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

Last updated: November 17, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Completed

Phase

3

Condition

Rectal Cancer

Colon Cancer

Colorectal Cancer

Treatment

favezelimab/pembrolizumab

regorafenib

TAS-102

Clinical Study ID

NCT05600309
4280A-007 China Extension
jRCT2031210482
MK-4280A-007 China Extension
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Has a histologically confirmed colorectal adenocarcinoma that is metastatic andunresectable.

  • 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 orafter or could not tolerate standard treatment.

  • Submits an archival (≤ 5 years) or newly obtained tumor tissue sample or newlyobtained tumor tissue sample that has not been previously irradiated.

  • Has an Eastern Cooperative Oncology Group Performance Score (ECOG PS) of 0 to 1within 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 clinicallysignificant gastrointestinal abnormalities that might alter absorption.

  • Has adequate organ function.

Exclusion

Exclusion Criteria:

  • Has previously been found to have deficient mismatch repair/microsatelliteinstability-high (dMMR/MSI-H) tumor status.

  • Has known active central nervous system (CNS) metastases and/or carcinomatousmeningitis 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, spinalmuscular atrophy)

  • Has clinically significant cardiovascular disease within 12 months from first doseof study intervention, including New York Heart Association Class III or IVcongestive heart failure, unstable angina, myocardial infarction, cerebral vascularaccident, 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 testwithin 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 kinaseinhibitor (TKI; eg, lenvatinib) other than rapidly accelerated fibrosarcoma (RAF)inhibitors (binimetinib is permitted if combined with a RAF inhibitor), or with anagent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxicT-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 agentswithin 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 requirecorticosteroids, and not have had radiation pneumonitis. A 1-week washout ispermitted 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 doseof study intervention.

  • Has a known additional malignancy that is progressing or has required activetreatment within the past 3 years.

  • Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of itsexcipients.

  • Has an active autoimmune disease that has required systemic treatment in past 2years.

  • Has a history of (noninfectious) pneumonitis/interstitial lung disease that requiredsteroids or has current pneumonitis/interstitial lung disease.

  • Has an active infection requiring systemic therapy (eg, tuberculosis, known viral orbacterial 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 laboratoryabnormality that might confound the results of the study, interfere with theparticipant's participation for the full duration of the study, or is not in thebest interest of the participant to participate, in the opinion of the treatinginvestigator.

  • Has had an allogenic tissue/solid organ transplant.

Study Design

Total Participants: 94
Treatment Group(s): 3
Primary Treatment: favezelimab/pembrolizumab
Phase: 3
Study Start date:
June 14, 2022
Estimated Completion Date:
February 21, 2025

Study Description

The China extension study will include participants previously enrolled in China in the global study for MK-4280A-007 (NCT05064059) plus those enrolled during the China extension enrollment period. A total of approximately 94 Chinese participants will be enrolled.

As of Amendment 3 of the supplemental statistical analysis plan, patient reported outcomes will no longer be secondary outcome measures of the study.

Connect with a study center

  • The Second Affiliated Hospital of Anhui Medical University ( Site 1179)

    Hefei, Anhui 230601
    China

    Site Not Available

  • The Second Affiliated Hospital of Anhui Medical University ( Site 1179)

    Hefei 1808722, Anhui 1818058 230601
    China

    Site Not Available

  • Chongqing Cancer Hospital ( Site 1151)

    Chongqing, Chongqing 400030
    China

    Site Not Available

  • Chongqing Cancer Hospital ( Site 1151)

    Chongqing 1814906, Chongqing Municipality 1814905 400030
    China

    Site Not Available

  • Fujian Province Cancer Hospital ( Site 1178)

    Fuzhou, Fujian 350014
    China

    Site Not Available

  • Fujian Province Cancer Hospital ( Site 1178)

    Fuzhou 1810821, Fujian 1811017 350014
    China

    Site Not Available

  • Southern Medical University Nanfang Hospital ( Site 1154)

    Guangzhou, Guangdong 510515
    China

    Site Not Available

  • Sun Yat-Sen University Cancer Center ( Site 1150)

    Guangzhou, Guangdong 510060
    China

    Site Not Available

  • The Sixth Affiliated Hospital of Sun Yat-sen University ( Site 1159)

    Guangzhou, Guangdong 510655
    China

    Site Not Available

  • Southern Medical University Nanfang Hospital ( Site 1154)

    Guangzhou 1809858, Guangdong 1809935 510515
    China

    Site Not Available

  • Sun Yat-Sen University Cancer Center ( Site 1150)

    Guangzhou 1809858, Guangdong 1809935 510060
    China

    Site Not Available

  • The Sixth Affiliated Hospital of Sun Yat-sen University ( Site 1159)

    Guangzhou 1809858, Guangdong 1809935 510655
    China

    Site Not Available

  • Guangxi Medical University Affiliated Tumor Hospital ( Site 1158)

    Nanning, Guangxi 531021
    China

    Site Not Available

  • Guangxi Medical University Affiliated Tumor Hospital ( Site 1158)

    Nanning 1799869, Guangxi 1809867 531021
    China

    Site Not Available

  • Hainan General Hospital ( Site 1177)

    Haikou, Hainan 570311
    China

    Site Not Available

  • Hainan General Hospital ( Site 1177)

    Haikou 1809078, Hainan 1809054 570311
    China

    Site Not Available

  • Hubei Cancer Hospital ( Site 1152)

    Wuhan, Hubei 430079
    China

    Site Not Available

  • Wuhan Union Hospital Cancer Center ( Site 1162)

    Wuhan, Hubei 430022
    China

    Site Not Available

  • Hubei Cancer Hospital ( Site 1152)

    Wuhan 1791247, Hubei 1806949 430079
    China

    Site Not Available

  • Wuhan Union Hospital Cancer Center ( Site 1162)

    Wuhan 1791247, Hubei 1806949 430022
    China

    Site Not Available

  • Hunan Cancer Hospital ( Site 1174)

    Changsha, Hunan 410013
    China

    Site Not Available

  • The Third Xiangya Hospital of Central South University ( Site 1175)

    Changsha, Hunan 410013
    China

    Site Not Available

  • Xiangya Hospital Central South University ( Site 1171)

    Changsha, Hunan 410008
    China

    Site Not Available

  • Hunan Cancer Hospital ( Site 1174)

    Changsha 1815577, Hunan 1806691 410013
    China

    Site Not Available

  • The Third Xiangya Hospital of Central South University ( Site 1175)

    Changsha 1815577, Hunan 1806691 410013
    China

    Site Not Available

  • Xiangya Hospital Central South University ( Site 1171)

    Changsha 1815577, Hunan 1806691 410008
    China

    Site Not Available

  • Changzhou Cancer Hospital-Department of Oncology ( Site 1183)

    Changzhou, Jiangsu 213000
    China

    Site Not Available

  • Affiliated Hospital of Jiangnan University(Wuxi Fourth People's Hospital ) ( Site 1185)

    Wuxi City, Jiangsu 214122
    China

    Site Not Available

  • Changzhou Cancer Hospital-Department of Oncology ( Site 1183)

    Changzhou 1815456, Jiangsu 1806260 213000
    China

    Site Not Available

  • Affiliated Hospital of Jiangnan University(Wuxi Fourth People's Hospital ) ( Site 1185)

    Wuxi 1790923, Jiangsu 1806260 214122
    China

    Site Not Available

  • Jilin Cancer Hospital ( Site 1163)

    Changchun, Jilin 130012
    China

    Site Not Available

  • Jilin Cancer Hospital ( Site 1163)

    Changchun 2038180, Jilin 2036500 130012
    China

    Site Not Available

  • Jinan Central Hospital ( Site 1167)

    Jinan, Shandong 250000
    China

    Site Not Available

  • Jinan Central Hospital ( Site 1167)

    Jinan 1805753, Shandong 1796328 250000
    China

    Site Not Available

  • Fudan University Shanghai Cancer Center ( Site 1176)

    Shangai, Shanghai 201321
    China

    Site Not Available

  • Shanghai Tenth People's Hospital ( Site 1170)

    Shanghai, Shanghai 200072
    China

    Site Not Available

  • Fudan University Shanghai Cancer Center ( Site 1176)

    Shanghai 1796236, Shanghai Municipality 1796231 201321
    China

    Site Not Available

  • Shanghai Tenth People's Hospital ( Site 1170)

    Shanghai 1796236, Shanghai Municipality 1796231 200072
    China

    Site Not Available

  • West China Hospital Sichuan University ( Site 1172)

    Chengdu, Sichuan 332001
    China

    Site Not Available

  • West China Hospital Sichuan University ( Site 1172)

    Chengdu 1815286, Sichuan 1794299 332001
    China

    Site Not Available

  • Tianjin Medical University Cancer Institute and Hospital ( Site 1161)

    Tianjin, Tianjin 300060
    China

    Site Not Available

  • Tianjin Medical University Cancer Institute and Hospital ( Site 1161)

    Tianjin 1792947, Tianjin Municipality 1792943 300060
    China

    Site Not Available

  • Yunnan Province Cancer Hospital-Colorectal surgery ( Site 1169)

    Kunming, Yunnan 650106
    China

    Site Not Available

  • Yunnan Province Cancer Hospital-Colorectal surgery ( Site 1169)

    Kunming 1804651, Yunnan 1785694 650106
    China

    Site Not Available

  • Sir Run Run Shaw Hospital-Medical Oncology ( Site 1173)

    Hangzhou, Zhejiang 310018
    China

    Site Not Available

  • Zhejiang Cancer Hospital ( Site 1180)

    Hangzhou, Zhejiang 310005
    China

    Site Not Available

  • Sir Run Run Shaw Hospital-Medical Oncology ( Site 1173)

    Hangzhou 1808926, Zhejiang 1784764 310018
    China

    Site Not Available

  • Zhejiang Cancer Hospital ( Site 1180)

    Hangzhou 1808926, Zhejiang 1784764 310005
    China

    Site Not Available

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