Program Status
RecruitingPhase
Phase 3Prior Immunotherapy Allowed
NoCRC-directed Trial
YesDrugs
5-Fluorouracil, Irinotecan, Leucovorin, oxaliplatinTags
MSI-H/ MMRdComments
Trial only in China, at several locations, for patients with MSI-H/MMRd metastatic colorectal cancer who have not received prior systemic therapy for stage IV colorectal cancer. No prior checkpoint inhibitor immunotherapy (anti-PD-1 or anti-CTLA-4) allowed.
Patients are randomized to receive pembrolizumab (anti PD-1, immunotherapy, Keytruda) or chemotherapy (which is the standard of care (SOC) for metastatic MSI-H/MMRd CRC in China.
Pembrolizumab is SOC for this type of patients in U.S.
Helpful Links
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9533375/Location | Location Status |
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China | |
Beijing Cancer hospital-Digestive Oncology ( Site 0001) Beijing, Beijing 100142 |
Recruiting |
Beijing Peking Union Medical College Hospital-Medical Oncology ( Site 0011) Beijing, Beijing 100730 |
Completed |
Tianjin Medical University Cancer Institute and Hospital-Gastric oncology ( Site 0019) Tianjin, Beijing |
Completed |
The First Affiliated Hospital of Chongqing Medical University ( Site 0051) Chongqing, Chongqing 400016 |
Recruiting |
Chongqing University Cancer Hospital-Medical Oncology ( Site 0012) Chongqing, Chongqing 400030 |
Recruiting |
Fujian Provincial Cancer Hospital ( Site 0009) Fuzhou, Fujian 350014 |
Recruiting |
Sun Yat-sen University Cancer Center ( Site 0047) Guangzhou, Guangdong 510060 |
Recruiting |
Guangdong Provincial People's Hospital ( Site 0035) Guangzhou, Guangdong 510080 |
Recruiting |
The First Affiliated Hospital, Sun Yat-sen University ( Site 0014) Guangzhou, Guangdong 510080 |
Recruiting |
The Sixth Affiliated Hospital of Sun Yat-sen University-Oncology ( Site 0048) Guangzhou, Guangdong 510655 |
Recruiting |
Cancer Hospital of Shantou University Medical College ( Site 0036) Shantou, Guangdong 515041 |
Completed |
Guangxi Medical University Affiliated Tumor Hospital ( Site 0039) Nanning, Guangxi 530200 |
Recruiting |
Harbin Medical University Cancer Hospital ( Site 0007) Harbin, Heilongjiang 150081 |
Recruiting |
Henan Cancer Hospital-henan cancer hospital ( Site 0015) Zhengzhou, Henan 450000 |
Recruiting |
Tongji Hospital Tongji Medical,Science & Technology-oncology ( Site 0018) Wuhan, Hubei 430000 |
Completed |
Wuhan Union Hospital Cancer Center-Cancer Center ( Site 0008) Wuhan, Hubei 430022 |
Recruiting |
The Third Xiangya Hospital of Central South University ( Site 0031) Changsha, Hunan 410013 |
Recruiting |
The Affiliated Jiangyin Hospital of Southeast University Medical College ( Site 0037) Jiangyin, Jiangsu 214400 |
Recruiting |
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology ( NanJing, Jiangsu 210008 |
Recruiting |
The first affiliated hospital of China medical university ( Site 0043) Shemyang, Liaoning 110001 |
Completed |
Tangdu Hospital of Fourth Military Medical University of Chi-General Surgery ( Site 0045) Xi'an, Shaanxi 710038 |
Recruiting |
Jinan Central Hospital-oncology department ( Site 0021) Jinan, Shandong 250013 |
Completed |
Shandong Cancer Hospital ( Site 0041) Jinan, Shandong 250117 |
Recruiting |
Fudan University Shanghai Cancer Center-Oncology ( Site 0046) Shanghai, Shanghai 200032 |
Recruiting |
Shanghai East Hospital ( Site 0022) Shanghai, Shanghai 200120 |
Recruiting |
Shanghai Changhai Hospital ( Site 0024) Shanghai, Shanghai 200433 |
Completed |
Shanxi Cancer Hospital ( Site 0032) Taiyuan, Shanxi 030013 |
Recruiting |
West China Hospital of Sichuan University ( Site 0044) Cheng Du, Sichuan 610041 |
Recruiting |
Sichuan Cancer Hospital. ( Site 0050) Chengdu, Sichuan 610042 |
Recruiting |
Xinjiang Medical University Cancer Hospital - Urumchi ( Site 0049) Urumchi, Xinjiang 830011 |
Recruiting |
Yunnan Province Cancer Hospital-Colorectal surgery ( Site 0006) Kunming, Yunnan 650106 |
Recruiting |
Zhejiang Cancer Hospital-oncology-abdominal neoplasms ( Site 0028) Hangzhou, Zhejiang 310022 |
Recruiting |
Contacts
Inclusion Criteria
The main inclusion and
Exclusion Criteria
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