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MK-6598 + Pembrolizumab for Advanced Solid Cancers
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
Has a histologically- or cytologically-confirmed advanced/metastatic solid tumor by pathology report and has received, or been intolerant to, all treatment known to confer clinical benefit.
Has one or more discrete malignant lesions that are amenable to a minimum of 2 separate biopsies.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 27 months
Awards & highlights
Study Summary
This trial tests a new drug combination to see if it's safe and effective in treating advanced or metastatic solid tumors.
Who is the study for?
Adults with advanced or metastatic solid tumors who've tried all other treatments can join this trial. They must have a tumor sample, measurable disease for assessment, and agree to biopsies. Women of childbearing potential and men must follow strict contraception guidelines. People with HIV can join if it's well-controlled.Check my eligibility
What is being tested?
The study is testing MK-6598 alone and combined with Pembrolizumab in adults with advanced solid tumors to find the safest dose that works best (RP2D). Participants will be assessed for how their tumors respond to these treatments.See study design
What are the potential side effects?
Possible side effects include reactions similar to those seen with monoclonal antibody therapies such as severe allergies, lung issues like pneumonitis, liver problems like hepatitis B or C reactivation, immune system complications leading to conditions like autoimmune diseases.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My advanced cancer is confirmed by tests and I've tried or can't tolerate all known beneficial treatments.
Select...
I have at least one cancerous lesion that can be biopsied twice.
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My cancer can be measured by standard imaging tests.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 27 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 27 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants Who Discontinue Study Treatment Due to an AE
Number of Participants Who Experience At Least One AE
Number of Participants with a Dose-Limiting Toxicity (DLT) Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events (AEs) Version 5.0
Secondary outcome measures
Area Under the Curve (AUC) of MK-6598
Maximum Serum Concentration (Cmax) of MK-6598
Minimum Serum Concentration (Cmin) of MK-6598
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: MK-6598 + PembrolizumabExperimental Treatment2 Interventions
Participants will receive MK-6598 QD at escalating dose levels from 50-500, plus pembrolizumab 200 mg once every 21-day cycle for up to 35 cycles (up to approximately 24 months).
Group II: MK-6598Experimental Treatment1 Intervention
Participants will receive MK-6598 daily (QD) at escalating dose levels from 50-500 mg for up to a total of 35 cycles (up to approximately 24 months).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCLead Sponsor
3,887 Previous Clinical Trials
5,054,604 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,394 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had radiotherapy in the last 2 weeks, nor do I need steroids for radiation side effects.I agree to use contraception and not donate sperm for 102 days after the study if I join.I have at least one cancerous lesion that can be biopsied twice.I stopped a cancer immunotherapy due to a severe side effect.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I have had a transplant from another person in the last 5 years or have signs of my body rejecting the transplant.I have a history of lung scarring or fibrosis.My advanced cancer is confirmed by tests and I've tried or can't tolerate all known beneficial treatments.I have another cancer that is getting worse or was treated in the last 2 years.I have had pneumonitis treated with steroids or have it now.My cancer can be measured by standard imaging tests.I have HIV and it is well controlled with medication.I am currently being treated for an infection.I have not received a live vaccine within the last 30 days.I have an autoimmune disease but only take replacement therapies like insulin.I have active brain metastases or cancer in the lining of my brain and spinal cord.I haven't had cancer treatment or clinical trial drugs in the last 4 weeks and have recovered from any side effects.I am not pregnant or breastfeeding, and if able to have children, I agree to follow birth control advice during and after the study.
Research Study Groups:
This trial has the following groups:- Group 1: MK-6598
- Group 2: MK-6598 + Pembrolizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this study currently seeking participants?
"Per the information avaliable on clinicaltrials.gov, this trial is still recruiting participants. It was first advertised on December 21st 2022 and recently updated for the last time January 6th 2023."
Answered by AI
How would you evaluate the security of a combination therapy using MK-6598 and Pembrolizumab?
"Given the limited data on efficacy and safety, MK-6598 + Pembrolizumab scored a 1 out of 3 for safety."
Answered by AI
To what extent is the enrollment of participants open for this study?
"Affirmative. The information on clinicaltrials.gov displays that this research trial is currently recruiting participants, with a first posting date of December 21st 2022 and the most recent update being January 6th 2023. This investigation requires 90 enrollees from 1 site to complete the study."
Answered by AI
What are the projected results of this medical experiment?
"According to the trial sponsor Merck Sharp & Dohme LLC, this clinical study will last for up to 21 days and aims to measure how many participants discontinue due to an adverse event. Secondary endpoints include measuring minimum serum concentration of MK-6598 through pre-dose blood samples and post-dose multiple time points, tumor phenylpyruvate concentrations from similar measurements, as well as maximum serum concentration of MK-6598 via a comparable method."
Answered by AI
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