Rucaparib in Combination With Nivolumab in Patients With Advanced or Metastatic Biliary Tract Can… (NCT03639935) | Clinical Trial Compass
CompletedPhase 2
Rucaparib in Combination With Nivolumab in Patients With Advanced or Metastatic Biliary Tract Cancer Following Platinum Therapy
United States32 participantsStarted 2019-03-28
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria
* Patients must have a pathologically confirmed adenocarcinoma of the biliary tract (intra-hepatic, extra-hepatic (hilar, distal) or gall bladder) that is not eligible for curative resection, transplantation, or ablative therapies. Tumors of mixed histology are excluded.
* 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 gen…
What they're measuring
1
Proportion of Patients Alive and Without Radiological or Clinical Progression at 4 Months