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A Study of Coformulated Favez...

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)

Last Updated: 2025-09-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

441 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-10

Study Completion Date

2025-02-21

Brief Summary

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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.

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Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

None (Open-label)

Study Groups

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Favezelimab/Pembrolizumab

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 Type EXPERIMENTAL

favezelimab/pembrolizumab

Intervention Type BIOLOGICAL

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

Standard of Care (Regorafenib or TAS-102)

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.

Group Type ACTIVE_COMPARATOR

regorafenib

Intervention Type DRUG

Oral

TAS-102

Intervention Type DRUG

Oral

Interventions

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favezelimab/pembrolizumab

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

Intervention Type BIOLOGICAL

regorafenib

Oral

Intervention Type DRUG

TAS-102

Oral

Intervention Type DRUG

Other Intervention Names

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MK-4280A STIVARGA® REGONIX® LONSURF®

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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Georgetown University Hospital ( Site 1148)

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

Site Status

Sibley Memorial Hospital ( Site 1143)

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

Site Status

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

Marietta, Georgia, United States

Site Status

Norton Cancer Institute ( Site 1139)

Louisville, Kentucky, United States

Site Status

Rutgers Cancer Institute of New Jersey ( Site 1105)

New Brunswick, New Jersey, United States

Site Status

Memorial Sloan Kettering Cancer Center ( Site 1703)

New York, New York, United States

Site Status

Oregon Health & Science University ( Site 1141)

Portland, Oregon, United States

Site Status

MUSC Hollings Cancer Center ( Site 1715)

Charleston, South Carolina, United States

Site Status

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

Germantown, Tennessee, United States

Site Status

UT Southwestern Medical Center ( Site 1709)

Dallas, Texas, United States

Site Status

Intermountain Medical Center ( Site 1707)

Murray, Utah, United States

Site Status

Inova Schar Cancer Institute ( Site 1130)

Fairfax, Virginia, United States

Site Status

VCU Health Adult Outpatient Pavillion ( Site 1712)

Richmond, Virginia, United States

Site Status

Blue Ridge Cancer Care ( Site 1718)

Roanoke, Virginia, United States

Site Status

Seattle Cancer Care Alliance ( Site 1107)

Seattle, Washington, United States

Site Status

Westmead Hospital ( Site 0057)

Westmead, New South Wales, Australia

Site Status

Royal Brisbane and Women s Hospital ( Site 0058)

Herston, Queensland, Australia

Site Status

Queen Elizabeth Hospital ( Site 0050)

Woodville South, South Australia, Australia

Site Status

Frankston Hospital ( Site 0056)

Frankston, Victoria, Australia

Site Status

Western Health-Sunshine & Footscray Hospitals ( Site 0052)

St Albans, Victoria, Australia

Site Status

St John of God Subiaco Hospital ( Site 0051)

Perth, Western Australia, Australia

Site Status

London Regional Cancer Program - London HSC ( Site 0154)

London, Ontario, Canada

Site Status

The Ottawa Hospital ( Site 0151)

Ottawa, Ontario, Canada

Site Status

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

Toronto, Ontario, Canada

Site Status

IC La Serena Research ( Site 0202)

La Serena, Coquimbo Region, Chile

Site Status