New hope for tough colorectal cancer? drug combo tested in Late-Stage trial
NCT ID NCT05600309
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 3 trial tests a new drug combination, MK-4280A (favezelimab plus pembrolizumab), against standard treatments (regorafenib or TAS-102) in 94 Chinese adults with advanced, PD-L1 positive colorectal cancer that has worsened after prior therapy. The main goal is to see if the new combo helps people live longer. The study is completed, and results are pending.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- favezelimab/pembrolizumab (MK-4280A)
- What this could lead to
- If successful, this could offer a new treatment option for people with advanced colorectal cancer that has not responded to prior therapy.
- What could go wrong
- This is a relatively small, China-only extension study. The experimental drug may not prove more effective than current treatments and could cause side effects like immune-related reactions.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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94 people
The number who actually took part.
- Started
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Jun 2022
- Finished
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Feb 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Affiliated Hospital of Jiangnan University(Wuxi Fourth People's Hospital ) ( Site 1185)
Wuxi, Jiangsu, 214122, China
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Changzhou Cancer Hospital-Department of Oncology ( Site 1183)
Changzhou, Jiangsu, 213000, China
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Chongqing Cancer Hospital ( Site 1151)
Chongqing, Chongqing Municipality, 400030, China
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Fudan University Shanghai Cancer Center ( Site 1176)
Shanghai, Shanghai Municipality, 201321, China
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Fujian Province Cancer Hospital ( Site 1178)
Fuzhou, Fujian, 350014, China
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Guangxi Medical University Affiliated Tumor Hospital ( Site 1158)
Nanning, Guangxi, 531021, China
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Hainan General Hospital ( Site 1177)
Haikou, Hainan, 570311, China
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Hubei Cancer Hospital ( Site 1152)
Wuhan, Hubei, 430079, China
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Hunan Cancer Hospital ( Site 1174)
Changsha, Hunan, 410013, China
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Jilin Cancer Hospital ( Site 1163)
Changchun, Jilin, 130012, China
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Jinan Central Hospital ( Site 1167)
Jinan, Shandong, 250000, China
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Shanghai Tenth People's Hospital ( Site 1170)
Shanghai, Shanghai Municipality, 200072, China
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Sir Run Run Shaw Hospital-Medical Oncology ( Site 1173)
Hangzhou, Zhejiang, 310018, China
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Southern Medical University Nanfang Hospital ( Site 1154)
Guangzhou, Guangdong, 510515, China
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Sun Yat-Sen University Cancer Center ( Site 1150)
Guangzhou, Guangdong, 510060, China
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The Second Affiliated Hospital of Anhui Medical University ( Site 1179)
Hefei, Anhui, 230601, China
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The Sixth Affiliated Hospital of Sun Yat-sen University ( Site 1159)
Guangzhou, Guangdong, 510655, China
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The Third Xiangya Hospital of Central South University ( Site 1175)
Changsha, Hunan, 410013, China
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Tianjin Medical University Cancer Institute and Hospital ( Site 1161)
Tianjin, Tianjin Municipality, 300060, China
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West China Hospital Sichuan University ( Site 1172)
Chengdu, Sichuan, 332001, China
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Wuhan Union Hospital Cancer Center ( Site 1162)
Wuhan, Hubei, 430022, China
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Xiangya Hospital Central South University ( Site 1171)
Changsha, Hunan, 410008, China
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Yunnan Province Cancer Hospital-Colorectal surgery ( Site 1169)
Kunming, Yunnan, 650106, China
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Zhejiang Cancer Hospital ( Site 1180)
Hangzhou, Zhejiang, 310005, China
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