Ivosidenib, Nivolumab, and Ipilimumab Combination in Previously Treated Patients With Nonresectable or Metastatic IDH1 Mutant Cholangiocarcinoma

Ivosidenib, Nivolumab, and Ipilimumab Combination in Previously Treated Patients With Nonresectable or Metastatic IDH1 Mutant Cholangiocarcinoma

This is a Phase 1/2 study evaluating the safety, tolerability, and activity of the targeted therapy ivosidenib in combination with immunotherapy in patients with nonresectable or metastatic cholangiocarcinoma with an IDH1 mutant. 

The study includes two phases: the safety lead-in phase to determine the recommended combination dose (RCD) of ivosidenib in combination with immunotherapy and the dose expansion phase to assess the efficacy of ivosidenib in combination with immunotherapy. Study treatment will be administered until participant experiences unacceptable toxicity, disease progression, or other discontinuation criteria are met.

The study is currently open and recruiting at:
University College London Hospital

NW1 2PG

And will open soon at:

The Christie Hospital,
Manchester M20 4BX

For more information, see:

https://clinicaltrials.gov/study/NCT05921760


ProvIDHe 

ProvIDHe, an early access Phase 3b study of ivosidenib in patients with pretreated locally advanced or metastatic cholangiocarcinoma.

On 31 January 2024, NICE approved the targeted therapy ivosidenib (TIBSOVO®) for those with cholangiocarcinoma who have an IDH1 mutation, and who have already undergone one other treatment.  To see the full guidance from NICE, click here 

And for more information on targeted therapies, including ivosidenib, see: https://ammf.org.uk/molecular-profiling-targeted-therapies-and-immunotherapy-updates/

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