Trial Outcomes & Findings for Study of Selumetinib (MK-5618) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Solid Tumors (MK-5618-001) (NCT NCT03833427)

Last Updated: 2024-11-07

Results Overview

DLT was defined as toxicities that: 1) were possibly, probably, or definitely related to study therapy, excluding toxicities clearly not related to the drug, such as disease progression, environmental factors, unrelated trauma; and 2) met pre-defined severity criteria. For each arm, the number of participants experiencing DLTs were assessed.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

32 participants

Primary outcome timeframe

Up to 21 days

Results posted on

2024-11-07

Participant Flow

Though the total planned enrollment for this study was 50 participants. Only 32 participants were allocated and included in Part 1, dose escalation for analysis. Part 2 cohort expansion was not initiated. The study was terminated after completion of dose escalation due to reasons unrelated to safety or tolerability.

Participant milestones

Participant milestones
Measure	Selumetinib 50mg + Pembrolizumab Participants received 200 mg pembrolizumab (IV infusion; every three weeks \[Q3W\]) in combination with selumetinib 50mg orally twice daily \[BID\]) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib was administered only for the first two weeks.	Selumetinib 75mg + Pembrolizumab Participants received 200 mg pembrolizumab (IV infusion; every three weeks \[Q3W\]) in combination with selumetinib 75mg orally twice daily \[BID\]) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib was administered only for the first two weeks.	Selumetinib 100mg + Pembrolizumab Participants received 200 mg pembrolizumab (IV infusion; every three weeks \[Q3W\]) in combination with selumetinib 100mg orally twice daily \[BID\]) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib was administered only for the first two weeks.	Selumetinib 125mg + Pembrolizumab Participants received 200 mg pembrolizumab (IV infusion; every three weeks \[Q3W\]) in combination with selumetinib 125mg orally twice daily \[BID\]) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib was administered only for the first two weeks.
Overall Study STARTED	4	3	11	14
Overall Study Discontinued	4	3	11	14
Overall Study COMPLETED	0	0	0	0
Overall Study NOT COMPLETED	4	3	11	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Selumetinib 50mg + Pembrolizumab Participants received 200 mg pembrolizumab (IV infusion; every three weeks \[Q3W\]) in combination with selumetinib 50mg orally twice daily \[BID\]) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib was administered only for the first two weeks.	Selumetinib 75mg + Pembrolizumab Participants received 200 mg pembrolizumab (IV infusion; every three weeks \[Q3W\]) in combination with selumetinib 75mg orally twice daily \[BID\]) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib was administered only for the first two weeks.	Selumetinib 100mg + Pembrolizumab Participants received 200 mg pembrolizumab (IV infusion; every three weeks \[Q3W\]) in combination with selumetinib 100mg orally twice daily \[BID\]) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib was administered only for the first two weeks.	Selumetinib 125mg + Pembrolizumab Participants received 200 mg pembrolizumab (IV infusion; every three weeks \[Q3W\]) in combination with selumetinib 125mg orally twice daily \[BID\]) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib was administered only for the first two weeks.
Overall Study Death	4	2	9	11
Overall Study Withdrawal by Subject	0	1	1	0
Overall Study Sponsor Decision	0	0	1	3

Baseline Characteristics

Study of Selumetinib (MK-5618) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Solid Tumors (MK-5618-001)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Selumetinib 50mg + Pembrolizumab n=4 Participants Participants received 200 mg pembrolizumab (IV infusion; every three weeks \[Q3W\]) in combination with selumetinib 50mg orally twice daily \[BID\]) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib was administered only for the first two weeks.	Selumetinib 75mg + Pembrolizumab n=3 Participants Participants received 200 mg pembrolizumab (IV infusion; every three weeks \[Q3W\]) in combination with selumetinib 75mg orally twice daily \[BID\]) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib was administered only for the first two weeks.	Selumetinib 100mg + Pembrolizumab n=11 Participants Participants received 200 mg pembrolizumab (IV infusion; every three weeks \[Q3W\]) in combination with selumetinib 100mg orally twice daily \[BID\]) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib was administered only for the first two weeks.	Selumetinib 125mg + Pembrolizumab n=14 Participants Participants received 200 mg pembrolizumab (IV infusion; every three weeks \[Q3W\]) in combination with selumetinib 125mg orally twice daily \[BID\]) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib was administered only for the first two weeks.	Total n=32 Participants Total of all reporting groups
Age, Customized Between 18 and 64 years	4 Participants n=99 Participants	3 Participants n=107 Participants	10 Participants n=206 Participants	12 Participants n=157 Participants	29 Participants n=390 Participants
Age, Customized From 65 to 84 years	0 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants	2 Participants n=157 Participants	3 Participants n=390 Participants
Age, Customized 85 years and over	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants	0 Participants n=390 Participants
Sex: Female, Male Female	2 Participants n=99 Participants	1 Participants n=107 Participants	4 Participants n=206 Participants	3 Participants n=157 Participants	10 Participants n=390 Participants
Sex: Female, Male Male	2 Participants n=99 Participants	2 Participants n=107 Participants	7 Participants n=206 Participants	11 Participants n=157 Participants	22 Participants n=390 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	4 Participants n=157 Participants	5 Participants n=390 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=99 Participants	1 Participants n=107 Participants	11 Participants n=206 Participants	10 Participants n=157 Participants	26 Participants n=390 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants	1 Participants n=390 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	1 Participants n=157 Participants	1 Participants n=390 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants	1 Participants n=157 Participants	2 Participants n=390 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants	0 Participants n=390 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants	0 Participants n=390 Participants
Race (NIH/OMB) White	4 Participants n=99 Participants	3 Participants n=107 Participants	9 Participants n=206 Participants	11 Participants n=157 Participants	27 Participants n=390 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants	0 Participants n=157 Participants	1 Participants n=390 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	1 Participants n=157 Participants	1 Participants n=390 Participants

PRIMARY outcome

Timeframe: Up to 21 days

Population: All allocated participants who received at least one dose of study treatment and met the protocol-specified criteria for DLT evaluability.

Outcome measures

Outcome measures
Measure	Selumetinib 50mg + Pembrolizumab n=2 Participants Participants received 200 mg pembrolizumab (IV infusion; every three weeks \[Q3W\]) in combination with selumetinib 50mg orally twice daily \[BID\]) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib was administered only for the first two weeks.	Selumetinib 75mg + Pembrolizumab n=3 Participants Participants received 200 mg pembrolizumab (IV infusion; every three weeks \[Q3W\]) in combination with selumetinib 75mg orally twice daily \[BID\]) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib was administered only for the first two weeks.	Selumetinib 100mg + Pembrolizumab n=11 Participants Participants received 200 mg pembrolizumab (IV infusion; every three weeks \[Q3W\]) in combination with selumetinib 100mg orally twice daily \[BID\]) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib was administered only for the first two weeks.	Selumetinib 125mg + Pembrolizumab n=14 Participants Participants received 200 mg pembrolizumab (IV infusion; every three weeks \[Q3W\]) in combination with selumetinib 125mg orally twice daily \[BID\]) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib was administered only for the first two weeks.
Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)	0 Participants	0 Participants	2 Participants	3 Participants

PRIMARY outcome

Timeframe: Up to ~28 months

Population: All allocated participants who received at least 1 dose of study treatment.

An AE was any unfavorable and unintended sign, symptom, or disease (new or exacerbated) in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. For each arm, the number of participants experiencing an AE will be assessed.

Outcome measures

Outcome measures
Measure	Selumetinib 50mg + Pembrolizumab n=4 Participants Participants received 200 mg pembrolizumab (IV infusion; every three weeks \[Q3W\]) in combination with selumetinib 50mg orally twice daily \[BID\]) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib was administered only for the first two weeks.	Selumetinib 75mg + Pembrolizumab n=3 Participants Participants received 200 mg pembrolizumab (IV infusion; every three weeks \[Q3W\]) in combination with selumetinib 75mg orally twice daily \[BID\]) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib was administered only for the first two weeks.	Selumetinib 100mg + Pembrolizumab n=11 Participants Participants received 200 mg pembrolizumab (IV infusion; every three weeks \[Q3W\]) in combination with selumetinib 100mg orally twice daily \[BID\]) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib was administered only for the first two weeks.	Selumetinib 125mg + Pembrolizumab n=14 Participants Participants received 200 mg pembrolizumab (IV infusion; every three weeks \[Q3W\]) in combination with selumetinib 125mg orally twice daily \[BID\]) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib was administered only for the first two weeks.
Number of Participants Who Experienced Adverse Event (AE)	4 Participants	3 Participants	11 Participants	14 Participants

PRIMARY outcome

Timeframe: Up to ~28 months

Population: All allocated participants who received at least 1 dose of study treatment.

An AE was any unfavorable and unintended sign, symptom, or disease (new or exacerbated) in a clinical study participant, temporally associated withthe use of study treatment, whether or not considered related to the study treatment. For each arm, the number of participants discontinuing study treatment due to an AE was assessed.

Outcome measures

Outcome measures
Measure	Selumetinib 50mg + Pembrolizumab n=4 Participants Participants received 200 mg pembrolizumab (IV infusion; every three weeks \[Q3W\]) in combination with selumetinib 50mg orally twice daily \[BID\]) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib was administered only for the first two weeks.	Selumetinib 75mg + Pembrolizumab n=3 Participants Participants received 200 mg pembrolizumab (IV infusion; every three weeks \[Q3W\]) in combination with selumetinib 75mg orally twice daily \[BID\]) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib was administered only for the first two weeks.	Selumetinib 100mg + Pembrolizumab n=11 Participants Participants received 200 mg pembrolizumab (IV infusion; every three weeks \[Q3W\]) in combination with selumetinib 100mg orally twice daily \[BID\]) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib was administered only for the first two weeks.	Selumetinib 125mg + Pembrolizumab n=14 Participants Participants received 200 mg pembrolizumab (IV infusion; every three weeks \[Q3W\]) in combination with selumetinib 125mg orally twice daily \[BID\]) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib was administered only for the first two weeks.
Number of Participants Discontinuing Study Treatment Due to an Adverse Event	0 Participants	1 Participants	4 Participants	3 Participants

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 4, 6, between 8 and 12 hours post dose on Day 1; Time 0 pre-dose at Cycle 2 Day 1, Cycle 2 Day 14, Cycle 5 Day 1 and Cycle 5 Day 14.

Population: All allocated participants who were compliant with the study procedures and had AUC data available from at least 1 treatment dose.

Plasma selumetinib concentration was quantified for each arm to determine AUC, defined as the area under the concentration-time curve for selumetinib. AUC(0-last) is area under the concentration-time curve from dosing (time 0) to the time of the last measured concentration. AUC (0-12) is area under the concentration-time curve from dosing (time 0) to 12 hours.

Outcome measures

Outcome measures
Measure	Selumetinib 50mg + Pembrolizumab n=4 Participants Participants received 200 mg pembrolizumab (IV infusion; every three weeks \[Q3W\]) in combination with selumetinib 50mg orally twice daily \[BID\]) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib was administered only for the first two weeks.	Selumetinib 75mg + Pembrolizumab n=3 Participants Participants received 200 mg pembrolizumab (IV infusion; every three weeks \[Q3W\]) in combination with selumetinib 75mg orally twice daily \[BID\]) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib was administered only for the first two weeks.	Selumetinib 100mg + Pembrolizumab n=11 Participants Participants received 200 mg pembrolizumab (IV infusion; every three weeks \[Q3W\]) in combination with selumetinib 100mg orally twice daily \[BID\]) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib was administered only for the first two weeks.	Selumetinib 125mg + Pembrolizumab n=14 Participants Participants received 200 mg pembrolizumab (IV infusion; every three weeks \[Q3W\]) in combination with selumetinib 125mg orally twice daily \[BID\]) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib was administered only for the first two weeks.
Area Under the Concentration-Time Curve (AUC) of Selumetinib. AUC0-last	2080 hr*ng/mL Geometric Coefficient of Variation 71.4	3800 hr*ng/mL Geometric Coefficient of Variation 5.7	4660 hr*ng/mL Geometric Coefficient of Variation 51.2	4430 hr*ng/mL Geometric Coefficient of Variation 57.6
Area Under the Concentration-Time Curve (AUC) of Selumetinib. AUC0-12	2160 hr*ng/mL Geometric Coefficient of Variation 73.1	4220 hr*ng/mL Geometric Coefficient of Variation 8.5	5060 hr*ng/mL Geometric Coefficient of Variation 47.7	4760 hr*ng/mL Geometric Coefficient of Variation 62.0

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 4, 6, between 8 and 12 hours post dose on Day 1; Time 0 pre-dose at Cycle 2 Day 1, Cycle 2 Day 14, Cycle 5 Day 1 and Cycle 5 Day 14.

Population: All allocated participants who were compliant with the study procedures and had Cmax data available from at least 1 treatment dose.

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

Outcome measures

Outcome measures
Measure	Selumetinib 50mg + Pembrolizumab n=4 Participants Participants received 200 mg pembrolizumab (IV infusion; every three weeks \[Q3W\]) in combination with selumetinib 50mg orally twice daily \[BID\]) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib was administered only for the first two weeks.	Selumetinib 75mg + Pembrolizumab n=3 Participants Participants received 200 mg pembrolizumab (IV infusion; every three weeks \[Q3W\]) in combination with selumetinib 75mg orally twice daily \[BID\]) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib was administered only for the first two weeks.	Selumetinib 100mg + Pembrolizumab n=11 Participants Participants received 200 mg pembrolizumab (IV infusion; every three weeks \[Q3W\]) in combination with selumetinib 100mg orally twice daily \[BID\]) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib was administered only for the first two weeks.	Selumetinib 125mg + Pembrolizumab n=14 Participants Participants received 200 mg pembrolizumab (IV infusion; every three weeks \[Q3W\]) in combination with selumetinib 125mg orally twice daily \[BID\]) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib was administered only for the first two weeks.
Maximum Observed Plasma Concentration (Cmax) of Selumetinib	852 ng/mL Geometric Coefficient of Variation 79.5	1400 ng/mL Geometric Coefficient of Variation 33.4	1690 ng/mL Geometric Coefficient of Variation 90.4	1410 ng/mL Geometric Coefficient of Variation 70.5

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 4, 6, between 8 and 12 hours post dose on Day 1; Time 0 pre-dose at Cycle 2 Day 1, Cycle 2 Day 14, Cycle 5 Day 1 and Cycle 5 Day 14.

Population: All allocated participants who were compliant with the study procedures and had Cmin data available from at least 1 treatment dose at each time point.

Plasma selumetinib concentration was quantified for each arm to determine Cmin, defined as the minimum observed concentration of selumetinib in plasma.

Outcome measures

Outcome measures
Measure	Selumetinib 50mg + Pembrolizumab n=2 Participants Participants received 200 mg pembrolizumab (IV infusion; every three weeks \[Q3W\]) in combination with selumetinib 50mg orally twice daily \[BID\]) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib was administered only for the first two weeks.	Selumetinib 75mg + Pembrolizumab n=3 Participants Participants received 200 mg pembrolizumab (IV infusion; every three weeks \[Q3W\]) in combination with selumetinib 75mg orally twice daily \[BID\]) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib was administered only for the first two weeks.	Selumetinib 100mg + Pembrolizumab n=7 Participants Participants received 200 mg pembrolizumab (IV infusion; every three weeks \[Q3W\]) in combination with selumetinib 100mg orally twice daily \[BID\]) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib was administered only for the first two weeks.	Selumetinib 125mg + Pembrolizumab n=12 Participants Participants received 200 mg pembrolizumab (IV infusion; every three weeks \[Q3W\]) in combination with selumetinib 125mg orally twice daily \[BID\]) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib was administered only for the first two weeks.
Minimum Observed Plasma Concentration (Cmin) of Selumetinib Selumetinib- Cycle 5 Day 14	67.8 %GCV Geometric Coefficient of Variation NA Method of dispersion could not be reported for N\<2	NA %GCV Geometric Coefficient of Variation NA NA=Geometric Mean (%GCV) were not calculated due to all Selumetinib plasma concentrations were below the level of detection at Cycle 5 Day 14.	529 %GCV Geometric Coefficient of Variation 98.3	175 %GCV Geometric Coefficient of Variation 192.7
Minimum Observed Plasma Concentration (Cmin) of Selumetinib Selumetinib-Cycle 2 Day 1	NA %GCV Geometric Coefficient of Variation NA NA=Geometric Mean (%GCV) were not calculated due to all Selumetinib plasma concentrations were below the level of detection at Cycle 2 Day 1.	NA %GCV Geometric Coefficient of Variation NA NA=Geometric Mean (%GCV) were not calculated due to all Selumetinib plasma concentrations were below the level of detection at Cycle 2 Day 1.	NA %GCV Geometric Coefficient of Variation NA NA=Geometric Mean (%GCV) were not calculated due to all Selumetinib plasma concentrations were below the level of detection at Cycle 2 Day 1.	2.05 %GCV Geometric Coefficient of Variation 313.1
Minimum Observed Plasma Concentration (Cmin) of Selumetinib Selumetinib- Cycle 2 Day 14	72.5 %GCV Geometric Coefficient of Variation 54.4	218 %GCV Geometric Coefficient of Variation NA Method of dispersion could not be reported for N\<2	225 %GCV Geometric Coefficient of Variation 82.6	283 %GCV Geometric Coefficient of Variation 123.2
Minimum Observed Plasma Concentration (Cmin) of Selumetinib Selumetinib- Cycle 5 Day 1	NA %GCV Geometric Coefficient of Variation NA NA=Geometric Mean (%GCV) were not calculated due to all Selumetinib plasma concentrations were below the level of detection at Cycle 5 Day 1.	NA %GCV Geometric Coefficient of Variation NA NA=Geometric Mean (%GCV) were not calculated due to all Selumetinib plasma concentrations were below the level of detection at Cycle 5 Day 1.	NA %GCV Geometric Coefficient of Variation NA NA=Geometric Mean (%GCV) were not calculated due to all Selumetinib plasma concentrations were below the level of detection at Cycle 5 Day 1.	NA %GCV Geometric Coefficient of Variation NA NA=Geometric Mean (%GCV) were not calculated due to all Selumetinib plasma concentrations were below the level of detection at Cycle 5 Day 1.

Adverse Events

Selumetinib 50mg + Pembrolizumab

Serious events: 2 serious events

Other events: 4 other events

Deaths: 4 deaths

Selumetinib 75mg + Pembrolizumab

Serious events: 2 serious events

Other events: 3 other events

Deaths: 2 deaths

Selumetinib 100mg + Pembrolizumab

Serious events: 4 serious events

Other events: 11 other events

Deaths: 10 deaths

Selumetinib 125mg + Pembrolizumab

Serious events: 4 serious events

Other events: 14 other events

Deaths: 11 deaths

Serious adverse events

Serious adverse events
Measure	Selumetinib 50mg + Pembrolizumab n=4 participants at risk Participants received 200 mg pembrolizumab (IV infusion; every three weeks \[Q3W\]) in combination with selumetinib 50mg orally twice daily \[BID\]) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib was administered only for the first two weeks.	Selumetinib 75mg + Pembrolizumab n=3 participants at risk Participants received 200 mg pembrolizumab (IV infusion; every three weeks \[Q3W\]) in combination with selumetinib 75mg orally twice daily \[BID\]) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib was administered only for the first two weeks.	Selumetinib 100mg + Pembrolizumab n=11 participants at risk Participants received 200 mg pembrolizumab (IV infusion; every three weeks \[Q3W\]) in combination with selumetinib 100mg orally twice daily \[BID\]) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib was administered only for the first two weeks.	Selumetinib 125mg + Pembrolizumab n=14 participants at risk Participants received 200 mg pembrolizumab (IV infusion; every three weeks \[Q3W\]) in combination with selumetinib 125mg orally twice daily \[BID\]) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib was administered only for the first two weeks.
Cardiac disorders Pericardial effusion	0.00% 0/4 • From randomization through study completion data cutoff date of 28-June-2022 (Up to ~ 39 months) All-Cause Mortality (ACM): All allocated participants. Safety: All allocated participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/3 • From randomization through study completion data cutoff date of 28-June-2022 (Up to ~ 39 months) All-Cause Mortality (ACM): All allocated participants. Safety: All allocated participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs.	9.1% 1/11 • Number of events 1 • From randomization through study completion data cutoff date of 28-June-2022 (Up to ~ 39 months) All-Cause Mortality (ACM): All allocated participants. Safety: All allocated participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/14 • From randomization through study completion data cutoff date of 28-June-2022 (Up to ~ 39 months) All-Cause Mortality (ACM): All allocated participants. Safety: All allocated participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs.
Cardiac disorders Sinus tachycardia	0.00% 0/4 • From randomization through study completion data cutoff date of 28-June-2022 (Up to ~ 39 months) All-Cause Mortality (ACM): All allocated participants. Safety: All allocated participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/3 • From randomization through study completion data cutoff date of 28-June-2022 (Up to ~ 39 months) All-Cause Mortality (ACM): All allocated participants. Safety: All allocated participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs.	9.1% 1/11 • Number of events 1 • From randomization through study completion data cutoff date of 28-June-2022 (Up to ~ 39 months) All-Cause Mortality (ACM): All allocated participants. Safety: All allocated participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/14 • From randomization through study completion data cutoff date of 28-June-2022 (Up to ~ 39 months) All-Cause Mortality (ACM): All allocated participants. Safety: All allocated participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs.
Endocrine disorders Adrenal insufficiency	0.00% 0/4 • From randomization through study completion data cutoff date of 28-June-2022 (Up to ~ 39 months) All-Cause Mortality (ACM): All allocated participants. Safety: All allocated participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/3 • From randomization through study completion data cutoff date of 28-June-2022 (Up to ~ 39 months) All-Cause Mortality (ACM): All allocated participants. Safety: All allocated participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/11 • From randomization through study completion data cutoff date of 28-June-2022 (Up to ~ 39 months) All-Cause Mortality (ACM): All allocated participants. Safety: All allocated participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs.	7.1% 1/14 • Number of events 1 • From randomization through study completion data cutoff date of 28-June-2022 (Up to ~ 39 months) All-Cause Mortality (ACM): All allocated participants. Safety: All allocated participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs.
Gastrointestinal disorders Diarrhoea	0.00% 0/4 • From randomization through study completion data cutoff date of 28-June-2022 (Up to ~ 39 months) All-Cause Mortality (ACM): All allocated participants. Safety: All allocated participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/3 • From randomization through study completion data cutoff date of 28-June-2022 (Up to ~ 39 months) All-Cause Mortality (ACM): All allocated participants. Safety: All allocated participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs.	9.1% 1/11 • Number of events 1 • From randomization through study completion data cutoff date of 28-June-2022 (Up to ~ 39 months) All-Cause Mortality (ACM): All allocated participants. Safety: All allocated participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/14 • From randomization through study completion data cutoff date of 28-June-2022 (Up to ~ 39 months) All-Cause Mortality (ACM): All allocated participants. Safety: All allocated participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/4 • From randomization through study completion data cutoff date of 28-June-2022 (Up to ~ 39 months) All-Cause Mortality (ACM): All allocated participants. Safety: All allocated participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/3 • From randomization through study completion data cutoff date of 28-June-2022 (Up to ~ 39 months) All-Cause Mortality (ACM): All allocated participants. Safety: All allocated participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs.	9.1% 1/11 • Number of events 1 • From randomization through study completion data cutoff date of 28-June-2022 (Up to ~ 39 months) All-Cause Mortality (ACM): All allocated participants. Safety: All allocated participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/14 • From randomization through study completion data cutoff date of 28-June-2022 (Up to ~ 39 months) All-Cause Mortality (ACM): All allocated participants. Safety: All allocated participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs.
Infections and infestations Pneumonia	25.0% 1/4 • Number of events 1 • From randomization through study completion data cutoff date of 28-June-2022 (Up to ~ 39 months) All-Cause Mortality (ACM): All allocated participants. Safety: All allocated participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/3 • From randomization through study completion data cutoff date of 28-June-2022 (Up to ~ 39 months) All-Cause Mortality (ACM): All allocated participants. Safety: All allocated participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs.	9.1% 1/11 • Number of events 1 • From randomization through study completion data cutoff date of 28-June-2022 (Up to ~ 39 months) All-Cause Mortality (ACM): All allocated participants. Safety: All allocated participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/14 • From randomization through study completion data cutoff date of 28-June-2022 (Up to ~ 39 months) All-Cause Mortality (ACM): All allocated participants. Safety: All allocated participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs.
Investigations Alanine aminotransferase increased	0.00% 0/4 • From randomization through study completion data cutoff date of 28-June-2022 (Up to ~ 39 months) All-Cause Mortality (ACM): All allocated participants. Safety: All allocated participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/3 • From randomization through study completion data cutoff date of 28-June-2022 (Up to ~ 39 months) All-Cause Mortality (ACM): All allocated participants. Safety: All allocated participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/11 • From randomization through study completion data cutoff date of 28-June-2022 (Up to ~ 39 months) All-Cause Mortality (ACM): All allocated participants. Safety: All allocated participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs.	7.1% 1/14 • Number of events 1 • From randomization through study completion data cutoff date of 28-June-2022 (Up to ~ 39 months) All-Cause Mortality (ACM): All allocated participants. Safety: All allocated participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs.
Investigations Blood bilirubin increased	0.00% 0/4 • From randomization through study completion data cutoff date of 28-June-2022 (Up to ~ 39 months) All-Cause Mortality (ACM): All allocated participants. Safety: All allocated participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/3 • From randomization through study completion data cutoff date of 28-June-2022 (Up to ~ 39 months) All-Cause Mortality (ACM): All allocated participants. Safety: All allocated participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/11 • From randomization through study completion data cutoff date of 28-June-2022 (Up to ~ 39 months) All-Cause Mortality (ACM): All allocated participants. Safety: All allocated participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs.	7.1% 1/14 • Number of events 1 • From randomization through study completion data cutoff date of 28-June-2022 (Up to ~ 39 months) All-Cause Mortality (ACM): All allocated participants. Safety: All allocated participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs.
Metabolism and nutrition disorders Hyponatraemia	25.0% 1/4 • Number of events 1 • From randomization through study completion data cutoff date of 28-June-2022 (Up to ~ 39 months) All-Cause Mortality (ACM): All allocated participants. Safety: All allocated participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/3 • From randomization through study completion data cutoff date of 28-June-2022 (Up to ~ 39 months) All-Cause Mortality (ACM): All allocated participants. Safety: All allocated participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/11 • From randomization through study completion data cutoff date of 28-June-2022 (Up to ~ 39 months) All-Cause Mortality (ACM): All allocated participants. Safety: All allocated participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/14 • From randomization through study completion data cutoff date of 28-June-2022 (Up to ~ 39 months) All-Cause Mortality (ACM): All allocated participants. Safety: All allocated participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/4 • From randomization through study completion data cutoff date of 28-June-2022 (Up to ~ 39 months) All-Cause Mortality (ACM): All allocated participants. Safety: All allocated participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/3 • From randomization through study completion data cutoff date of 28-June-2022 (Up to ~ 39 months) All-Cause Mortality (ACM): All allocated participants. Safety: All allocated participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs.	9.1% 1/11 • Number of events 1 • From randomization through study completion data cutoff date of 28-June-2022 (Up to ~ 39 months) All-Cause Mortality (ACM): All allocated participants. Safety: All allocated participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/14 • From randomization through study completion data cutoff date of 28-June-2022 (Up to ~ 39 months) All-Cause Mortality (ACM): All allocated participants. Safety: All allocated participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/4 • From randomization through study completion data cutoff date of 28-June-2022 (Up to ~ 39 months) All-Cause Mortality (ACM): All allocated participants. Safety: All allocated participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs.	33.3% 1/3 • Number of events 1 • From randomization through study completion data cutoff date of 28-June-2022 (Up to ~ 39 months) All-Cause Mortality (ACM): All allocated participants. Safety: All allocated participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/11 • From randomization through study completion data cutoff date of 28-June-2022 (Up to ~ 39 months) All-Cause Mortality (ACM): All allocated participants. Safety: All allocated participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/14 • From randomization through study completion data cutoff date of 28-June-2022 (Up to ~ 39 months) All-Cause Mortality (ACM): All allocated participants. Safety: All allocated participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/4 • From randomization through study completion data cutoff date of 28-June-2022 (Up to ~ 39 months) All-Cause Mortality (ACM): All allocated participants. Safety: All allocated participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/3 • From randomization through study completion data cutoff date of 28-June-2022 (Up to ~ 39 months) All-Cause Mortality (ACM): All allocated participants. Safety: All allocated participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/11 • From randomization through study completion data cutoff date of 28-June-2022 (Up to ~ 39 months) All-Cause Mortality (ACM): All allocated participants. Safety: All allocated participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs.	21.4% 3/14 • Number of events 3 • From randomization through study completion data cutoff date of 28-June-2022 (Up to ~ 39 months) All-Cause Mortality (ACM): All allocated participants. Safety: All allocated participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs.
Vascular disorders Venous thrombosis	0.00% 0/4 • From randomization through study completion data cutoff date of 28-June-2022 (Up to ~ 39 months) All-Cause Mortality (ACM): All allocated participants. Safety: All allocated participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs.	33.3% 1/3 • Number of events 1 • From randomization through study completion data cutoff date of 28-June-2022 (Up to ~ 39 months) All-Cause Mortality (ACM): All allocated participants. Safety: All allocated participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/11 • From randomization through study completion data cutoff date of 28-June-2022 (Up to ~ 39 months) All-Cause Mortality (ACM): All allocated participants. Safety: All allocated participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/14 • From randomization through study completion data cutoff date of 28-June-2022 (Up to ~ 39 months) All-Cause Mortality (ACM): All allocated participants. Safety: All allocated participants who got ≥1 dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs.

Other adverse events

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
Publication restrictions are in place

Restriction type: OTHER