Evaluation of Co-formulated Pembrolizumab/Quavonlimab (MK-1308A) Versus Other Treatments in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer (CRC) (MK-1308A-008/KEYSTEP-008).

Running, not enrolling · Phase 2

Conditions studied: Colorectal Cancer

In brief

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.

Key facts

Study ID: NCT04895722
Run by: Merck Sharp & Dohme LLC
People needed: 302
Starts: 2021-06-25
Expected to finish: 2026-08-06
Last updated by the study team: 2026-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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
Has a life expectancy of at least 3 months
Female participants are eligible to participate if not pregnant or breastfeeding, and not a woman of childbearing potential (WOCBP), or if a WOCBP then uses a contraceptive method that is highly effective or is abstinent on a long-term and persistent basis, during the intervention period and for at least 120 days after the last dose of study intervention
Has measurable disease per RECIST 1.1 as assessed by the site and verified by BICR
Submit an archival (within 5 years of Screening) or newly obtained tumor tissue sample that has not been previously irradiated; formalin-fixed, paraffin embedded (FFPE) blocks are preferred to slides.
Has adequate organ function
Cohort A:
Has been previously treated for their Stage IV dMMR/MSI-H CRC and radiographically progressed on or after or could not tolerate standard treatment, which must include all of the following agents if approved and locally available in the country where the participant is randomized:
Fluoropyrimidine, irinotecan and oxaliplatin (capecitabine is acceptable as equivalent to fluorouracil in prior therapy)
With or without an anti-vascular endothelial growth factor (VEGF) monoclonal antibody (e.g., bevacizumab)
At least one of the anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (cetuximab or panitumumab) for rat sarcoma viral oncogene homolog (RAS) wild-type participants with left-sided tumors. Prior EGFR therapy is optional for patients with right sided RAS Wild-type (WT) tumors.
Cohort B:
Has untreated Stage IV dMMR/MSI-H CRC with no prior chemotherapy or immunotherapy for this disease

You may not qualify if…

Has received prior therapy with an agent directed to another stimulatory or coinhibitory T-cell receptor
Has received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention
Has not recovered adequately from a surgery procedure, and/or has any complications from a prior surgery before starting study intervention
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
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication
Has a known additional malignancy that is progressing or has required active treatment within the past 2 years
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Has severe hypersensitivity (≥Grade 3) to pembrolizumab, quavonlimab, favezelimab, vibostolimab, MK-4830, and/or any of their excipients
Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs)
Has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis
Has a history of acute or chronic pancreatitis
Has neuromuscular disorders associated with an elevated creatine kinase
Has urine protein ≥1 gram/24 hours
Has an active infection requiring systemic therapy (e.g., tuberculosis, known viral or bacterial infections, etc.)
Has a known history of Human Immunodeficiency Virus (HIV) infection
Concurrent active Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] positive and/or detectable Hepatitis B Virus [HBV] deoxyribonucleic acid [DNA]) and Hepatitis C virus (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid [RNA] infection
Has clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 6 months from Day 1 of study intervention administration, or New York Heart Association Class III or IV congestive heart failure. Medically controlled arrhythmia stable on medication is permitted.
Has present or progressive accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks before randomization/allocation
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
Has had an allogenic tissue/solid organ transplant

Where it is running

University Cancer & Blood Center, LLC ( Site 1521) — Athens, Georgia, United States
University of Chicago Medical Center-Medicine - Section of Hematology/Oncology - Gastrointestinal P — Chicago, Illinois, United States
Icahn School of Medicine at Mount Sinai ( Site 1528) — New York, New York, United States
Hematology Oncology Associates of Rockland ( Site 1525) — Nyack, New York, United States
UPMC Hillman Cancer Center ( Site 1516) — Pittsburgh, Pennsylvania, United States
The West Clinic, PLLC dba West Cancer Center ( Site 1576) — Germantown, Tennessee, United States
Vanderbilt University Medical Center-Vanderbilt-Ingram Cancer Center ( Site 1509) — Nashville, Tennessee, United States
UT Southwestern Medical Center ( Site 1551) — Dallas, Texas, United States
Baylor Scott & White Medical Center - Temple-Division of Hematology/Oncology ( Site 1549) — Temple, Texas, United States
Northwest Medical Specialties, PLLC ( Site 1546) — Tacoma, Washington, United States
UZ Brussel ( Site 0105) — Brussels, Bruxelles-Capitale, Region de, Belgium
Cliniques universitaires Saint-Luc-Medical Oncology ( Site 0104) — Brussels, Bruxelles-Capitale, Region de, Belgium
Université Catholique de Louvain-Namur - Centre Hospitalier -Oncology ( Site 0102) — Yvoir, Namur, Belgium
UZ Leuven ( Site 0101) — Leuven, Vlaams-Brabant, Belgium
AZ Delta vzw ( Site 0106) — Roeselare, West-Vlaanderen, Belgium
The Moncton Hospital-Oncology ( Site 0307) — Moncton, New Brunswick, Canada
Sunnybrook Research Institute - Odette Cancer Centre ( Site 0316) — Toronto, Ontario, Canada
McGill University Health Centre-CIM - Oncology ( Site 0306) — Montreal, Quebec, Canada
Instituto de Cancerología ( Site 1610) — Medellín, Antioquia, Colombia
Fundación Colombiana de Cancerología Clínica Vida ( Site 1606) — Medellín, Antioquia, Colombia
Clinica de la Costa S.A.S. ( Site 1608) — Barranquilla, Atlántico, Colombia
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 1611) — Bogotá, Bogota D.C., Colombia
Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 1601) — Valledupar, Cesar Department, Colombia
Oncomédica S.A.S ( Site 1602) — Montería, Departamento de Córdoba, Colombia
Mid Florida Cancer Center ( Site 1519) — Orange City, Florida, United States

Full record on ClinicalTrials.gov

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