Ivosidenib Plus Durvalumab and Gemcitabine/Cisplatin as First-Line Therapy in Participants With Locally Advanced or Metastatic Cholangiocarcinoma With an IDH1 Mutation

Recruiting Phase 1 Phase 2 Interventional Study
Locally Advanced, Unresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
52 (estimated)
Sponsor
Institut de Recherches Internationales Servier · Other
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About This Trial
The objective of this study is to investigate the safety, tolerability and preliminary activity of ivosidenib in combination with durvalumab and gemcitabine/cisplatin as first-line therapy in participants with locally advanced, unresectable or metastatic cholangiocarcinoma with an IDH1 mutation. The study will begin with a safety lead-in phase (Phase 1b study) to determine the recommended combinat…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Have a histopathological confirmed diagnosis consistent with locally advanced unresectable or metastatic cholangiocarcinoma. * Have documented IDH1 gene-mutated cholangiocarcinoma based on local or central laboratory testing (R132C/L/G/H/S mutation variants tested). * Have at …
Contacts

Institut de Recherches Internationales Servier (I.R.I.S.) Clinical Studies Department

+33 1 55 72 60 00

scientificinformation@servier.com

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