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New hope for rare bile duct cancer: targeted pill shows promise in Late-Stage trial

NCT ID NCT05876754

Disease control Sponsor: Servier Affaires Médicales Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

This study tests a daily pill called ivosidenib in 220 adults with advanced bile duct cancer that has a specific IDH1 gene mutation and has not responded to prior treatment. The goal is to confirm the drug's safety and effectiveness. Participants take the tablet once daily in 28-day cycles as long as they benefit and tolerate it.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ivosidenib (oral tablet)
What this could lead to
If successful, this could provide a treatment option for people with a specific genetic form of advanced bile duct cancer that has not responded to other therapies.
What could go wrong
This is an early-access study, not a final approval trial. Side effects like heart rhythm changes or other adverse events may occur, and the drug may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

299 people

The number who actually took part.

Started

May 2023

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosis of nonresectable or metastatic Cholangiocarcinoma (CCA), not eligible for curative-intent resection, transplantation, or ablative therapies * Have a documented IDH1 R132C, R132L, R132G, R132H, or R132S gene-mutated disease * Have tried at least 1 prior type of systemic therapy for CCA, and have recovered from any side effects * Female patients of childbearing potential must have a negative blood pregnancy test prior to starting treatment and must agree to use 2 forms of contraception from the time they enroll to 1 month after their last dose of study drug * Male patients with a female partner with childbearing potential must also agree to use 2 forms of contraception from the time they enroll to 1 month after their last dose of study drug Exclusion Criteria: * Received a prior IDH1 inhibitor * Have received a transplant * Have received systemic cancer treatment or radiotherapy within 2 weeks prior to Day 1 of Cycle 1 * Have received hepatic radiation, chemoembolization, and radiofrequency ablation within 4 weeks prior to Day 1 of Cycle 1 * Have ongoing brain metastases requiring steroids * Have underwent major surgery within 4 weeks of Day 1 of Cycle 1 prior to C1D1 * Have an active hepatitis B (HBV) or hepatitis C (HCV) infections, known positive human immunodeficiency virus (HIV) antibody results, or acquired immunodeficiency syndrome (AIDS) related illness * Are pregnant or breastfeeding

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Conditions

The condition(s) this trial relates to.

cholangiocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cholangiocarcinoma

Contacts and locations

Locations

  • A.O.U. Città della Salute e della Scienza di Torino

    Turin, Italy

  • AOU Careggi

    Florence, Italy

  • AOUI Verona - Ospedale Borgo Roma

    Verona, Italy

  • Amsterdam UMC, location AMC

    Amsterdam, Netherlands

  • Asan Medical Center

    Seoul, South Korea

  • CHA Bundang Medical Center

    Seongnam, South Korea

  • CHU Bordeaux, Hôpital Haut-Lévêque

    Pessac, France

  • CHU Montpellier

    Montpellier, France

  • CHU de Poitiers

    Poitiers, France

  • Centre Hospitalier Universitaire de Nantes CHU de Nantes

    Nantes, France

  • Centrul de Oncologie Sfantu Necta

    Craiova, Romania

  • Charite Universittsmedizin Berlin

    Berlin, Germany

  • Cliniques Univ St Luc - Gastro-Enterology

    Woluwe-Saint-Lambert, Belgium

  • Complejo Hospitalario Universitario A Coruña (CHUAC)

    A Coruña, Spain

  • Cork University Hospital

    Cork, Ireland

  • Erebouni MC

    Yerevan, Armenia

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, Italy

  • Hokkaido University Hospital

    Sapporo, Japan

  • Hopital de la Timone

    Marseille, France

  • Hospital General Universitario Gregorio Maranon

    Madrid, Spain

  • Hospital General de Elche

    Elche, Spain

  • Hospital Universitari Vall d'Hebron/Vall Hebron Institute of Oncology (VHIO)

    Barcelona, Spain

  • Hospital Universitario 12 de octubre

    Madrid, Spain

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, Spain

  • Hospital Universitario HM Sanchinarro

    Madrid, Spain

  • Hospital Universitario Marqués de Valdecilla

    Santander, Spain

  • Hospital Universitario Reina Sofa

    Córdoba, Spain

  • Hospital Universitario de Navarra

    Pamplona, Spain

  • Humanitas Research Hospital

    Rozzano, Italy

  • Hôpital Privé Jean Mermoz

    Lyon, France

  • IRCCS Arcispedale Santa Maria Nuova

    Reggio Emilia, Italy

  • Imperial College London

    London, United Kingdom

  • Institute Mutualiste Montsouris

    Paris, France

  • Institutul Clinic Fundeni

    Bucharest, Romania

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale

    Naples, Italy

  • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale Casa Sollievo della Sofferenza (CSS)

    San Giovanni Rotondo, Italy

  • Kanagawa Cancer Center

    Kanagawa, Japan

  • Karolinska University Hospital

    Stockholm, Sweden

  • Kinghorn Cancer Centre

    Sydney, Australia

  • Klinik für Gastroenterologie, Hepatologie und Infektiologie Universitätsklinikum Düsseldorf

    Düsseldorf, 40225, Germany

  • Klinikum der Universitaet Muenchen-Grosshadern

    München, Germany

  • Kumamoto University hospital

    Kumamoto, Japan

  • London Regional Cancer Program

    London, Canada

  • Medizinische Fakultaet der Universitaet Freiburg

    Freiburg im Breisgau, Germany

  • Medizinische Hochschule Hannover

    Hanover, Germany

  • Medizinische Universitaet Graz

    Graz, Austria

  • Medizinische Universitaet Wien Universitaetsklinik fuer Innere Medizin I

    Vienna, Austria

  • Municipal Hospital Ploiesti

    Ploieşti, Romania

  • NSHA, QEII Health Sciences Centre

    Halifax, Canada

  • National Cancer Center Hospital

    Tokyo, Japan

  • National Center of Oncology of Ra M

    Yerevan, Armenia

  • Ordensklinikum Linz GmbH

    Linz, Austria

  • Osaka International Cancer Institution

    Osaka, Japan

  • Ospedale San Raffaele

    Milan, Italy

  • Policlinico S. Orsola-Malpighi

    Bologna, Italy

  • Princess Margaret Cancer Center

    Toronto, Canada

  • Radiotherapy Center Cluj

    Otopeni, Romania

  • Regional Institute of Gastroenterology and Hepatology

    Cluj-Napoca, Romania

  • Royal brisbane & Women's Hospital

    Brisbane, Australia

  • Sahlgrenska University Hospital

    Gothenburg, Sweden

  • Samsung Medical Center

    Seoul, South Korea

  • Seoul National University

    Seoul, South Korea

  • Shikoku Cancer Center

    Matsuyama, Japan

  • St John of God Hospital - Bendat Family Comprehensive Cancer Centre (BFCCC)

    Subiaco, Australia

  • St Vincent's Hospital

    Fitzroy, Australia

  • St. James Hospital

    Dublin, Ireland

  • St. Vincent's Private Hospital

    Dublin, Ireland

  • Sunnybrook Health Sciences Centre

    Toronto, Canada

  • The Beatson Institute West of Scotland Cancer Research

    Glasgow, United Kingdom

  • The Christie NHS Foundation Trust

    Manchester, United Kingdom

  • The Newcastle Upon Tyne Hospitals

    Newcastle upon Tyne, United Kingdom

  • The Queen Elizabeth Hospital

    Woodville, Australia

  • Tom Baker Cancer Center

    Calgary, Canada

  • UZ Leuven

    Leuven, Belgium

  • Universitaetsklinik fuer Innere Medizin III, mit Hämatologie, internistischer Onkologie, Hämostaseologie, Infektiologie, Rheumatologie und Onkologisches Zentrum

    Salzburg, Austria

  • Universitaetsklinikum Carl-Gustav-Carus

    Dresden, Germany

  • Universitaetsklinikum Frankfurt

    Frankfurt, Germany

  • Universitair Ziekenhuis Gent UZ Gent

    Ghent, Belgium

  • Universite Libre de Bruxelles ULB -

    Brussels, Belgium

  • Universiteit Maastricht UM - Maastricht University Medical Centre MUMC

    Limburg, Netherlands

  • University College London Hospital NHS Trust

    London, United Kingdom

  • University Hospitals Birmingham (UHB) NHS Foundation Trust - Queen Elizabeth Hospital Birmingham (QEHB)

    Birmingham, United Kingdom

  • Yonsei University Health System

    Seoul, South Korea

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Other studies related to the condition(s) this trial covers.