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OncoMatch/Clinical Trials/NCT05876754

An Early Access Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma

Is NCT05876754 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies Ivosidenib Oral Tablet for cholangiocarcinoma.

Phase 3RecruitingServier Affaires MédicalesNCT05876754Data as of Jun 2026Location: International · 16 countries

Treatment: Ivosidenib Oral TabletA Phase 3b research study to consolidate the data that ivosidenib is safe and effective in adult patients with previously treated, locally advanced, or metastatic cholangiocarcinoma (CCA). All patients who meet inclusion criteria will be enrolled to receive ivosidenib tablets orally once daily for 28 day cycles, continuing as long as clinical benefit and consent for participation is maintained. There will be a minimum of 6 study visits from screening until the final follow-up, if one cycle of treatment is completed and consent is maintained through 18 months of follow-up. Each additional cycle completed will add one study visit, on the first day of each cycle.

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Extracted eligibility criteria

Treatments studied

Other

Ivosidenib Oral Tablet

Cancer type

Cholangiocarcinoma

Biomarker criteria

Required: IDH1 r132c

Required: IDH1 r132g

Required: IDH1 r132h

Required: IDH1 r132l

Required: IDH1 r132s

Prior therapy

Min 1 prior line

Must have received: systemic therapy

Cannot have received: idh1 inhibitor

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT05876754 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior idh1 inhibitor disqualifies patients from enrollment.

Does this trial require IDH1?

Yes, IDH1 r132c is a required biomarker for enrollment.

Does this trial require IDH1?

Yes, IDH1 r132g is a required biomarker for enrollment.

Does this trial require IDH1?

Yes, IDH1 r132h is a required biomarker for enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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