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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 32
- Locations
- 3
- Primary Endpoint
- Proportion of Patients Alive and Without Radiological or Clinical Progression at 4 Months
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 (Drug)
Rucaparib and Nivolumab
Rucaparib 600 mg PO BID days 1-28 Nivolumab 240 mg IV days 1 and 15
Intervention: Nivolumab (Drug)
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)