Trials in set up
These are brief descriptions of trials currently in set up. Information will be updated as soon as details are finalised, centres are known and are the trials are starting.
Phase 3 KEYNOTE-966 Trial: Pembrolizumab in Combination With Gemcitabine and Cisplatin for the Treatment of Advanced Biliary Tract Cancer.
This immunotherapy study is a global study of a first-line treatment for patients with advanced disease (metastatic or unresectable) and is randomised pembrolizumab (or placebo) alongside cisplatin and gemcitabine in all patients.
July 2020: This trial is currently open in St Vincent’s University Hospital, Dublin, Ireland, and is expected to open in a number of centres the UK very soon.
A Phase 2 study of neoadjuvant cisplatin and gemcitabine chemotherapy versus upfront surgery in patients with locally advanced/borderline resectable proximal biliary tract cancer.
This study will investigate the possible benefit of neo-adjuvant chemotherapy in those cholangiocarcinoma patients diagnosed with borderline resectability.
For more information see: https://www.lctu.org.uk
FOENIX-CCA3: An open-label, randomized Phase 3 study of futibatinib (TAS-120) versus gemcitabine-cisplatin chemotherapy as first-line treatment for patients with advanced cholangiocarcinoma harbouring fibroblast growth factor receptor 2 gene rearrangements (FOENIX-CCA3)
This study will compare chemotherapy (CisGem) with an FGFR-inhibitor in FGFR2-altered patients and will require prior analysis of a tumour biopsy to determine that there is the appropriate FGFR-alteration
ZW25 (Zanidatamab) is a Phase 2 single-arm, multicenter trial for people with advanced or metastatic HER2-amplified biliary tract cancers.
For more information see: https://clinicaltrials.gov/ct2/show/NCT04466891
July 2020: This trial is expected to open soon in the UK in the following sites:
Royal Free London NHS Foundation Trust
Imperial College Healthcare NHS Trust
The Clatterbridge Cancer Centre NHS Foundation Trust
University College London Hospitals(UCLH)
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