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
NCT ID: NCT05600309
Last Updated: 2025-11-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
94 participants
INTERVENTIONAL
2022-06-14
2025-02-21
Brief Summary
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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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As of Amendment 3 of the supplemental statistical analysis plan, patient reported outcomes will no longer be secondary outcome measures of the study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
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.
favezelimab/pembrolizumab
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.
regorafenib
Oral
TAS-102
Oral
Interventions
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favezelimab/pembrolizumab
Coformulated favezelimab/pembrolizumab (800 mg/200 mg), IV infusion
regorafenib
Oral
TAS-102
Oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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The Second Affiliated Hospital of Anhui Medical University ( Site 1179)
Hefei, Anhui, China
Chongqing Cancer Hospital ( Site 1151)
Chongqing, Chongqing Municipality, China
Fujian Province Cancer Hospital ( Site 1178)
Fuzhou, Fujian, China
Sun Yat-Sen University Cancer Center ( Site 1150)
Guangzhou, Guangdong, China
Southern Medical University Nanfang Hospital ( Site 1154)
Guangzhou, Guangdong, China
The Sixth Affiliated Hospital of Sun Yat-sen University ( Site 1159)
Guangzhou, Guangdong, China
Guangxi Medical University Affiliated Tumor Hospital ( Site 1158)
Nanning, Guangxi, China
Hainan General Hospital ( Site 1177)
Haikou, Hainan, China
Wuhan Union Hospital Cancer Center ( Site 1162)
Wuhan, Hubei, China
Hubei Cancer Hospital ( Site 1152)
Wuhan, Hubei, China
Xiangya Hospital Central South University ( Site 1171)
Changsha, Hunan, China
Hunan Cancer Hospital ( Site 1174)
Changsha, Hunan, China
The Third Xiangya Hospital of Central South University ( Site 1175)
Changsha, Hunan, China
Changzhou Cancer Hospital-Department of Oncology ( Site 1183)
Changzhou, Jiangsu, China
Affiliated Hospital of Jiangnan University(Wuxi Fourth People's Hospital ) ( Site 1185)
Wuxi, Jiangsu, China
Jilin Cancer Hospital ( Site 1163)
Changchun, Jilin, China
Jinan Central Hospital ( Site 1167)
Jinan, Shandong, China
Shanghai Tenth People's Hospital ( Site 1170)
Shanghai, Shanghai Municipality, China
Fudan University Shanghai Cancer Center ( Site 1176)
Shanghai, Shanghai Municipality, China
West China Hospital Sichuan University ( Site 1172)
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute and Hospital ( Site 1161)
Tianjin, Tianjin Municipality, China
Yunnan Province Cancer Hospital-Colorectal surgery ( Site 1169)
Kunming, Yunnan, China
Zhejiang Cancer Hospital ( Site 1180)
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital-Medical Oncology ( Site 1173)
Hangzhou, Zhejiang, China
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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MK-4280A-007 China Extension
Identifier Type: OTHER
Identifier Source: secondary_id
jRCT2031210482
Identifier Type: REGISTRY
Identifier Source: secondary_id
4280A-007 China Extension
Identifier Type: -
Identifier Source: org_study_id
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