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)

PHASE2RecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

September 23, 2024

Primary Completion Date

August 31, 2026

Study Completion Date

August 31, 2028

Conditions
Cholangiocarcinoma
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.

Trial Locations (8)

2050

RECRUITING

Chris O'Brien Lifehouse, Camperdown

2065

NOT_YET_RECRUITING

Royal North Shore Hospital, St Leonards

2145

NOT_YET_RECRUITING

Westmead Hospital, Westmead

2500

NOT_YET_RECRUITING

Wollongong Hospital, Wollongong

3084

RECRUITING

Austin Health, Melbourne

3168

NOT_YET_RECRUITING

Monash Medical Centre, Clayton

4102

RECRUITING

Princess Alexandra Hospital, Woolloongabba

Unknown

RECRUITING

Flinders Medical Centre, Bedford Park

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Wayne Elphinstone Research Fund

UNKNOWN

collaborator

AstraZeneca

INDUSTRY

lead

Australasian Gastro-Intestinal Trials Group

NETWORK