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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

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 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

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 2
~2070

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,950 Previous Clinical Trials
5,174,883 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,834 Previous Clinical Trials
8,079,680 Total Patients Enrolled
~67 spots leftby Jul 2029
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