Spots Global Cancer Trial Database for Study of CBP501/Cisplatin/Nivolumab Combinations in Advanced Pancreatic Cancer
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Trial Identification
Brief Title: Study of CBP501/Cisplatin/Nivolumab Combinations in Advanced Pancreatic Cancer
Official Title: Multicenter, Randomized, Parallel Group, Phase 2 to Establish the Efficacy and Safety of Combinations of CBP501, Cisplatin, and Nivolumab for ≥3rd Line Treatment of Patients With Exocrine Pancreatic Cancer and WBC <10,000/mm3 at Screening
Study ID: NCT04953962
Conditions
Study Description
Brief Summary: Multicenter, randomized, open-label, parallel group phase 2 study to assess the efficacy and tolerance of four combinations of CBP501, cisplatin, and nivolumab administered once every 21 days to patients with stage IV exocrine pancreatic cancer and WBC \< 10,000/mm3 at screening.
Detailed Description: Multicenter, randomized, open-label, parallel group phase 2 study to assess the efficacy and tolerance of four combinations of CBP501, cisplatin, and nivolumab administered once every 21 days to patients with stage IV exocrine pancreatic cancer and WBC \< 10,000/mm3 at screening. Patients will be randomized 1:1:1:1 to the following four treatment groups, with randomization stratified by ECOG PS (0 vs 1) and liver metastasis (present vs absent): 1. CBP501 25 mg/m2 + cisplatin 60 mg/m2 + nivolumab 240 mg 2. CBP501 16 mg/m2 + cisplatin 60 mg/m2 + nivolumab 240 mg 3. CBP501 25 mg/m2 + cisplatin 60 mg/m2 4. Cisplatin 60 mg/m2 + nivolumab 240 mg No more than 4 cycles of combination therapy may be administered but patients who remain progression-free after 4 cycles may receive up to 6 additional cycle of single-agent nivolumab. A Fleming two-stage design will be used. For each study arm, the null hypothesis that the true percentage of patients progression-free at 3 months is 10% will be tested against a one-sided alternative. In the first stage, 9 patients will be accrued to each study arm. In the first stage, if there are 1 or fewer patient progression-free at 3 months the study will be stopped for futility and if there are 4 or more patients progression-free at 3 months the study will stopped and the null hypothesis rejected. Otherwise, 14 additional patients will be accrued to the study arm for a total of 23. The null hypothesis will be rejected if 6 or more of 23 patients are progression-free at 3 months. This design yields a type I error rate of 2.5% and power of 80% when the true percentage of patients progression-free at 3 months is 35%.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arizona Oncology Associates, PC-HOPE, Tucson, Arizona, United States
Ochsner Clinic Foundation, Los Angeles, California, United States
University of Colorado Cancer Center, Aurora, Colorado, United States
Medical Oncology Hematology Consultants, PA, Newark, Delaware, United States
Illinois Cancer Specialists, Arlington Heights, Illinois, United States
University of Michigan hospital, Ann Arbor, Michigan, United States
Minnesota oncology Hematology, P.A., Minneapolis, Minnesota, United States
James D Sanchez, Henderson, Nevada, United States
Oncology Hematology Care, Inc., Cincinnati, Ohio, United States
Texas Oncology-Austin Midtown, Austin, Texas, United States
Mary Crowley Medical Research Center, Dallas, Texas, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
Texas Oncology-McAllen South Second Street, McAllen, Texas, United States
Texas Oncology- McKinney, McKinney, Texas, United States
Texas Oncology-San Antonio Northeast, San Antonio, Texas, United States
Baylor Scott & White Medical Center, Temple, Texas, United States
Texas Oncology-Northeast Texas, Tyler, Texas, United States
Virginia Cancer Specialists, PC, Arrington, Virginia, United States
Northwest Medical Specialties, Tacoma, Washington, United States
Northwest Cancer Specialists, P.C., Vancouver, Washington, United States
Contact Details
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