Study of MK-7162 in Combination With Pembrolizumab (MK-34... | NCT03364049

ID	Type	Description	Link
2017-000418-49	EudraCT Number
MK-7162-002	Other Identifier	Merck Protocol Number

Label	Type	Description	Intervention Names
MK-7162 25 mg +Pembrolizumab (Pembro)	Experimental	Participants receive MK-7162 25 mg via oral tablets once daily (QD) throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-7162 25 mg orally QD PLUS pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (every 3 weeks [Q3W]).	Drug: MK-7162 Biological: Pembrolizumab
MK-7162 50 mg + Pembro	Experimental	Participants receive MK-7162 50 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-71625 50 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W	Drug: MK-7162 Biological: Pembrolizumab
MK-7162 100 mg + Pembro	Experimental	Participants receive MK-7162 100 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-7162 100 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W	Drug: MK-7162 Biological: Pembrolizumab
MK-7162 200 mg + Pembro	Experimental	Participants receive MK-7162 200 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-7162 200 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W	Drug: MK-7162 Biological: Pembrolizumab

Name	Type	Description	Arm Group Labels	Other Names
MK-7162	Drug	oral tablets	MK-7162 100 mg + Pembro MK-7162 200 mg + Pembro MK-7162 25 mg +Pembrolizumab (Pembro) MK-7162 50 mg + Pembro

Measure	Description	Time Frame
Number of Participants Experiencing Dose-limiting Toxicities (DLTs) as Assessed Using Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 by the Investigator	The following events, if considered drug related by the investigator, are considered a DLT: Grade 4 nonhematologic toxicity; Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia; Grade 4 thrombocytopenia of any duration; Grade 3 thrombocytopenia associated with bleeding; Nonhematologic Adverse Events (AE) ≥Grade 3 with exceptions; Grade 3 or Grade 4 non-hematologic laboratory values if requires medical intervention, leads to hospitalization, persists for >1 week, or results in a Drug-induced Liver Injury with exceptions; Grade 3 of 4 febrile neutropenia; Treatment-related toxicities that lead to discontinuation of study treatment during Cycles 1 or 2; Prolonged delay (>2 weeks) in initiating Cycles 2 or 3 due to treatment-related toxicity; Missing >25% of MK-7162 doses as a result of treatment-related AE during Cycles 1 or 2; Grade 5 toxicity.	Cycle 1 and Cycle 2 (Up to 6 weeks)
Number of Participants Who Experienced an Adverse Event (AE)	An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. 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 treatment.	Up to Approximately 27 Months
Number of Participants Who Discontinued Study Drug Due to an AE	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.	Up to Approximately 26 Months

Measure	Description	Time Frame
Area Under the Concentration-Time Curve (AUC) From 0-8 Hours of MK-7261 Alone and in Combination With Pembrolizumab	Blood samples were collected at designated time points for determining the AUC₀-₈ of MK-7162 in plasma when administered alone and in combination with pembrolizumab.	Pre-dose and at 1, 2, 4, and 8 hours post-dose on Cycle 1, Days 1 & 15; and Cycle 3, Day 1

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Has a histologically- or cytologically-confirmed advanced/metastatic solid tumor by pathology report and have received, or been intolerant to, or been ineligible for all treatment known to confer clinical benefit. Participants with solid tumors of any type are eligible for enrollment.
Has stage III or stage IV disease that is not surgically resectable.
Has measurable disease by RECIST 1.1 criteria as assessed by the local site investigator/radiology.
Has 1 or more discrete malignant lesions that are amenable to ≥2 separate biopsies guided by one of the following modalities: visual inspection, ultrasound guidance, or cross sectional image guidance (computed tomography/magnetic resonance imaging [CT/MRI]).
Has an evaluable baseline tumor sample to submit for analysis.
Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
Demonstrates adequate organ function.
If male, must agree to use contraception and refrain from donating sperm during the treatment period and for ≥120 days after last dose of study treatment.
If female, is not pregnant or breastfeeding, and if a woman of childbearing potential (WOCCBP), agrees to use contraception during the treatment period and for ≥120 days after last dose of study treatment.

Exclusion Criteria:

Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years. (Note: The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer, in situ cervical cancer, or other in-situ cancers.)
Has a known active central nervous system metastasis and/or carcinomatous meningitis.
Has had a severe hypersensitivity reaction to treatment with a monoclonal antibody/components of the study treatment(s).
Has an active autoimmune disease that has required systemic treatment in the past 2 years except vitiligo or resolved childhood asthma/atopy.
Has a history of vasculitis.
Has an active infection requiring systemic therapy.
Has symptomatic ascites or pleural effusion.
Has interstitial lung disease that has required oral or intravenous glucocorticoids to assist with management.
Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
Has undergone prior allogeneic hematopoietic stem cell transplantation within the last 5 years. (Note: Participants who have had a stem cell transplant >5 years ago are eligible as long as there are no symptoms of graft-versus-host disease [GVHD].)
Has a known history of human immunodeficiency virus (HIV) infection.
Has known active Hepatitis B or known active Hepatitis C virus infection.
Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.
Has not fully recovered from any effects of major surgery without significant detectable infection.
Has received prior systemic anti-cancer therapy including investigational agents or has used an investigational device within 28 days prior to the first dose of study treatment. (Notes: Participants must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline. Prior exposure to immunotherapeutics is allowed, including programmed cell death-1 (PD-1) and programmed cell death-ligand 1 (PD-L1) inhibitors, provided the participant did not experience ≥Grade 3 drug-related toxicity on monotherapy with a PD-1 or PD-L1 inhibitor.
Has been previously treated with an Indoleamine-2,3-dioxygenase-1 (IDO1) inhibitor (e.g., epacadostat, BMS-986205)
Has received prior radiotherapy within 2 weeks of start of study treatment.
Is receiving a monoamine oxidase inhibitor (MAOI) or any drug which has significant MAOI activity (e.g., meperidine, linezolid, methylene blue) within the 21 days before screening, or has a history of Serotonin Syndrome after receiving serotonergic drugs.
Is expected to require any non-protocol antineoplastic therapy while on study.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy in excess of replacement doses (the equivalent of prednisone ≤10 mg/day is acceptable), or on any other form of immunosuppressive medication.
Has received a live-virus vaccine within 30 days prior to first dose of study medication.

Name	Affiliation	Role
Medical Director	Merck Sharp & Dohme LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
UCLA Medical Center ( Site 0002)		Santa Monica	California	90404	United States
START Midwest ( Site 0007)

ID	Title	Description
FG000	MK-7162 25 mg + Pembrolizumab (Pembro)	Cycle 1: Participants receive MK-7162 25 mg via oral tablets once daily (QD) throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-7162 25 mg orally QD PLUS pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (every 3 weeks [Q3W]).
FG001

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jul 21, 2020

ID	Title	Description
BG000	MK-7162 25 mg + Pembro	Participants receive MK-7162 25 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-7162 25 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W
BG001	MK-7162 50 mg + Pembro	Participants receive MK-7162 50 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-71625 50 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W
BG002	MK-7162 100 mg + Pembro	Participants receive MK-7162 100 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-7162 100 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W
BG003	MK-7162 200 mg + Pembro	Participants receive MK-7162 200 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-7162 200 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG0006 BG0016 BG0026 BG00315 BG00433

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants Experiencing Dose-limiting Toxicities (DLTs) as Assessed Using Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 by the Investigator

The following events, if considered drug related by the investigator, are considered a DLT: Grade 4 nonhematologic toxicity; Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia; Grade 4 thrombocytopenia of any duration; Grade 3 thrombocytopenia associated with bleeding; Nonhematologic Adverse Events (AE) ≥Grade 3 with exceptions; Grade 3 or Grade 4 non-hematologic laboratory values if requires medical intervention, leads to hospitalization, persists for >1 week, or results in a Drug-induced Liver Injury with exceptions; Grade 3 of 4 febrile neutropenia; Treatment-related toxicities that lead to discontinuation of study treatment during Cycles 1 or 2; Prolonged delay (>2 weeks) in initiating Cycles 2 or 3 due to treatment-related toxicity; Missing >25% of MK-7162 doses as a result of treatment-related AE during Cycles 1 or 2; Grade 5 toxicity.

All participants who received at least one dose of study treatment and were observed for safety for 21 days after the first dose of assigned treatment or experienced a DLT prior to 21 days after the first dose of treatment.

Posted

Count of Participants

Participants

Cycle 1 and Cycle 2 (Up to 6 weeks)

ID	Title	Description
OG000	MK-7162 25 mg + Pembro	Participants receive MK-7162 25 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-7162 25 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W
OG001	MK-7162 50 mg + Pembro	Participants receive MK-7162 50 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-71625 50 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W
OG002	MK-7162 100 mg + Pembro	Participants receive MK-7162 100 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-7162 100 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W
OG003	MK-7162 200 mg + Pembro	Participants receive MK-7162 200 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-7162 200 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W

Units	Counts
Participants	OG0006 OG0016 OG0026 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Primary

Number of Participants Who Experienced an Adverse Event (AE)

An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. 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 treatment.

All participants who received at least one dose of study treatment

Posted

Count of Participants

Participants

Up to Approximately 27 Months

ID	Title	Description
OG000	MK-7162 25 mg + Pembro	Participants receive MK-7162 25 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-7162 25 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W
OG001	MK-7162 50 mg + Pembro	Participants receive MK-7162 50 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-71625 50 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W
OG002	MK-7162 100 mg + Pembro	Participants receive MK-7162 100 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-7162 100 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W

Primary

Number of Participants Who Discontinued Study Drug Due to an AE

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.

All participants who received at least one dose of study treatment

Posted

Count of Participants

Participants

Up to Approximately 26 Months

ID	Title	Description
OG000	MK-7162 25 mg + Pembro	Participants receive MK-7162 25 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-7162 25 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W
OG001	MK-7162 50 mg + Pembro	Participants receive MK-7162 50 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-71625 50 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W
OG002	MK-7162 100 mg + Pembro	Participants receive MK-7162 100 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-7162 100 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W

Secondary

Area Under the Concentration-Time Curve (AUC) From 0-8 Hours of MK-7261 Alone and in Combination With Pembrolizumab

Blood samples were collected at designated time points for determining the AUC₀-₈ of MK-7162 in plasma when administered alone and in combination with pembrolizumab.

All participants who were compliant with the study procedures and have available data from at least one treatment.

Posted

Geometric Mean

Geometric Coefficient of Variation

hr*nM

Pre-dose and at 1, 2, 4, and 8 hours post-dose on Cycle 1, Days 1 & 15; and Cycle 3, Day 1

ID	Title	Description
OG000	MK-7162 25 mg + Pembro	Participants receive MK-7162 25 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-7162 25 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W
OG001	MK-7162 50 mg + Pembro	Participants receive MK-7162 50 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-71625 50 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W
OG002	MK-7162 100 mg + Pembro	Participants receive MK-7162 100 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-7162 100 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W

Secondary

Minimum Plasma Concentration (Cmin) of MK-7162

Blood samples were obtained at designated time points to determine the Cmin of MK-7162 in plasma.

All participants who were compliant with the study procedures and have available plasma data.

Posted

Geometric Mean

Geometric Coefficient of Variation

Pre-dose and at 1, 2, 4, and 8 hours post-dose on Cycle 1, Day 14

ID	Title	Description
OG000	MK-7162 25 mg + Pembro	Participants receive MK-7162 25 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-7162 25 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W
OG001	MK-7162 50 mg + Pembro	Participants receive MK-7162 50 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-71625 50 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W
OG002	MK-7162 100 mg + Pembro	Participants receive MK-7162 100 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-7162 100 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W

Secondary

Maximum Plasma Concentration (Cmax) of MK-7162 When Administered Alone and in Combination With Pembrolizumab

Blood samples were collected at designated time points to determine the Cmax of MK-7162 in plasma when administered alone and in combination with pembrolizumab.

All participants who were compliant with the study procedures and have available data from at least one treatment.

Posted

Geometric Mean

Geometric Coefficient of Variation

Pre-dose and at 1, 2, 4, and 8 hours post-dose on Cycle 1, Days 1 and 15 and Cycle 3, Day 1

ID	Title	Description
OG000	MK-7162 25 mg + Pembro	Participants receive MK-7162 25 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-7162 25 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W
OG001	MK-7162 50 mg + Pembro	Participants receive MK-7162 50 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-71625 50 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W
OG002	MK-7162 100 mg + Pembro	Participants receive MK-7162 100 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-7162 100 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W

Secondary

Kynurenine (KYN) Biomarker Plasma Concentration

MK-7162 is a selective inhibitor of Indoleamine-2,3-dioxygenase-1 (IDO1) activity which, in turn, reduces the conversion of TRP to KYN. Venous blood samples were collected after an overnight fast for measurement of plasma levels of KYN as a pharmacodynamic biomarker of IDO1 inhibition.

All participants who were compliant with the study procedures and have available data from at least one treatment

Posted

Mean

Full Range

μmol/L

Cycle 1 Days 1 & 15: predose, 1, 2, 4 & 8 hours postdose; Cycle 2 Day 1: predose; Cycle 3 Day 1: predose, 1, 2, 4 & 8 hours postdose; Cycle 3 Day 15: predose

ID	Title	Description
OG000	MK-7162 25 mg + Pembro	Participants receive MK-7162 25 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-7162 25 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W
OG001	MK-7162 50 mg + Pembro	Participants receive MK-7162 50 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-71625 50 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W
OG002	MK-7162 100 mg + Pembro

Secondary

Tryptophan (TRP) Biomarker Plasma Concentration

MK-7162 is a selective inhibitor of Indoleamine-2,3-dioxygenase-1 (IDO1) activity which, in turn, reduces the conversion of TRP to KYN. Venous blood samples were collected at designated time points after an overnight fast for measurement of plasma levels of TRP as a pharmacodynamic biomarker of IDO1 inhibition.

All participants who were compliant with the study procedures and have available data from at least one treatment

Posted

Mean

Full Range

mg/dL

Cycle 1 Days 1 & 15: predose, 1, 2, 4 & 8 hours postdose; Cycle 2 Day 1: predose; Cycle 3 Day 1: predose, 1, 2, 4 & 8 hours postdose; Cycle 3 Day 15: predose

ID	Title	Description
OG000	MK-7162 25 mg + Pembro	Participants receive MK-7162 25 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-7162 25 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W
OG001	MK-7162 50 mg + Pembro	Participants receive MK-7162 50 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-71625 50 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W
OG002	MK-7162 100 mg + Pembro

Secondary

Objective Response Rate (ORR) Based on Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by the Investigator

ORR is defined as the percentage of participants in the analysis population who have 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, taking as reference the baseline sum diameters) per RECIST 1.1 as assessed by the Investigator. The percentage of participants who experience a CR or PR based on RECIST 1.1 will be presented.

All participants with a baseline scan that demonstrated measurable disease by the investigator's assessment, and who were administered at least one dose of study treatment

Posted

Number

95% Confidence Interval

Percentage of Participants

Up to approximately 28 months

ID	Title	Description
OG000	MK-7162 25 mg + Pembro	Participants receive MK-7162 25 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-7162 25 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W
OG001	MK-7162 50 mg + Pembro	Participants receive MK-7162 50 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-71625 50 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W

Secondary

Overall Response Based on Immune Response Evaluation Criteria (iRECIST) In Solid Tumors

Participants with PD by RECIST 1.1 as determined by investigator underwent confirmatory imaging to classify the disease as confirmed progressive disease (iCPD), unconfirmed progressive disease [iUPD]), stable disease (iSD), partial response (iPR) or complete response (iCR). iCPD definition: Worsening of target lesions (increase in the sum of diameters of ≥5 mm); Any significant growth in non-target lesions, Appearance of new lesions, increase in new lesion sum of diameters by ≥5 mm; Visible growth of new non-target lesions; or appearance of new factor that would have triggered PD by RECIST 1.1. Responses are classified as iSD or iPR (depending on the sum of diameters of the target lesions), or iCR if all lesions resolve. iUPD overall response is defined as none of the progression-confirming factors identified in iCPD occurs AND The target lesion sum of diameters (initial target lesions) remains above the initial PD threshold (by RECIST 1.1)

All participants who had follow up tumor imaging subsequent to initial progressive disease per RECIST 1.1 by investigator assessment

Posted

Number

95% Confidence Interval

Percentage of Participants

Up to approximately 28 months

ID	Title	Description
OG000	MK-7162 25 mg + Pembro	Participants receive MK-7162 25 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-7162 25 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W
OG001	MK-7162 50 mg + Pembro

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0022 events1 affected6 at risk EG0030 events0 affected15 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
Immune-mediated hepatitis	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Afferent loop syndrome	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Tumour ulceration	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Female genital tract fistula	Reproductive system and breast disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Embolism	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected6 at risk EG0013 events3 affected6 at risk EG0020 events0 affected6 at risk EG0032 events2 affected15 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
Dry eye	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Vision blurred	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0012 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
Abdominal wall haemorrhage	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0013 events3 affected6 at risk EG0023 events3 affected6 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0012 events2 affected6 at risk EG0020 events0 affected6 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0021 events1 affected6 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Melaena	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0016 events2 affected6 at risk EG0022 events2 affected6 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Rectal tenesmus	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0014 events2 affected6 at risk EG0023 events2 affected6 at risk EG003
Asthenia	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Catheter site pain	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Chest discomfort	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
Fatigue	General disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0013 events3 affected6 at risk EG0023 events3 affected6 at risk EG003
General physical health deterioration	General disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Localised oedema	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
Oedema	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
Oedema peripheral	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
Pain	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
Pyrexia	General disorders	MedDRA 23.1	Systematic Assessment	EG0003 events1 affected6 at risk EG0014 events1 affected6 at risk EG0025 events2 affected6 at risk EG003
Cholangitis	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Portal vein thrombosis	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
Candida infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
Influenza	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0002 events1 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
Pneumonia	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Tonsillitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Tooth infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0013 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
Vulvovaginitis trichomonal	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Limb injury	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
Radiation injury	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Blood bilirubin increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Blood creatinine increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
International normalised ratio increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Lymphocyte count decreased	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0012 events2 affected6 at risk EG0020 events0 affected6 at risk EG003
Neutrophil count decreased	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
Platelet count decreased	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0012 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
Weight decreased	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0013 events3 affected6 at risk EG0020 events0 affected6 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0013 events2 affected6 at risk EG0022 events2 affected6 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0012 events2 affected6 at risk EG0021 events1 affected6 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0012 events2 affected6 at risk EG0020 events0 affected6 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0002 events1 affected6 at risk EG0012 events2 affected6 at risk EG0020 events0 affected6 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0012 events2 affected6 at risk EG0021 events1 affected6 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0021 events1 affected6 at risk EG003
Dizziness	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
Headache	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0022 events1 affected6 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Presyncope	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
Syncope	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
Vocal cord paralysis	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0022 events2 affected6 at risk EG003
Chromaturia	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0012 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
Vaginal discharge	Reproductive system and breast disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0012 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0013 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
Sneezing	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0014 events3 affected6 at risk EG0021 events1 affected6 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0021 events1 affected6 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Flushing	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected6 at risk EG0012 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
Hypotension	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Lymphoedema	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
Vena cava thrombosis	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	MK-7162 25mg + Pembro	Participants receive MK-7162 25 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-7162 25 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W	6	6	1	6	6	6
EG001	MK-7162 50mg + Pembro	Participants receive MK-7162 50 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-7162 50 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W	4	6	3	6	6	6
EG002	MK-7162 100mg + Pembro	Participants receive MK-7162 100 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-7162 100 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W	5	6	3	6	6	6
EG003	MK-7162 200mg + Pembro	Participants receive MK-7162 200 mg via oral tablets QD throughout the 3-week cycle. Cycles 2 through 36: Participants receive MK-7162 200 mg orally QD PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle Q3W	14	15	5	15	15	15