MK-4280A for Colorectal Cancer

Recruiting at 152 trial locations

Overseen By Toll Free Number

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Merck Sharp & Dohme Corp.

Must not be taking: PD-1 inhibitors, PD-L1 inhibitors

Disqualifiers: CNS metastases, Cardiovascular disease, Autoimmune disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: Up to 27 months

441 Participants Needed

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either coformulated favezelimab/pembrolizumab (MK-4280A) intravenously every 3 weeks or standard of care treatment with regorafenib or TAS-102 in 28-day cycles

Up to 27 months

Every 3 weeks for MK-4280A group; every 28 days for standard of care group

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 4 weeks

Long-term follow-up

Participants are monitored for overall survival and other long-term outcomes

Up to 26 months

Treatment Details

Interventions

• Favezelimab
• Pembrolizumab
• Regorafenib
• TAS-102

Trial Overview The 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

Group I: Favezelimab/Pembrolizumab Experimental Treatment 1 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 Control 2 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.

Who Is Running the Clinical Trial?

Merck Sharp & Dohme Corp.

Lead Sponsor

Trials

2,287

Recruited

4,582,000+

Chirfi Guindo

Merck Sharp & Dohme Corp.

Chief Medical Officer

Engineering degree from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme Corp.

Chief Executive Officer since 2021

J.D. from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University