Cholangiocarcinoma Clinical Trial
Official title:
Phase II Study of the Combination of Durvalumab (MEDI4736) (PDL1 Inhibitor) and Olaparib (PARP Inhibitor) in Advanced Cholangiocarcinoma After Initial Chemotherapy and Durvalumab (BIL-PPP)
The aim of this study is to investigate whether the combination of durvalumab and olaparib in the maintenance setting after initial chemotherapy and durvalumab will benefit patients with locally advanced or metastatic cholangiocarcinoma.
The primary objectives are (i) To describe the efficacy of PARPi and PDL1 inhibition in the maintenance setting of metastatic cholangiocarcinomas. (ii) To refine selection of the patient population who are most likely to benefit from the combination of PDL1 (Durvalumab) and PARP (Olaparib) inhibition in the maintenance setting following initial chemotherapy (cisplatin + gemcitabine + Durvalumab) (post hoc translational analysis). The secondary objectives are (i) To evaluate toxicity of the combination of durvalumab and olaparib. (ii) To evaluate progression-free and overall survival with the combination of durvalumab and olaparib (PFS, OS). ;
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