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)-China Extension Study
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)
3 other identifiers
interventional
94
1 country
24
Brief Summary
The purpose of this China extension study is to assess the safety and efficacy of coformulated favezelimab/pembrolizumab (MK-4280A) in adult Chinese 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 colorectal-cancer
Started Jun 2022
Shorter than P25 for phase_3 colorectal-cancer
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 14, 2022
CompletedFirst Submitted
Initial submission to the registry
October 26, 2022
CompletedFirst Posted
Study publicly available on registry
October 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 21, 2025
CompletedResults Posted
Study results publicly available
September 17, 2025
CompletedNovember 26, 2025
November 1, 2025
2.2 years
October 26, 2022
July 31, 2025
November 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS)
OS was defined as the time from randomization to death due to any cause.
Up to approximately 26 months
Secondary Outcomes (5)
Progression-Free Survival (PFS) According Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
Up to approximately 26 months
Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR
Up to approximately 26 months
Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR
Up to approximately 26 months
Number of Participants Who Experienced at Least One Adverse Event (AE)
Up to approximately 20 months
Number of Participants Who Discontinued Study Treatment Due to an AE
Up to approximately 17 months
Study Arms (2)
Favezelimab/Pembrolizumab
EXPERIMENTALParticipants will receive coformulated favezelimab/pembrolizumab (800 mg/200 mg) intravenously (IV) on Day 1, then every 3 weeks (Q3W), for up to 35 infusions.
Standard of Care (Regorafenib or TAS-102)
ACTIVE COMPARATORAt 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.
Interventions
Coformulated favezelimab/pembrolizumab (800 mg/200 mg), IV infusion
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
The Second Affiliated Hospital of Anhui Medical University ( Site 1179)
Hefei, Anhui, 230601, China
Chongqing Cancer Hospital ( Site 1151)
Chongqing, Chongqing Municipality, 400030, China
Fujian Province Cancer Hospital ( Site 1178)
Fuzhou, Fujian, 350014, China
Sun Yat-Sen University Cancer Center ( Site 1150)
Guangzhou, Guangdong, 510060, China
Southern Medical University Nanfang Hospital ( Site 1154)
Guangzhou, Guangdong, 510515, China
The Sixth Affiliated Hospital of Sun Yat-sen University ( Site 1159)
Guangzhou, Guangdong, 510655, China
Guangxi Medical University Affiliated Tumor Hospital ( Site 1158)
Nanning, Guangxi, 531021, China
Hainan General Hospital ( Site 1177)
Haikou, Hainan, 570311, China
Wuhan Union Hospital Cancer Center ( Site 1162)
Wuhan, Hubei, 430022, China
Hubei Cancer Hospital ( Site 1152)
Wuhan, Hubei, 430079, China
Xiangya Hospital Central South University ( Site 1171)
Changsha, Hunan, 410008, China
Hunan Cancer Hospital ( Site 1174)
Changsha, Hunan, 410013, China
The Third Xiangya Hospital of Central South University ( Site 1175)
Changsha, Hunan, 410013, China
Changzhou Cancer Hospital-Department of Oncology ( Site 1183)
Changzhou, Jiangsu, 213000, China
Affiliated Hospital of Jiangnan University(Wuxi Fourth People's Hospital ) ( Site 1185)
Wuxi, Jiangsu, 214122, China
Jilin Cancer Hospital ( Site 1163)
Changchun, Jilin, 130012, China
Jinan Central Hospital ( Site 1167)
Jinan, Shandong, 250000, China
Shanghai Tenth People's Hospital ( Site 1170)
Shanghai, Shanghai Municipality, 200072, China
Fudan University Shanghai Cancer Center ( Site 1176)
Shanghai, Shanghai Municipality, 201321, China
West China Hospital Sichuan University ( Site 1172)
Chengdu, Sichuan, 332001, China
Tianjin Medical University Cancer Institute and Hospital ( Site 1161)
Tianjin, Tianjin Municipality, 300060, China
Yunnan Province Cancer Hospital-Colorectal surgery ( Site 1169)
Kunming, Yunnan, 650106, China
Zhejiang Cancer Hospital ( Site 1180)
Hangzhou, Zhejiang, 310005, China
Sir Run Run Shaw Hospital-Medical Oncology ( Site 1173)
Hangzhou, Zhejiang, 310018, China
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme LLC
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- None (Open-label)
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2022
First Posted
October 31, 2022
Study Start
June 14, 2022
Primary Completion
August 15, 2024
Study Completion
February 21, 2025
Last Updated
November 26, 2025
Results First Posted
September 17, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf