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

Last updated: November 10, 2025
Sponsor: Servier Bio-Innovation LLC
Overall Status: Active - Recruiting

Phase

3

Condition

Sarcoma (Pediatric)

Neoplasm Metastasis

Bone Neoplasm

Treatment

Placebo

Ivosidenib 500mg

Clinical Study ID

NCT06127407
CL3-95031-007
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have a histopathological diagnosis (fresh or banked tumor biopsy sample collectedwithin the last 3 years) consistent with locally advanced or metastatic conventionalchondrosarcoma 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 providedmeasurable disease falls outside of the treatment field or within the field and hasshown ≥20% growth in size since post-treatment assessment.

  • Have received 0 or 1 prior systemic treatment regimen in the advanced/metastaticsetting for chondrosarcoma.

  • Have radiographic progression/recurrence of disease according to RECIST v1.1 definedas:

  1. Radiographic progression of disease (local and/or distant) documented by 2imaging assessments performed no more than 6 months (±2 weeks) apart within 12months before randomization.OR

  2. Any recurrence of disease (local and/or distant) after complete surgicalresection and documented by imaging within 6 months (±2 weeks) beforerandomization.

  • Have documented IDH1 gene-mutated disease (from a fresh tumor biopsy or the mostrecent banked tumor tissue available that was sourced from either a primary ormetastatic tumor lesion) based on central laboratory testing (R132C/L/G/H/S mutationvariants tested)

  • Have recovered from any clinically relevant sequelae and toxic effects of any priorsurgery, radiotherapy, or other therapy intended for the treatment of cancer.

Exclusion

Exclusion Criteria:

  • Are unable to swallow oral medication.

  • Pregnant or lactating women.

  • Are participating in another interventional study at the same time; participation innoninterventional registries or epidemiological studies is allowed.

  • Have received prior therapy with an IDH1 inhibitor

  • Have received systemic anticancer therapy <2 weeks prior to randomization (forinvestigational 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 areeligible if they have completed their treatment and have recovered from the acuteeffects of radiation therapy or surgery prior to randomization, have discontinued orreduced corticosteroid treatment <=10 mg per day for these metastases for at least 4weeks and have radiographically stable disease of brain lesions for at least 3months prior to randomization.

  • Have a history of another primary cancer, with the exception of: a) curativelyresected 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 primarysolid or liquid tumor for ≥ 1 year prior to the start of study treatment and, in theopinion of the Investigator, the disease will not affect participant's outcome inthe 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 heartfailure; myocardial infarction; unstable angina; and/or stroke.

  • Have LVEF <40% by ECHO scan (or by other methods according to institutionalpractice) obtained within 28 days prior to randomization.

  • Have a heart-rate corrected QT interval (using Fridericia's formula) (QTcF) ≥ 450msec 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 maybe permitted based on local cardiology assessment.

  • Have known medical history of progressive multifocal leukoencephalopathy (PML).

Study Design

Total Participants: 136
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
July 09, 2024
Estimated Completion Date:
November 26, 2030

Connect with a study center

  • Flinders Medical Centre

    Bedford Park, 5042
    Australia

    Site Not Available

  • Flinders Medical Centre

    Bedford Park 2076918, 5042
    Australia

    Active - Recruiting

  • Chris O'Brien Lifehouse

    Camperdown, 2050
    Australia

    Site Not Available

  • Chris O'Brien Lifehouse

    Camperdown 2172563, 2050
    Australia

    Site Not Available

  • St Vincent'S Hospital Melbourne

    Fitzroy, 3065
    Australia

    Site Not Available

  • St Vincent'S Hospital Melbourne

    Fitzroy 2166584, 3065
    Australia

    Active - Recruiting

  • Sir Charles Gairdner Hospital

    Nedlands, 6009
    Australia

    Site Not Available

  • Sir Charles Gairdner Hospital

    Nedlands 2064874, 6009
    Australia

    Active - Recruiting

  • Princess Alexandra Hospital

    Woolloongabba, 4102
    Australia

    Site Not Available

  • Princess Alexandra Hospital

    Woolloongabba 6943568, 4102
    Australia

    Active - Recruiting

  • Cliniques Universitaires St. Luc

    Brussels 2800866, 1200
    Belgium

    Active - Recruiting

  • U.Z. Gent

    Ghent 2797656, 9000
    Belgium

    Active - Recruiting

  • Centre Multidisciplinaire de Oncologie Medicale

    Liège 2792413, 4000
    Belgium

    Active - Recruiting

  • Liga Norte Riograndense Contra O Cancer

    Natal 3394023, Rio Grande do Norte 3390290 59062-000
    Brazil

    Active - Recruiting

  • Hospital de Amor - Barretos

    Barretos, 14784-400
    Brazil

    Site Not Available

  • Hospital de Amor - Barretos

    Barretos 3470451, 14784-400
    Brazil

    Active - Recruiting

  • Hospital Das Clínicas Da Ufmg

    Belo Horizonte, 30130-100
    Brazil

    Site Not Available

  • Hospital Das Clínicas Da Ufmg

    Belo Horizonte 3470127, 30130-100
    Brazil

    Active - Recruiting

  • CIONC

    Curitiba, 80810-050
    Brazil

    Site Not Available

  • CIONC

    Curitiba 3464975, 80810-050
    Brazil

    Active - Recruiting

  • Cepon - Centro de Pesquisas Oncologicas

    Florianópolis, 88034-000
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    Site Not Available

  • Cepon - Centro de Pesquisas Oncologicas

    Florianópolis 3463237, 88034-000
    Brazil

    Active - Recruiting

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    Jaú, 17210-080
    Brazil

    Site Not Available

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    Jaú 3460005, 17210-080
    Brazil

    Active - Recruiting

  • Instituto Nacional Do Câncer - Inca

    Rio De Janeiro, 20220-410
    Brazil

    Site Not Available

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    Rio de Janeiro 3451190, 20220-410
    Brazil

    Active - Recruiting

  • Hospital A C Camargo

    São Paulo, 01509-010
    Brazil

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    São Paulo, 05652-900
    Brazil

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    São Paulo, 01246-000
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  • Impar Serviços Hospitalares S.A. - Hospital Nove de Julho

    São Paulo, 01409-902
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    São Paulo 3448439, 01509-010
    Brazil

    Active - Recruiting

  • Hospital Albert Einstein

    São Paulo 3448439, 05652-900
    Brazil

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  • Icesp - Instituto Do Câncer Do Estado de São Paulo

    São Paulo 3448439, 01246-000
    Brazil

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

    São Paulo 3448439, 01409-902
    Brazil

    Active - Recruiting

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    Calgary 5913490, Alberta 5883102 T2N-5G2
    Canada

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  • UNIVERSITY HEALTH NETWORK, Princess Margaret Cancer Centre,

    Toronto, Ontario M5G 2M9
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  • University Health Network

    Toronto, Ontario M5G 2M9
    Canada

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    Toronto 6167865, Ontario 6093943 M5G 2M9
    Canada

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  • University Health Network

    Toronto 6167865, Ontario 6093943 M5G 2M9
    Canada

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  • Muhc Glen Site

    Montréal, Quebec H4A 3J1
    Canada

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    Montreal 6077243, Quebec 6115047 H4A 3J1
    Canada

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  • The First Affiliated Hospital of Sun Yat-Sen University

    Guangzhou 1809858, Guangdong 1809935 510080
    China

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    Wuhan, Hubei 430023
    China

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    Wuhan 1791247, Hubei 1806949 430023
    China

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    Shanghai, Shanghai 200080
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    Shang'ai, Shanghai Municipality 1796231 200000
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  • Shanghai General Hospital

    Shanghai 1796236, Shanghai Municipality 1796231 200080
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    Shanghai 1796236, Shanghai Municipality 1796231 200025
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  • West China Hopital of Sichuan University

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • West China Hopital of Sichuan University

    Chengdu 1815286, Sichuan 1794299 610041
    China

    Active - Recruiting

  • The Second Affiliated Hospital Zhejiang University School of Medical

    Hangzhou, Zhejiang 310025
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    Hangzhou 1808926, Zhejiang 1784764 310025
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    Beijing 1816670, 100142
    China

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    Beijing 1816670, 102208
    China

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    Guangzhou 1809858, 450003
    China

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    Aarhus 2624652, 8200
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    Herlev 2620431, 2730
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    Bordeaux 3031582, 33076
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    Lille 2998324, 59020
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    Lyon 2996944, 69008
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    Marseille 2995469, 13005
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  • INSTITUT de CANCEROLOGIE de l'Ouest

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  • Helios Klinikum Bad Saarow

    Bad Saarow, 15526
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    Berlin, 13353
    Germany

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    Germany

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  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden, 01307
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    Dresden 2935022, 01307
    Germany

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  • Universitatsklinikum Hamburg-Eppendorf

    Hamburg 2911298, 20246
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  • Universitätsmedizin Mannheim (Umm)

    Mannheim, 68167
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  • Universitätsmedizin Mannheim (Umm)

    Mannheim 2873891, 68167
    Germany

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  • Lmu Klinikum

    Muenchen, 81377
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  • Lmu Klinikum

    München 2867711, 81377
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  • Ukm - Sarkom-Zentrum

    Münster 2867543, 48149
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    Active - Recruiting

  • Universitaetsklinikum Ulm

    Ulm 2820256, 89081
    Germany

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  • Irccs Istituto Ortopedico Rizzoli

    Bologna 3181928, 40136
    Italy

    Active - Recruiting

  • Irccs Fondazione Istituto Nazionale Dei Tumori

    Milan 6951411, 20133
    Italy

    Active - Recruiting

  • San Luigi Gonzaga University Hospital of Turin

    Orbassano 3171986, 10043
    Italy

    Active - Recruiting

  • Istituto Oncologico Veneto Iov - Irccs

    Padua 3171728, 35128
    Italy

    Active - Recruiting

  • Aou Policlinico Paolo Giaccone

    Palermo, 90127
    Italy

    Site Not Available

  • Aou Policlinico Paolo Giaccone

    Palermo 2523920, 90127
    Italy

    Active - Recruiting

  • Ospedale Santo Stefano

    Prato, 59100
    Italy

    Site Not Available

  • Ospedale Santo Stefano

    Prato 3169921, 59100
    Italy

    Active - Recruiting

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

    Roma, 00144
    Italy

    Active - Recruiting

  • Policlinico Universitario Campus Biomedico

    Roma, 00128
    Italy

    Site Not Available

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

    Roma 8957247, 00144
    Italy

    Active - Recruiting

  • Policlinico Universitario Campus Biomedico

    Roma 8957247, 00128
    Italy

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  • Hokkaido Cancer Center

    Sapporo, Hokkaido 003-0804
    Japan

    Site Not Available

  • Hokkaido Cancer Center

    Sapporo 2128295, Hokkaido 2130037 003-0804
    Japan

    Active - Recruiting

  • Kanazawa University Hospital

    Kanazawa, Ishikawa 920-8641
    Japan

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  • Kanazawa University Hospital

    Kanazawa 1860243, Ishikawa-ken 1861387 920-8641
    Japan

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  • Nagoya University Hospital

    Showa-ku, Nagoya-shi, Aichi 466-8560
    Japan

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  • Nagoya University Hospital

    Shōwaku 10352247, Nagoya-shi, Aichi 466-8560
    Japan

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  • Niigata University Medical and Dental General Hospital

    Chūōku 10262791, Niigata City 951-8510
    Japan

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  • Oita University Hospital

    Yufu, Oita 879-5503
    Japan

    Site Not Available

  • Oita University Hospital

    Yufu-Shi, Oita Prefecture 1854484 879-5593
    Japan

    Active - Recruiting

  • Osaka International Cancer Institute

    Chuo Ku, Osaka-shi, Osaka 700-8558
    Japan

    Site Not Available

  • Osaka International Cancer Institute

    Chūōku 10262791, Osaka-shi, Osaka 700-8558
    Japan

    Active - Recruiting

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045
    Japan

    Active - Recruiting

  • Fukushima Medical University Hospital

    Fukushima 2112923, 960-1295
    Japan

    Active - Recruiting

  • Kyushu University Hospital

    Higashi, 812-8582
    Japan

    Site Not Available

  • Kyushu University Hospital

    Higashi 1862855, 812-8582
    Japan

    Active - Recruiting

  • Cancer Institute Hospital of Jfcr

    Koto-Ku, Tokyo, 135-8550
    Japan

    Active - Recruiting

  • Okayama University Hospital

    Okayama, 700-8558
    Japan

    Site Not Available

  • Okayama University Hospital

    Okayama 1854383, 700-8558
    Japan

    Active - Recruiting

  • Cancer Institute Hospital of Jfcr

    Tokyo, 135-8550
    Japan

    Site Not Available

  • Okayama University Hospital

    Yufu, 879-5503
    Japan

    Active - Recruiting

  • Okayama University Hospital

    Yufu-shi, 879-5503
    Japan

    Active - Recruiting

  • Oita University Hospital

    Yufu-shi, Oita, 879-5503
    Japan

    Site Not Available

  • Universitair Medisch Centrum Groningen (Umcg)

    Groningen, 9713 GZ
    Netherlands

    Site Not Available

  • Universitair Medisch Centrum Groningen (Umcg)

    Groningen 2755251, 9713 GZ
    Netherlands

    Active - Recruiting

  • Leids Universitair Medisch Centrum

    Leiden, 2333 ZA
    Netherlands

    Site Not Available

  • Leids Universitair Medisch Centrum

    Leiden 2751773, 2333 ZA
    Netherlands

    Active - Recruiting

  • Radboud Umc

    Nijmegen, 6525 GA
    Netherlands

    Site Not Available

  • Radboud Umc

    Nijmegen 2750053, 6525 GA
    Netherlands

    Active - Recruiting

  • Pan American Center For Oncology Trials, LLC

    Rio Piedras 4829037, 00935
    Puerto Rico

    Active - Recruiting

  • Asan Medical Center

    Seoul 1835848, 05505
    South Korea

    Active - Recruiting

  • Samsung Medical Center

    Seoul 1835848, 06351
    South Korea

    Active - Recruiting

  • Seoul National University Hospital

    Seoul 1835848, 03080
    South Korea

    Active - Recruiting

  • Severance Hospital

    Seoul 1835848, 03722
    South Korea

    Active - Recruiting

  • Hospital Universitario Valle de Hebrón - Vhio

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital de La Santa Creu I Sant Pau

    Barcelona, 08041
    Spain

    Active - Recruiting

  • Hospital Universitario Valle de Hebrón - Vhio

    Barcelona 3128760, 08035
    Spain

    Active - Recruiting

  • Hospital de La Santa Creu I Sant Pau

    Barcelona 3128760, 08041
    Spain

    Active - Recruiting

  • Hospital de Bellvitge - Ico

    L'Hospitalet De Llobregat, 08908
    Spain

    Site Not Available

  • Hospital de Bellvitge - Ico

    L'Hospitalet de Llobregat 3120619, 08908
    Spain

    Active - Recruiting

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040
    Spain

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  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

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  • Hospital General Universitario Gregorio

    Madrid 3117735, 28007
    Spain

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  • Hospital Universitario Fundación Jiménez Díaz

    Madrid 3117735, 28040
    Spain

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  • Hospital Universitario La Paz

    Madrid 3117735, 28046
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  • Hospital Universitario Y Politecnico La Fe

    Valencia, 46026
    Spain

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  • Hospital Universitario Y Politecnico La Fe

    Valencia 2509954, 46026
    Spain

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  • National Taiwan University Hospital

    Taipei, 100225
    Taiwan

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    Taipei 1668341, 100225
    Taiwan

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  • Taipei Veterans General Hospital

    Taipei 1668341, 112201
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  • Western General Hospital

    Edinburgh,
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    Edinburgh 2650225,
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  • Royal Marsden Hospital

    London,
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  • UCLH

    London,
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    London 2643743,
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  • UCLH

    London 2643743,
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  • Christie Hospital

    Manchester, M20 4BX
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    Manchester 2643123, M20 4BX
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  • Churchill Hospital

    Oxford,
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    Oxford 2640729,
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  • Usc Norris Comprehensive Cancer Center

    Los Angeles, California 90033
    United States

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  • Sarcoma Oncology Research Center

    Santa Monica, California 90403
    United States

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    Los Angeles 5368361, California 5332921 90033
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    Santa Monica 5393212, California 5332921 90403
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    Aurora, Colorado 80045
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    Aurora 5412347, Colorado 5417618 80045
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  • Yale Cancer Center

    New Haven, Connecticut 06511
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    New Haven 4839366, Connecticut 4831725 06511
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  • Mayo Clinic - Jacksonville, Fl

    Jacksonville, Florida 32224
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    Miami, Florida 33136-1002
    United States

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    Jacksonville 4160021, Florida 4155751 32224
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  • University of Miami

    Miami 4164138, Florida 4155751 33136-1002
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  • Emory Winship Cancer Institute

    Atlanta, Georgia 30308
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    Atlanta 4180439, Georgia 4197000 30308
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  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University

    Chicago, Illinois 60611-5975
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  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University

    Chicago 4887398, Illinois 4896861 60611-5975
    United States

    Active - Recruiting

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

    Iowa City, Iowa 52242
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    Iowa City 4862034, Iowa 4862182 52242
    United States

    Active - Recruiting

  • Johns Hopkins University

    Baltimore 4347778, Maryland 4361885 21287
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  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
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    Boston 4930956, Massachusetts 6254926 02215
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  • Mayo Clinic - Rochester, Mn

    Rochester, Minnesota 55905
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    Rochester 5043473, Minnesota 5037779 55905
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    Active - Recruiting

  • The Washington University

    Saint Louis, Missouri 63110
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    St Louis 4407066, Missouri 4398678 63110
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  • Nebraska Methodist Hospital

    Omaha, Nebraska 68118
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    Omaha 5074472, Nebraska 5073708 68118
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  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
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  • Memorial Sloan Kettering Cancer Center

    New York 5128581, New York 5128638 10065
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  • Duke University

    Durham, North Carolina 27710
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  • Usc Norris Comprehensive Cancer Center

    Durham, North Carolina 27710
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  • Duke University

    Durham 4464368, North Carolina 4482348 27710
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  • Cleveland Clinic

    Cleveland, Ohio 44195
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    Columbus, Ohio 43210
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  • Cleveland Clinic

    Cleveland 5150529, Ohio 5165418 44195
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  • The Ohio State University Comprehensive Cancer Center

    Columbus 4509177, Ohio 5165418 43210
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  • Oregon Health & Science University Knight Cancer Institute

    Portland, Oregon 97239
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    Portland 5746545, Oregon 5744337 97239
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  • University of Pittsburgh Medical Center-Hillman Cancer Center

    Pittsburgh, Pennsylvania 15232
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    Pittsburgh 5206379, Pennsylvania 6254927 15232
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  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
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    Site Not Available

  • Vanderbilt University Medical Center

    Nashville 4644585, Tennessee 4662168 37232
    United States

    Active - Recruiting

  • The Univeristy of Texas Md Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • The Univeristy of Texas Md Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

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