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MK-0472 + Pembrolizumab for Advanced 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 56 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug called MK-0472, alone and with other drugs, in patients with advanced or spreading solid tumors. The goal is to see if it is safe and effective in treating these cancers.

Who is the study for?
This trial is for adults with advanced or metastatic solid tumors that have alterations in certain genes and who've tried all other treatments. They must not have serious eye conditions, skin disorders, known allergies to the drugs being tested, recent use of certain stomach acid medications, or a history of severe reactions to similar cancer therapies.
What is being tested?
The study tests MK-0472 alone and combined with Pembrolizumab on participants with specific genetic tumor profiles. It aims to evaluate the effectiveness and safety without a primary hypothesis; meaning they're exploring how well these treatments work without trying to prove a specific idea.
What are the potential side effects?
Possible side effects include typical immune therapy-related issues like inflammation in various organs, infusion reactions (problems during drug administration), fatigue, digestive problems, blood disorders, increased risk of infections and potential worsening of autoimmune diseases.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 56 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 56 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 Treatment Due to an Adverse Event (AE)
Number of Participants Who Experience One or More Adverse Events (AEs)
Number of Participants Who Experience a Dose Limiting Toxicity (DLT) as Assessed Using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Secondary study objectives
Area Under the Concentration Time-curve From Time 0 to the Last Quantifiable Concentration (AUC0-t) of MK-0472
Lowest Plasma Concentration (Ctrough) of MK-0472
Maximum Serum Concentration (Cmax) of MK-0472

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: MK-0472 + PembrolizumabExperimental Treatment2 Interventions
Participants receive MK-0472 via oral capsule according to one of the protocol-specified dosing regimens until disease progression or withdrawal/discontinuation, plus pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).
Group II: MK-0472 + MK-1084Experimental Treatment2 Interventions
Participants receive MK-0472 via oral capsule according to one of the protocol-specified dosing regimens, plus MK-1084 via oral capsule QD until disease progression or withdrawal/discontinuation.
Group III: MK-0472Experimental Treatment1 Intervention
Participants receive MK-0472 via oral capsule according to one of the protocol-specified dosing regimens until disease progression or withdrawal/discontinuation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MK-1084
2023
Completed Phase 1
~60
Pembrolizumab
2017
Completed Phase 3
~2810

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for metastatic tumors include targeted therapies and immunotherapies. Targeted therapies inhibit specific molecules like tyrosine kinases that are essential for tumor growth and survival. Immunotherapies boost the immune system's ability to recognize and destroy cancer cells. These approaches are important for metastatic tumor patients as they provide more personalized treatment options, potentially improving outcomes and reducing side effects compared to conventional chemotherapy.
The Mechanism of Action of Regorafenib in Colorectal Cancer: A Guide for the Community Physician.Clinical and histopathological features of carcinosarcoma of the renal pelvis: a systematic review of a rare tumor.[New recommendations in oncocardiology].

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,978 Previous Clinical Trials
5,177,851 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,864 Previous Clinical Trials
8,082,297 Total Patients Enrolled

Media Library

MK-0472 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05853367 — Phase 1
Metastatic Tumor Research Study Groups: MK-0472 + MK-1084, MK-0472, MK-0472 + Pembrolizumab
Metastatic Tumor Clinical Trial 2023: MK-0472 Highlights & Side Effects. Trial Name: NCT05853367 — Phase 1
MK-0472 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05853367 — Phase 1
~119 spots leftby Feb 2028