NCT04953962

Study of CBP501/Cisplatin/Nivolumab Combinations in Advanced Pancreatic Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: CanBas Co. Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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%.

Conditions

• Pancreatic Cancer Stage IV

Interventions

Type	Name	Description
DRUG	CBP501 (16)	16 mg/m2
DRUG	CBP501 (25)	25 mg/m2
DRUG	Cisplatin	60mg/m2
DRUG	Nivolumab	240 mg

Timeline

• Start date: 2021-12-18
• Primary completion: 2023-04-14
• Completion: 2023-04-14
• First posted: 2021-07-08
• Last updated: 2023-08-15

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated drug study