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RECRUITING

NCT06127407

PHASE3

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

Sponsor: Servier Bio-Innovation LLC

View on ClinicalTrials.gov

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 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.

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 Systemic Treatment Regimen

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

136

Start Date

2024-07-09

Completion Date

2030-11-26

Last Updated

2026-02-06

Healthy Volunteers

Conditions

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

Interventions

DRUG

Ivosidenib 500mg

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

DRUG

Placebo

Provided as tablets, taken orally once daily.

Inclusion Criteria: * Have a histopathological diagnosis (fresh or banked tumor biopsy sample collected within the last 3 years) 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 or 1 prior systemic treatment regimen in the advanced/metastatic setting for chondrosarcoma. * Have radiographic progression/recurrence of disease according to RECIST v1.1 defined as: 1. 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 2. 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. Exclusion Criteria: * 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. * 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).

Locations (114)

Usc Norris Comprehensive Cancer Center

Los Angeles, California, United States

Sarcoma Oncology Research Center

Santa Monica, California, United States

University of Colorado Cancer Center

Aurora, Colorado, United States

Yale Cancer Center

New Haven, Connecticut, United States

Mayo Clinic - Jacksonville, Fl

Jacksonville, Florida, United States

University of Miami

Miami, Florida, United States

Emory Winship Cancer Institute

Atlanta, Georgia, United States

Robert H. Lurie Comprehensive Cancer Center of Northwestern University

Chicago, Illinois, United States

University of Iowa Hospitals & Clinics- Holden Comprehensive Cancer Center

Iowa City, Iowa, United States

Johns Hopkins University

Baltimore, Maryland, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Mayo Clinic - Rochester, Mn

Rochester, Minnesota, United States

The Washington University

St Louis, Missouri, United States

Nebraska Methodist Hospital

Omaha, Nebraska, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Duke University

Durham, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Oregon Health & Science University Knight Cancer Institute

Portland, Oregon, United States

University of Pittsburgh Medical Center-Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

The Univeristy of Texas Md Anderson Cancer Center

Houston, Texas, United States

Flinders Medical Centre

Bedford Park, Australia

Chris O'Brien Lifehouse

Camperdown, Australia

Chris O'Brien Lifehouse

Camperdown, Australia

St Vincent'S Hospital Melbourne

Fitzroy, Australia

Sir Charles Gairdner Hospital

Nedlands, Australia

Princess Alexandra Hospital

Woolloongabba, Australia

Cliniques Universitaires St. Luc

Brussels, Belgium

U.Z. Gent

Ghent, Belgium

Centre Multidisciplinaire de Oncologie Medicale

Liège, Belgium

Liga Norte Riograndense Contra O Cancer

Natal, Rio Grande do Norte, Brazil

Hospital de Amor - Barretos

Barretos, Brazil

Hospital Das Clínicas Da Ufmg

Belo Horizonte, Brazil

CIONC

Curitiba, Brazil

Cepon - Centro de Pesquisas Oncologicas

Florianópolis, Brazil

Fundação Amaral Carvalho - Jaú/ Sp

Jaú, Brazil

Instituto Nacional Do Câncer - Inca

Rio de Janeiro, Brazil

Icesp - Instituto Do Câncer Do Estado de São Paulo

São Paulo, Brazil

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

São Paulo, Brazil

Hospital A C Camargo

São Paulo, Brazil

Hospital Albert Einstein

São Paulo, Brazil

Alberta Health Services

Calgary, Alberta, Canada

University Health Network

Toronto, Ontario, Canada

Muhc Glen Site

Montreal, Quebec, Canada

The First Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

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

Wuhan, Hubei, China

Shanghai Changzheng Hospital

Shang'ai, Shanghai Municipality, China

Shanghai Ruijin Hospital

Shanghai, Shanghai Municipality, China

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

West China Hopital of Sichuan University

Chengdu, Sichuan, China

The Second Affiliated Hospital Zhejiang University School of Medical

Hangzhou, Zhejiang, China

Beijing Cancer Hospital

Beijing, China

Beijing Jishuitan Hospital

Beijing, China

Henan Cancer Hospital

Guangzhou, China

Aarhus Universitetshospital

Aarhus, Denmark

Herlev & Gentofte Hospital

Herlev, Denmark

Institut Bergonié

Bordeaux, France

Centre Oscar Lambret

Lille, France

Hôpital Léon Bérard

Lyon, France

Hopital de La Timone

Marseille, France

Hôpital Cochin

Paris, France

INSTITUT de CANCEROLOGIE de l'Ouest

Saint-Herblain, France

Iuct-Oncopole Institut Universitaire Du Cancer

Toulouse, France

Institut Gustave Roussy

Villejuif, France

Helios Klinikum Bad Saarow

Bad Saarow, Germany

Charite Universitatsmedizin

Berlin, Germany

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, Germany

Universitatsklinikum Hamburg-Eppendorf

Hamburg, Germany

Universitätsmedizin Mannheim (Umm)

Mannheim, Germany

Lmu Klinikum

München, Germany

Ukm - Sarkom-Zentrum

Münster, Germany

Universitaetsklinikum Ulm

Ulm, Germany

Irccs Istituto Ortopedico Rizzoli

Bologna, Italy

Irccs Fondazione Istituto Nazionale Dei Tumori

Milan, Italy

San Luigi Gonzaga University Hospital of Turin

Orbassano, Italy

Istituto Oncologico Veneto Iov - Irccs

Padova, Italy

Aou Policlinico Paolo Giaccone

Palermo, Italy

Ospedale Santo Stefano

Prato, Italy

Policlinico Universitario Campus Biomedico

Roma, Italy

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

Roma, Italy

Hokkaido Cancer Center

Sapporo, Hokkaido, Japan

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, Japan

Nagoya University Hospital

Shōwaku, Nagoya-shi, Aichi, Japan

Niigata University Medical and Dental General Hospital

Chūōku, Niigata City, Japan

Oita University Hospital

Yufu-Shi, Oita Prefecture, Japan

Osaka International Cancer Institute

Chūōku, Osaka-shi, Osaka, Japan

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

Fukushima Medical University Hospital

Fukushima, Japan

Kyushu University Hospital

Higashi, Japan

Cancer Institute Hospital of Jfcr

Koto-Ku, Tokyo, Japan

Okayama University Hospital

Okayama, Japan

Universitair Medisch Centrum Groningen (Umcg)

Groningen, Netherlands

Leids Universitair Medisch Centrum

Leiden, Netherlands

Radboud Umc

Nijmegen, Netherlands

Pan American Center For Oncology Trials, LLC

Rio Piedras, Puerto Rico

Seoul National University Hospital

Seoul, South Korea

Severance Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Hospital Universitario Valle de Hebrón - Vhio

Barcelona, Spain

Hospital de La Santa Creu I Sant Pau

Barcelona, Spain

Hospital de Bellvitge - Ico

L'Hospitalet de Llobregat, Spain

Hospital General Universitario Gregorio

Madrid, Spain

Hospital Universitario Fundación Jiménez Díaz

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Universitario Y Politecnico La Fe

Valencia, Spain

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Western General Hospital

Edinburgh, United Kingdom

Royal Marsden Hospital

London, United Kingdom

UCLH

London, United Kingdom

Christie Hospital

Manchester, United Kingdom

Churchill Hospital

Oxford, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (114)