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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
Study Summary
This trial tests the effectiveness, safety, and tolerability of two drugs for advanced/metastatic solid tumors. No primary hypothesis is tested.
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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 56 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 56 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 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 outcome measures
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
Trial Design
2Treatment groups
Experimental Treatment
Group I: MK-0472 + PembrolizumabExperimental Treatment2 Interventions
Participants receive MK-0472 capsule up to 300 mg orally QD 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-0472Experimental Treatment1 Intervention
Participants receive MK-0472 capsule up to 300 mg orally once daily (QD) until disease progression or withdrawal/discontinuation.
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
3,892 Previous Clinical Trials
5,061,046 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,064,304 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have another cancer that is growing or was treated in the last 2 years.I am hepatitis B positive but have been on antiviral therapy for over 4 weeks with an undetectable viral load.I have a serious heart condition.I had another cancer but was treated successfully and have been cancer-free for 2 years.I stopped a cancer treatment due to side effects.I have had high calcium levels or parathyroid issues.I haven't had cancer treatment or experimental drugs in the last 4 weeks.I still experience side effects from cancer treatment received over 4 weeks ago.I have HIV and have been on stable HIV medication for over 4 weeks.I am currently on medication for an infection.I am still recovering from major surgery or have complications.My advanced cancer has specific genetic changes and I've tried all known beneficial treatments.I have or had lung inflammation that needed steroids.I have high eye pressure, glaucoma, or certain retinal diseases.I have an autoimmune disease but haven't needed systemic treatment in the last 2 years.I have an immune system disorder or have been on steroids or other immune-weakening medicines recently.I have taken acid reflux medication within the last week.I have stable brain metastases and haven't needed steroids for 14 days.I have not received a live vaccine in the last 30 days.I had hepatitis C but my current tests show no virus.I have a severe skin condition with blistering.
Research Study Groups:
This trial has the following groups:- Group 1: MK-0472
- Group 2: MK-0472 + 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.
Has the combination treatment of MK-0472 and Pembrolizumab been certified by the FDA?
"As this is an early-stage Phase 1 trial, with limited evidence of safety and efficacy, MK-0472 + Pembrolizumab was given a score of 1."
Answered by AI
Are there any open enrollments for this experiment?
"Affirmative, the information available on clinicaltrials.gov suggests that this research is currently seeking participants for enrollment. The trial was initially announced on July 5th 2023 and has since been modified up until June 28th of the same year. 100 individuals are being accepted at a single medical centre."
Answered by AI
What is the maximum number of participants accepted for this clinical experiment?
"Affirmative. According to clinicaltrials.gov, this scientific study is actively searching for volunteers and was initially posted on July 5th 2023 with its most recent update taking place the 28th of June in 2023. One hundred individuals are needed from one research facility for enrollment."
Answered by AI
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