Phase 2 Study of Maintenance Treatment with Olaparib With or Without Durvalumab for Advanced DNA Damage Repair Gene Mutated Biliary Tract Cancer After Platinum Chemotherapy

What this Trial Is About

Researchers are studying advanced biliary tract cancer in patients whose disease has certain DNA damage repair gene mutations. This trial aims to find out if maintenance treatment with olaparib alone or combined with durvalumab can improve outcomes after patients have completed first-line platinum-based chemotherapy. The study addresses the need for effective maintenance therapies, as current treatments offer limited progression-free survival after initial chemotherapy. Participants will receive one of two treatments olaparib taken twice daily, or olaparib combined with durvalumab given intravenously every four weeks. Both treatments are given over regular cycles. The study is randomized and open-label, comparing the combination therapy against olaparib alone. This phase 2 trial evaluates the safety and effectiveness of these maintenance options for patients with unresectable or metastatic biliary tract cancer. During the study, participants will be monitored through clinical visits to assess treatment effects and side effects, including progression-free survival measured at six months as the primary outcome. Additional outcomes include overall survival, response rates, and toxicity profiles tracked over up to one year. Regular exams and lab tests will help track health status and treatment tolerance. The study lasts until disease progression or unacceptable toxicity, with careful follow-up throughout.

Olaparib With or Without Durvalumab for DDR Gene Mutated Biliary Tract Cancer Following Platinum-based Chemotherapy