An Early Access Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma (NCT05876754)
An Open-Label Early Access Phase 3b Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma
🩺 Plain-English Summary (8th-Grade Level)
A 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.
Who can join: Review the eligibility criteria below.
Location: Erebouni MC — Yerevan
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (84 Sites)
Showing the first 25 of 84 sites.
- Erebouni MC — Yerevan,
- National Center of Oncology of Ra M — Yerevan,
- Royal brisbane & Women's Hospital — Brisbane,
- St Vincent's Hospital — Fitzroy,
- St John of God Hospital - Bendat Family Comprehensive Cancer Centre (BFCCC) — Subiaco,
- Kinghorn Cancer Centre — Sydney,
- The Queen Elizabeth Hospital — Woodville,
- Medizinische Universitaet Graz — Graz,
- Ordensklinikum Linz GmbH — Linz,
- Universitaetsklinik fuer Innere Medizin III, mit Hämatologie, internistischer Onkologie, Hämostaseologie, Infektiologie, Rheumatologie und Onkologisches Zentrum — Salzburg,
- Medizinische Universitaet Wien Universitaetsklinik fuer Innere Medizin I — Vienna,
- Universite Libre de Bruxelles ULB - — Brussels,
- Universitair Ziekenhuis Gent UZ Gent — Ghent,
- UZ Leuven — Leuven,
- Cliniques Univ St Luc - Gastro-Enterology — Woluwe-Saint-Lambert,
- Tom Baker Cancer Center — Calgary,
- NSHA, QEII Health Sciences Centre — Halifax,
- London Regional Cancer Program — London,
- Princess Margaret Cancer Center — Toronto,
- Sunnybrook Health Sciences Centre — Toronto,
- Hôpital Privé Jean Mermoz — Lyon,
- Hopital de la Timone — Marseille,
- CHU Montpellier — Montpellier,
- Centre Hospitalier Universitaire de Nantes CHU de Nantes — Nantes,
- Institute Mutualiste Montsouris — Paris,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- [18F]FTT Positron Emission Tomography/Computed Tomography to Predict Treatment Response in Patients Scheduled to Receive Gemcitabine, Cisplatin, and Durvalumab for Newly Diagnosed Cholangiocarcinoma — Seattle, Washington
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.