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

Exclusion Criteria

• •Patients must have received 1st line platinum-based systemic chemotherapy for advanced BTC for 4-6 months without radiologic or clinical progression. Last systemic infusion of 1st line platinum-based therapy may not be more than 4 weeks from study informed consent. Prior peri-operative chemotherapy is permitted provided it was completed \> 6 months from start of platinum-based therapy for advanced disease.
• •Prior surgical resection, radiation, chemoembolization, radioembolization or other local ablative therapies are permitted if completed \> 4 weeks prior to enrollment AND if patient has recovered to \< 1 grade 1 toxicity.
• •Patients must have measurable disease (as per RECISTv1.1) in at least one site not previously treated with radiation or liver directed therapy (including bland, chemo- or radio-embolization, or ablation) either within the liver or in a metastatic site unless the patient has had complete response to 1st line platinum-based therapy.
• •Age≥18 years
• •Child-Pugh score of A or B7 (Scoring system used to assess the prognosis of chronic liver disease, mainly cirrhosis)
• •ECOG performance status of 0-1 (Eastern Cooperative Oncology Group scoring system used to quantify general well-being and activities of daily life; scores range from 0 to 5 where 0 represents perfect health and 5 represents death.)
• •Ability to understand and willingness to sign IRB-approved informed consent
• •Available archived tissue (FFPE block or 20 unstained slides from prior core biopsy or surgery)
• •Must be able to tolerate CT and/or MRI with contrast
• •Adequate organ function obtained ≤ 2 weeks prior to registration
• +12 more criteria