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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)

NCT06441747 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-05-06

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Durvalumab

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

DRUG

Olaparib

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.

Sponsors & Collaborators

  • Wayne Elphinstone Research Fund

    collaborator UNKNOWN

  • AstraZeneca

    collaborator INDUSTRY

  • Australasian Gastro-Intestinal Trials Group

    lead NETWORK

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-23
Primary Completion
2026-08-31
Completion
2028-08-31

Countries

  • Australia

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06441747 on ClinicalTrials.gov