MK-4280A for Colorectal Cancer

Recruiting in Palo Alto (17 mi)

+152 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Merck Sharp & Dohme Corp.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing a new combination treatment for patients with advanced colorectal cancer. The treatment aims to boost the immune system's ability to fight cancer more effectively than current options.

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

This trial is for adults with metastatic colorectal cancer that's PD-L1 positive and has worsened after standard treatment. They must be able to take oral meds, have a life expectancy of at least 3 months, and an ECOG score of 0-1 (which means they are fully active or restricted in physically strenuous activity but can do light work).

Inclusion Criteria

My organs are functioning well.

I am fully active or restricted in physically strenuous activity but can do light work.

The patient has a measurable disease according to the RECIST 1.1 guidelines as assessed by the local site investigator.

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Exclusion Criteria

I have not had cancer treatment or been in a cancer study in the last 4 weeks.

I have a muscle disorder that causes high levels of creatine kinase.

I have a history of Hepatitis B or an active Hepatitis C infection.

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Treatment Details

Interventions

Favezelimab (Monoclonal Antibodies)
Pembrolizumab (Monoclonal Antibodies)
Regorafenib (Other)
TAS-102 (Other)

Trial OverviewThe study tests MK-4280A, a combo of favezelimab/pembrolizumab, against the usual treatments regorafenib and TAS-102. The goal is to see if MK-4280A helps patients live longer compared to the standard care.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Favezelimab/PembrolizumabExperimental Treatment1 Intervention

Participants will receive coformulated favezelimab/pembrolizumab (800 mg/200 mg) intravenously (IV) on Day 1, then every 3 weeks (Q3W), for up to 35 infusions.

Group II: Standard of Care (Regorafenib or TAS-102)Active Control2 Interventions

At the Investigator's choice, participants will receive 160 mg regorafenib orally daily on Days 1-12 of each 28-day cycle or 35 mg/m\^2 TAS-102 orally twice daily on Days 1-5 and Days 8-12 of each 28-day cycle.