CBP501, Cisplatin and Nivolumab in Advanced Refractory Tumors
|Study Design:||Intervention Model: Single Group Assignment
Intervention Model Description:
Dose finding cohort plus confirmatory expansion cohortMasking: No masking
Primary Purpose: Treatment
|Official Title:||Phase 1b Clinical Study of CBP501, Cisplatin and Nivolumab Administered Every 3 Weeks in Patients With Advanced Refractory Tumors|
- Recommended dose [ Time Frame: 21 days ]Define the recommended doses (RD) of CBP501, cisplatin and nivolumab when administered in combination once every 21 days in patients with previously treated advanced solid tumors
|Anticipated Study Start Date:||May 2017|
|Estimated Study Completion Date:||March 2019|
|Estimated Primary Completion Date:||December 2018 (Final data collection date for primary outcome measure)|
Experimental: CBP501, CDDP, Nivolumab
CBP501, Cisplatin and Nivolumab Administered Every 3 Weeks in Patients with Advanced Refractory Tumors
CBP501, CDDP plus Nivolumab
This is a multicenter, open-label, phase 1b study of CBP501/cisplatin/nivolumab combination administered once every 21 days to patients with advanced solid tumors. The study will be conducted in two parts.
The first part of the study involves dose-escalation, in which successive cohorts of three patients (expanded to six patients in the event of a dose-limiting toxicity) will receive escalating doses of CBP501 and/or cisplatin until the maximum tolerated dose (MTD) is reached, based on tolerability observed during the first 21 days of treatment.
The second part of the study involves treatment of expansion cohorts of 9 to 12 patients each in specific indications (to be specified by protocol amendment) to confirm the tolerability of treatment at the RD and evaluate evidence of anti-tumor activity in specific indications.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03113188
|Contact: Takumi Kawabe, MDPhDemail@example.com|
|Principal Investigator:||Geoffrey I Shapiro, MD||Dana-Farber Cancer Institute|