ClarIDHy
In previously treated IDH1-mutant advanced cholangiocarcinoma, does ivosidenib improve progression-free survival compared with placebo?
Trial design and population
Key results
Median PFS 2.7 months with ivosidenib vs 1.4 months with placebo (HR 0.37; 95% CI 0.25–0.54; one-sided p<0.0001). In final OS analysis, median OS was 10.3 vs 7.5 months (ITT HR 0.79; 95% CI 0.56–1.12), with crossover-adjusted analysis supporting benefit.
Source-reported outcome visualization
Median progression-free survival · Median, months
Bars display source-reported values for the named endpoint; where the endpoint is a median, bars compare medians and do not represent probabilities. No unreported rates are inferred.
Absolute Effect
Median PFS difference 1.3 months; this is not a fixed-time absolute risk difference.
NNT: Not quantifiable from median PFS difference. No NNT is derived from median survival/PFS differences.
NNH / harm: Grade ≥3 events were broadly similar; ascites was among the most common. Monitor QTc, electrolytes and drug interactions with ivosidenib.
NNT/NNH are only displayed where the endpoint and time horizon support a defensible absolute-risk calculation. Otherwise, the source-reported outcome is visualized.
Safety and treatment burden
Grade ≥3 events were broadly similar; ascites was among the most common. Monitor QTc, electrolytes and drug interactions with ivosidenib.
Follow-up, maturity and limitations
Molecularly selected population only. Placebo crossover complicates ITT OS interpretation; PFS was the primary endpoint. Small median PFS increment should be interpreted with the HR and tolerability.
Clinical interpretation
Current-practice context · reviewed 20 October 2026
This page separates original trial findings from contemporary treatment context. Confirm current disease-specific guidelines, local regulatory status, biomarker requirements, prior treatment exposure and patient-specific contraindications before applying the evidence. Historical comparators may no longer represent current standard practice; subgroup findings and immature endpoints should not be generalized.