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MK-6837 + Pembrolizumab for Cancer

Phase 1

Recruiting

Research Sponsored by Merck Sharp & Dohme LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically confirmed solid tumor by pathology report that is advanced or metastatic

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 59 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test the safety, how well the drug is tolerated, how the drug moves through the body, and the initial effectiveness of MK-6837 alone and with pembrolizumab

Who is the study for?

This trial is for people with advanced or metastatic solid tumors that haven't improved with standard treatments. It's open to those who have controlled HIV on medication, and those with a history of Hepatitis B or C if their viral load is undetectable. Participants must have confirmed solid tumor pathology reports.

What is being tested?

The study tests MK-6837 alone and combined with Pembrolizumab in treating advanced cancer. It aims to assess the safety, how well the body handles these drugs (pharmacokinetics), and initial effectiveness without any hypothesis testing.

What are the potential side effects?

Potential side effects may include typical reactions associated with cancer therapies such as immune-related issues, infusion reactions, fatigue, nausea, liver function changes but specific side effects of MK-6837 will be studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My cancer is confirmed to be advanced or has spread, based on a lab report.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 59 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 59 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 59 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants who discontinue study intervention due to an AE

Number of participants who experience one or more adverse events (AEs)

Number of participants who experience one or more dose-limiting toxicities (DLTs)

Secondary study objectives

Area Under the Concentration-Time Curve (AUC) of MK-6837 in plasma

Maximum concentration (Cmax) of MK-6837 in plasma

Minimum concentration (Ctrough) of MK-6837 in plasma

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm 2: MK-6837 + Pembrolizumab Combination TherapyExperimental Treatment2 Interventions

Participants receive escalating doses of MK-6837 via IV infusion Q3W (Day 1 of every 21-day cycle) until progressive disease or discontinuation PLUS 200mg of pembrolizumab via IV infusion Q3W (Day 1 of every 21-day cycle) for up to 35 administrations (up to \~2 years).

Group II: Arm 1: MK-6837 MonotherapyExperimental Treatment1 Intervention

Participants receive escalating doses of MK-6837 via intravenous (IV) infusion once every 3 weeks (Q3W) (Day 1 of every 21-day cycle) until progressive disease or discontinuation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

0 / 1Eligibility criteria met