Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Cisplatin

Nivolumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

CBP501 25mg/m2 and Cisplatin 60mg/m2 will be administered simultaneously. Nivolumab 240mg will be administered following the completion of CBP501 and cisplatin infusions.

CBP501 16mg/m2 and Cisplatin 60mg/m2 will be administered simultaneously. Nivolumab 240mg will be administered following the completion of CBP501 and cisplatin infusions.

CBP501 25mg/m2 and Cisplatin 60mg/m2 will be administered simultaneously.

Cisplatin 60mg/m2 will be administered as infusion and then Nivolumab 240mg will be administered.

CBP501 (16)

CBP501 (25)

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.

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%.

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

Tumor assessment by RECIST v.1.1 criteria will be performed at screening, every 8 weeks starting after Cycle 1 Day 1, at the End-of-Treatment visit, and every 3 months after the End-of-Treatment visit until disease progression is observed.

Safety will be assessed throughout the study through clinical and laboratory safety evaluations. These include physical examinations, vital sign measurements, 12-lead ECGs, laboratory safety tests (hematology, INR, serum chemistry, serum cardiac markers), and clinical adverse experience monitoring. Adverse events will be evaluated at each visit throughout the study and assigned a grade, defined by NCI-CTCAE version 5.0 criteria, and relationship to study treatment (unrelated, related).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of CBP501/Cisplatin/Nivolumab Combinations in Advanced Pancreatic Cancer	NCT04953962	Pancreatic Canc...	CBP501 (16) CBP501 (25) Cisplatin Nivolumab	18 Years -	CanBas Co. Ltd.
Study of CBP501/Cisplatin/Nivolumab Combinations in Advanced Pancreatic Cancer	NCT04953962	Pancreatic Canc...	CBP501 (16) CBP501 (25) Cisplatin Nivolumab	18 Years -	CanBas Co. Ltd.

Spots Global Cancer Trial Database for cbp501 (16)

Every month we try and update this database with for cbp501 (16) cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cbp501 (16)

Every month we try and update this database with for cbp501 (16) cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cbp501 (16) cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.