Study Name
Rucaparib in Combination With Nivolumab in Patients With Advanced or Metastatic Biliary Tract Cancer Following Platinum Therapy
ClinicalTrials.gov Identifier (if applicable)
NCT03639935
Clinical Trial Category (check all that apply)
  • First Line Therapy
  • Targeted Therapy
  • Immunotherapy
Study Center
Institution Name
University of Michigan
State
Michigan
Zip Code
48109
Country
United States
List additional Institutions (include address, phone number, and website)
Dana Farber Cancer Institute
Vanderbilt University
Beth Israel Deaconess Medical Center
Study Contacts
Principal Investigator
Vaibhav Sahai
P.I. Phone
(800) 865-1125
P.I. Email
CancerAnswerline@med.umich.edu
Study Coordinator
Dominique Dippman
Study Coordinator Phone
(800) 865-1125
Study Coordinator Email
CancerAnswerline@med.umich.edu
OVERVIEW – in layman’s terms (150 words max)
A combination of PARP inhibitor (daily pill) + immunotherapy (30 min infusion every 2 weeks) in patients with advanced biliary cancer who have not progressed after 4-6 months of first-line chemotherapy (platinum-based).
Enrollment
32
Study Start Date
01/15/2019
Estimated Completion Date
12/31/2021
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items)
  • Improve survival of patients with advanced biliary cancer
  • Provide maintenance therapy with minimal impact on quality of life
Inclusion Criteria – Patients Must:
  • Tissue diagnosis of biliary cancer
  • Must have received 4-6 months of first line platinum-based chemotherapy without progression
  • Prior surgery, liver directed therapies, radiation allowed
  • Must have measurable ds on scans
  • Age >=18 years
  • Liver function adequate (Child-Pugh A or B7)
  • Performance status ECOG 0 or 1
  • Available tissue from cancer
  • Must be able to tolerate CT or MRI scans
  • Adequate organ (kidneys, liver, bone marrow) function
Exclusion Criteria – Patients Must NOT:
  • No diagnosis of autoimmune disorder (with some exceptions)
  • No prior organ transplantation
  • No brain metastasis unless stable and treated
  • No diagnosis of immunodeficiency or immunosuppression (e.g. chronic systemic steroids)
  • No recent surgery <4 weeks from study registration
  • No other cancer (with some exceptions such as skin cancer)
  • No ongoing or uncontrolled infection
  • No live vaccine in past 30 days
  • Must not be pregnant or breast feeding
REQUIRED TESTS PRIOR TO BEGINNING STUDY TREATMENT – in layman’s terms
  • Blood tests, CT or MR scans
POTENTIAL SIDE-EFFECTS – in layman’s terms
  • Tiredness (fatigue)
  • Low blood counts (e.g. anemia)
  • Nausea (usually mild to none)
  • Autoimmune side effects from immunotherapy (e.g. rash, shortness of breath, thyroid dysfunction, elevation of liver enzymes, diarrhea, etc)