Actively Recruiting
Ivosidenib in Participants With Locally Advanced or Metastatic Conventional Chondrosarcoma Untreated or Previously Treated With 1 Systemic Treatment Regimen
Led by Servier Bio-Innovation LLC · Updated on 2026-02-06
136
Participants Needed
114
Research Sites
333 weeks
Total Duration
On this page
Sponsors
S
Servier Bio-Innovation LLC
Lead Sponsor
I
Institut de Recherches Internationales Servier
Collaborating Sponsor
AI-Summary
What this Trial Is About
Study CL3-95031-007 (CHONQUER) is a Phase 3, international, multicenter, double-blind, randomized, placebo-controlled study of orally administered ivosidenib. Participants are required to have a histopathological diagnosis consistent with isocitrate dehydrogenase-1 (IDH1) gene-mutated, locally advanced or metastatic conventional chondrosarcoma Grades 1, 2, or 3 and not eligible for curative resection. IDH1 mutant status will be determined during pre-screening/screening phase. Participant must have radiographic progression/recurrence of disease according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and have received 0 to 1 prior systemic treatment regimen in the advanced/metastatic setting for conventional chondrosarcoma. The primary endpoint is progression-free survival (PFS) in Grades 1 and 2 participants. Key secondary endpoints are PFS in all randomized participants, overall survival (OS) in Grades 1 and 2 participants, and OS in all randomized participants. Participants who meet enrollment criteria will be randomized 1:1 to receive oral ivosidenib 500mg once daily, or a matching placebo once daily.
CONDITIONS
Official Title
Ivosidenib in Participants With Locally Advanced or Metastatic Conventional Chondrosarcoma Untreated or Previously Treated With 1 Systemic Treatment Regimen
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have a histopathological diagnosis of locally advanced or metastatic conventional chondrosarcoma Grades 1, 2, or 3 not eligible for curative resection, confirmed by biopsy within the last 3 years
- Have at least one measurable lesion confirmed by central imaging review using RECIST v1.1
- Have received zero or one prior systemic treatment regimen for advanced or metastatic chondrosarcoma
- Have radiographic progression or recurrence of disease documented by imaging within specified timeframes before randomization
- Have documented IDH1 gene-mutated disease from fresh or recent tumor tissue tested centrally
- Have recovered from effects of any prior cancer treatment including surgery or radiotherapy
You will not qualify if you...
- Unable to swallow oral medication
- Pregnant or lactating women
- Currently participating in another interventional clinical study
- Prior treatment with an IDH1 inhibitor
- Received systemic anticancer therapy less than 2 weeks before randomization (4 weeks for investigational immune therapies)
- Received radiotherapy less than 2 weeks before randomization
- Have symptomatic brain metastases requiring high-dose steroids, or unstable brain metastases
- History of other primary cancers except certain treated or low-risk cancers
- Major surgery within 4 weeks prior to randomization
- Significant active heart disease within 6 months before randomization
- Left ventricular ejection fraction below 40% within 28 days before randomization
- Prolonged QT interval or other risk factors for arrhythmia
- Known history of progressive multifocal leukoencephalopathy (PML)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 114 locations
1
Usc Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
2
Sarcoma Oncology Research Center
Santa Monica, California, United States, 90403
Actively Recruiting
3
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
Actively Recruiting
4
Yale Cancer Center
New Haven, Connecticut, United States, 06511
Actively Recruiting
5
Mayo Clinic - Jacksonville, Fl
Jacksonville, Florida, United States, 32224
Actively Recruiting
6
University of Miami
Miami, Florida, United States, 33136-1002
Actively Recruiting
7
Emory Winship Cancer Institute
Atlanta, Georgia, United States, 30308
Actively Recruiting
8
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, United States, 60611-5975
Actively Recruiting
9
University of Iowa Hospitals & Clinics- Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242
Actively Recruiting
10
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Actively Recruiting
11
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
12
Mayo Clinic - Rochester, Mn
Rochester, Minnesota, United States, 55905
Actively Recruiting
13
The Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
14
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68118
Actively Recruiting
15
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
16
Duke University
Durham, North Carolina, United States, 27710
Actively Recruiting
17
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
18
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
19
Oregon Health & Science University Knight Cancer Institute
Portland, Oregon, United States, 97239
Actively Recruiting
20
University of Pittsburgh Medical Center-Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
21
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
22
The Univeristy of Texas Md Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
23
Flinders Medical Centre
Bedford Park, Australia, 5042
Actively Recruiting
24
Chris O'Brien Lifehouse
Camperdown, Australia, 2050
Not Yet Recruiting
25
Chris O'Brien Lifehouse
Camperdown, Australia, 2050
Actively Recruiting
26
St Vincent'S Hospital Melbourne
Fitzroy, Australia, 3065
Actively Recruiting
27
Sir Charles Gairdner Hospital
Nedlands, Australia, 6009
Actively Recruiting
28
Princess Alexandra Hospital
Woolloongabba, Australia, 4102
Actively Recruiting
29
Cliniques Universitaires St. Luc
Brussels, Belgium, 1200
Actively Recruiting
30
U.Z. Gent
Ghent, Belgium, 9000
Actively Recruiting
31
Centre Multidisciplinaire de Oncologie Medicale
Liège, Belgium, 4000
Actively Recruiting
32
Liga Norte Riograndense Contra O Cancer
Natal, Rio Grande do Norte, Brazil, 59062-000
Actively Recruiting
33
Hospital de Amor - Barretos
Barretos, Brazil, 14784-400
Actively Recruiting
34
Hospital Das Clínicas Da Ufmg
Belo Horizonte, Brazil, 30130-100
Actively Recruiting
35
CIONC
Curitiba, Brazil, 80810-050
Actively Recruiting
36
Cepon - Centro de Pesquisas Oncologicas
Florianópolis, Brazil, 88034-000
Actively Recruiting
37
Fundação Amaral Carvalho - Jaú/ Sp
Jaú, Brazil, 17210-080
Actively Recruiting
38
Instituto Nacional Do Câncer - Inca
Rio de Janeiro, Brazil, 20220-410
Actively Recruiting
39
Icesp - Instituto Do Câncer Do Estado de São Paulo
São Paulo, Brazil, 01246-000
Actively Recruiting
40
Impar Serviços Hospitalares S.A. - Hospital Nove de Julho
São Paulo, Brazil, 01409-902
Actively Recruiting
41
Hospital A C Camargo
São Paulo, Brazil, 01509-010
Actively Recruiting
42
Hospital Albert Einstein
São Paulo, Brazil, 05652-900
Actively Recruiting
43
Alberta Health Services
Calgary, Alberta, Canada, T2N-5G2
Actively Recruiting
44
University Health Network
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
45
Muhc Glen Site
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
46
The First Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China, 510080
Actively Recruiting
47
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430023
Actively Recruiting
48
Shanghai Changzheng Hospital
Shang'ai, Shanghai Municipality, China, 200000
Actively Recruiting
49
Shanghai Ruijin Hospital
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
50
Shanghai General Hospital
Shanghai, Shanghai Municipality, China, 200080
Actively Recruiting
51
West China Hopital of Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
52
The Second Affiliated Hospital Zhejiang University School of Medical
Hangzhou, Zhejiang, China, 310025
Actively Recruiting
53
Beijing Cancer Hospital
Beijing, China, 100142
Actively Recruiting
54
Beijing Jishuitan Hospital
Beijing, China, 102208
Actively Recruiting
55
Henan Cancer Hospital
Guangzhou, China, 450003
Actively Recruiting
56
Aarhus Universitetshospital
Aarhus, Denmark, 8200
Actively Recruiting
57
Herlev & Gentofte Hospital
Herlev, Denmark, 2730
Actively Recruiting
58
Institut Bergonié
Bordeaux, France, 33076
Actively Recruiting
59
Centre Oscar Lambret
Lille, France, 59020
Actively Recruiting
60
Hôpital Léon Bérard
Lyon, France, 69008
Actively Recruiting
61
Hopital de La Timone
Marseille, France, 13005
Actively Recruiting
62
Hôpital Cochin
Paris, France, 75014
Actively Recruiting
63
INSTITUT de CANCEROLOGIE de l'Ouest
Saint-Herblain, France, 44805
Actively Recruiting
64
Iuct-Oncopole Institut Universitaire Du Cancer
Toulouse, France, 31059
Actively Recruiting
65
Institut Gustave Roussy
Villejuif, France, 94800
Actively Recruiting
66
Helios Klinikum Bad Saarow
Bad Saarow, Germany, 15526
Actively Recruiting
67
Charite Universitatsmedizin
Berlin, Germany, 13353
Actively Recruiting
68
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, Germany, 01307
Actively Recruiting
69
Universitatsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Actively Recruiting
70
Universitätsmedizin Mannheim (Umm)
Mannheim, Germany, 68167
Actively Recruiting
71
Lmu Klinikum
München, Germany, 81377
Actively Recruiting
72
Ukm - Sarkom-Zentrum
Münster, Germany, 48149
Actively Recruiting
73
Universitaetsklinikum Ulm
Ulm, Germany, 89081
Actively Recruiting
74
Irccs Istituto Ortopedico Rizzoli
Bologna, Italy, 40136
Actively Recruiting
75
Irccs Fondazione Istituto Nazionale Dei Tumori
Milan, Italy, 20133
Actively Recruiting
76
San Luigi Gonzaga University Hospital of Turin
Orbassano, Italy, 10043
Actively Recruiting
77
Istituto Oncologico Veneto Iov - Irccs
Padova, Italy, 35128
Actively Recruiting
78
Aou Policlinico Paolo Giaccone
Palermo, Italy, 90127
Actively Recruiting
79
Ospedale Santo Stefano
Prato, Italy, 59100
Actively Recruiting
80
Policlinico Universitario Campus Biomedico
Roma, Italy, 00128
Actively Recruiting
81
Istituti Fisioterapici Ospitalieri (Ifo) - Istituto Nazionale Tumori Regina Elena (Ire)
Roma, Italy, 00144
Actively Recruiting
82
Hokkaido Cancer Center
Sapporo, Hokkaido, Japan, 003-0804
Actively Recruiting
83
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, Japan, 920-8641
Actively Recruiting
84
Nagoya University Hospital
Shōwaku, Nagoya-shi, Aichi, Japan, 466-8560
Actively Recruiting
85
Niigata University Medical and Dental General Hospital
Chūōku, Niigata City, Japan, 951-8510
Actively Recruiting
86
Oita University Hospital
Yufu-Shi, Oita Prefecture, Japan, 879-5593
Actively Recruiting
87
Osaka International Cancer Institute
Chūōku, Osaka-shi, Osaka, Japan, 700-8558
Actively Recruiting
88
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan, 104-0045
Actively Recruiting
89
Fukushima Medical University Hospital
Fukushima, Japan, 960-1295
Actively Recruiting
90
Kyushu University Hospital
Higashi, Japan, 812-8582
Actively Recruiting
91
Cancer Institute Hospital of Jfcr
Koto-Ku, Tokyo, Japan, 135-8550
Actively Recruiting
92
Okayama University Hospital
Okayama, Japan, 700-8558
Actively Recruiting
93
Universitair Medisch Centrum Groningen (Umcg)
Groningen, Netherlands, 9713 GZ
Actively Recruiting
94
Leids Universitair Medisch Centrum
Leiden, Netherlands, 2333 ZA
Actively Recruiting
95
Radboud Umc
Nijmegen, Netherlands, 6525 GA
Actively Recruiting
96
Pan American Center For Oncology Trials, LLC
Rio Piedras, Puerto Rico, 00935
Actively Recruiting
97
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
98
Severance Hospital
Seoul, South Korea, 03722
Actively Recruiting
99
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
100
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
101
Hospital Universitario Valle de Hebrón - Vhio
Barcelona, Spain, 08035
Actively Recruiting
102
Hospital de La Santa Creu I Sant Pau
Barcelona, Spain, 08041
Actively Recruiting
103
Hospital de Bellvitge - Ico
L'Hospitalet de Llobregat, Spain, 08908
Actively Recruiting
104
Hospital General Universitario Gregorio
Madrid, Spain, 28007
Actively Recruiting
105
Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain, 28040
Actively Recruiting
106
Hospital Universitario La Paz
Madrid, Spain, 28046
Actively Recruiting
107
Hospital Universitario Y Politecnico La Fe
Valencia, Spain, 46026
Actively Recruiting
108
National Taiwan University Hospital
Taipei, Taiwan, 100225
Actively Recruiting
109
Taipei Veterans General Hospital
Taipei, Taiwan, 112201
Actively Recruiting
110
Western General Hospital
Edinburgh, United Kingdom
Actively Recruiting
111
Royal Marsden Hospital
London, United Kingdom
Actively Recruiting
112
UCLH
London, United Kingdom
Actively Recruiting
113
Christie Hospital
Manchester, United Kingdom, M20 4BX
Actively Recruiting
114
Churchill Hospital
Oxford, United Kingdom
Actively Recruiting
Research Team
I
Institut de Recherches Internationales Servier (I.R.I.S.), Clinical Studies Department
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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