Rucaparib in Combination With Nivolumab in Patients With Advanced or Metastatic Biliary Tract Cancer Following Platinum Therapy

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
University of Michigan Rogel Cancer Center
Study ID
NCT03639935
Phase
PHASE2
Status
Completed

Conditions

  • Biliary Tract Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rucaparib — DRUG
    Rucaparib 600 mg PO BID days 1-28
  • Nivolumab — DRUG
    Nivolumab 240 mg IV days 1 and 15

Study Details

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.

Key Dates

Start date
Mar 28, 2019
Status verified
May 2025
Primary completion
Feb 7, 2023
Completion
Apr 30, 2024

Study Design

Enrollment
32 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Rucaparib and Nivolumab
    Rucaparib 600 mg PO BID days 1-28 Nivolumab 240 mg IV days 1 and 15

Primary Outcome Measure

Proportion of Patients Alive and Without Radiological or Clinical Progression at 4 Months [ Time Frame: 4 months ]

Locations (3)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Rogel Cancer CenterAnn ArborMichigan48109-
Vanderbilt University Medical CenterNashvilleTennessee37232-

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