200 mg Q3W for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.	Standard Treatment n=116 Participants Participants received capecitabine 1000 mg/m\^2 orally (PO) twice each day (BID) on Days 1-14 of each 3-week cycle, or gemcitabine 1250 mg/m\^2 IV on Days 1 and 8 of each 3-week cycle, or docetaxel 75 mg/m\^2 IV on Day 1 of each 3-week cycle until PD or unacceptable toxicity.	Total n=233 Participants Total of all reporting groups
Age, Continuous	50.6 Years STANDARD_DEVIATION 12.7 • n=5 Participants	53.1 Years STANDARD_DEVIATION 11.2 • n=7 Participants	51.9 Years STANDARD_DEVIATION 12.0 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	21 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	98 Participants n=5 Participants	95 Participants n=7 Participants	193 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	116 Participants n=5 Participants	113 Participants n=7 Participants	229 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	110 Participants n=5 Participants	112 Participants n=7 Participants	222 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Presence of Baseline Liver Metastasis Liver Metastasis Present	57 Participants n=5 Participants	56 Participants n=7 Participants	113 Participants n=5 Participants
Presence of Baseline Liver Metastasis Liver Metastasis Absent	60 Participants n=5 Participants	60 Participants n=7 Participants	120 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to approximately 53 months (through analysis cut-off date of 30-Nov-2020)

Population: All randomized participants (Intent-to-Treat \[ITT\]) were analyzed.

Outcome measures

Outcome measures
Measure	Pembrolizumab n=117 Participants Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) until progressive disease (PD) or unacceptable toxicity for a maximum of up to 35 cycles (up to approximately 2 years). Eligible participants who stopped pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab 200 mg Q3W for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.	Standard Treatment n=116 Participants Participants received capecitabine 1000 mg/m\^2 orally (PO) twice each day (BID) on Days 1-14 of each 3-week cycle, or gemcitabine 1250 mg/m\^2 IV on Days 1 and 8 of each 3-week cycle, or docetaxel 75 mg/m\^2 IV on Day 1 of each 3-week cycle until PD or unacceptable toxicity.
Overall Survival (OS)	17.2 Months Interval 11.7 to 22.9	15.3 Months Interval 10.9 to 18.1

SECONDARY outcome

Timeframe: Up to approximately 53 months (through analysis cut-off date of 30-Nov-2020)

Population: All randomized participants (ITT) were analyzed.

PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on blinded independent central review (BICR), or death due to any cause, whichever occurs earlier. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. PFS was reported for each treatment arm. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020.

Outcome measures

Outcome measures
Measure	Pembrolizumab n=117 Participants Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) until progressive disease (PD) or unacceptable toxicity for a maximum of up to 35 cycles (up to approximately 2 years). Eligible participants who stopped pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab 200 mg Q3W for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.	Standard Treatment n=116 Participants Participants received capecitabine 1000 mg/m\^2 orally (PO) twice each day (BID) on Days 1-14 of each 3-week cycle, or gemcitabine 1250 mg/m\^2 IV on Days 1 and 8 of each 3-week cycle, or docetaxel 75 mg/m\^2 IV on Day 1 of each 3-week cycle until PD or unacceptable toxicity.
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)	4.1 Months Interval 2.1 to 5.6	5.5 Months Interval 4.0 to 8.1

SECONDARY outcome

Timeframe: Up to approximately 53 months (through analysis cut-off date of 30-Nov-2020)

Population: All randomized participants (ITT) were analyzed.

ORR was defined as the percentage of participants in the analysis population who had a confirmed Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. based upon BICR. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. ORR was reported for each treatment arm. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020.

Outcome measures

Outcome measures
Measure	Pembrolizumab n=117 Participants Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) until progressive disease (PD) or unacceptable toxicity for a maximum of up to 35 cycles (up to approximately 2 years). Eligible participants who stopped pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab 200 mg Q3W for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.	Standard Treatment n=116 Participants Participants received capecitabine 1000 mg/m\^2 orally (PO) twice each day (BID) on Days 1-14 of each 3-week cycle, or gemcitabine 1250 mg/m\^2 IV on Days 1 and 8 of each 3-week cycle, or docetaxel 75 mg/m\^2 IV on Day 1 of each 3-week cycle until PD or unacceptable toxicity.
Objective Response Rate (ORR) Per RECIST 1.1	21.4 Percentage of Participants Interval 14.3 to 29.9	23.3 Percentage of Participants Interval 15.9 to 32.0

SECONDARY outcome

Timeframe: Up to approximately 53 months (through analysis cut-off date of 30-Nov-2020)

Population: All randomized participants (ITT population) who demonstrated a confirmed CR or PR were analyzed.

For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by BICR, DOR was defined as the time from first documented evidence of confirmed CR or PR until PD or death due to any cause, whichever occurred first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. DOR was reported for each treatment arm. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020.

Outcome measures

Outcome measures
Measure	Pembrolizumab n=25 Participants Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) until progressive disease (PD) or unacceptable toxicity for a maximum of up to 35 cycles (up to approximately 2 years). Eligible participants who stopped pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab 200 mg Q3W for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.	Standard Treatment n=27 Participants Participants received capecitabine 1000 mg/m\^2 orally (PO) twice each day (BID) on Days 1-14 of each 3-week cycle, or gemcitabine 1250 mg/m\^2 IV on Days 1 and 8 of each 3-week cycle, or docetaxel 75 mg/m\^2 IV on Day 1 of each 3-week cycle until PD or unacceptable toxicity.
Duration of Response (DOR) Per RECIST 1.1	12.0 Months Interval 6.0 to 19.9	13.1 Months Interval 9.7 to 18.9

SECONDARY outcome

Timeframe: 12 months

Population: All randomized participants (ITT) were analyzed.

OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last known contact. The percentage of participants surviving (OS rate) at 12 months is reported for each treatment arm based on the product-limit (Kaplan-Meier) method for censored data. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020.

Outcome measures

Outcome measures
Measure	Pembrolizumab n=117 Participants Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) until progressive disease (PD) or unacceptable toxicity for a maximum of up to 35 cycles (up to approximately 2 years). Eligible participants who stopped pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab 200 mg Q3W for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.	Standard Treatment n=116 Participants Participants received capecitabine 1000 mg/m\^2 orally (PO) twice each day (BID) on Days 1-14 of each 3-week cycle, or gemcitabine 1250 mg/m\^2 IV on Days 1 and 8 of each 3-week cycle, or docetaxel 75 mg/m\^2 IV on Day 1 of each 3-week cycle until PD or unacceptable toxicity.
Percentage of Participants Surviving (OS Rate) at 12 Months	58.1 Percentage of Participants Interval 48.7 to 66.4	57.4 Percentage of Participants Interval 47.8 to 65.8

SECONDARY outcome

Timeframe: 24 months

Population: All randomized participants (ITT) were analyzed.

OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last known contact. The percentage of participants surviving (OS rate) at 24 months is reported for each treatment arm based on the product-limit (Kaplan-Meier) method for censored data. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020.

Outcome measures

Outcome measures
Measure	Pembrolizumab n=117 Participants Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) until progressive disease (PD) or unacceptable toxicity for a maximum of up to 35 cycles (up to approximately 2 years). Eligible participants who stopped pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab 200 mg Q3W for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.	Standard Treatment n=116 Participants Participants received capecitabine 1000 mg/m\^2 orally (PO) twice each day (BID) on Days 1-14 of each 3-week cycle, or gemcitabine 1250 mg/m\^2 IV on Days 1 and 8 of each 3-week cycle, or docetaxel 75 mg/m\^2 IV on Day 1 of each 3-week cycle until PD or unacceptable toxicity.
Percentage of Participants Surviving (OS Rate) at 24 Months	40.2 Percentage of Participants Interval 31.3 to 48.9	32.2 Percentage of Participants Interval 23.9 to 40.8

SECONDARY outcome

Timeframe: 6 months

Population: All randomized participants (ITT) were analyzed.

PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurs earlier. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. The percentage of participants with PFS (PFS rate) at 6 months is reported for each treatment arm based on the product-limit (Kaplan-Meier) method for censored data. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020.

Outcome measures

Outcome measures
Measure	Pembrolizumab n=117 Participants Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) until progressive disease (PD) or unacceptable toxicity for a maximum of up to 35 cycles (up to approximately 2 years). Eligible participants who stopped pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab 200 mg Q3W for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.	Standard Treatment n=116 Participants Participants received capecitabine 1000 mg/m\^2 orally (PO) twice each day (BID) on Days 1-14 of each 3-week cycle, or gemcitabine 1250 mg/m\^2 IV on Days 1 and 8 of each 3-week cycle, or docetaxel 75 mg/m\^2 IV on Day 1 of each 3-week cycle until PD or unacceptable toxicity.
Percentage of Participants With PFS (PFS Rate) at 6 Months	36.3 Percentage of Participants Interval 27.0 to 45.5	43.9 Percentage of Participants Interval 33.6 to 53.7

SECONDARY outcome

Timeframe: 12 months

Population: All randomized participants (ITT) were analyzed.

PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurs earlier. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. The percentage of participants with PFS (PFS rate) at 12 months is reported for each treatment arm based on the product-limit (Kaplan-Meier) method for censored data. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020.

Outcome measures

Outcome measures
Measure	Pembrolizumab n=117 Participants Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) until progressive disease (PD) or unacceptable toxicity for a maximum of up to 35 cycles (up to approximately 2 years). Eligible participants who stopped pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab 200 mg Q3W for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.	Standard Treatment n=116 Participants Participants received capecitabine 1000 mg/m\^2 orally (PO) twice each day (BID) on Days 1-14 of each 3-week cycle, or gemcitabine 1250 mg/m\^2 IV on Days 1 and 8 of each 3-week cycle, or docetaxel 75 mg/m\^2 IV on Day 1 of each 3-week cycle until PD or unacceptable toxicity.
Percentage of Participants With PFS (PFS Rate) at 12 Months	18.7 Percentage of Participants Interval 11.5 to 27.3	30.8 Percentage of Participants Interval 21.0 to 41.0

SECONDARY outcome

Timeframe: Up to approximately 73 months

Population: All randomized participants who received at least 1 dose of study treatment were analyzed.

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable 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. The percentage of participants that experienced at least one AE was reported for each treatment arm. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm.

Outcome measures

Outcome measures
Measure	Pembrolizumab n=116 Participants Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) until progressive disease (PD) or unacceptable toxicity for a maximum of up to 35 cycles (up to approximately 2 years). Eligible participants who stopped pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab 200 mg Q3W for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.	Standard Treatment n=112 Participants Participants received capecitabine 1000 mg/m\^2 orally (PO) twice each day (BID) on Days 1-14 of each 3-week cycle, or gemcitabine 1250 mg/m\^2 IV on Days 1 and 8 of each 3-week cycle, or docetaxel 75 mg/m\^2 IV on Day 1 of each 3-week cycle until PD or unacceptable toxicity.
Percentage of Participants Who Experience One or More Adverse Events (AEs)	97.4 Percentage of Participants	97.3 Percentage of Participants

SECONDARY outcome

Timeframe: Up to approximately 72 months

Population: All randomized participants who received at least 1 dose of study treatment were analyzed.

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable 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. The percentage of participants that discontinued study treatment due to an AE was reported for each treatment arm. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm.

Outcome measures

Outcome measures
Measure	Pembrolizumab n=116 Participants Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) until progressive disease (PD) or unacceptable toxicity for a maximum of up to 35 cycles (up to approximately 2 years). Eligible participants who stopped pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab 200 mg Q3W for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.	Standard Treatment n=112 Participants Participants received capecitabine 1000 mg/m\^2 orally (PO) twice each day (BID) on Days 1-14 of each 3-week cycle, or gemcitabine 1250 mg/m\^2 IV on Days 1 and 8 of each 3-week cycle, or docetaxel 75 mg/m\^2 IV on Day 1 of each 3-week cycle until PD or unacceptable toxicity.
Percentage of Participants Who Discontinue Study Treatment Due to an AE	8.6 Percentage of Participants	15.2 Percentage of Participants

Adverse Events

Pembrolizumab First Course

Serious events: 39 serious events

Other events: 100 other events

Deaths: 103 deaths

Standard Treatment First Course

Serious events: 41 serious events

Other events: 103 other events

Deaths: 104 deaths

Pembrolizumab Second Course

Serious events: 3 serious events

Other events: 3 other events

Deaths: 3 deaths

Serious adverse events

Other adverse events

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 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

Serious adverse events
Measure	Pembrolizumab First Course n=116 participants at risk Participants received pembrolizumab 200 mg IV Q3W until PD or unacceptable toxicity for a maximum of up to 35 cycles (up to approximately 2 years).	Standard Treatment First Course n=112 participants at risk Participants received capecitabine 1000 mg/m\^2 orally (PO) twice each day (BID) on Days 1-14 of each 3-week cycle, or gemcitabine 1250 mg/m\^2 IV on Days 1 and 8 of each 3-week cycle, or docetaxel 75 mg/m\^2 IV on Day 1 of each 3-week cycle until PD or unacceptable toxicity.	Pembrolizumab Second Course n=5 participants at risk Eligible participants randomized to the pembrolizumab arm who stopped pembrolizumab with SD or better but progressed after discontinuation 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	0.00% 0/116 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	2.7% 3/112 • Number of events 3 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/116 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	2.7% 3/112 • Number of events 3 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Cardiac disorders Acute coronary syndrome	0.00% 0/116 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.89% 1/112 • Number of events 1 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Cardiac disorders Sinus tachycardia	0.86% 1/116 • Number of events 1 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/112 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Endocrine disorders Adrenal insufficiency	0.86% 1/116 • Number of events 1 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/112 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Gastrointestinal disorders Abdominal pain	0.86% 1/116 • Number of events 1 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/112 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Gastrointestinal disorders Constipation	0.00% 0/116 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.89% 1/112 • Number of events 1 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Gastrointestinal disorders Diarrhoea	0.00% 0/116 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	3.6% 4/112 • Number of events 4 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Gastrointestinal disorders Enteritis	0.00% 0/116 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.89% 1/112 • Number of events 1 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Gastrointestinal disorders Gastrointestinal toxicity	0.00% 0/116 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.89% 1/112 • Number of events 1 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Gastrointestinal disorders Vomiting	1.7% 2/116 • Number of events 2 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/112 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
General disorders Chest pain	0.86% 1/116 • Number of events 1 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.89% 1/112 • Number of events 1 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
General disorders Death	0.86% 1/116 • Number of events 1 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.89% 1/112 • Number of events 1 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
General disorders Pyrexia	2.6% 3/116 • Number of events 4 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.89% 1/112 • Number of events 1 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Hepatobiliary disorders Hepatic failure	0.86% 1/116 • Number of events 1 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/112 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Hepatobiliary disorders Immune-mediated hepatitis	0.86% 1/116 • Number of events 1 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/112 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Infections and infestations Abdominal wall abscess	0.86% 1/116 • Number of events 1 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/112 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Infections and infestations Abscess jaw	0.00% 0/116 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.89% 1/112 • Number of events 1 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Infections and infestations Abscess neck	0.00% 0/116 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.89% 1/112 • Number of events 1 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Infections and infestations Acute sinusitis	0.86% 1/116 • Number of events 1 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/112 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Infections and infestations Appendicitis	0.86% 1/116 • Number of events 1 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/112 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Infections and infestations Bronchitis	0.86% 1/116 • Number of events 1 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/112 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Infections and infestations Cellulitis	0.00% 0/116 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.89% 1/112 • Number of events 2 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Infections and infestations Chest wall abscess	0.86% 1/116 • Number of events 1 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/112 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Infections and infestations Herpes zoster	0.86% 1/116 • Number of events 1 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.89% 1/112 • Number of events 1 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Infections and infestations Influenza	0.86% 1/116 • Number of events 1 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.89% 1/112 • Number of events 1 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Infections and infestations Lower respiratory tract infection	0.86% 1/116 • Number of events 1 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.89% 1/112 • Number of events 1 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Infections and infestations Meningitis	0.00% 0/116 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.89% 1/112 • Number of events 1 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Infections and infestations Muscle abscess	0.86% 1/116 • Number of events 1 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/112 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Infections and infestations Pharyngeal abscess	0.86% 1/116 • Number of events 1 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/112 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Infections and infestations Pharyngitis	0.00% 0/116 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.89% 1/112 • Number of events 1 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Infections and infestations Pneumonia	7.8% 9/116 • Number of events 10 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	8.0% 9/112 • Number of events 10 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Infections and infestations Pneumonia aspiration	3.4% 4/116 • Number of events 7 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/112 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	20.0% 1/5 • Number of events 1 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Infections and infestations Pulmonary sepsis	0.00% 0/116 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	1.8% 2/112 • Number of events 2 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Infections and infestations Pulmonary tuberculosis	0.00% 0/116 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.89% 1/112 • Number of events 1 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/116 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.89% 1/112 • Number of events 1 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Infections and infestations Sepsis	1.7% 2/116 • Number of events 3 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/112 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Infections and infestations Sinusitis	0.86% 1/116 • Number of events 1 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/112 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Infections and infestations Upper respiratory tract infection	0.86% 1/116 • Number of events 1 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/112 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Infections and infestations Urinary tract infection	0.00% 0/116 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.89% 1/112 • Number of events 1 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.

Other adverse events
Measure	Pembrolizumab First Course n=116 participants at risk Participants received pembrolizumab 200 mg IV Q3W until PD or unacceptable toxicity for a maximum of up to 35 cycles (up to approximately 2 years).	Standard Treatment First Course n=112 participants at risk Participants received capecitabine 1000 mg/m\^2 orally (PO) twice each day (BID) on Days 1-14 of each 3-week cycle, or gemcitabine 1250 mg/m\^2 IV on Days 1 and 8 of each 3-week cycle, or docetaxel 75 mg/m\^2 IV on Day 1 of each 3-week cycle until PD or unacceptable toxicity.	Pembrolizumab Second Course n=5 participants at risk Eligible participants randomized to the pembrolizumab arm who stopped pembrolizumab with SD or better but progressed after discontinuation 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	11.2% 13/116 • Number of events 15 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	29.5% 33/112 • Number of events 47 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Endocrine disorders Hypothyroidism	17.2% 20/116 • Number of events 20 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	9.8% 11/112 • Number of events 12 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Eye disorders Vision blurred	5.2% 6/116 • Number of events 6 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	1.8% 2/112 • Number of events 2 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Gastrointestinal disorders Abdominal pain	5.2% 6/116 • Number of events 8 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	2.7% 3/112 • Number of events 3 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Gastrointestinal disorders Constipation	11.2% 13/116 • Number of events 15 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	15.2% 17/112 • Number of events 20 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Gastrointestinal disorders Diarrhoea	10.3% 12/116 • Number of events 17 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	17.0% 19/112 • Number of events 27 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Gastrointestinal disorders Dry mouth	5.2% 6/116 • Number of events 7 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	3.6% 4/112 • Number of events 7 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Gastrointestinal disorders Dysphagia	6.0% 7/116 • Number of events 7 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	7.1% 8/112 • Number of events 10 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Gastrointestinal disorders Nausea	9.5% 11/116 • Number of events 12 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	16.1% 18/112 • Number of events 30 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Gastrointestinal disorders Stomatitis	2.6% 3/116 • Number of events 3 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	14.3% 16/112 • Number of events 19 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Gastrointestinal disorders Vomiting	11.2% 13/116 • Number of events 21 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	15.2% 17/112 • Number of events 20 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
General disorders Chest pain	8.6% 10/116 • Number of events 12 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	1.8% 2/112 • Number of events 2 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
General disorders Chills	4.3% 5/116 • Number of events 11 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	5.4% 6/112 • Number of events 8 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
General disorders Fatigue	20.7% 24/116 • Number of events 29 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	25.9% 29/112 • Number of events 37 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
General disorders Malaise	6.0% 7/116 • Number of events 9 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	5.4% 6/112 • Number of events 7 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
General disorders Mucosal inflammation	2.6% 3/116 • Number of events 4 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	8.9% 10/112 • Number of events 13 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
General disorders Oedema peripheral	5.2% 6/116 • Number of events 7 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	6.2% 7/112 • Number of events 8 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
General disorders Pyrexia	15.5% 18/116 • Number of events 29 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	25.0% 28/112 • Number of events 51 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Infections and infestations Nasopharyngitis	4.3% 5/116 • Number of events 8 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	7.1% 8/112 • Number of events 13 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Infections and infestations Upper respiratory tract infection	11.2% 13/116 • Number of events 17 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	14.3% 16/112 • Number of events 24 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Investigations Alanine aminotransferase increased	6.9% 8/116 • Number of events 9 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	4.5% 5/112 • Number of events 13 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Investigations Aspartate aminotransferase increased	8.6% 10/116 • Number of events 10 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	4.5% 5/112 • Number of events 8 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Investigations Blood alkaline phosphatase increased	7.8% 9/116 • Number of events 10 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.89% 1/112 • Number of events 2 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Investigations Blood creatinine increased	4.3% 5/116 • Number of events 6 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	9.8% 11/112 • Number of events 14 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Investigations Neutrophil count decreased	1.7% 2/116 • Number of events 3 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	33.9% 38/112 • Number of events 109 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Investigations Platelet count decreased	0.86% 1/116 • Number of events 1 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	8.9% 10/112 • Number of events 61 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Investigations Weight decreased	6.9% 8/116 • Number of events 9 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	6.2% 7/112 • Number of events 7 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Investigations White blood cell count decreased	0.00% 0/116 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	17.0% 19/112 • Number of events 52 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Metabolism and nutrition disorders Decreased appetite	19.8% 23/116 • Number of events 24 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	12.5% 14/112 • Number of events 18 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Metabolism and nutrition disorders Hypokalaemia	8.6% 10/116 • Number of events 17 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	7.1% 8/112 • Number of events 20 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Metabolism and nutrition disorders Hyponatraemia	9.5% 11/116 • Number of events 13 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	6.2% 7/112 • Number of events 11 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Musculoskeletal and connective tissue disorders Arthralgia	12.9% 15/116 • Number of events 22 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	3.6% 4/112 • Number of events 5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Musculoskeletal and connective tissue disorders Back pain	12.1% 14/116 • Number of events 16 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	11.6% 13/112 • Number of events 15 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.86% 1/116 • Number of events 2 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/112 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	20.0% 1/5 • Number of events 1 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Musculoskeletal and connective tissue disorders Myalgia	7.8% 9/116 • Number of events 9 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	8.0% 9/112 • Number of events 10 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Musculoskeletal and connective tissue disorders Pain in extremity	9.5% 11/116 • Number of events 12 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	4.5% 5/112 • Number of events 7 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Nervous system disorders Dizziness	13.8% 16/116 • Number of events 21 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	17.9% 20/112 • Number of events 22 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Nervous system disorders Headache	13.8% 16/116 • Number of events 19 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	9.8% 11/112 • Number of events 22 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Nervous system disorders Hypoaesthesia	5.2% 6/116 • Number of events 6 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	3.6% 4/112 • Number of events 4 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
Nervous system disorders Neuropathy peripheral	1.7% 2/116 • Number of events 2 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	7.1% 8/112 • Number of events 9 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.	0.00% 0/5 • All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022) All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.