# ClarIDHy

Source: https://onco.cc/trials/claridhy/  
OnCo record `claridhy` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The first randomised trial of a targeted drug in bile duct cancer; it slowed the disease without shrinking it.

## Summary

ClarIDHy, trial NCT02989857 sponsored by Agios, now Servier, and reported in 2020, was the first randomised trial of a targeted drug in bile duct cancer, testing ivosidenib against placebo in previously treated IDH1-mutant cholangiocarcinoma. It randomised 187 patients, met its primary progression-free survival endpoint with a large relative effect, and showed an overall survival benefit once adjusted for crossover, but the response rate was only about two percent, so it slowed the disease without shrinking it. OnCo links it to biliary tract cancer, IDH1 and IDH2 as targets, ivosidenib and Ghassan K. Abou-Alfa. Whether a drug that stabilises rather than shrinks tumours is worth its cost in a setting with few alternatives is the open question.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT02989857
- Phase: 3
- Setting: Previously treated IDH1-mutant cholangiocarcinoma: ivosidenib vs placebo
- Sponsor: Agios (now Servier)
- Enrolled: 187
- Result: PFS HR 0.37; crossover-adjusted OS HR 0.49.
- Outcomes: Progression-free survival: Ivosidenib 2.7 months vs Placebo 1.4 months, HR 0.37; Overall survival (crossover-adjusted): Ivosidenib 10.3 months vs Placebo 7.5 months, HR 0.49

## Notes

- Gallbladder cancer: 91 percent of ClarIDHy patients had intrahepatic cholangiocarcinoma and 92 percent had metastatic disease (Tibsovo label); IDH1 mutation is an intrahepatic feature and the trial gives no gallbladder evidence.

## Sources

- ClinicalTrials.gov NCT02989857: https://clinicaltrials.gov/study/NCT02989857
- Tibsovo label (openFDA): ClarIDHy baseline characteristics: https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22TIBSOVO%22

## Connected records

- cancers: [Biliary tract cancer (cholangiocarcinoma)](https://onco.cc/cancers/cholangiocarcinoma/), [Intrahepatic cholangiocarcinoma](https://onco.cc/cancers/intrahepatic-cholangiocarcinoma/)
- technologies: [Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET)](https://onco.cc/technologies/epigenetic-drugs/), [IDH inhibitors](https://onco.cc/technologies/idh-inhibitors/), [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- targets: [IDH1 / IDH2](https://onco.cc/targets/idh/)
- drugs: [Ivosidenib](https://onco.cc/drugs/ivosidenib/)
- people: [Ghassan K. Abou-Alfa](https://onco.cc/people/ghassan-abou-alfa/)
- terms: [Crossover in trials](https://onco.cc/terms/crossover/)
- roadmaps: [Epigenetic therapy roadmap: loosening silenced genes → mutation-specific enzymes → editing the epigenome](https://onco.cc/roadmaps/epigenetics-roadmap/)

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JSON: https://onco.cc/api/v1/entities/claridhy.json