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Набира участници Фаза 3 NCT05239741

Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Chinese Participants With Stage IV Colorectal Cancer (MK-3475-C66)

Фаза 3 – широко изпитване преди одобрение
Заболявания: Colorectal Neoplasms

Спонсор: Merck Sharp & Dohme LLC

Налично на: БГ
Обобщение
In this study, Chinese participants with MSI-H or dMMR advanced colorectal cancer will be assigned to receive either pembrolizumab or the Investigator's choice of 1 of 6 standard of care (SOC) chemotherapy regimens for treatment. There is no hypothesis testing for this study.
Кой може да участва
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
Интервенции
Pembrolizumab
BIOLOGICAL
Oxaliplatin
DRUG
Leucovorin
DRUG
5-fluorouracil
DRUG
Irinotecan
DRUG
Bevacizumab
BIOLOGICAL
Cetuximab
BIOLOGICAL
Места на провеждане 32
Китай (32)
Beijing Cancer hospital-Digestive Oncology ( Site 0001)
Beijing , Beijing Municipality
Study Coordinator
Beijing Peking Union Medical College Hospital-Medical Oncology ( Site 0011)
Beijing , Beijing Municipality
COMPLETED
The Third Xiangya Hospital of Central South University ( Site 0031)
Changsha , Hunan
Study Coordinator
Sichuan Cancer Hospital. ( Site 0050)
Chengdu , Sichuan
Study Coordinator
West China Hospital, Sichuan University ( Site 0044)
Chengdu , Sichuan
Study Coordinator
The First Affiliated Hospital of Chongqing Medical University ( Site 0051)
Chongqing , Chongqing Municipality
Study Coordinator
Chongqing University Cancer Hospital-Medical Oncology ( Site 0012)
Chongqing , Chongqing Municipality
Study Coordinator
Fujian Provincial Cancer Hospital ( Site 0009)
Fuzhou , Fujian
Study Coordinator
Sun Yat-sen University Cancer Center ( Site 0047)
Guangzhou , Guangdong
Study Coordinator
Guangdong Provincial People's Hospital ( Site 0035)
Guangzhou , Guangdong
Study Coordinator
The First Affiliated Hospital, Sun Yat-sen University ( Site 0014)
Guangzhou , Guangdong
Study Coordinator
The Sixth Affiliated Hospital of Sun Yat-sen University-Oncology ( Site 0048)
Guangzhou , Guangdong
Study Coordinator
Zhejiang Cancer Hospital-oncology-abdominal neoplasms ( Site 0028)
Hangzhou , Zhejiang
Study Coordinator
Harbin Medical University Cancer Hospital ( Site 0007)
Harbin , Heilongjiang
Study Coordinator
The Affiliated Jiangyin Hospital of Southeast University Medical College ( Site 0037)
Jiangyin , Jiangsu
Study Coordinator
Jinan Central Hospital-oncology department ( Site 0021)
Jinan , Shandong
COMPLETED
Shandong Cancer Hospital ( Site 0041)
Jinan , Shandong
Study Coordinator
Yunnan Province Cancer Hospital-Colorectal surgery ( Site 0006)
Kunming , Yunnan
Study Coordinator
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology ( Site 0002)
Nanjing , Jiangsu
Study Coordinator
Guangxi Medical University Affiliated Tumor Hospital ( Site 0039)
Nanning , Guangxi
Study Coordinator
Shanghai Changhai Hospital ( Site 0024)
Shanghai , Shanghai Municipality
COMPLETED
Shanghai East Hospital ( Site 0022)
Shanghai , Shanghai Municipality
Study Coordinator
Fudan University Shanghai Cancer Center-Oncology ( Site 0046)
Shanghai , Shanghai Municipality
Study Coordinator
Cancer Hospital of Shantou University Medical College ( Site 0036)
Shantou , Guangdong
COMPLETED
The first affiliated hospital of China medical university ( Site 0043)
Shemyang , Liaoning
COMPLETED
Shanxi Cancer Hospital ( Site 0032)
Taiyuan , Shanxi
ACTIVE_NOT_RECRUITING
Tianjin Medical University Cancer Institute and Hospital-Gastric oncology ( Site 0019)
Tianjin , Beijing Municipality
COMPLETED
The Affiliated Cancer Hospital of Xinjiang Medical University ( Site 0049)
Ürümqi , Xinjiang
Study Coordinator
Tongji Hospital Tongji Medical,Science & Technology-oncology ( Site 0018)
Wuhan , Hubei
COMPLETED
Wuhan Union Hospital Cancer Center-Cancer Center ( Site 0008)
Wuhan , Hubei
Study Coordinator
Tangdu Hospital of Fourth Military Medical University of Chi-General Surgery ( Site 0045)
Xi'an , Shaanxi
Study Coordinator
Henan Cancer Hospital-henan cancer hospital ( Site 0015)
Zhengzhou , Henan
Study Coordinator
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
02.04.2022
Крайна дата
19.09.2028
Регистрационен номер
NCT05239741
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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