Trial Outcomes & Findings for Pembrolizumab and Gemcitabine Chemotherapy in Leiomyosarcoma and Undifferentiated Pleomorphic Sarcoma (NCT NCT03123276)

Last Updated: 2026-02-13

Results Overview

Part A dose escalation part patients were treated cohorts and assessed for safety until the maximum tolerated dose of gemcitabine that can be safely combined with pembrolizumab in the absence of dose limiting toxicities (DLT). Outcome measure here is the proportion of patients with DLT for each dose level. Protocol definition of DLT: (1) Neutropenia \<0.5 x 109/L for \>5 days. This must be confirmed with repeat blood tests at the Royal Marsden Hospital within 6 days of the diagnosis of neutropenia. (2) Febrile neutropaenia as per definition by ESMO (\>38.3°C or two consecutive readings of \>38.0°C for 2 hours and an absolute neutrophil count (ANC) of \<0.5 x 109/L or expected to fall below \<0.5 x 109/L). (3) Thrombocytopenia \<25 x 109/L. (4) Any non-haematological CTCAE Grade 3 or 4 toxicity that is, in the opinion of the investigator, clinically significant. All the above must be in the investigator's opinion, likely to be causally linked with the administration of Gemcitabine.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

25 participants

Primary outcome timeframe

Treatment start date until completion of 1 full cycle of treatment (21 days)

Results posted on

2026-02-13

Participant Flow

Eligible patients must have histologically confirmed leiomyosarcoma or undifferentiated pleomorphic sarcoma, measurable and biopsiable disease, ECOG 0-1, life expectancy \>12 weeks, and adequate organ function. Mandatory paired biopsies and blood samples required. Exclude active infection, autoimmune disease, CNS metastases, prior PD-1 therapy. Consent before procedures; screening labs within 28 days; treatment starts within 7 days of eligibility.

Participant milestones

Participant milestones
Measure	Cohort 1: 800mg/m2 Cohort 1: 800mg/m2 Part A - Dose escalation phase - Dose level 1: 800mg/m2	Cohort 2: 1000mg/m2 Part A - Dose escalation phase - Dose level 2: 1000mg/m2	Cohort 3: 1200mg/m2 Part A - Dose escalation phase - Dose level 3: 1200mg/m2	Part B Dose Expansion Cohort - 1200mg/m2 Part B - Expansion phase - Treated with dose level 3: 1200mg/m2
Overall Study STARTED	3	7	3	12
Overall Study COMPLETED	3	7	3	12
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pembrolizumab and Gemcitabine Chemotherapy in Leiomyosarcoma and Undifferentiated Pleomorphic Sarcoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: 800mg/m2 n=3 Participants Part A - Dose escalation phase - Dose level 1: 800mg/m2	Cohort 2: 1000mg/m2 n=7 Participants Part A - Dose escalation phase - Dose level 2: 1000mg/m2	Cohort 3 - 1200mg/m2 n=3 Participants Part A - Dose escalation phase - Dose level 3: 1200mg/m2	Part B Dose Expansion Cohort - 1200mg/m2 n=12 Participants Part B - Expansion phase - Treated with dose level 3: 1200mg/m2	Total n=25 Participants Total of all reporting groups
Race/Ethnicity, Customized Caucasian	3 Participants n=41 Participants	5 Participants n=1581 Participants	3 Participants n=4626 Participants	11 Participants n=72 Participants	22 Participants
Age, Continuous	51 years n=41 Participants	57 years n=1581 Participants	46 years n=4626 Participants	57 years n=72 Participants	56 years
Sex: Female, Male Female	2 Participants n=41 Participants	5 Participants n=1581 Participants	3 Participants n=4626 Participants	9 Participants n=72 Participants	19 Participants
Sex: Female, Male Male	1 Participants n=41 Participants	2 Participants n=1581 Participants	0 Participants n=4626 Participants	3 Participants n=72 Participants	6 Participants
Race/Ethnicity, Customized African	0 Participants n=41 Participants	1 Participants n=1581 Participants	0 Participants n=4626 Participants	1 Participants n=72 Participants	2 Participants
Race/Ethnicity, Customized Oriental	0 Participants n=41 Participants	1 Participants n=1581 Participants	0 Participants n=4626 Participants	0 Participants n=72 Participants	1 Participants
Region of Enrollment United Kingdom	3 Participants n=41 Participants	7 Participants n=1581 Participants	3 Participants n=4626 Participants	12 Participants n=72 Participants	25 Participants
ECOG ECOG-0 (Asymptomatic, fully active, able to carry on all pre-disease activities without restriction)	2 Participants n=41 Participants	6 Participants n=1581 Participants	2 Participants n=4626 Participants	8 Participants n=72 Participants	18 Participants
ECOG ECOG-1 (Symptomatic but completely ambulatory, restricted in physically strenuous activity)	1 Participants n=41 Participants	1 Participants n=1581 Participants	1 Participants n=4626 Participants	4 Participants n=72 Participants	7 Participants
Prior Oncology Surgery No	0 Participants n=41 Participants	1 Participants n=1581 Participants	0 Participants n=4626 Participants	1 Participants n=72 Participants	2 Participants
Prior Oncology Surgery Yes	3 Participants n=41 Participants	6 Participants n=1581 Participants	3 Participants n=4626 Participants	11 Participants n=72 Participants	23 Participants
Sarcoma types LMS	3 Participants n=41 Participants	6 Participants n=1581 Participants	2 Participants n=4626 Participants	8 Participants n=72 Participants	19 Participants
Sarcoma types UPS	0 Participants n=41 Participants	1 Participants n=1581 Participants	1 Participants n=4626 Participants	4 Participants n=72 Participants	6 Participants
Metastatic Disease Sites Lung · No	1 Participants n=41 Participants	4 Participants n=1581 Participants	2 Participants n=4626 Participants	1 Participants n=72 Participants	8 Participants
Metastatic Disease Sites Lung · Yes	2 Participants n=41 Participants	3 Participants n=1581 Participants	1 Participants n=4626 Participants	11 Participants n=72 Participants	17 Participants
Metastatic Disease Sites Bone · No	2 Participants n=41 Participants	6 Participants n=1581 Participants	3 Participants n=4626 Participants	11 Participants n=72 Participants	22 Participants
Metastatic Disease Sites Bone · Yes	1 Participants n=41 Participants	1 Participants n=1581 Participants	0 Participants n=4626 Participants	1 Participants n=72 Participants	3 Participants
Metastatic Disease Sites Adrenals · No	2 Participants n=41 Participants	7 Participants n=1581 Participants	3 Participants n=4626 Participants	12 Participants n=72 Participants	24 Participants
Metastatic Disease Sites Adrenals · Yes	1 Participants n=41 Participants	0 Participants n=1581 Participants	0 Participants n=4626 Participants	0 Participants n=72 Participants	1 Participants
Metastatic Disease Sites Liver · No	1 Participants n=41 Participants	4 Participants n=1581 Participants	2 Participants n=4626 Participants	6 Participants n=72 Participants	13 Participants
Metastatic Disease Sites Liver · Yes	2 Participants n=41 Participants	3 Participants n=1581 Participants	1 Participants n=4626 Participants	6 Participants n=72 Participants	12 Participants
Metastatic Disease Sites Other · No	0 Participants n=41 Participants	3 Participants n=1581 Participants	1 Participants n=4626 Participants	4 Participants n=72 Participants	8 Participants
Metastatic Disease Sites Other · Yes	3 Participants n=41 Participants	4 Participants n=1581 Participants	2 Participants n=4626 Participants	8 Participants n=72 Participants	17 Participants

PRIMARY outcome

Timeframe: Treatment start date until completion of 1 full cycle of treatment (21 days)

Population: Intention to treat - Cohort of patients recruited in the individual dose levels and received at least 1 treatment dose during the Part A dose escalation phase of the study.

Outcome measures

Outcome measures
Measure	Part B Dose Expansion Cohort - 1200mg/m2 Gemcitabine Part B - Expansion phase - Patients treated with dose level 3: 1200mg/m2	Cohort 1: 800mg/m2 Gemcitabine n=3 Participants Part A - Dose escalation phase - Dose level 1: 800mg/m2	Cohort 2: 1000mg/m2 Gemcitabine n=7 Participants Part A - Dose escalation phase - Dose level 2: 1000mg/m2	Cohort 3: 1200mg/m2 Gemcitabine n=3 Participants Part A - Dose escalation phase - Dose level 3 1200mg/m2
Number of Patients With Dose Limiting Toxicities.	—	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Treatment initiation until 9 weeks of starting treatment

Population: Intention to treat analysis population: all patients consented and registered into the study and have had treatment.

Objective response rate presented as number and proportion of patients with a response of CR or PR at 9 weeks of starting treatment according to the RECIST criteria. Similarly, for disease control rate proportion of patients with a response of CR or PR or SD at 9 weeks.

Outcome measures

Outcome measures
Measure	Part B Dose Expansion Cohort - 1200mg/m2 Gemcitabine n=12 Participants Part B - Expansion phase - Patients treated with dose level 3: 1200mg/m2	Cohort 1: 800mg/m2 Gemcitabine n=3 Participants Part A - Dose escalation phase - Dose level 1: 800mg/m2	Cohort 2: 1000mg/m2 Gemcitabine n=7 Participants Part A - Dose escalation phase - Dose level 2: 1000mg/m2	Cohort 3: 1200mg/m2 Gemcitabine n=3 Participants Part A - Dose escalation phase - Dose level 3 1200mg/m2
Preliminary Evaluation of Response by Using RECIST v1.1. Number of Patients With Objective Response and Disease Control Objective response rate (ORR)	2 Participants	0 Participants	1 Participants	2 Participants
Preliminary Evaluation of Response by Using RECIST v1.1. Number of Patients With Objective Response and Disease Control Disease control rate (DCR)	9 Participants	3 Participants	6 Participants	1 Participants

Adverse Events

Cohort 1 - 800mg/m2 Gemcitabine

Serious events: 2 serious events

Other events: 3 other events

Deaths: 3 deaths

Cohort 2 - 1000mg/m2 Gemcitabine

Serious events: 2 serious events

Other events: 7 other events

Deaths: 5 deaths

Cohort 3 - 1200mg/m2 Gemcitabine

Serious events: 2 serious events

Other events: 3 other events

Deaths: 2 deaths

Part B Dose Expansion Cohort - 1200mg/m2 Gemcitabine

Serious events: 6 serious events

Other events: 12 other events

Deaths: 5 deaths

Serious adverse events

Other adverse events

Additional Information

Clinical Trials Manager - Angelie Tirona

The Royal Marsden NHS Foundation Trust

Phone: 020 8642 6011

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Cohort 1 - 800mg/m2 Gemcitabine n=3 participants at risk Part A - Dose escalation phase - Dose level 1: 800mg/m2	Cohort 2 - 1000mg/m2 Gemcitabine n=7 participants at risk Part A - Dose escalation phase - Dose level 2: 1000mg/m2	Cohort 3 - 1200mg/m2 Gemcitabine n=3 participants at risk Part A - Dose escalation phase - Dose level 3: 1200mg/m2	Part B Dose Expansion Cohort - 1200mg/m2 Gemcitabine n=12 participants at risk Part B - Expansion phase - Patients treated with dose level 3: 1200mg/m2
General disorders Fever	66.7% 2/3 • Number of events 5 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	14.3% 1/7 • Number of events 4 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	33.3% 1/3 • Number of events 1 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	16.7% 2/12 • Number of events 2 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
Cardiac disorders Heart Failure	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/7 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	8.3% 1/12 • Number of events 1 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
Cardiac disorders Ventricular arrhythmia	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/7 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	8.3% 1/12 • Number of events 1 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	14.3% 1/7 • Number of events 1 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	8.3% 1/12 • Number of events 1 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
Infections and infestations Lung infection	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/7 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	8.3% 1/12 • Number of events 1 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
Infections and infestations Skin infection	33.3% 1/3 • Number of events 2 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/7 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	8.3% 1/12 • Number of events 1 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
Investigations Blood Bilirubin Increased	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/7 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	8.3% 1/12 • Number of events 1 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/7 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	33.3% 1/3 • Number of events 1 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/12 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	14.3% 1/7 • Number of events 1 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/12 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
Vascular disorders Thromboembolic event	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/7 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	8.3% 1/12 • Number of events 1 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
Eye disorders Other	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	14.3% 1/7 • Number of events 1 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/12 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
Surgical and medical procedures Other	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/7 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	33.3% 1/3 • Number of events 1 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	8.3% 1/12 • Number of events 1 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
Gastrointestinal disorders Other	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/7 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	33.3% 1/3 • Number of events 1 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/12 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
Infections and infestations Other	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/7 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	8.3% 1/12 • Number of events 1 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
Renal and urinary disorders Other	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/7 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	8.3% 1/12 • Number of events 1 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
Hepatobiliary disorders Other	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/7 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	8.3% 1/12 • Number of events 1 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.

Other adverse events
Measure	Cohort 1 - 800mg/m2 Gemcitabine n=3 participants at risk Part A - Dose escalation phase - Dose level 1: 800mg/m2	Cohort 2 - 1000mg/m2 Gemcitabine n=7 participants at risk Part A - Dose escalation phase - Dose level 2: 1000mg/m2	Cohort 3 - 1200mg/m2 Gemcitabine n=3 participants at risk Part A - Dose escalation phase - Dose level 3: 1200mg/m2	Part B Dose Expansion Cohort - 1200mg/m2 Gemcitabine n=12 participants at risk Part B - Expansion phase - Patients treated with dose level 3: 1200mg/m2
Blood and lymphatic system disorders Anemia	33.3% 1/3 • Number of events 10 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	57.1% 4/7 • Number of events 7 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	33.3% 1/3 • Number of events 1 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	16.7% 2/12 • Number of events 7 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
Endocrine disorders Hyperthyroidism	33.3% 1/3 • Number of events 1 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	42.9% 3/7 • Number of events 4 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/12 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
Endocrine disorders Hypothyroidism	100.0% 3/3 • Number of events 5 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	57.1% 4/7 • Number of events 5 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	33.3% 1/3 • Number of events 1 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	16.7% 2/12 • Number of events 3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
Gastrointestinal disorders Abdominal pain	66.7% 2/3 • Number of events 3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	42.9% 3/7 • Number of events 6 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	33.3% 1/3 • Number of events 1 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	41.7% 5/12 • Number of events 5 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
Gastrointestinal disorders Constipation	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	28.6% 2/7 • Number of events 2 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	33.3% 1/3 • Number of events 1 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	33.3% 4/12 • Number of events 4 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
Gastrointestinal disorders Diarrhea	66.7% 2/3 • Number of events 3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	57.1% 4/7 • Number of events 7 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	33.3% 1/3 • Number of events 2 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	16.7% 2/12 • Number of events 3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
Gastrointestinal disorders Gastroesophageal reflux disease	33.3% 1/3 • Number of events 1 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	14.3% 1/7 • Number of events 2 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	8.3% 1/12 • Number of events 1 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
Gastrointestinal disorders Mucositis oral	33.3% 1/3 • Number of events 3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	14.3% 1/7 • Number of events 1 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	33.3% 1/3 • Number of events 1 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	16.7% 2/12 • Number of events 2 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
Gastrointestinal disorders Nausea	66.7% 2/3 • Number of events 4 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	57.1% 4/7 • Number of events 16 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	33.3% 1/3 • Number of events 2 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	50.0% 6/12 • Number of events 9 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
Gastrointestinal disorders Oral pain	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/7 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	66.7% 2/3 • Number of events 2 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/12 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
Gastrointestinal disorders Vomiting	33.3% 1/3 • Number of events 1 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	71.4% 5/7 • Number of events 7 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	33.3% 1/3 • Number of events 2 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	25.0% 3/12 • Number of events 3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
General disorders Chills	33.3% 1/3 • Number of events 1 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	28.6% 2/7 • Number of events 3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/12 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
General disorders Edema limbs	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	14.3% 1/7 • Number of events 3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	16.7% 2/12 • Number of events 2 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
General disorders Fatigue	100.0% 3/3 • Number of events 9 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	71.4% 5/7 • Number of events 10 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	66.7% 2/3 • Number of events 4 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	66.7% 8/12 • Number of events 10 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
General disorders Fever	66.7% 2/3 • Number of events 10 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	14.3% 1/7 • Number of events 4 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	66.7% 2/3 • Number of events 2 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	33.3% 4/12 • Number of events 6 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
General disorders Flu like symptoms	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	28.6% 2/7 • Number of events 2 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	8.3% 1/12 • Number of events 1 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
General disorders Localized edema	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	14.3% 1/7 • Number of events 2 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	8.3% 1/12 • Number of events 1 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
General disorders Pain	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/7 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	33.3% 4/12 • Number of events 4 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
Hepatobiliary disorders Hepatic pain	33.3% 1/3 • Number of events 1 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	14.3% 1/7 • Number of events 1 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/12 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
Infections and infestations Papulopustular rash	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	14.3% 1/7 • Number of events 2 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/12 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
Infections and infestations Skin infection	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	28.6% 2/7 • Number of events 2 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	33.3% 1/3 • Number of events 1 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/12 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
Infections and infestations Upper respiratory infection	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	28.6% 2/7 • Number of events 2 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	33.3% 1/3 • Number of events 1 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	8.3% 1/12 • Number of events 1 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
Infections and infestations Urinary tract infection	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/7 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	8.3% 1/12 • Number of events 4 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
Investigations Alanine aminotransferase increased	33.3% 1/3 • Number of events 2 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	42.9% 3/7 • Number of events 3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	33.3% 1/3 • Number of events 4 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	41.7% 5/12 • Number of events 6 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
Investigations Alkaline phosphatase increased	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/7 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	33.3% 4/12 • Number of events 9 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
Investigations Aspartate aminotransferase increased	33.3% 1/3 • Number of events 1 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	14.3% 1/7 • Number of events 1 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	25.0% 3/12 • Number of events 6 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
Infections and infestations GGT increased	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/7 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	33.3% 1/3 • Number of events 1 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	16.7% 2/12 • Number of events 5 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
Investigations Neutrophil count decreased	66.7% 2/3 • Number of events 2 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	85.7% 6/7 • Number of events 10 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	100.0% 3/3 • Number of events 8 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	8.3% 1/12 • Number of events 1 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
Investigations Platelet count decreased	33.3% 1/3 • Number of events 4 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	28.6% 2/7 • Number of events 4 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	8.3% 1/12 • Number of events 1 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
Investigations Serum amylase increased	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/7 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	33.3% 1/3 • Number of events 3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/12 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
Investigations White blood cell decreased	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	28.6% 2/7 • Number of events 5 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/12 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
Metabolism and nutrition disorders Anorexia	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	71.4% 5/7 • Number of events 5 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	33.3% 1/3 • Number of events 1 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	16.7% 2/12 • Number of events 2 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
Metabolism and nutrition disorders Hypophosphatemia	33.3% 1/3 • Number of events 2 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/7 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/12 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	57.1% 4/7 • Number of events 8 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	66.7% 2/3 • Number of events 2 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/12 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	42.9% 3/7 • Number of events 6 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	25.0% 3/12 • Number of events 3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
Musculoskeletal and connective tissue disorders Myalgia	66.7% 2/3 • Number of events 3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	14.3% 1/7 • Number of events 1 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	100.0% 3/3 • Number of events 3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	16.7% 2/12 • Number of events 3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
Musculoskeletal and connective tissue disorders Neck pain	33.3% 1/3 • Number of events 1 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	28.6% 2/7 • Number of events 3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	8.3% 1/12 • Number of events 1 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	28.6% 2/7 • Number of events 6 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/12 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
Metabolism and nutrition disorders Hypocalcemia	33.3% 1/3 • Number of events 1 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/7 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/12 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/7 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	0.00% 0/3 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.	8.3% 1/12 • Number of events 1 • AEs were graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, and at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 12 months). All cause mortality were recorded until death or end of trial (36 months). An AE is defined as any untoward, undesired or unplanned occurrence (including deterioration of a pre-existing medical condition) in a patient administered a pharmaceutical product or undertaking a protocol-specified procedure.