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Immunotherapy drug shows promise for Tough-to-Treat colorectal cancer in china

NCT ID NCT05239741

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study compares the immunotherapy drug pembrolizumab with standard chemotherapy in about 100 Chinese patients whose advanced colorectal cancer has a specific genetic feature (MSI-H or dMMR). The goal is to see if pembrolizumab can slow cancer growth or improve survival better than chemotherapy. Participants are randomly assigned to receive either pembrolizumab or one of six standard chemotherapy regimens.

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

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2022

Expected to finish

Sep 2028

An estimate. End dates often move.

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.

The main inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: Inclusion Criteria include, but are not limited to: * Has a histologically confirmed diagnosis of colorectal adenocarcinoma that is at stage IV (as defined by American Joint Committee on Cancer eighth edition) \[National Comprehensive Cancer Network 2018\] * Has centrally confirmed Microsatellite Instability-High/Mismatch Repair Deficient (MSI-H/dMMR) status * Has centrally confirmed RAS and BRAF mutation status * A woman of child-bearing potential (WOCBP) must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours for urine or within 72 hours for serum before the first dose of study intervention. * Has measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 as assessed by the local site investigator/radiology * Must provide an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 3 days before randomization * Has a life expectancy of at least 3 months * Has received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable hepatitis B virus (HBV) viral load prior to randomization if hepatitis B surface antigen (HBsAg) positive * Has an undetectable Hepatitis C Virus (HCV) viral load if HCV infected * Has well controlled Human Immunodeficiency Virus (HIV) on antiretroviral therapy (ART) if HIV infected Exclusion Criteria: Exclusion Criteria include, but are not limited to: * Has received prior systemic therapy for stage IV colorectal cancer (CRC). Participants may have received prior adjuvant/neoadjuvant chemotherapy for CRC as long as it was completed at least 6 months prior to randomization * Has undergone major operation within 4 weeks of randomization or has not adequately recovered from major surgery or has ongoing surgical complications * Has received prior therapy with an anti-programmed cell death 1 protein (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-programmed cell death ligand 2 (anti PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\], tumor necrosis factor receptor superfamily, member 4 \[OX 40\], tumor necrosis factor receptor superfamily member 9 \[CD137\]) * Has received prior radiotherapy within 2 weeks of start of study intervention or has radiation-related toxicities, requiring corticosteroids * Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention * Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration. * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication * Has a known additional malignancy that is progressing or has required active treatment within the past 5 years, with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis * 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 infection) * Has HIV-infection with a history of Kaposi's sarcoma or Multicentric Castleman's Disease * 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 cancer colorectal neoplasm

As listed by the trial registrant

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

Colorectal neoplasms

Contacts and locations

Locations

  • Beijing Cancer hospital-Digestive Oncology ( Site 0001)

    Beijing, Beijing Municipality, 100142, China

  • Beijing Peking Union Medical College Hospital-Medical Oncology ( Site 0011)

    Beijing, Beijing Municipality, 100730, China

  • Cancer Hospital of Shantou University Medical College ( Site 0036)

    Shantou, Guangdong, 515041, China

  • Chongqing University Cancer Hospital-Medical Oncology ( Site 0012)

    Chongqing, Chongqing Municipality, 400030, China

  • Fudan University Shanghai Cancer Center-Oncology ( Site 0046)

    Shanghai, Shanghai Municipality, 201321, China

  • Fujian Provincial Cancer Hospital ( Site 0009)

    Fuzhou, Fujian, 350014, China

  • Guangdong Provincial People's Hospital ( Site 0035)

    Guangzhou, Guangdong, 510080, China

  • Guangxi Medical University Affiliated Tumor Hospital ( Site 0039)

    Nanning, Guangxi, 530200, China

  • Harbin Medical University Cancer Hospital ( Site 0007)

    Harbin, Heilongjiang, 150081, China

  • Henan Cancer Hospital-henan cancer hospital ( Site 0015)

    Zhengzhou, Henan, 450000, China

  • Jinan Central Hospital-oncology department ( Site 0021)

    Jinan, Shandong, 250013, China

  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology ( Site 0002)

    Nanjing, Jiangsu, 210008, China

  • Shandong Cancer Hospital ( Site 0041)

    Jinan, Shandong, 250117, China

  • Shanghai Changhai Hospital ( Site 0024)

    Shanghai, Shanghai Municipality, 200433, China

  • Shanghai East Hospital ( Site 0022)

    Shanghai, Shanghai Municipality, 201200, China

  • Shanxi Cancer Hospital ( Site 0032)

    Taiyuan, Shanxi, 030000, China

  • Sichuan Cancer Hospital. ( Site 0050)

    Chengdu, Sichuan, 610041, China

  • Sun Yat-sen University Cancer Center ( Site 0047)

    Guangzhou, Guangdong, 510060, China

  • Tangdu Hospital of Fourth Military Medical University of Chi-General Surgery ( Site 0045)

    Xi'an, Shaanxi, 710038, China

  • The Affiliated Cancer Hospital of Xinjiang Medical University ( Site 0049)

    Ürümqi, Xinjiang, 830000, China

  • The Affiliated Jiangyin Hospital of Southeast University Medical College ( Site 0037)

    Jiangyin, Jiangsu, 214400, China

  • The First Affiliated Hospital of Chongqing Medical University ( Site 0051)

    Chongqing, Chongqing Municipality, 400016, China

  • The First Affiliated Hospital, Sun Yat-sen University ( Site 0014)

    Guangzhou, Guangdong, 510080, China

  • The Sixth Affiliated Hospital of Sun Yat-sen University-Oncology ( Site 0048)

    Guangzhou, Guangdong, 510655, China

  • The Third Xiangya Hospital of Central South University ( Site 0031)

    Changsha, Hunan, 410013, China

  • The first affiliated hospital of China medical university ( Site 0043)

    Shemyang, Liaoning, 110001, China

  • Tianjin Medical University Cancer Institute and Hospital-Gastric oncology ( Site 0019)

    Tianjin, Beijing Municipality, China

  • Tongji Hospital Tongji Medical,Science & Technology-oncology ( Site 0018)

    Wuhan, Hubei, 430000, China

  • West China Hospital, Sichuan University ( Site 0044)

    Chengdu, Sichuan, 610066, China

  • Wuhan Union Hospital Cancer Center-Cancer Center ( Site 0008)

    Wuhan, Hubei, 430022, China

  • Yunnan Province Cancer Hospital-Colorectal surgery ( Site 0006)

    Kunming, Yunnan, 650106, China

  • Zhejiang Cancer Hospital-oncology-abdominal neoplasms ( Site 0028)

    Hangzhou, Zhejiang, 310022, China

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