MS200647_0055_Gemcitabine Plus Cisplatin with or without M7824
Research type
Research Study
Full title
A Phase II/III, Multicenter, Randomized, Placebo-controlled Study of Gemcitabine Plus Cisplatin With or Without M7824 (bintrafusp alfa) as First-line Treatment of Biliary Tract Cancer
IRAS ID
271310
Contact name
John Bridgewater
Contact email
Sponsor organisation
Merck Healthcare KGaA
Eudract number
2019-001992-35
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
3 years, 8 months, 24 days
Research summary
This is a phase 2/3, multicentre, randomised, placebo-controlled Study of
gemcitabine plus cisplatin with or without M7824 (bintrafusp alfa) as first-line treatment of Biliary Tract Cancer (BTC).People diagnosed with different types of BTC:
• intrahepatic cholangiocarcinoma (CCA), cancer that develops in the cells within the bile ducts inside the liver
• extrahepatic CCA, cancer that develops in the cells within the bile ducts outside the liver
• gallbladder cancer
• ampullary cancer (ampulla of Vater’s cancer).The study consists of two parts;
Part 1 - an open-label, safety run-in part. 12 – 24 patients will take part in Part 1.
Part 2 - a randomised, double-blind, placebo-controlled Phase II/III part.150 to 500 participants will join Part 2 of the study, depending on the outcome of the result analysed by an Independent Data Monitoring Committee (IDMC). Data will be analysed after 150 patients, when 80 progression-free survival (PFS) events have occurred.
A total of about 512 to 524 people will participate in the study, conducted in Asia, Europe, South America, and the United States.
The study will last approx. until 2023.Key Inclusion and Exclusion criteria:
Inclusion:
• Patients aged ≥ 18 years of age at the time of signing the informed consent.
• Participants with histologically or cytologically confirmed locally advanced or metastatic BTC, including intrahepatic CCA and extrahepatic CCA, gallbladder cancer and ampulla of Vater's cancer.
• Naïve to chemotherapy, immunotherapy, and interventional radiological treatment (transaortic chemo-embolization, transaortic embolization, transaortic infusion) for locally advanced or metastatic BTC. Participants whose disease has recurred ≥ 6 months after completion of neoadjuvant or adjuvant treatments will be considered eligible.Exclusion:
• Previous and/or intercurrent cancers. With the exception of: curatively-treated cancers with no recurrence in > 3 years or early cancers treated with curative intent, including but not limited to cervical carcinoma in situ, superficial, noninvasive bladder cancer, basal cell
carcinoma, squamous cell carcinoma in situ, or endoscopically resected gastrointestinal cancers limited in mucosal layer.
• Rapid clinical deterioration not related to malignancy which, in the opinion of the Investigator, may predispose to inability to tolerate treatment or study procedures.
• Participants with symptomatic central nervous system (CNS) metastases are excluded. Participants with a history of treated CNS metastases (by surgery or radiation therapy) are not eligible unless they are judged to have fully recovered from treatment.REC name
London - City & East Research Ethics Committee
REC reference
19/LO/1851
Date of REC Opinion
19 Dec 2019
REC opinion
Favourable Opinion