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Pembrolizumab/Quavonlimab for Advanced Colorectal Cancer

Phase 2
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has a histologically confirmed diagnosis of Stage IV CRC adenocarcinoma (as defined by American Joint Committee on Cancer [AJCC] version 8)
Has locally confirmed dMMR/MSI-H
Must not have
Has received prior radiotherapy within 2 weeks of start of study intervention
Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 50 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare the effectiveness and safety of co-formulated pembrolizumab/quavonlimab with other treatments for people with MSI-H or dMMR metastatic stage IV colorectal cancer.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects include allergic reactions to the drugs' components; immune-related issues such as inflammation in organs; increased risk of infections due to weakened immunity; fatigue; digestive problems; skin reactions; hormonal gland changes leading to hormone deficiencies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My condition is Stage IV colon cancer.
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My cancer is confirmed to have a specific genetic feature (dMMR/MSI-H).
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I have Stage IV colon cancer that is MSI-H/dMMR and have not received any treatment.
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My cancer can be measured by scans.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I had radiotherapy less than 2 weeks before starting the study treatment.
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I have not received a live vaccine in the last 30 days.
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I am currently being treated for an active infection.
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I have had pancreatitis before.
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I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.
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I have a muscle disorder that causes high levels of creatine kinase.
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I have been treated for an autoimmune disease with medication in the last 2 years.
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I have fluid buildup needing drainage or medication in the last 2 weeks.
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I have cancer that has spread to my brain or spinal cord.
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I have been diagnosed with HIV.
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I am highly allergic to specific cancer drugs or their ingredients.
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I have been treated with drugs targeting immune cells before.
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I have had pneumonitis treated with steroids or have it now.
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I have received an organ or tissue transplant from another person.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 50 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 50 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
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR)
Secondary study objectives
DOR per RECIST 1.1 as assessed by Investigator
Duration of Response (DOR) per RECIST 1.1 as assessed by BICR
Number of Participants Discontinuing Study Treatment Due to an AE
+5 more

Awards & Highlights

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

Trial Design

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
Participants receive pembrolizumab 400 mg intravenously (IV) every 6 weeks (Q6W) for up to approximately 2 years.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab/Quavonlimab
2017
Completed Phase 2
~420
Pembrolizumab
2017
Completed Phase 3
~3130
MK-4830
2022
Completed Phase 2
~160

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,582,285 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
4,032 Previous Clinical Trials
5,189,481 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,905 Previous Clinical Trials
8,091,149 Total Patients Enrolled

Media Library

MK-4830 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04895722 — Phase 2
Colorectal Cancer Research Study Groups: Pembrolizumab Plus MK-4830, Pembrolizumab, Pembrolizumab/Quavonlimab, Pembrolizumab/Favezelimab, Pembrolizumab/Vibostolimab
Colorectal Cancer Clinical Trial 2023: MK-4830 Highlights & Side Effects. Trial Name: NCT04895722 — Phase 2
MK-4830 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04895722 — Phase 2
~96 spots leftby Jun 2026
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