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COMPLETED

NCT05064059

PHASE3

A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Standard of Care in Subjects With Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (MK-4280A-007)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the safety and efficacy of coformulated favezelimab/pembrolizumab (MK-4280A) in participants with metastatic colorectal cancer. The study will also compare MK-4280A with the standard of care treatment of regorafenib and TAS-102 (trifluridine and tipiracil). The primary study hypothesis is that coformulated favezelimab/pembrolizumab (MK-4280A) is superior to standard of care with respect to overall survival.

Official title: A Phase 3 Study of MK-4280A (Coformulated Favezelimab [MK-4280] Plus Pembrolizumab [MK-3475]) Versus Standard of Care in Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (KEYFORM-007)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

441

Start Date

2021-11-10

Completion Date

2025-02-21

Last Updated

2026-05-26

Healthy Volunteers

Conditions

Colorectal Cancer

Interventions

BIOLOGICAL

favezelimab/pembrolizumab

Coformulated favezelimab/pembrolizumab (800 mg/200 mg), IV infusion

DRUG

regorafenib

Oral

DRUG

TAS-102

Oral

Inclusion Criteria: * Has a histologically confirmed colorectal adenocarcinoma that is metastatic and unresectable. * Has measurable disease per RECIST 1.1 as assessed by the local site investigator. * Has been previously treated for the disease and radiographically progressed on or after or could not tolerate standard treatment. * Submits an archival (≤ 5 years) or newly obtained tumor tissue sample or newly obtained tumor tissue sample that has not been previously irradiated. * Has an Eastern Cooperative Oncology Group Performance Score (ECOG PS) of 0 to 1 within 10 days prior to first dose of study intervention. * Has a life expectancy of at least 3 months, based on the investigator assessment. * Has the ability to swallow and retain oral medication and not have any clinically significant gastrointestinal abnormalities that might alter absorption. * Has adequate organ function. Exclusion Criteria: * Has previously been found to have deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H) tumor status. * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis or leptomeningeal disease. * Has a history of acute or chronic pancreatitis. * Has neuromuscular disorders associated with an elevated creatine kinase (eg, inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy). * Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability. * Has urine protein greater than or equal to 1g/24h. * A woman of childbearing potential who has a positive urine/serum pregnancy test within 24/72 hours prior to the first dose of study intervention. * Has received prior therapy with an anti-programmed cell death 1 (PD-1), anti-programmed death ligand 1 (PD-L1), or anti-programmed cell death ligand 2 (PD-L2), anti-lymphocyte activation gene 3 (LAG-3) antibody, with a tyrosine kinase inhibitor (TKI; eg, lenvatinib) other than rapidly accelerated fibrosarcoma (RAF) inhibitors (binimetinib is permitted if combined with a RAF inhibitor), or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4, OX-40, cluster of differentiation \[CD\] 137). * Has previously received regorafenib or TAS-102. * Has received prior systemic anticancer therapy including investigational agents within 28 days before randomization. * Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease. * Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. * Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. * Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients. * Has an active autoimmune disease that has required systemic treatment in past 2 years. * Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. * Has an active infection requiring systemic therapy (eg, tuberculosis, known viral or bacterial infections, etc.). * Has a known history of human immunodeficiency virus (HIV) infection. * Has known history of Hepatitis B or known active Hepatitis C virus infection. * 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 had an allogenic tissue/solid organ transplant.

Locations (152)

Georgetown University Hospital ( Site 1148)

Washington D.C., District of Columbia, United States

Sibley Memorial Hospital ( Site 1143)

Washington D.C., District of Columbia, United States

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 1118)

Marietta, Georgia, United States

Norton Cancer Institute ( Site 1139)

Louisville, Kentucky, United States

Rutgers Cancer Institute of New Jersey ( Site 1105)

New Brunswick, New Jersey, United States

Memorial Sloan Kettering Cancer Center ( Site 1703)

New York, New York, United States

Oregon Health & Science University ( Site 1141)

Portland, Oregon, United States

MUSC Hollings Cancer Center ( Site 1715)

Charleston, South Carolina, United States

The West Clinic, PLLC dba West Cancer Center ( Site 1149)

Germantown, Tennessee, United States

UT Southwestern Medical Center ( Site 1709)

Dallas, Texas, United States

Intermountain Medical Center ( Site 1707)

Murray, Utah, United States

Inova Schar Cancer Institute ( Site 1130)

Fairfax, Virginia, United States

VCU Health Adult Outpatient Pavillion ( Site 1712)

Richmond, Virginia, United States

Blue Ridge Cancer Care ( Site 1718)

Roanoke, Virginia, United States

Seattle Cancer Care Alliance ( Site 1107)

Seattle, Washington, United States

Westmead Hospital ( Site 0057)

Westmead, New South Wales, Australia

Royal Brisbane and Women s Hospital ( Site 0058)

Herston, Queensland, Australia

Queen Elizabeth Hospital ( Site 0050)

Woodville South, South Australia, Australia

Frankston Hospital ( Site 0056)

Frankston, Victoria, Australia

Western Health-Sunshine & Footscray Hospitals ( Site 0052)

St Albans, Victoria, Australia

St John of God Subiaco Hospital ( Site 0051)

Perth, Western Australia, Australia

London Regional Cancer Program - London HSC ( Site 0154)

London, Ontario, Canada

The Ottawa Hospital ( Site 0151)

Ottawa, Ontario, Canada

Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0155)

Toronto, Ontario, Canada

Centro Investigacion Cancer James Lind ( Site 0204)

Temuco, Araucania, Chile

IC La Serena Research ( Site 0202)

La Serena, Coquimbo Region, Chile

Clinica Puerto Montt ( Site 0211)

Port Montt, Los Lagos Region, Chile

Fundacion Arturo Lopez Perez FALP ( Site 0208)