AzTrials
AzTrials

Locally Advanced or Metastatic Conventional Chondrosarcoma With an IDH1 Mutation, Untreated or Previously Treated With 1 Systemic Treatment RegimenPhase 3CHONQUERNCT06127407

Ivosidenib in Participants With Locally Advanced or Metastatic Conventional Chondrosarcoma Untreated or Previously Treated With 1 or 2 Systemic Treatment Regimens

A Phase 3 study testing Ivosidenib 500mg in people with Locally Advanced or Metastatic Conventional Chondrosarcoma With an IDH1 Mutation, Untreated or Previously Treated With 1 Systemic Treatment Regimen, run by Servier Bio-Innovation LLC at 115 sites in 17 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ivosidenib 500mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
156 participants
Where
115 sitesin 17 countries
Study dates
9 Jul 2024to 26 Nov 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have a histopathological diagnosis consistent with locally advanced or metastatic conventional chondrosarcoma Grades 1, 2, or 3 and not eligible for curative resection.
  • Have at least one BICR-confirmed measurable lesion as defined by RECIST v1.1. Participants who have received prior radiation therapy are eligible provided measurable disease falls outside of the treatment field or within the field and has shown ≥20% growth in size since post-treatment assessment.
  • Have received 0 to 2 prior systemic treatment regimens in the advanced/metastatic setting for chondrosarcoma.
  • Have radiographic progression/recurrence of disease according to RECIST v1.1 defined as:
  • Radiographic progression of disease (local and/or distant) documented by 2 imaging assessments performed no more than 6 months (±2 weeks) apart within 12 months before randomization.
  • OR
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  • Any recurrence of disease (local and/or distant) after complete surgical resection and documented by imaging within 6 months (±2 weeks) before randomization.
  • Have documented IDH1 gene-mutated disease (from a fresh tumor biopsy or the most recent banked tumor tissue available that was sourced from either a primary or metastatic tumor lesion) based on central laboratory testing (R132C/L/G/H/S mutation variants tested)
  • Have recovered from any clinically relevant sequelae and toxic effects of any prior surgery, radiotherapy, or other therapy intended for the treatment of cancer.

Who cannot join

  • Are unable to swallow oral medication.
  • Pregnant or lactating women.
  • Are participating in another interventional study at the same time; participation in noninterventional registries or epidemiological studies is allowed.
  • Have received prior therapy with an IDH1 inhibitor
  • Have received systemic anticancer therapy <2 weeks prior to randomization (for investigational or immune-based anticancer therapy <4 weeks).
  • Have received radiotherapy <2 weeks prior to randomization.
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  • Have known symptomatic brain metastases requiring steroids >10 mg per day prednisone (or equivalent). Participants with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to randomization, have discontinued or reduced corticosteroid treatment <=10 mg per day for these metastases for at least 4 weeks and have radiographically stable disease of brain lesions for at least 3 months prior to randomization.
  • Have a history of another primary cancer, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated carcinoma in situ; or c) pT1-2 prostatic cancer Gleason score <6 or d) participant is free of other primary solid or liquid tumor for ≥ 1 year prior to the start of study treatment and, in the opinion of the Investigator, the disease will not affect participant's outcome in the setting of current chondrosarcoma diagnosis.
  • Have had major surgery within 4 weeks prior to randomization.
  • Have significant active cardiac disease within 6 months prior to randomization, including New York Heart Association (NYHA) Class III or IV congestive heart failure; myocardial infarction; unstable angina; and/or stroke.
  • Have LVEF <40% by ECHO scan (or by other methods according to institutional practice) obtained within 28 days prior to randomization.
  • Have a heart-rate corrected QT interval (using Fridericia's formula) (QTcF) ≥ 450 msec or other factors that increase the risk of QT prolongation or arrhythmic events (eg, heart failure, hypokalemia, family history of long QT interval syndrome). Participants with a bundle branch block combined with a prolonged QTcF interval may be permitted based on local cardiology assessment.
  • Have known medical history of progressive multifocal leukoencephalopathy (PML).

Trial locations and contacts

115 sites in 17 countries. Contact the study team or a site near you to ask about taking part.

Institut de Recherches Internationales Servier (I.R.I.S.), Clinical Studies Department contact

+33 1 55 72 60 00

scientificinformation@servier.com

115 sites in 17 countries

United States22 sites, 21 recruiting

  • Emory Winship Cancer Institute

    Atlanta, Georgia, 30308

    William Read, william.l.read@emory.edu

    Recruiting

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

    Recruiting

  • Johns Hopkins University

    Baltimore, Maryland, 21287

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    DFCI Sarcoma Center, 617-632-5204

    Recruiting

  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University

    Chicago, Illinois, 60611-5975

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    216-444-7923, cancerawareness@ccf.org

    Recruiting

  • The Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

    Luiza Stoeva, 614-814-1053, SarcomaCRCs@osumc.edu

    Recruiting

  • Duke University

    Durham, North Carolina, 27710

    Richard Riedel, MD, 888-275-3852, vivek.bhadri@lh.org.au

    Recruiting

  • The Univeristy of Texas Md Anderson Cancer Center

    Houston, Texas, 77030

    Recruiting

  • University of Iowa Hospitals & Clinics- Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

    Recruiting

  • Mayo Clinic - Jacksonville, Fl

    Jacksonville, Florida, 32224

    Steven Attia, Dr, attia.steven@mayo.edu

    Recruiting

  • Usc Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

    Terminated

  • University of Miami

    Miami, Florida, 33136-1002

    Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

    Clinical Research Coordinator, 800-811-8480, cip@vumc.org

    Recruiting

  • Yale Cancer Center

    New Haven, Connecticut, 06511

    Sharon Huie, 475-331-5081, sharon.huie@yale.edu

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    646-888-4163, tapw@mskcc.org

    William Tap, MD

    Recruiting

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68118

    Recruiting

  • University of Pittsburgh Medical Center-Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

    Recruiting

  • Oregon Health & Science University Knight Cancer Institute

    Portland, Oregon, 97239

    OHSU Clinical Trials Office, 503-494-1080, trials@ohsu.edu

    Recruiting

  • Mayo Clinic - Rochester, Mn

    Rochester, Minnesota, 55905

    Recruiting

  • Sarcoma Oncology Research Center

    Santa Monica, California, 90403

    Victoria Chua-Alcala, MD, 310-552-9999, vchua@sarcomaoncology.com

    Recruiting

  • The Washington University

    St Louis, Missouri, 63110

    Recruiting

Other trials in United States

China11 sites, 11 recruiting

  • Beijing Cancer Hospital

    Beijing, 100142

    Recruiting

  • Beijing Jishuitan Hospital

    Beijing, 102208

    Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410000

    Recruiting

  • West China Hopital of Sichuan University

    Chengdu, Sichuan, 610041

    Recruiting

  • The First Affiliated Hospital of Sun Yat-Sen University

    Guangzhou, Guangdong, 510080

    Recruiting

  • The Second Affiliated Hospital Zhejiang University School of Medical

    Hangzhou, Zhejiang, 310025

    Recruiting

  • Shanghai Changzheng Hospital

    Shang'ai, Shanghai Municipality, 200000

    Recruiting

  • Shanghai Ruijin Hospital

    Shanghai, Shanghai Municipality, 200025

    Recruiting

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, 200080

    Recruiting

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430023

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450003

    Recruiting

Other trials in China

Japan11 sites, 11 recruiting

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045

    Recruiting

  • Niigata University Medical and Dental General Hospital

    Chūōku, Niigata City, 951-8510

    Recruiting

  • Osaka International Cancer Institute

    Chūōku, Osaka-shi, Osaka, 700-8558

    Recruiting

  • Fukushima Medical University Hospital

    Fukushima, 960-1295

    Recruiting

  • Kyushu University Hospital

    Higashi, 812-8582

    Recruiting

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken, 920-8641

    +81 76 265 2785, an0510@staff.kanazawa-u.ac.jp

    AKIHIRO NISHIYAMA, MD

    Recruiting

  • Cancer Institute Hospital of Jfcr

    Koto-Ku, Tokyo, 135-8550

    0335200111

    KENJI NAKANO, MD

    Recruiting

  • Okayama University Hospital

    Okayama, 700-8558

    +81 86 235 7534, chiken@okayama-u.ac.jp

    Tomohiro Fujiwara, MD

    Recruiting

  • Hokkaido Cancer Center

    Sapporo, Hokkaido, 003-0804

    Recruiting

  • Nagoya University Hospital

    Shōwaku, Nagoya-shi, Aichi, 466-8560

    Recruiting

  • Oita University Hospital

    Yufu-Shi, Oita Prefecture, 879-5593

    Recruiting

Other trials in Japan

Brazil10 sites, 9 recruiting

  • Hospital de Amor - Barretos

    Barretos, 14784-400

    Recruiting

  • Hospital Das Clínicas Da Ufmg

    Belo Horizonte, 30130-100

    Recruiting

  • CIONC

    Curitiba, 80810-050

    Recruiting

  • Cepon - Centro de Pesquisas Oncologicas

    Florianópolis, 88034-000

    Recruiting

  • Fundação Amaral Carvalho - Jaú/ Sp

    Jaú, 17210-080

    Recruiting

  • Liga Norte Riograndense Contra O Cancer

    Natal, Rio Grande do Norte, 59062-000

    Recruiting

  • Icesp - Instituto Do Câncer Do Estado de São Paulo

    São Paulo, 01246-000

    Recruiting

  • Impar Serviços Hospitalares S.A. - Hospital Nove de Julho

    São Paulo, 01409-902

    Terminated

  • Hospital A C Camargo

    São Paulo, 01509-010

    Recruiting

  • Hospital Albert Einstein

    São Paulo, 05652-900

    Recruiting

Other trials in Brazil

France9 sites, 9 recruiting

  • Institut Bergonié

    Bordeaux, 33076

    Recruiting

  • Centre Oscar Lambret

    Lille, 59020

    Recruiting

  • Hôpital Léon Bérard

    Lyon, 69008

    Recruiting

  • Hopital de La Timone

    Marseille, 13005

    Recruiting

  • Hôpital Cochin

    Paris, 75014

    Recruiting

  • INSTITUT de CANCEROLOGIE de l'Ouest

    Saint-Herblain, 44805

    Recruiting

  • Hôpital de Hautepierre

    Strasbourg, 67200

    Recruiting

  • Iuct-Oncopole Institut Universitaire Du Cancer

    Toulouse, 31059

    Recruiting

  • Institut Gustave Roussy

    Villejuif, 94800

    Recruiting

Other trials in France

Germany8 sites, 8 recruiting

  • Helios Klinikum Bad Saarow

    Bad Saarow, 15526

    Daniel Pink, MD, 0049 33631 7 3728, daniel.pink@helios-gesundheit.de

    Simone Micheel, simone.micheel@helios-gesundheit.de

    Recruiting

  • Charite Universitatsmedizin

    Berlin, 13353

    Recruiting

  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden, 01307

    Uniklinik Dresden Studiensekretariat Onkologie, +49351-4587683, oncostudy@ukdd.de

    Recruiting

  • Universitatsklinikum Hamburg-Eppendorf

    Hamburg, 20246

    Recruiting

  • Universitätsmedizin Mannheim (Umm)

    Mannheim, 68167

    Recruiting

  • Lmu Klinikum

    München, 81377

    Recruiting

  • Ukm - Sarkom-Zentrum

    Münster, 48149

    PD. Dr. med. Torsten Keßler, meda-studien@ukmuenster.de

    Recruiting

  • Universitaetsklinikum Ulm

    Ulm, 89081

    Recruiting

Other trials in Germany

Italy8 sites, 8 recruiting

  • Irccs Istituto Ortopedico Rizzoli

    Bologna, 40136

    Recruiting

  • Irccs Fondazione Istituto Nazionale Dei Tumori

    Milan, 20133

    Recruiting

  • San Luigi Gonzaga University Hospital of Turin

    Orbassano, 10043

    Dr. Lorenzo D'Ambrosio, +39 0119026105, lorenzo.dambrosio@unito.it

    Recruiting

  • Istituto Oncologico Veneto Iov - Irccs

    Padova, 35128

    Recruiting

  • Aou Policlinico Paolo Giaccone

    Palermo, 90127

    Recruiting

  • Ospedale Santo Stefano

    Prato, 59100

    Baldi Giacomo Giulio, +39 0574 802531, giacomogiulio.baldi@uslcentro.toscana.it

    +39 0574 805304, aiutopoint.oncologia.prato@uslcentro.toscana.it

    Recruiting

  • Policlinico Universitario Campus Biomedico

    Roma, 00128

    Bruno Vincenzi, MD, +39-(0)6-225411617, b.vincenzi@policlinicocampus.it

    Recruiting

  • Istituti Fisioterapici Ospitalieri (Ifo) - Istituto Nazionale Tumori Regina Elena (Ire)

    Roma, 00144

    Recruiting

Other trials in Italy

Spain7 sites, 7 recruiting

  • Hospital Universitario Valle de Hebrón - Vhio

    Barcelona, 08035

    Claudia Valverde, cvalverde@vhio.net

    Recruiting

  • Hospital de La Santa Creu I Sant Pau

    Barcelona, 08041

    Recruiting

  • Hospital de Bellvitge - Ico

    L'Hospitalet de Llobregat, 08908

    Recruiting

  • Hospital General Universitario Gregorio

    Madrid, 28007

    Recruiting

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040

    Nadia Hindi, 91 550 4800 ext. 4667, nadia.hindi@quironsalud.es

    Javier Martin Broto

    Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046

    Recruiting

  • Hospital Universitario Y Politecnico La Fe

    Valencia, 46026

    Roberto Díaz Beveridge, MD, diaz_rob@gva.es

    Recruiting

Other trials in Spain

Australia6 sites, 6 recruiting

  • Flinders Medical Centre

    Bedford Park, 5042

    ganessan.kichenadasse@sa.gov.au

    61882044997

    Recruiting

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050

    Recruiting

  • Chris O'Brien Lifehouse

    Camperdown, 2050

    Vivek Bhadri, MD, 0061285140749, vivek.bhadri@lh.org.au

    Not yet recruiting

  • St Vincent'S Hospital Melbourne

    Fitzroy, Victoria, 3065

    Melissa Moore, Dr, 0061392313177, melissa.moore@svha.org.au

    Recruiting

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

    Recruiting

  • Princess Alexandra Hospital

    Woolloongabba, 4102

    Vladimir Andelkovic, Dr, Vladimir.andelkovic@health.qld.gov.au

    Recruiting

Other trials in Australia

United Kingdom5 sites, 5 recruiting

  • Western General Hospital

    Edinburgh, EH4 2XU

    Recruiting

  • UCLH

    London, NW1 2PG

    Carla Dalton, 07811785094, carla.dalton1@nhs.net

    Anna Mazepa, a.mazepa@nhs.net

    Recruiting

  • Royal Marsden Hospital

    London

    Recruiting

  • Christie Hospital

    Manchester, M20 4BX

    Recruiting

  • Churchill Hospital

    Oxford, OX3 7LE

    Recruiting

Other trials in United Kingdom

South Korea4 sites, 4 recruiting

  • Seoul National University Hospital

    Seoul, 03080

    Recruiting

  • Severance Hospital

    Seoul, 03722

    Recruiting

  • Asan Medical Center

    Seoul, 05505

    Recruiting

  • Samsung Medical Center

    Seoul, 06351

    Recruiting

Other trials in South Korea

Belgium3 sites, 3 recruiting

  • Cliniques Universitaires St. Luc

    Brussels, 1200

    Recruiting

  • U.Z. Gent

    Ghent, 9000

    Recruiting

  • Centre Multidisciplinaire de Oncologie Medicale

    Liège, 4000

    Recruiting

Other trials in Belgium

Canada3 sites, 2 recruiting

  • Alberta Health Services

    Calgary, Alberta, T2N-5G2

    Matthew Young, matthew.young@albertahealthservices.ca

    Recruiting

  • Muhc Glen Site

    Montreal, Quebec, H4A 3J1

    Terminated

  • University Health Network

    Toronto, Ontario, M5G 2M9

    4165964200 ext. 5553

    ABDULAZEEZ SALAWU, MD

    Recruiting

Other trials in Canada

Netherlands3 sites, 3 recruiting

  • Universitair Medisch Centrum Groningen (Umcg)

    Groningen, 9713 GZ

    Jacco de Haan, 0031503612821, researchcoordinator@onco.umcg.nl

    Recruiting

  • Leids Universitair Medisch Centrum

    Leiden, 2333 ZA

    Hans Gelderblom, 0031715261093, a.j.gelderblom@lumc.nl

    Recruiting

  • Radboud Umc

    Nijmegen, 6525 GA

    Ingrid Desar, 0031 24 3610353, Studies.onco@radnboudumc.nl

    Recruiting

Other trials in Netherlands

Denmark2 sites, 2 recruiting

  • Aarhus Universitetshospital

    Aarhus, 8200

    Recruiting

  • Herlev & Gentofte Hospital

    Herlev, 2730

    Recruiting

Other trials in Denmark

Taiwan2 sites, 2 recruiting

  • National Taiwan University Hospital

    Taipei, 100225

    Wei-Wu Chen, saxotomy@gmail.com, tomwchen@ntuh.gov.tw

    Recruiting

  • Taipei Veterans General Hospital

    Taipei, 112201

    Po-Kuei Wu, drwuvgh@gmail.com

    Recruiting

Other trials in Taiwan

Puerto Rico1 site, 1 recruiting

  • Pan American Center For Oncology Trials, LLC

    Rio Piedras, 00935

    Recruiting

Other trials in Puerto Rico

About this study

Official title: A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled Study of Ivosidenib in Participants ≥18 Years of Age With Locally Advanced or Metastatic Conventional Chondrosarcoma With an IDH1 Mutation, Untreated or Previously Treated With 1 or 2 Systemic Treatment Regimens

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 2 prior systemic treatment regimens 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.

Being tested
Ivosidenib 500mg, Placebo
Keywords
Conventional chondrosarcoma, IDH1, ivosidenib, locally advanced, metastatic
Medical subject headings
Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ivosidenib 500mgDrug

    Provided as tablets, taken orally as two 250mg tablets once daily.

  • PlaceboDrug

    Provided as tablets, taken orally once daily.

Study groups in NCT06127407
Study groupRoleWhat they receive
IvosidenibExperimentalTaken continuously until BICR-confirmed disease progression, unacceptable toxicity, confirmed pregnancy, death, withdrawal of consent, lost to follow-up, or the Sponsor ends the study (estimated average treatment duration of two years).
Receives: Drug: Ivosidenib 500mg
PlaceboPlacebo comparatorTaken continuously until BICR-confirmed disease progression, unacceptable toxicity, confirmed pregnancy, death, withdrawal of consent, lost to follow-up, or the Sponsor ends the study (estimated average treatment duration of two years). Participants randomized to the placebo arm who experience BICR-confirmed disease progression and meet the crossover eligibility criteria will be given the opportunity to cross over and receive ivosidenib.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS) based on Blinded Independent Central Reviewer (BICR) assessment in Grade 1 and Grade 2 participants

    From randomization until BICR confirmed progressive disease or death due to any cause, whichever occurs first

    Measured: Up to approximately 31 months

Secondary outcomes (24)

  1. PFS based on BICR assessment in all randomized participants

    From randomization until BICR confirmed progressive disease or death due to any cause, whichever occurs first

    Measured: Up to approximately 31 months

  2. Overall survival (OS) in Grade 1 and Grade 2 participants

    From randomization until death

    Measured: Up to 5 years

  3. OS in all randomized participants

    From randomization until death

    Measured: Up to 5 years

  4. PFS based on Investigator assessment in Grade 1 and Grade 2 participants

    From randomization until BICR confirmed progressive disease or death due to any cause, whichever occurs first

    Measured: Up to approximately 31 months

  5. PFS based on Investigator assessment in all randomized participants

    From randomization until BICR confirmed progressive disease or death due to any cause, whichever occurs first

    Measured: Up to approximately 31 months

  6. Objective response (OR) (confirmed complete response(CR) or confirmed partial response (PR)) of anti-tumor activity (using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1) in Grade 1 and Grade 2 participants

    From randomization until confirmed CR or PR

    Measured: Up to approximately 31 months

  7. OR (confirmed CR or confirmed PR) of anti-tumor activity (using RECIST v1.1) in all randomized participants

    From randomization until confirmed CR or PR

    Measured: Up to approximately 31 months

  8. Duration of response (DOR) in Grade 1 and Grade 2 participants

    The time from date of first documented confirmed CR or confirmed PR to date of first documented disease progression or death due to any cause.

    Measured: Up to approximately 31 months

  9. DOR in all randomized participants

    The time from date of first documented confirmed CR or confirmed PR to date of first documented disease progression or death due to any cause.

    Measured: Up to approximately 31 months

  10. Time to response (TTR) in Grade 1 and Grade 2 participants

    The time from the date of randomization to date of first documented confirmed complete response (CR) or confirmed partial response (PR).

    Measured: Up to approximately 31 months

  11. TTR in all randomized participants

    The time from the date of randomization to date of first documented confirmed complete response (CR) or confirmed partial response (PR).

    Measured: Up to approximately 31 months

  12. Disease control (DC) confirmed CR, confirmed PR, or stable disease (SD)) in Grade 1 and Grade 2 participants

    Measured: Through the end of the study (a maximum of 5 years after the study start)

  13. DC (confirmed CR, confirmed PR, or SD) in all randomized participants

    Measured: Through the end of the study (a maximum of 5 years after the study start)

  14. Duration of disease control (DoDC) in Grade 1 and Grade 2 participants

    Measured: Through the end of the study (a maximum of 5 years after the study start)

  15. DoDC in all randomized participants

    Measured: Through the end of the study (a maximum of 5 years after the study start)

  16. Number of Adverse Events (AEs)

    Measured: Through the Safety Follow-up Visit (28-33 days after discontinuation of treatment)

  17. Number of Serious Adverse Events (SAEs)

    Measured: Through the Safety Follow-up Visit (28-33 days after discontinuation of treatment)

  18. Number of Adverse Events of Special Interest (AESIs)

    Measured: Through the Safety Follow-up Visit (28-33 days after discontinuation of treatment)

  19. Number of Adverse Events (AEs) leading to discontinuation, treatment interruption, and dose reduction

    Measured: Through the Safety Follow-up Visit (28-33 days after discontinuation of treatment)

  20. European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) score

    The EORTC-QLQ-C30 contains 30 items across 5 functional scales, 9 symptom scales and a global health status. Raw scores are converted to scales ranging from 0 - 100. For the functional scales and global health status, the higher score represents the better functioning or global health status; for the symptom scales, the higher score represents an increase in symptoms.

    Measured: Through the Safety Follow-up Visit (28-33 days after discontinuation of treatment)

  21. European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) score

    The 5-level EQ-5D-5L scores range from 5 to 25 with a higher number representing a worse health status.

    Measured: Through the Safety Follow-up Visit (28-33 days after discontinuation of treatment)

  22. Patient-Reported Outcomes Measurement Information System (PROMIS) score

    The PROMIS Item Bank v1.0 Physical Function with Mobility Aid - Short Form questionnaire score ranges from 1 "Unable to do" to 5 "Can do without a problem" for each capability.

    Measured: Through the Safety Follow-up Visit (28-33 days after discontinuation of treatment)

  23. Ivosidenib concentration in plasma

    Measured: Through the end of the study (a maximum of 5 years after the study start)

  24. 2-hydroxyglutarate (2-HG) concentration in plasma

    Measured: Through the end of the study (a maximum of 5 years after the study start)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2023
  2. Study start9 Jul 2024
  3. Primary completion1 Feb 2028 (estimated)
  4. Study completion26 Nov 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
156 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06127407
Sponsor's protocol ID
CL3-95031-007
Acronym
CHONQUER
Status last verified
Oct 2026
First submitted
7 Nov 2023
Last updated
28 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data. Access can be requested for all interventional clinical studies: * used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope. In addition, access can be requested for all interventional clinical studies in patients: * sponsored by Servier * with a first patient enrolled as of 1 January 2004 onwards * for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

Publications

  • Tap WD, Cote GM, Burris H, Gore L, Elias A, Beeram M, Conley AP, Gianolio DA, Qu Z, Pandya S, Trent JC. Phase I Study of the Mutant IDH1 Inhibitor Ivosidenib: Long-term Safety and Clinical Activity in Patients with Conventional Chondrosarcoma. Clin Cancer Res. 2025 Jun 3;31(11):2108-2114. doi: 10.1158/1078-0432.CCR-24-4128.

    PubMed 40100120

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ivosidenib 500mg in people with Locally Advanced or Metastatic Conventional Chondrosarcoma With an IDH1 Mutation, Untreated or Previously Treated With 1 Systemic Treatment Regimen, run by Servier Bio-Innovation LLC at 115 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 115 sites in United States, China, Japan, Brazil, France and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Institut de Recherches Internationales Servier (I.R.I.S.), Clinical Studies Department (+33 1 55 72 60 00, scientificinformation@servier.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) based on Blinded Independent Central Reviewer (BICR) assessment in Grade 1 and Grade 2 participants (time frame: Up to approximately 31 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06127407, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.

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