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
Study ID
NCT06441747
Phase
PHASE2
Status
Recruiting
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Conditions

  • Cholangiocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    Durvalumab will be administered at a dose of 1500mg intravenously every 4 weeks.
  • Olaparib — DRUG
    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.

Study Details

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.

Key Dates

Start date
Sep 23, 2024
Status verified
May 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Durvalumab and Olaparib
    This is a trial of Durvalumab in combination with olaparib. Durvalumab will be administered at a dose of 1500mg intravenously every 4 weeks. Olaparib will be administered orally at a dose of 300mg twice daily continuously. This combination will be administered for a maximum of two years unless unacceptable toxicities or progressive disease.

Primary Outcome Measure

Primary Objective [ Time Frame: 12 months post randomisation ]

Central Contacts

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