Study of Pembrolizumab and Olaparib in Bile Duct Cancer

Cholangiocarcinoma Clinical Trial

Official title: A Phase II, Single-arm Study of Combination Pembrolizumab and Olaparib in the Treatment of Patients With Advanced Cholangiocarcinoma

Status Active, not recruiting

Clinical Trial Summary

The investigators propose an open label, one-arm study to assess the safety and efficacy of olaparib and pembrolizumab in patients with cholangiocarcinoma who have progressed on or cannot tolerate gemcitabine-based therapy.

Clinical Trial Description

The primary objective of the study is to assess the ORR of patients with advanced cholangiocarcinoma receiving a combination of pembrolizumab and olaparib. It is hypothesized that the addition of olaparib will improve the response rate of second line systemic therapy from 17.5% to 35% in patients with advanced cholangiocarcinoma.

The study is designed to enroll 33 subjects (for 85% power) with advanced stage cholangiocarcinoma to test the hypothesis that the combination of olaparib and pembrolizumab will increase the ORR in comparison with the ORR from second line systemic chemotherapy (historical control) in this patient population. As the primary study endpoint, which is also being used to determine the sample size of the study, the investigators propose that the combination of olaparib and pembrolizumab will increase the ORR to 35% from 17.5% (achieved with systemic cytotoxic chemotherapy including mFOLFOX-historical control). To allow a 10% patient drop off rate, the investigators expect to enroll a total of 36 subjects into this study. In addition, as secondary study endpoints the investigators expect to see an increase in the PFS and OS of patients receiving combination therapy compared to cytotoxic chemotherapy.

In this study, the investigators propose the collection of three biopsies-one at baseline prior to the start of treatment, one at the beginning of week 4, three weeks after the administration of combination olaparib and pembrolizumab, and one at the time of cancer progression-for the elucidation of exploratory study endpoints. Patients will have a CT or MRI scan at the beginning of treatment and then every 6 weeks thereafter for the first six months of study treatment administration, then every 9 weeks for up to 12 months after the start of treatment, followed by every 12 weeks up to 24 months on study. All patients will continue to receive olaparib and pembrolizumab combination treatment as tolerated unless unacceptable toxicities or cancer progression occur, at which time therapy will cease. In the absence of any problems, the planned study duration is 20-36 months. ;

Related Conditions & MeSH terms

• Cholangiocarcinoma

• NCT number: NCT04306367
• Study type: Interventional
• Source: Georgetown University
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: April 1, 2020
• Completion date: December 1, 2023