Pembrolizumab/Quavonlimab for Advanced Colorectal Cancer

Recruiting in Palo Alto (17 mi)

+112 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Merck Sharp & Dohme Corp.

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The purpose of this study is to assess the efficacy and safety of co-formulated pembrolizumab/quavonlimab versus other treatments in participants with MSI-H or dMMR Metastatic Stage IV Colorectal Cancer.

Eligibility Criteria

This trial is for adults with Stage IV colorectal cancer that's either MSI-H or dMMR. They should have measurable disease, adequate organ function, and a life expectancy of at least 3 months. Women must not be pregnant/breastfeeding and use effective contraception if of childbearing potential. Excluded are those with recent treatments/surgeries, live vaccines, other cancers within 2 years, CNS metastases, severe drug hypersensitivity, active infections like HIV/Hepatitis B/C, certain heart diseases or conditions that could affect study participation.

Inclusion Criteria

My condition is Stage IV colon cancer.

My cancer is confirmed to have a specific genetic feature (dMMR/MSI-H).

I have Stage IV colon cancer that is MSI-H/dMMR and have not received any treatment.

My cancer can be measured by scans.

Exclusion Criteria

I had radiotherapy less than 2 weeks before starting the study treatment.

I have not received a live vaccine in the last 30 days.

I am currently being treated for an active infection.

I have had pancreatitis before.

I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.

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

I have been treated for an autoimmune disease with medication in the last 2 years.

I have fluid buildup needing drainage or medication in the last 2 weeks.

I have cancer that has spread to my brain or spinal cord.

I have been diagnosed with HIV.

I am highly allergic to specific cancer drugs or their ingredients.

I have been treated with drugs targeting immune cells before.

I have had pneumonitis treated with steroids or have it now.

I have received an organ or tissue transplant from another person.

Participant Groups

The trial tests the effectiveness and safety of a combined treatment (pembrolizumab/quavonlimab) against other therapies in patients with advanced colorectal cancer characterized by MSI-H/dMMR. It compares this combination to pembrolizumab alone or with favezelimab/vibostolimab/MK-4830 to see which works best.

5Treatment groups

Experimental Treatment

Active Control

Group I: Pembrolizumab/VibostolimabExperimental Treatment1 Intervention

Participants receive co-formulated pembrolizumab/vibostolimab (200 mg/200 mg) Q3W for up to approximately 2 years.

Group II: Pembrolizumab/QuavonlimabExperimental Treatment1 Intervention

Participants receive co-formulated pembrolizumab/quavonlimab (400 mg/25 mg) Q6W for up to approximately 2 years.

Group III: Pembrolizumab/FavezelimabExperimental Treatment1 Intervention

Participants receive co-formulated pembrolizumab/favezelimab (200 mg/800 mg) every 3 weeks (Q3W) for up to approximately 2 years.

Group IV: Pembrolizumab Plus MK-4830Experimental Treatment2 Interventions

Participants receive pembrolizumab 200 mg plus MK-4830 800 mg Q3W for up to approximately 2 years.

Group V: PembrolizumabActive Control1 Intervention