Study of Vorasidenib (AG-881) in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO)

Study Purpose

Study AG881-C-004 is a phase 3, multicenter, randomized, double-blind, placebo-controlled study comparing the efficacy of vorasidenib to placebo in participants with residual or recurrent Grade 2 glioma with an IDH1 or IDH2 mutation who have undergone surgery as their only treatment. Participants will be required to have central confirmation of IDH mutation status prior to randomization. Approximately 340 participants are planned to be randomized 1:1 to receive orally administered vorasidenib 40 mg QD or placebo.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 12 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Key

Inclusion Criteria:

  • - Be at least 12 years of age and weigh at least 40 kg.
  • - Have Grade 2 oligodendroglioma or astrocytoma per WHO 2016 criteria.
  • - Have had at least 1 prior surgery for glioma (biopsy, sub-total resection, gross-total resection), with the most recent surgery having occurred at least 1 year (-1 month) and not more than 5 years (+3 months) before the date of randomization, and no other prior anticancer therapy, including chemotherapy and radiotherapy and not be in need of immediate chemotherapy or radiotherapy in the opinion of the Investigator.
  • - Have confirmed IDH1 (IDH1 R132H/C/G/S/L mutation variants tested) or IDH2 (IDH2 R172K/M/W/S/G mutation variants tested) gene mutation status disease by central laboratory testing during the Prescreening period and available 1p19q status by local testing (eg, fluorescence in situ hybridization [FISH], comparative genomic hybridization [CGH] array, sequencing) using an accredited laboratory.
  • - Have MRI-evaluable, measurable, non-enhancing disease, as confirmed by the BIRC.
  • - Have a Karnofsky Performance Scale (KPS) score (for participants ≥16 years of age) or Lansky Play Performance Scale (LPPS) score (for participants <16 years of age) of ≥80%.
Key

Exclusion Criteria:

  • - Have had any prior anticancer therapy other than surgery (biopsy, sub-total resection, gross-total resection) for treatment of glioma including systemic chemotherapy, radiotherapy, vaccines, small-molecules, IDH inhibitors, investigational agents, laser ablation, etc. - Have features assessed as high-risk by the Investigator, including brainstem involvement either as primary location or by tumor extension, clinically relevant functional or neurocognitive deficits due to the tumor in the opinion of the Investigator (deficits resulting from surgery are allowed), or uncontrolled seizures (defined as persistent seizures interfering with activities of daily life AND failed 3 lines of antiepileptic drug regimens including at least 1 combination regimen).

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04164901
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Institut de Recherches Internationales Servier
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Active, not recruiting
Countries Canada, France, Germany, Israel, Italy, Japan, Netherlands, Spain, Switzerland, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Grade 2 Glioma, Residual Glioma, Recurrent Glioma
Arms & Interventions

Arms

Experimental: Vorasidenib

Vorasidenib 40 mg, continuous daily dosing.

Placebo Comparator: Matching Placebo

Matching placebo 40 mg, continuous daily dosing.

Interventions

Drug: - Vorasidenib

Vorasidenib oral film-coated tablets

Drug: - Matching Placebo

Matching Placebo oral tablets

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Alabama at Birmingham, Birmingham 4049979, Alabama 4829764

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Address

University of Alabama at Birmingham

Birmingham 4049979, Alabama 4829764, 35294

City of Hope, Duarte 5344147, California 5332921

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Address

City of Hope

Duarte 5344147, California 5332921, 91010

University of California San Diego, La Jolla 5363943, California 5332921

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Address

University of California San Diego

La Jolla 5363943, California 5332921, 92093

UCLA Oncology Center, Los Angeles 5368361, California 5332921

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Address

UCLA Oncology Center

Los Angeles 5368361, California 5332921, 90095

Orange 5379513, California 5332921

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Address

University of California Irvine - Hospital

Orange 5379513, California 5332921, 92868

University of California San Francisco, San Francisco 5391959, California 5332921

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Address

University of California San Francisco

San Francisco 5391959, California 5332921, 94143

Stanford Cancer Center, Stanford 5398563, California 5332921

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Address

Stanford Cancer Center

Stanford 5398563, California 5332921, 94305

Aurora 5412347, Colorado 5417618

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Address

University of Colorado Hospital - Anschutz Cancer Pavilion

Aurora 5412347, Colorado 5417618, 80045

Yale University, Yale Cancer Center, New Haven 4839366, Connecticut 4831725

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Address

Yale University, Yale Cancer Center

New Haven 4839366, Connecticut 4831725, 06510

Mayo Clinic Jacksonville, Jacksonville 4160021, Florida 4155751

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Address

Mayo Clinic Jacksonville

Jacksonville 4160021, Florida 4155751, 32224

Miami 4164138, Florida 4155751

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Sylvester Comprehensive Cancer Center - University of Miami Hospital and Clinics

Miami 4164138, Florida 4155751, 33136

Northwestern University, Chicago 4887398, Illinois 4896861

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Northwestern University

Chicago 4887398, Illinois 4896861, 60611

University of Chicago, Chicago 4887398, Illinois 4896861

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Address

University of Chicago

Chicago 4887398, Illinois 4896861, 60637

Indiana University Medical Center, Indianapolis 4259418, Indiana 4921868

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Address

Indiana University Medical Center

Indianapolis 4259418, Indiana 4921868, 46202

University of Kansas Medical Center, Kansas City 4273837, Kansas 4273857

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University of Kansas Medical Center

Kansas City 4273837, Kansas 4273857, 66160

University of Kentucky, Lexington 4297983, Kentucky 6254925

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Address

University of Kentucky

Lexington 4297983, Kentucky 6254925, 40536

Maine Medical Partners Neurology, Scarborough 4977882, Maine 4971068

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Address

Maine Medical Partners Neurology

Scarborough 4977882, Maine 4971068, 04074

John Hopkins Cancer Center, Baltimore 4347778, Maryland 4361885

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John Hopkins Cancer Center

Baltimore 4347778, Maryland 4361885, 21231

Tufts Medical Center, Boston 4930956, Massachusetts 6254926

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Tufts Medical Center

Boston 4930956, Massachusetts 6254926, 02111

Massachusetts General Hospital, Boston 4930956, Massachusetts 6254926

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Massachusetts General Hospital

Boston 4930956, Massachusetts 6254926, 02114

Dana-Farber Cancer Institute, Boston 4930956, Massachusetts 6254926

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Address

Dana-Farber Cancer Institute

Boston 4930956, Massachusetts 6254926, 02215

Ann Arbor 4984247, Michigan 5001836

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University of Michigan Comprehensive Cancer Center

Ann Arbor 4984247, Michigan 5001836, 48109

Henry Ford Hospital, Detroit 4990729, Michigan 5001836

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Address

Henry Ford Hospital

Detroit 4990729, Michigan 5001836, 48202

Metro Minnesota Community Oncology, Minneapolis 5037649, Minnesota 5037779

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Address

Metro Minnesota Community Oncology

Minneapolis 5037649, Minnesota 5037779, 55416

Mayo Comprehensive Cancer, Rochester 5043473, Minnesota 5037779

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Address

Mayo Comprehensive Cancer

Rochester 5043473, Minnesota 5037779, 55905

Washington University School of Medicine, St Louis 4407066, Missouri 4398678

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Address

Washington University School of Medicine

St Louis 4407066, Missouri 4398678, 63110

Columbia University Medical Center, New York 5128581, New York 5128638

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Columbia University Medical Center

New York 5128581, New York 5128638, 10032

Memorial Sloan Kettering Cancer Center, New York 5128581, New York 5128638

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Memorial Sloan Kettering Cancer Center

New York 5128581, New York 5128638, 10065

Duke University Medical Center, Durham 4464368, North Carolina 4482348

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Duke University Medical Center

Durham 4464368, North Carolina 4482348, 27710

Columbus 4509177, Ohio 5165418

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Address

Ohio State University Comprehensive Cancer Center

Columbus 4509177, Ohio 5165418, 43210

Oregon Health and Science University, Portland 5746545, Oregon 5744337

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Oregon Health and Science University

Portland 5746545, Oregon 5744337, 97239

University of Pennsylvania, Philadelphia 4560349, Pennsylvania 6254927

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University of Pennsylvania

Philadelphia 4560349, Pennsylvania 6254927, 19104

Pittsburgh 5206379, Pennsylvania 6254927

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University of Pittsburgh Hillman Cancer Center

Pittsburgh 5206379, Pennsylvania 6254927, 15232

Medical University of South Carolina, Charleston 4574324, South Carolina 4597040

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Medical University of South Carolina

Charleston 4574324, South Carolina 4597040, 29425

Tennessee Oncology, Nashville 4644585, Tennessee 4662168

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Tennessee Oncology

Nashville 4644585, Tennessee 4662168, 37203

Baylor University Medical Center, Dallas 4684888, Texas 4736286

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Baylor University Medical Center

Dallas 4684888, Texas 4736286, 75246

Dallas 4684888, Texas 4736286

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University of Texas Southwestern Medical Center

Dallas 4684888, Texas 4736286, 75390

MD Anderson Cancer Center, Houston 4699066, Texas 4736286

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MD Anderson Cancer Center

Houston 4699066, Texas 4736286, 77030

Salt Lake City 5780993, Utah 5549030

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Address

The University of Utah, Huntsman Cancer Hospital

Salt Lake City 5780993, Utah 5549030, 84112

Seattle Cancer Care Alliance, Seattle 5809844, Washington 5815135

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Seattle Cancer Care Alliance

Seattle 5809844, Washington 5815135, 98109

International Sites

BC Cancer Agency, Vancouver 6173331, British Columbia 5909050, Canada

Status

Address

BC Cancer Agency

Vancouver 6173331, British Columbia 5909050, V5Z 4E6

London Health Sciences Centre, London 6058560, Ontario 6093943, Canada

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Address

London Health Sciences Centre

London 6058560, Ontario 6093943, N6A 5W9

Sunnybrook Health Sciences Centre, Toronto 6167865, Ontario 6093943, Canada

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Sunnybrook Health Sciences Centre

Toronto 6167865, Ontario 6093943, M4N 3M5

Princess Margaret Hospital, Toronto 6167865, Ontario 6093943, Canada

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Princess Margaret Hospital

Toronto 6167865, Ontario 6093943,

McGill University Health Center, Montreal 6077243, Quebec 6115047, Canada

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McGill University Health Center

Montreal 6077243, Quebec 6115047, H3A 2B4

Lille 2998324, France

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Address

Centre Hospitalier Universitaire de Lille

Lille 2998324, , 59037

Hôpital Pierre Wertheimer, Lyon 2996944, France

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Address

Hôpital Pierre Wertheimer

Lyon 2996944, , 69394

Hopitaux de La Timone, Marseille 2995469, France

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Address

Hopitaux de La Timone

Marseille 2995469, , 13385

Hospitalier Pitié Salpétrière, Paris 2988507, France

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Address

Hospitalier Pitié Salpétrière

Paris 2988507, , 75013

Universitätsklinikum Essen, Essen 2928810, Germany

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Universitätsklinikum Essen

Essen 2928810, , 45122

Universitätsklinikum Hamburg Eppendorf, Hamburg 2911298, Germany

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Universitätsklinikum Hamburg Eppendorf

Hamburg 2911298, , 20246

Universitätsklinikum Heidelberg, Heidelberg 2907911, Germany

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Universitätsklinikum Heidelberg

Heidelberg 2907911, , 69120

Klinikum Mannheim Universitätsklinikum, Mannheim 2873891, Germany

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Address

Klinikum Mannheim Universitätsklinikum

Mannheim 2873891, , 68135

Hadassah Medical Center, Jerusalem 281184, Israel

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Address

Hadassah Medical Center

Jerusalem 281184, , 91120

Rabin Medical Center, Petah Tikva 293918, Israel

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Address

Rabin Medical Center

Petah Tikva 293918, , 49100

Chaim Sheba Medical Center, Ramat Gan 293788, Israel

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Address

Chaim Sheba Medical Center

Ramat Gan 293788, , 52621

Tel Aviv Sourasky Medical Center, Tel Aviv 293397, Israel

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Address

Tel Aviv Sourasky Medical Center

Tel Aviv 293397, , 6423906

Turin 3165524, Piedmont 3170831, Italy

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Azienda Ospedaliera Città della Salute e della Scienza di Torino

Turin 3165524, Piedmont 3170831, 10126

Ospedale Bellaria, Bologna 3181928, Italy

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Address

Ospedale Bellaria

Bologna 3181928, , 40139

Istituto Oncologico Veneto - I.R.C.C.S., Padua 3171728, Italy

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Address

Istituto Oncologico Veneto - I.R.C.C.S.

Padua 3171728, , 35128

Istituto Nazionale Tumori Regina Elena, Roma 8957247, Italy

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Address

Istituto Nazionale Tumori Regina Elena

Roma 8957247, , 144

Istituto Clinico Humanitas, Rozzano 3168837, Italy

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Address

Istituto Clinico Humanitas

Rozzano 3168837, , 20089

Nagoya University Hospital, Nagoya 1856057, Aichi-ken 1865694, Japan

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Nagoya University Hospital

Nagoya 1856057, Aichi-ken 1865694, 466-8560

Fujita Health University Hospital, Toyoake 6822210, Aichi-ken 1865694, Japan

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Fujita Health University Hospital

Toyoake 6822210, Aichi-ken 1865694, 470-1192

Hiroshima University Hospital, Minami-Ku, Hiroshima 1862413, Japan

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Hiroshima University Hospital

Minami-Ku, Hiroshima 1862413, 734-8551

The University of Tokyo Hospital, Bunkyō-Ku, Tokyo 1850144, Japan

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The University of Tokyo Hospital

Bunkyō-Ku, Tokyo 1850144, 113-8655

National Cancer Center Hospital, Chuo Ku, Tokyo 1850144, Japan

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National Cancer Center Hospital

Chuo Ku, Tokyo 1850144, 104-0045

Kumamoto University Hospital, Kumamoto 1858421, Japan

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Kumamoto University Hospital

Kumamoto 1858421, , 860-8556

Kyoto 1857910, Japan

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University Hospital, Kyoto Prefectural University of Medicine

Kyoto 1857910, , 602-8566

Kyoto University Hospital, Kyoto 1857910, Japan

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Kyoto University Hospital

Kyoto 1857910, , 606-8507

Okayama University Hospital, Okayama 1854383, Japan

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Address

Okayama University Hospital

Okayama 1854383, , 700-8558

Haaglanden MC, Antoniushove, Leidschendam 2751769, South Holland 2743698, Netherlands

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Haaglanden MC, Antoniushove

Leidschendam 2751769, South Holland 2743698, 2262 BA

Erasmus Medical Center, Rotterdam 2747891, Netherlands

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Address

Erasmus Medical Center

Rotterdam 2747891, , 3015 GD

Universitair Medisch Centrum Utrecht, Utrecht 2745912, Netherlands

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Address

Universitair Medisch Centrum Utrecht

Utrecht 2745912, , 3584 CX

Hospital Universitario Vall d'Hebrón, Barcelona 3128760, Spain

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Address

Hospital Universitario Vall d'Hebrón

Barcelona 3128760, , 08035

Hospital Universitario Ramon y Cajal, Madrid 3117735, Spain

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Hospital Universitario Ramon y Cajal

Madrid 3117735, , 28034

Hospital Universitario 12 de Octubre, Madrid 3117735, Spain

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Hospital Universitario 12 de Octubre

Madrid 3117735, , 28041

Hôpitaux Universitaire de Genève, Geneva 2660646, Switzerland

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Hôpitaux Universitaire de Genève

Geneva 2660646, , 1211

Centre Hospitalier Universitaire Vaudois, Lausanne 2659994, Switzerland

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Address

Centre Hospitalier Universitaire Vaudois

Lausanne 2659994, , 1011

Universitätsspital Zürich, Zurich 2657896, Switzerland

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Address

Universitätsspital Zürich

Zurich 2657896, , 8006

Freeman Hospital, Newcastle upon Tyne 2641673, England 6269131, United Kingdom

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Freeman Hospital

Newcastle upon Tyne 2641673, England 6269131, NE7 7DN

The Royal Marsden NHS Foundation Trust, Sutton 2636503, Surrey, United Kingdom

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The Royal Marsden NHS Foundation Trust

Sutton 2636503, Surrey, SM2 5PT

Edinburgh 2650225, United Kingdom

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Address

Western General Hospital Edinburgh - PPDS

Edinburgh 2650225, , EH4 2XY

The Christie NHS Foundation Trust, Manchester 2643123, United Kingdom

Status

Address

The Christie NHS Foundation Trust

Manchester 2643123, , M20 4BX

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