Trial Outcomes & Findings for Safety and Efficacy of Vicriviroc (MK-7690) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Microsatellite Stable (MSS) Colorectal Cancer (CRC) (MK-7690-046) (NCT NCT03631407)

NCT ID: NCT03631407

Last Updated: 2024-11-21

Results Overview

Objective response rate (ORR) was defined as the percentage of participants who experienced a complete response (CR; disappearance of all target lesions) or a partial response (PR; at least a 30% decrease in the sum of diameters of target lesions) and was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by the investigator. ORR was estimated and analyzed using Clopper-Pearson interval.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 41 participants
• Primary outcome timeframe: Up to ~32 months
• Results posted on: 2024-11-21

Participant Flow

41 participants with advanced/metastatic microsatellite stable (MSS) colorectal cancer (CRC) were randomized to receive vicriviroc in combination with pembrolizumab in this study. Qualified participants were randomized 1:1 to receive vicriviroc (150 mg or 250 mg) in combination with pembrolizumab (200 mg Q3W) using an interactive response technology (IRT).

Participant milestones

Measure	Vicriviroc QD at Dose Level 1 (150 mg) + Pembrolizumab (200 mg) Participants received vicriviroc 150 mg tablets per os (PO) every day (QD) of each 21-day cycle up to 35 cycles and pembrolizumab 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21 day cycle up to 35 cycles (cycle length: 21 days).	Vicriviroc QD at Dose Level 2 (250 mg) + Pembrolizumab (200 mg) Participants received vicriviroc 250 mg tablets per os (PO) every day (QD) of each 21-day cycle up to 35 cycles and pembrolizumab 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21 day cycle up to 35 cycles (cycle length: 21 days).
Overall Study STARTED	21	20
Overall Study Treated	20	20
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	20	20

Reasons for withdrawal

Measure	Vicriviroc QD at Dose Level 1 (150 mg) + Pembrolizumab (200 mg) Participants received vicriviroc 150 mg tablets per os (PO) every day (QD) of each 21-day cycle up to 35 cycles and pembrolizumab 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21 day cycle up to 35 cycles (cycle length: 21 days).	Vicriviroc QD at Dose Level 2 (250 mg) + Pembrolizumab (200 mg) Participants received vicriviroc 250 mg tablets per os (PO) every day (QD) of each 21-day cycle up to 35 cycles and pembrolizumab 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21 day cycle up to 35 cycles (cycle length: 21 days).
Overall Study Withdrawal by Subject	3	2
Overall Study Sponsor Decision	0	2
Overall Study Death	16	16
Overall Study Randomized by mistake without study treatment	1	0

Baseline Characteristics

Safety and Efficacy of Vicriviroc (MK-7690) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Microsatellite Stable (MSS) Colorectal Cancer (CRC) (MK-7690-046)

Baseline characteristics by cohort

Measure	Vicriviroc QD at Dose Level 1 (150 mg) + Pembrolizumab (200 mg) n=21 Participants Participants received vicriviroc 150 mg tablets per os (PO) every day (QD) of each 21-day cycle up to 35 cycles and pembrolizumab 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21 day cycle up to 35 cycles (cycle length: 21 days).	Vicriviroc QD at Dose Level 2 (250 mg) + Pembrolizumab (200 mg) n=20 Participants Participants received vicriviroc 250 mg tablets per os (PO) every day (QD) of each 21-day cycle up to 35 cycles and pembrolizumab 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21 day cycle up to 35 cycles (cycle length: 21 days).	Total n=41 Participants Total of all reporting groups
Age, Continuous	58.3 Years STANDARD_DEVIATION 12.1 • n=5 Participants	60.4 Years STANDARD_DEVIATION 11.4 • n=7 Participants	59.3 Years STANDARD_DEVIATION 11.7 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants	18 Participants n=7 Participants	34 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants	17 Participants n=7 Participants	35 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to ~32 months

Population: The analysis population consisted of all participants who received at least 1 dose of study treatment, and had a baseline scan with measurable disease per investigator's assessment per RECIST 1.1.

Objective response rate (ORR) was defined as the percentage of participants who experienced a complete response (CR; disappearance of all target lesions) or a partial response (PR; at least a 30% decrease in the sum of diameters of target lesions) and was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by the investigator. ORR was estimated and analyzed using Clopper-Pearson interval.

Outcome measures

Measure	Vicriviroc QD at Dose Level 1 (150 mg) + Pembrolizumab (200 mg) n=20 Participants Participants received vicriviroc 150 mg tablets per os (PO) every day (QD) of each 21-day cycle up to 35 cycles and pembrolizumab 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21 day cycle up to 35 cycles (cycle length: 21 days).	Vicriviroc QD at Dose Level 2 (250 mg) + Pembrolizumab (200 mg) n=20 Participants Participants received vicriviroc 250 mg tablets per os (PO) every day (QD) of each 21-day cycle up to 35 cycles and pembrolizumab 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21 day cycle up to 35 cycles (cycle length: 21 days).
Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1)	5.0 Percentage of Participants Interval 0.1 to 24.9	5.0 Percentage of Participants Interval 0.1 to 24.9

PRIMARY outcome

Timeframe: Up to Day 21 of Cycle 1 (each cycle is 21 days)

Population: The analysis population consisted of all treated participants who received at least one dose of study drug and finished Cycle 1 without a DLT or experienced a DLT in Cycle 1.

DLTs were assessed during the first cycle (21 days) & were defined as: Grade (Gr) 4 nonhematologic toxicity; Gr 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia, Gr 4 thrombocytopenia of any duration, Gr 3 thrombocytopenia associated with bleeding; nonhematologic adverse event (AE) ≥ Gr 3 (with exceptions); Gr 3 or 4 nonhematologic lab abnormality (if medical intervention was required, lead to hospitalization, or persisted for >72 hours); Gr 3 or 4 febrile neutropenia; inability to receive ≥75% of the planned vicriviroc dose because of drug-related tolerability; drug-related toxicity that caused a >2 week delay in Cycle 2 initiation; elevated aspartate aminotransferase or alanine aminotransferase lab value that is >3× upper limit of normal (ULN) & an elevated total bilirubin value >2× ULN & an alkaline phosphatase value <2× ULN, in which no alternative reasons were found.

Outcome measures

Measure	Vicriviroc QD at Dose Level 1 (150 mg) + Pembrolizumab (200 mg) n=18 Participants Participants received vicriviroc 150 mg tablets per os (PO) every day (QD) of each 21-day cycle up to 35 cycles and pembrolizumab 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21 day cycle up to 35 cycles (cycle length: 21 days).	Vicriviroc QD at Dose Level 2 (250 mg) + Pembrolizumab (200 mg) n=18 Participants Participants received vicriviroc 250 mg tablets per os (PO) every day (QD) of each 21-day cycle up to 35 cycles and pembrolizumab 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21 day cycle up to 35 cycles (cycle length: 21 days).
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)	0 Participants	2 Participants

PRIMARY outcome

Timeframe: Up to ~28 months

Population: The analysis population consisted of all participants who received at least one dose of study drug.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants with at least one AE was assessed.

Outcome measures

Measure	Vicriviroc QD at Dose Level 1 (150 mg) + Pembrolizumab (200 mg) n=20 Participants Participants received vicriviroc 150 mg tablets per os (PO) every day (QD) of each 21-day cycle up to 35 cycles and pembrolizumab 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21 day cycle up to 35 cycles (cycle length: 21 days).	Vicriviroc QD at Dose Level 2 (250 mg) + Pembrolizumab (200 mg) n=20 Participants Participants received vicriviroc 250 mg tablets per os (PO) every day (QD) of each 21-day cycle up to 35 cycles and pembrolizumab 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21 day cycle up to 35 cycles (cycle length: 21 days).
Number of Participants Who Experienced an Adverse Event (AE)	20 Participants	20 Participants

PRIMARY outcome

Timeframe: Up to ~25 months

Population: The analysis population consisted of all participants who received at least one dose of study drug.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued treatment due to an AE was assessed

Outcome measures

Measure	Vicriviroc QD at Dose Level 1 (150 mg) + Pembrolizumab (200 mg) n=20 Participants Participants received vicriviroc 150 mg tablets per os (PO) every day (QD) of each 21-day cycle up to 35 cycles and pembrolizumab 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21 day cycle up to 35 cycles (cycle length: 21 days).	Vicriviroc QD at Dose Level 2 (250 mg) + Pembrolizumab (200 mg) n=20 Participants Participants received vicriviroc 250 mg tablets per os (PO) every day (QD) of each 21-day cycle up to 35 cycles and pembrolizumab 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21 day cycle up to 35 cycles (cycle length: 21 days).
Number of Participants Who Discontinued Study Treatment Due to an AE	4 Participants	7 Participants

SECONDARY outcome

Timeframe: Up to ~32 months

Population: The analysis population consisted of all participants who received at least 1 dose of study treatment, and had a baseline scan with measurable disease per investigator's assessment per modified iRECIST.

An objective response rate was defined as the percentage of participants who experienced an immune-based complete response (iCR: disappearance of all target lesions) or immune-based partial response (iPR: at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experienced an iCR or iPR using immune-based therapeutics Response Evaluation Criteria in Solid Tumors (iRECIST) per investigator was presented. ORR was estimated and analyzed using Clopper-Pearson interval.

Outcome measures

Measure	Vicriviroc QD at Dose Level 1 (150 mg) + Pembrolizumab (200 mg) n=20 Participants Participants received vicriviroc 150 mg tablets per os (PO) every day (QD) of each 21-day cycle up to 35 cycles and pembrolizumab 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21 day cycle up to 35 cycles (cycle length: 21 days).	Vicriviroc QD at Dose Level 2 (250 mg) + Pembrolizumab (200 mg) n=20 Participants Participants received vicriviroc 250 mg tablets per os (PO) every day (QD) of each 21-day cycle up to 35 cycles and pembrolizumab 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21 day cycle up to 35 cycles (cycle length: 21 days).
Objective Response Rate (ORR) Based on Modified Response Evaluation Criteria in Solid Tumors 1.1 for Immune-based Therapeutics (iRECIST)	5.0 Percentage of Participants Interval 0.1 to 24.9	5.0 Percentage of Participants Interval 0.1 to 24.9

SECONDARY outcome

Timeframe: Up to ~32 months

Population: The analysis population consisted of all participants who received at least 1 dose of study treatment, and had a baseline scan with measurable disease per investigator's assessment per RECIST 1.1.

PFS was defined as the time from the first dose of study treatment to the date of the first documentation of disease progression, as determined by investigator per RECIST 1.1 or death due to any cause (whichever occurred first). Disease progression was defined as at least 20 percent (%) increase (including an absolute increase of at least 5 millimeter [mm]) in the sum of diameter of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. PFS was estimated and analyzed using Kaplan-Meier method.

Outcome measures

Measure	Vicriviroc QD at Dose Level 1 (150 mg) + Pembrolizumab (200 mg) n=20 Participants Participants received vicriviroc 150 mg tablets per os (PO) every day (QD) of each 21-day cycle up to 35 cycles and pembrolizumab 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21 day cycle up to 35 cycles (cycle length: 21 days).	Vicriviroc QD at Dose Level 2 (250 mg) + Pembrolizumab (200 mg) n=20 Participants Participants received vicriviroc 250 mg tablets per os (PO) every day (QD) of each 21-day cycle up to 35 cycles and pembrolizumab 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21 day cycle up to 35 cycles (cycle length: 21 days).
Progression-Free Survival (PFS) Based on Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1)	2.1 Months Interval 1.8 to 3.0	2.1 Months Interval 1.6 to 3.9

SECONDARY outcome

Timeframe: Up to ~32 months

Population: The analysis population consisted of all participants who received at least 1 dose of study treatment, and had a baseline scan with measurable disease per investigator's assessment per modified iRECIST.

PFS was defined as the time from the first dose of study treatment to the date of the first documentation of disease progression, as determined by investigator per modified iRECIST or death due to any cause (whichever occurred first). Disease progression was defined as at least 20 percent (%) increase (including an absolute increase of at least 5 millimeter [mm]) in the sum of diameter of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. PFS was estimated and analyzed using Kaplan-Meier method.

Outcome measures

Measure	Vicriviroc QD at Dose Level 1 (150 mg) + Pembrolizumab (200 mg) n=20 Participants Participants received vicriviroc 150 mg tablets per os (PO) every day (QD) of each 21-day cycle up to 35 cycles and pembrolizumab 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21 day cycle up to 35 cycles (cycle length: 21 days).	Vicriviroc QD at Dose Level 2 (250 mg) + Pembrolizumab (200 mg) n=20 Participants Participants received vicriviroc 250 mg tablets per os (PO) every day (QD) of each 21-day cycle up to 35 cycles and pembrolizumab 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21 day cycle up to 35 cycles (cycle length: 21 days).
PFS Based on Modified Response Evaluation Criteria in Solid Tumors 1.1 for Immune-based Therapeutics (iRECIST)	4.0 Months Interval 2.7 to 5.6	4.9 Months Interval 3.1 to 8.0

SECONDARY outcome

Timeframe: Up to ~32 months

Population: The analysis population consisted of all participants who received at least 1 dose of study treatment, and had a baseline scan with measurable disease per investigator's assessment.

OS is defined as the time from the first dose of study treatment until death from any cause.

Outcome measures

Measure	Vicriviroc QD at Dose Level 1 (150 mg) + Pembrolizumab (200 mg) n=20 Participants Participants received vicriviroc 150 mg tablets per os (PO) every day (QD) of each 21-day cycle up to 35 cycles and pembrolizumab 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21 day cycle up to 35 cycles (cycle length: 21 days).	Vicriviroc QD at Dose Level 2 (250 mg) + Pembrolizumab (200 mg) n=20 Participants Participants received vicriviroc 250 mg tablets per os (PO) every day (QD) of each 21-day cycle up to 35 cycles and pembrolizumab 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21 day cycle up to 35 cycles (cycle length: 21 days).
Overall Survival (OS)	4.6 Months Interval 2.7 to 12.6	5.3 Months Interval 3.2 to 8.0

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 4, and 8 hours after vicriviroc administration on Cycle 1 (each cycle= 21-days) Day 1, Cycle 2 Day 1.

Population: The analysis population consisted of all participants who received at least 1 treatment and who contributed blood samples for analysis of AUC 0-8hrs. Per protocol, AUC 0-8hrs was calculated for the participants who had concentration values.

Plasma vicriviroc concentration was quantified for each arm to determine AUC 0-8hrs, defined as the area under the concentration vs. time curve for vicriviroc from 0 to 8 hours.

Outcome measures

Measure	Vicriviroc QD at Dose Level 1 (150 mg) + Pembrolizumab (200 mg) n=20 Participants Participants received vicriviroc 150 mg tablets per os (PO) every day (QD) of each 21-day cycle up to 35 cycles and pembrolizumab 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21 day cycle up to 35 cycles (cycle length: 21 days).	Vicriviroc QD at Dose Level 2 (250 mg) + Pembrolizumab (200 mg) n=20 Participants Participants received vicriviroc 250 mg tablets per os (PO) every day (QD) of each 21-day cycle up to 35 cycles and pembrolizumab 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21 day cycle up to 35 cycles (cycle length: 21 days).
Plasma Area Under the Concentration Time-Curve From 0 to 8 Hours (AUC 0-8hrs) of Vicriviroc Cycle 1	2600 hr*ng/mL Geometric Coefficient of Variation 30.6	4790 hr*ng/mL Geometric Coefficient of Variation 62.6
Plasma Area Under the Concentration Time-Curve From 0 to 8 Hours (AUC 0-8hrs) of Vicriviroc Cycle 2	4940 hr*ng/mL Geometric Coefficient of Variation 46.4	10600 hr*ng/mL Geometric Coefficient of Variation 84.4

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 4, and 8 hours after vicriviroc administration on Cycle 1 (each cycle= 21-days) Day 1, Cycle 2 Day 1.

Population: The analysis population consisted of all participants who received at least 1 treatment and who contributed blood samples for analysis of Cmax. Per protocol, Cmax was calculated for the participants who had concentration values.

Plasma vicriviroc concentration was quantified for each arm to determine Cmax, defined as the maximum observed concentration of vicriviroc in plasma.

Outcome measures

Measure	Vicriviroc QD at Dose Level 1 (150 mg) + Pembrolizumab (200 mg) n=20 Participants Participants received vicriviroc 150 mg tablets per os (PO) every day (QD) of each 21-day cycle up to 35 cycles and pembrolizumab 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21 day cycle up to 35 cycles (cycle length: 21 days).	Vicriviroc QD at Dose Level 2 (250 mg) + Pembrolizumab (200 mg) n=20 Participants Participants received vicriviroc 250 mg tablets per os (PO) every day (QD) of each 21-day cycle up to 35 cycles and pembrolizumab 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21 day cycle up to 35 cycles (cycle length: 21 days).
Maximum Observed Plasma Concentration (Cmax) of Vicriviroc Cycle 1	656 ng/mL Geometric Coefficient of Variation 37.1	1130 ng/mL Geometric Coefficient of Variation 65.3
Maximum Observed Plasma Concentration (Cmax) of Vicriviroc Cycle 2	955 ng/mL Geometric Coefficient of Variation 45.6	1940 ng/mL Geometric Coefficient of Variation 72.7

SECONDARY outcome

Timeframe: Pre-dose, and 1, 2, 4, and 8 hours after vicriviroc administration on Cycle 1 (each cycle= 21-days) Day 1; Cycle 3 Day 21.

Population: The analysis population consisted of all participants who received at least 1 treatment and who contributed blood samples for analysis of Ctrough. Per protocol, Ctrough was calculated for the participants who had concentration values.

Plasma vicriviroc concentration was quantified for each arm to determine Ctrough, defined as the minimum plasma concentration of vicriviroc observed after administration and just before the subsequent dose.

Outcome measures

Measure	Vicriviroc QD at Dose Level 1 (150 mg) + Pembrolizumab (200 mg) n=15 Participants Participants received vicriviroc 150 mg tablets per os (PO) every day (QD) of each 21-day cycle up to 35 cycles and pembrolizumab 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21 day cycle up to 35 cycles (cycle length: 21 days).	Vicriviroc QD at Dose Level 2 (250 mg) + Pembrolizumab (200 mg) n=11 Participants Participants received vicriviroc 250 mg tablets per os (PO) every day (QD) of each 21-day cycle up to 35 cycles and pembrolizumab 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21 day cycle up to 35 cycles (cycle length: 21 days).
Trough Plasma Concentration (Ctrough) of Vicriviroc Cycle 1	338 ng/mL Geometric Coefficient of Variation 102.3	468 ng/mL Geometric Coefficient of Variation 162.6
Trough Plasma Concentration (Ctrough) of Vicriviroc Cycle 3	217 ng/mL Geometric Coefficient of Variation 61.9	635 ng/mL Geometric Coefficient of Variation 62.4

Adverse Events

Vicriviroc QD at Dose Level 1 (150 mg) + Pembrolizumab (200 mg)

Serious events: 12 serious events

Other events: 14 other events

Deaths: 19 deaths

Vicriviroc QD at Dose Level 2 (250 mg) + Pembrolizumab (200 mg)

Serious events: 10 serious events

Other events: 19 other events

Deaths: 17 deaths

Serious adverse events

Measure	Vicriviroc QD at Dose Level 1 (150 mg) + Pembrolizumab (200 mg) n=20 participants at risk Participants received vicriviroc 150 mg tablets per os (PO) every day (QD) of each 21-day cycle up to 35 cycles and pembrolizumab 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21 day cycle up to 35 cycles (cycle length: 21 days).	Vicriviroc QD at Dose Level 2 (250 mg) + Pembrolizumab (200 mg) n=20 participants at risk Participants received vicriviroc 250 mg tablets per os (PO) every day (QD) of each 21-day cycle up to 35 cycles and pembrolizumab 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21 day cycle up to 35 cycles (cycle length: 21 days).
Cardiac disorders Atrial fibrillation	5.0% 1/20 • Number of events 1 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	0.00% 0/20 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Endocrine disorders Hyperthyroidism	0.00% 0/20 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	5.0% 1/20 • Number of events 1 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Eye disorders Visual field defect	0.00% 0/20 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	5.0% 1/20 • Number of events 1 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Gastrointestinal disorders Abdominal pain	10.0% 2/20 • Number of events 2 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	5.0% 1/20 • Number of events 1 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Gastrointestinal disorders Dysphagia	0.00% 0/20 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	5.0% 1/20 • Number of events 1 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/20 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	5.0% 1/20 • Number of events 1 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Gastrointestinal disorders Intestinal perforation	5.0% 1/20 • Number of events 1 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	0.00% 0/20 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Gastrointestinal disorders Small intestinal obstruction	5.0% 1/20 • Number of events 1 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	5.0% 1/20 • Number of events 2 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
General disorders Death	5.0% 1/20 • Number of events 1 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	5.0% 1/20 • Number of events 1 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
General disorders Ill-defined disorder	0.00% 0/20 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	5.0% 1/20 • Number of events 1 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
General disorders Pyrexia	0.00% 0/20 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	5.0% 1/20 • Number of events 1 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Hepatobiliary disorders Jaundice cholestatic	5.0% 1/20 • Number of events 1 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	0.00% 0/20 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Infections and infestations Coccidioidomycosis	5.0% 1/20 • Number of events 1 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	0.00% 0/20 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Infections and infestations Pneumonia	5.0% 1/20 • Number of events 1 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	0.00% 0/20 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Infections and infestations Sepsis	5.0% 1/20 • Number of events 1 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	0.00% 0/20 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Infections and infestations Urinary tract infection	5.0% 1/20 • Number of events 2 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	0.00% 0/20 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Injury, poisoning and procedural complications Stomal hernia	5.0% 1/20 • Number of events 1 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	0.00% 0/20 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Investigations Blood bilirubin increased	0.00% 0/20 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	10.0% 2/20 • Number of events 2 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Metabolism and nutrition disorders Dehydration	5.0% 1/20 • Number of events 1 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	0.00% 0/20 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/20 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	5.0% 1/20 • Number of events 1 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/20 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	5.0% 1/20 • Number of events 1 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/20 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	5.0% 1/20 • Number of events 1 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Musculoskeletal and connective tissue disorders Back pain	5.0% 1/20 • Number of events 1 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	0.00% 0/20 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	5.0% 1/20 • Number of events 1 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	0.00% 0/20 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	5.0% 1/20 • Number of events 1 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	5.0% 1/20 • Number of events 1 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Nervous system disorders Encephalopathy	0.00% 0/20 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	5.0% 1/20 • Number of events 1 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Nervous system disorders Lethargy	0.00% 0/20 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	5.0% 1/20 • Number of events 1 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Psychiatric disorders Confusional state	0.00% 0/20 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	5.0% 1/20 • Number of events 1 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Renal and urinary disorders Acute kidney injury	5.0% 1/20 • Number of events 1 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	5.0% 1/20 • Number of events 1 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Reproductive system and breast disorders Female genital tract fistula	5.0% 1/20 • Number of events 1 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	0.00% 0/20 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Respiratory, thoracic and mediastinal disorders Pleural effusion	5.0% 1/20 • Number of events 1 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	0.00% 0/20 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/20 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	5.0% 1/20 • Number of events 1 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.

Other adverse events

Measure	Vicriviroc QD at Dose Level 1 (150 mg) + Pembrolizumab (200 mg) n=20 participants at risk Participants received vicriviroc 150 mg tablets per os (PO) every day (QD) of each 21-day cycle up to 35 cycles and pembrolizumab 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21 day cycle up to 35 cycles (cycle length: 21 days).	Vicriviroc QD at Dose Level 2 (250 mg) + Pembrolizumab (200 mg) n=20 participants at risk Participants received vicriviroc 250 mg tablets per os (PO) every day (QD) of each 21-day cycle up to 35 cycles and pembrolizumab 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21 day cycle up to 35 cycles (cycle length: 21 days).
Blood and lymphatic system disorders Anaemia	5.0% 1/20 • Number of events 1 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	30.0% 6/20 • Number of events 8 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Gastrointestinal disorders Abdominal distension	5.0% 1/20 • Number of events 2 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	15.0% 3/20 • Number of events 4 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Gastrointestinal disorders Abdominal pain	25.0% 5/20 • Number of events 5 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	15.0% 3/20 • Number of events 3 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Gastrointestinal disorders Constipation	35.0% 7/20 • Number of events 7 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	15.0% 3/20 • Number of events 3 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Gastrointestinal disorders Diarrhoea	10.0% 2/20 • Number of events 2 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	20.0% 4/20 • Number of events 6 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Gastrointestinal disorders Flatulence	10.0% 2/20 • Number of events 2 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	0.00% 0/20 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Gastrointestinal disorders Haematochezia	0.00% 0/20 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	10.0% 2/20 • Number of events 2 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Gastrointestinal disorders Nausea	30.0% 6/20 • Number of events 7 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	25.0% 5/20 • Number of events 6 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Gastrointestinal disorders Vomiting	25.0% 5/20 • Number of events 6 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	20.0% 4/20 • Number of events 4 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
General disorders Chills	5.0% 1/20 • Number of events 1 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	10.0% 2/20 • Number of events 2 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
General disorders Fatigue	30.0% 6/20 • Number of events 7 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	40.0% 8/20 • Number of events 8 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
General disorders Pyrexia	5.0% 1/20 • Number of events 1 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	10.0% 2/20 • Number of events 2 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Infections and infestations Urinary tract infection	15.0% 3/20 • Number of events 6 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	30.0% 6/20 • Number of events 8 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Investigations Alanine aminotransferase increased	15.0% 3/20 • Number of events 3 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	35.0% 7/20 • Number of events 7 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Investigations Aspartate aminotransferase increased	10.0% 2/20 • Number of events 2 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	40.0% 8/20 • Number of events 8 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Investigations Blood alkaline phosphatase increased	5.0% 1/20 • Number of events 1 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	15.0% 3/20 • Number of events 3 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Investigations Blood bilirubin increased	5.0% 1/20 • Number of events 1 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	10.0% 2/20 • Number of events 2 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Investigations Blood creatinine increased	20.0% 4/20 • Number of events 4 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	15.0% 3/20 • Number of events 4 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Investigations Weight decreased	15.0% 3/20 • Number of events 3 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	10.0% 2/20 • Number of events 2 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Metabolism and nutrition disorders Decreased appetite	10.0% 2/20 • Number of events 2 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	20.0% 4/20 • Number of events 4 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Metabolism and nutrition disorders Dehydration	0.00% 0/20 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	10.0% 2/20 • Number of events 3 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/20 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	15.0% 3/20 • Number of events 7 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/20 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	10.0% 2/20 • Number of events 2 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Metabolism and nutrition disorders Hypokalaemia	20.0% 4/20 • Number of events 4 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	20.0% 4/20 • Number of events 10 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Metabolism and nutrition disorders Hypomagnesaemia	5.0% 1/20 • Number of events 1 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	10.0% 2/20 • Number of events 4 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Metabolism and nutrition disorders Hyponatraemia	5.0% 1/20 • Number of events 1 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	15.0% 3/20 • Number of events 4 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Metabolism and nutrition disorders Iron deficiency	0.00% 0/20 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	10.0% 2/20 • Number of events 2 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/20 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	10.0% 2/20 • Number of events 2 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/20 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	15.0% 3/20 • Number of events 4 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Musculoskeletal and connective tissue disorders Muscular weakness	5.0% 1/20 • Number of events 1 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	10.0% 2/20 • Number of events 2 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	10.0% 2/20 • Number of events 2 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	0.00% 0/20 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Nervous system disorders Dizziness	5.0% 1/20 • Number of events 1 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	30.0% 6/20 • Number of events 7 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Nervous system disorders Dysgeusia	10.0% 2/20 • Number of events 2 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	0.00% 0/20 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Nervous system disorders Headache	10.0% 2/20 • Number of events 2 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	5.0% 1/20 • Number of events 1 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Psychiatric disorders Anxiety	0.00% 0/20 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	10.0% 2/20 • Number of events 2 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Psychiatric disorders Confusional state	0.00% 0/20 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	10.0% 2/20 • Number of events 2 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Psychiatric disorders Insomnia	0.00% 0/20 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	25.0% 5/20 • Number of events 5 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Renal and urinary disorders Nocturia	10.0% 2/20 • Number of events 2 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	5.0% 1/20 • Number of events 1 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Respiratory, thoracic and mediastinal disorders Dyspnoea	15.0% 3/20 • Number of events 3 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	15.0% 3/20 • Number of events 3 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/20 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	10.0% 2/20 • Number of events 2 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/20 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	10.0% 2/20 • Number of events 2 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Skin and subcutaneous tissue disorders Hyperhidrosis	10.0% 2/20 • Number of events 2 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	5.0% 1/20 • Number of events 1 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
Skin and subcutaneous tissue disorders Pruritus	20.0% 4/20 • Number of events 4 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.	20.0% 4/20 • Number of events 6 • For AEs: Up to ~28 months. All-cause mortality (ACM): Up to ~32 months. All-cause mortality includes all randomized participants. Safety includes participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission.
• Publication restrictions are in place

Restriction type: OTHER