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New hope for tough colorectal cancer? drug combo tested in Late-Stage trial

NCT ID NCT05600309

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

94 people

The number who actually took part.

Started

Jun 2022

Finished

Feb 2025

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

autosomal dominant Parkinson disease 4 colorectal adenocarcinoma colorectal cancer colorectal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal cancer

Contacts and locations

Locations

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

    Wuxi, Jiangsu, 214122, China

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

    Changzhou, Jiangsu, 213000, China

  • Chongqing Cancer Hospital ( Site 1151)

    Chongqing, Chongqing Municipality, 400030, China

  • Fudan University Shanghai Cancer Center ( Site 1176)

    Shanghai, Shanghai Municipality, 201321, China

  • Fujian Province Cancer Hospital ( Site 1178)

    Fuzhou, Fujian, 350014, China

  • Guangxi Medical University Affiliated Tumor Hospital ( Site 1158)

    Nanning, Guangxi, 531021, China

  • Hainan General Hospital ( Site 1177)

    Haikou, Hainan, 570311, China

  • Hubei Cancer Hospital ( Site 1152)

    Wuhan, Hubei, 430079, China

  • Hunan Cancer Hospital ( Site 1174)

    Changsha, Hunan, 410013, 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

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

    Hangzhou, Zhejiang, 310018, China

  • Southern Medical University Nanfang Hospital ( Site 1154)

    Guangzhou, Guangdong, 510515, China

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

    Guangzhou, Guangdong, 510060, China

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

    Hefei, Anhui, 230601, China

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

    Guangzhou, Guangdong, 510655, China

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

    Changsha, Hunan, 410013, China

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

    Tianjin, Tianjin Municipality, 300060, China

  • West China Hospital Sichuan University ( Site 1172)

    Chengdu, Sichuan, 332001, China

  • Wuhan Union Hospital Cancer Center ( Site 1162)

    Wuhan, Hubei, 430022, China

  • Xiangya Hospital Central South University ( Site 1171)

    Changsha, Hunan, 410008, China

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

    Kunming, Yunnan, 650106, China

  • Zhejiang Cancer Hospital ( Site 1180)

    Hangzhou, Zhejiang, 310005, China

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