Phase II Multi-Center Study of PARP Inhibitor Rucaparib in Combination With Anti-PD-1 Antibody Nivolumab in Patients With Advanced or Metastatic Biliary Tract Cancer Following Platinum Therapy
Overview
- Phase
- Phase 2
- Intervention
- Rucaparib
- Conditions
- Biliary Tract Cancer
- Sponsor
- University of Michigan Rogel Cancer Center
- Enrollment
- 32
- Locations
- 3
- Primary Endpoint
- Proportion of Patients Alive and Without Radiological or Clinical Progression at 4 Months
- Status
- Completed
- Last Updated
- 11 months ago
Overview
Brief Summary
Investigators hypothesize that following first-line platinum based chemotherapy, rucaparib in combination with nivolumab, will improve progression-free survival and overall survival in BTC patients.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Rucaparib and Nivolumab
Rucaparib 600 mg PO BID days 1-28 Nivolumab 240 mg IV days 1 and 15
Intervention: Rucaparib
Rucaparib and Nivolumab
Rucaparib 600 mg PO BID days 1-28 Nivolumab 240 mg IV days 1 and 15
Intervention: Nivolumab
Outcomes
Primary Outcomes
Proportion of Patients Alive and Without Radiological or Clinical Progression at 4 Months
Time Frame: 4 months
Progressive disease is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions (with a minimum absolute increase of 5 mm), taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions. A clinical decision of progression by the site investigator will be based on the subject's overall clinical condition, including performance status, clinical symptoms, and laboratory data.
Secondary Outcomes
- The Proportion of Patients That Respond to Treatment(up 2 years after starting treatment, average of 4 months)
- Progression Free Survival (PFS) Time as Measured From Treatment Start(Up to 2 years)
- Progression Free Survival (PFS) Time as Measured From Start of 1st Line Platinum Therapy(Up to two years post treatment discontinuation)
- Overall Survival (OS) Time as Measured From Treatment Start(Up to two years post treatment discontinuation)
- Overall Survival (OS) Time as Measured From Start of 1st Line Platinum Therapy(Up to two years post treatment discontinuation)