RecruitingPhase 2NCT06441747

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)

Sponsor

Australasian Gastro-Intestinal Trials Group

Enrollment

40 participants

Start Date

Sep 23, 2024

Study Type

INTERVENTIONAL

Conditions

Cholangiocarcinoma

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two targeted drugs — durvalumab (an immunotherapy) and olaparib (a PARP inhibitor that blocks cancer cell DNA repair) — for people with advanced bile duct cancer (cholangiocarcinoma) that has not gotten worse during or after initial chemotherapy with durvalumab. **You may be eligible if...** - You are 18 years old or older and weigh more than 30 kg - You have confirmed advanced or metastatic cholangiocarcinoma (bile duct cancer) - Your cancer did not progress after 6–8 cycles of gemcitabine, cisplatin, and durvalumab chemotherapy - You have at least one measurable tumor lesion **You may NOT be eligible if...** - Your cancer progressed during or after initial chemotherapy - You have had previous PARP inhibitor treatment - You have significant autoimmune disease or organ dysfunction - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGDurvalumab

Durvalumab will be administered at a dose of 1500mg intravenously every 4 weeks.

DRUGOlaparib

Olaparib is administered at a dose of 300mg bd in a continuous 28-day cycle. On day 1 of each cycle, the morning dose of Olaparib should be taken no more than 1 hour prior to infusion of durvalumab. It is expected that patients will receive up to 24 months of a combination of olaparib and durvalumab, or until disease progression, unacceptable toxicities, or withdrawal of consent.