Actively Recruiting
An Early Access Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma
Led by Servier Affaires Médicales · Updated on 2026-02-19
220
Participants Needed
84
Research Sites
239 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
An Early Access Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of nonresectable or metastatic Cholangiocarcinoma (CCA), not eligible for curative-intent resection, transplantation, or ablative therapies
- Documented IDH1 R132C, R132L, R132G, R132H, or R132S gene-mutated disease
- Have tried at least 1 prior type of systemic therapy for CCA and recovered from side effects
- Female patients of childbearing potential must have a negative pregnancy test before treatment and agree to use 2 forms of contraception during and 1 month after treatment
- Male patients with female partners of childbearing potential must agree to use 2 forms of contraception during and 1 month after treatment
You will not qualify if you...
- Received a prior IDH1 inhibitor
- Have received a transplant
- Received systemic cancer treatment or radiotherapy within 2 weeks prior to Day 1 of Cycle 1
- Received hepatic radiation, chemoembolization, or radiofrequency ablation within 4 weeks prior to Day 1 of Cycle 1
- Have ongoing brain metastases requiring steroids
- Underwent major surgery within 4 weeks prior to Day 1 of Cycle 1
- Have active hepatitis B or C infections, positive HIV antibody, or AIDS-related illness
- Are pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 84 locations
1
Erebouni MC
Yerevan, Armenia
Completed
2
National Center of Oncology of Ra M
Yerevan, Armenia
Completed
3
Royal brisbane & Women's Hospital
Brisbane, Australia
Completed
4
St Vincent's Hospital
Fitzroy, Australia
Completed
5
St John of God Hospital - Bendat Family Comprehensive Cancer Centre (BFCCC)
Subiaco, Australia
Completed
6
Kinghorn Cancer Centre
Sydney, Australia
Completed
7
The Queen Elizabeth Hospital
Woodville, Australia
Completed
8
Medizinische Universitaet Graz
Graz, Austria
Completed
9
Ordensklinikum Linz GmbH
Linz, Austria
Completed
10
Universitaetsklinik fuer Innere Medizin III, mit Hämatologie, internistischer Onkologie, Hämostaseologie, Infektiologie, Rheumatologie und Onkologisches Zentrum
Salzburg, Austria
Completed
11
Medizinische Universitaet Wien Universitaetsklinik fuer Innere Medizin I
Vienna, Austria
Completed
12
Universite Libre de Bruxelles ULB -
Brussels, Belgium
Completed
13
Universitair Ziekenhuis Gent UZ Gent
Ghent, Belgium
Completed
14
UZ Leuven
Leuven, Belgium
Completed
15
Cliniques Univ St Luc - Gastro-Enterology
Woluwe-Saint-Lambert, Belgium
Completed
16
Tom Baker Cancer Center
Calgary, Canada
Completed
17
NSHA, QEII Health Sciences Centre
Halifax, Canada
Completed
18
London Regional Cancer Program
London, Canada
Completed
19
Princess Margaret Cancer Center
Toronto, Canada
Completed
20
Sunnybrook Health Sciences Centre
Toronto, Canada
Completed
21
Hôpital Privé Jean Mermoz
Lyon, France
Completed
22
Hopital de la Timone
Marseille, France
Completed
23
CHU Montpellier
Montpellier, France
Completed
24
Centre Hospitalier Universitaire de Nantes CHU de Nantes
Nantes, France
Completed
25
Institute Mutualiste Montsouris
Paris, France
Completed
26
CHU Bordeaux, Hôpital Haut-Lévêque
Pessac, France
Completed
27
CHU de Poitiers
Poitiers, France
Completed
28
Charite Universittsmedizin Berlin
Berlin, Germany
Completed
29
Universitaetsklinikum Carl-Gustav-Carus
Dresden, Germany
Completed
30
Klinik für Gastroenterologie, Hepatologie und Infektiologie Universitätsklinikum Düsseldorf
Düsseldorf, Germany, 40225
Completed
31
Universitaetsklinikum Frankfurt
Frankfurt, Germany
Completed
32
Medizinische Fakultaet der Universitaet Freiburg
Freiburg im Breisgau, Germany
Completed
33
Medizinische Hochschule Hannover
Hanover, Germany
Completed
34
Klinikum der Universitaet Muenchen-Grosshadern
München, Germany
Completed
35
Cork University Hospital
Cork, Ireland
Completed
36
St. James Hospital
Dublin, Ireland
Completed
37
St. Vincent's Private Hospital
Dublin, Ireland
Completed
38
Policlinico S. Orsola-Malpighi
Bologna, Italy
Completed
39
AOU Careggi
Florence, Italy
Completed
40
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
Completed
41
Ospedale San Raffaele
Milan, Italy
Completed
42
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Naples, Italy
Completed
43
IRCCS Arcispedale Santa Maria Nuova
Reggio Emilia, Italy
Completed
44
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy
Completed
45
Humanitas Research Hospital
Rozzano, Italy
Completed
46
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale Casa Sollievo della Sofferenza (CSS)
San Giovanni Rotondo, Italy
Completed
47
A.O.U. Città della Salute e della Scienza di Torino
Turin, Italy
Completed
48
AOUI Verona - Ospedale Borgo Roma
Verona, Italy
Completed
49
Kanagawa Cancer Center
Kanagawa, Japan
Actively Recruiting
50
Kumamoto University hospital
Kumamoto, Japan
Actively Recruiting
51
Shikoku Cancer Center
Matsuyama, Japan
Actively Recruiting
52
Osaka International Cancer Institution
Osaka, Japan
Actively Recruiting
53
Hokkaido University Hospital
Sapporo, Japan
Actively Recruiting
54
National Cancer Center Hospital
Tokyo, Japan
Actively Recruiting
55
Amsterdam UMC, location AMC
Amsterdam, Netherlands
Completed
56
Universiteit Maastricht UM - Maastricht University Medical Centre MUMC
Limburg, Netherlands
Completed
57
Institutul Clinic Fundeni
Bucharest, Romania
Completed
58
Regional Institute of Gastroenterology and Hepatology
Cluj-Napoca, Romania
Completed
59
Centrul de Oncologie Sfantu Necta
Craiova, Romania
Completed
60
Radiotherapy Center Cluj
Otopeni, Romania
Completed
61
Municipal Hospital Ploiesti
Ploieşti, Romania
Completed
62
CHA Bundang Medical Center
Seongnam, South Korea
Completed
63
Asan Medical Center
Seoul, South Korea
Completed
64
Samsung Medical Center
Seoul, South Korea
Completed
65
Seoul National University
Seoul, South Korea
Completed
66
Yonsei University Health System
Seoul, South Korea
Completed
67
Complejo Hospitalario Universitario A Coruña (CHUAC)
A Coruña, Spain
Completed
68
Hospital Universitari Vall d'Hebron/Vall Hebron Institute of Oncology (VHIO)
Barcelona, Spain
Completed
69
Hospital Universitario Reina Sofa
Córdoba, Spain
Completed
70
Hospital General de Elche
Elche, Spain
Completed
71
Hospital General Universitario Gregorio Maranon
Madrid, Spain
Completed
72
Hospital Universitario 12 de octubre
Madrid, Spain
Completed
73
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
Completed
74
Hospital Universitario HM Sanchinarro
Madrid, Spain
Completed
75
Hospital Universitario de Navarra
Pamplona, Spain
Completed
76
Hospital Universitario Marqués de Valdecilla
Santander, Spain
Completed
77
Sahlgrenska University Hospital
Gothenburg, Sweden
Completed
78
Karolinska University Hospital
Stockholm, Sweden
Completed
79
University Hospitals Birmingham (UHB) NHS Foundation Trust - Queen Elizabeth Hospital Birmingham (QEHB)
Birmingham, United Kingdom
Completed
80
The Beatson Institute West of Scotland Cancer Research
Glasgow, United Kingdom
Completed
81
Imperial College London
London, United Kingdom
Completed
82
University College London Hospital NHS Trust
London, United Kingdom
Completed
83
The Christie NHS Foundation Trust
Manchester, United Kingdom
Completed
84
The Newcastle Upon Tyne Hospitals
Newcastle upon Tyne, United Kingdom
Completed
Research Team
I
Institut de Recherches Internationales Servier, Clinical Studies Department
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here