CWoW - Durvalumab vs. Placebo in Patients with Advanced Biliary Tract Cancer
Research type
Research Study
Full title
A Phase III Randomized, Double-Blind, Placebo-Controlled, Multi-Regional, International Study of Durvalumab in Combination with Gemcitabine plus Cisplatin versus Placebo in Combination with Gemcitabine plus Cisplatin for Patients with First-Line Advanced Biliary Tract Cancers
IRAS ID
261666
Contact name
Maireed McNamara
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2018-004688-30
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 9 months, 16 days
Research summary
The study will be conducted at hospitals with expertise in the treatment of Biliary Tract Cancer across about 15 countries. In order to participate patients must be aged 18 years or above and have Biliary Tract Cancer. Patients will be required to provide a sample of their tumour prior to study entry.
The study involves a screening period and a treatment period. The screening period will last approximately 1 month and may require a few visits to determine whether a patient is eligible to take part in the study. If eligible, patients will be assigned randomly to one of two treatments groups and will come for visits to the hospital for 3-weekly cycles of treatment until their tumour worsens.
Once a patient’s tumour has worsened they will be contacted every 2 months to see how well they are and what treatment they are taking for their cancer, if any.
REC name
North West - Haydock Research Ethics Committee
REC reference
19/NW/0174
Date of REC Opinion
24 May 2019
REC opinion
Further Information Favourable Opinion