An Investigational Immuno-therapy Study of Nivolumab Combined With Ipilimumab Compared to Nivolumab by Itself After Complete Surgical Removal of Stage IIIb/c/d or Stage IV Melanoma

Study Purpose

The purpose of this study is to determine whether an investigational immunotherapy Nivolumab, when combined with Ipilimumab, is more effective than Nivolumab by itself, in delaying the return of cancer in patients who have had a complete surgical removal of stage IIIb/c/d or stage IV Melanoma

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

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

  • - Completely surgically resected stage IIIb/c/d or stage IV melanoma within 12 weeks of participation in study.
  • - Must have full activity or, if limited, must be able to walk and carry out activities such as light house work or office work.
  • - No prior anti-cancer treatment for melanoma (except surgery for the melanoma lesion(s) and/or except for adjuvant radiation therapy (RT) after neurosurgical resection for central nervous system (CNS) lesions)

    Exclusion Criteria:

    - History of uveal melanoma.
  • - Patients with active, known or suspected autoimmune disease.
  • - Prior treatment with interferon (if complete < 6 months prior to participation in study), anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
Other protocol defined inclusion/exclusion criteria could apply

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.

NCT03068455
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.

Bristol-Myers Squibb
Principal Investigator

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

Bristol-Myers Squibb
Principal Investigator Affiliation Bristol-Myers Squibb
Agency Class

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

Industry
Overall Status Active, not recruiting
Countries Australia, Austria, Belgium, Brazil, Canada, Czechia, France, Germany, Greece, Israel, Italy, New Zealand, Poland, Romania, Russian Federation, Spain, Switzerland, United Kingdom, United States
Conditions

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

Melanoma
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: nivolumab + ipilimumab

Specified Dose on Specified Days

Experimental: nivolumab

Specified Dose on Specified Days

Interventions

Biological: - nivolumab

Specified Dose on Specified Days

Biological: - ipilimumab

Specified Dose on Specified Days

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 Arizona Cancer Center, Tucson, Arizona

Status

Address

University of Arizona Cancer Center

Tucson, Arizona, 85724

The Angeles Clinic & Research Institute, Los Angeles, California

Status

Address

The Angeles Clinic & Research Institute

Los Angeles, California, 90025

California Pacific Medical Center, San Francisco, California

Status

Address

California Pacific Medical Center

San Francisco, California, 94115

University Of Colorado, Aurora, Colorado

Status

Address

University Of Colorado

Aurora, Colorado, 80045

Georgetown University Med Ctr, Washington, District of Columbia

Status

Address

Georgetown University Med Ctr

Washington, District of Columbia, 20007

Mount Sinai Comprehensive Cancer Center, Miami Beach, Florida

Status

Address

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, 33140

Orlando, Florida

Status

Address

UF Health Cancer Center at Orlando Health

Orlando, Florida, 32806

Winship Cancer Institute, Atlanta, Georgia

Status

Address

Winship Cancer Institute

Atlanta, Georgia, 30322

Northwestern University, Chicago, Illinois

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Address

Northwestern University

Chicago, Illinois, 60611

University Of Chicago, Chicago, Illinois

Status

Address

University Of Chicago

Chicago, Illinois, 60637

Oncology Specialists, S.C., Park Ridge, Illinois

Status

Address

Oncology Specialists, S.C.

Park Ridge, Illinois, 60068

Mass General Hospital, Boston, Massachusetts

Status

Address

Mass General Hospital

Boston, Massachusetts, 02114

Beth Israel Deaconess Medical Center, Boston, Massachusetts

Status

Address

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

Dana-Farber Cancer Institute, Boston, Massachusetts

Status

Address

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

University Of Michigan Health System, Ann Arbor, Michigan

Status

Address

University Of Michigan Health System

Ann Arbor, Michigan, 48109-5848

Virginia Piper Cancer Institute, Minneapolis, Minnesota

Status

Address

Virginia Piper Cancer Institute

Minneapolis, Minnesota, 55407

Mayo Clinic Rochester, Rochester, Minnesota

Status

Address

Mayo Clinic Rochester

Rochester, Minnesota, 55905

Washington University School Of Medicine, Saint Louis, Missouri

Status

Address

Washington University School Of Medicine

Saint Louis, Missouri, 63110

NYU Langone Medical Center, New York, New York

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Address

NYU Langone Medical Center

New York, New York, 10016

Memorial Sloan Kettering Nassau, New York, New York

Status

Address

Memorial Sloan Kettering Nassau

New York, New York, 10065

Carolinas Med Ctr, Charlotte, North Carolina

Status

Address

Carolinas Med Ctr

Charlotte, North Carolina, 28204

Duke University Medical Center, Durham, North Carolina

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Address

Duke University Medical Center

Durham, North Carolina, 27710

Portland, Oregon

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Address

Providence Cancer Center Oncology And Hematology Care

Portland, Oregon, 97213

Oregon Health & Science University, Portland, Oregon

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Address

Oregon Health & Science University

Portland, Oregon, 97239

St. Luke's University Health Network, Easton, Pennsylvania

Status

Address

St. Luke's University Health Network

Easton, Pennsylvania, 18045

Local Institution, Nashville, Tennessee

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Address

Local Institution

Nashville, Tennessee, 37232

Texas Oncology Sammons Cancer Center, Dallas, Texas

Status

Address

Texas Oncology Sammons Cancer Center

Dallas, Texas, 75246

Md Anderson Can Cnt, Houston, Texas

Status

Address

Md Anderson Can Cnt

Houston, Texas, 77030-4009

Huntsman Cancer Institute, Salt Lake City, Utah

Status

Address

Huntsman Cancer Institute

Salt Lake City, Utah, 84112

University Of Virginia Health System, Charlottesville, Virginia

Status

Address

University Of Virginia Health System

Charlottesville, Virginia, 22908

Inova Melanoma and Skin Cancer Center, Fairfax, Virginia

Status

Address

Inova Melanoma and Skin Cancer Center

Fairfax, Virginia, 55905

Seattle, Washington

Status

Address

University Of Washington Cancer Care Alliance

Seattle, Washington, 98109-1023

International Sites

Local Institution, North Sydney, New South Wales, Australia

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Address

Local Institution

North Sydney, New South Wales, 2060

Local Institution, Waratah, New South Wales, Australia

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Address

Local Institution

Waratah, New South Wales, 2298

Local Institution, Westmead, New South Wales, Australia

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Address

Local Institution

Westmead, New South Wales, 2145

Local Institution, Greenslopes, Queensland, Australia

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Address

Local Institution

Greenslopes, Queensland, 4120

Local Institution, Southport, Queensland, Australia

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Address

Local Institution

Southport, Queensland, 4215

Local Institution, Woolloongabba, Queensland, Australia

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Address

Local Institution

Woolloongabba, Queensland, 4120

Local Institution, Adelaide, South Australia, Australia

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Address

Local Institution

Adelaide, South Australia, 5000

Local Institution, Box Hill, Victoria, Australia

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Address

Local Institution

Box Hill, Victoria, 3128

Local Institution, Melbourne, Victoria, Australia

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Address

Local Institution

Melbourne, Victoria, 3000

Local Institution, Melbourne, Victoria, Australia

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Address

Local Institution

Melbourne, Victoria, 3004

Local Institution, Nedlands, Western Australia, Australia

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Address

Local Institution

Nedlands, Western Australia, 6009

Local Institution, Subiaco, Western Australia, Australia

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Address

Local Institution

Subiaco, Western Australia, 6008

Local Institution, Graz, Austria

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Address

Local Institution

Graz, , 8036

Local Institution, Wien, Austria

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Address

Local Institution

Wien, , 1090

Local Institution, Brussels, Belgium

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Address

Local Institution

Brussels, , 1090

Local Institution, Bruxelles, Belgium

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Address

Local Institution

Bruxelles, , 1200

Local Institution, Gent, Belgium

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Address

Local Institution

Gent, , B-9000

Local Institution, Liege, Belgium

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Address

Local Institution

Liege, , 4000

Local Institution, Salvador, Bahia, Brazil

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Address

Local Institution

Salvador, Bahia, 41950-610

Local Institution, Belo Horizonte, Minas Gerais, Brazil

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Address

Local Institution

Belo Horizonte, Minas Gerais, 30130-090

Local Institution, Ijui, RIO Grande DO SUL, Brazil

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Address

Local Institution

Ijui, RIO Grande DO SUL, 98700-000

Local Institution, Porto Alegre, RIO Grande DO SUL, Brazil

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Address

Local Institution

Porto Alegre, RIO Grande DO SUL, 90610-000

Local Institution, Florianopolis, Santa Catarina, Brazil

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Address

Local Institution

Florianopolis, Santa Catarina, 88034-000

Local Institution, Barretos, SAO Paulo, Brazil

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Address

Local Institution

Barretos, SAO Paulo, 14780-070

Local Institution, Sao Jose do Rio Preto, SAO Paulo, Brazil

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Address

Local Institution

Sao Jose do Rio Preto, SAO Paulo, 15090-000

Local Institution, Rio De Janeiro, Brazil

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Local Institution

Rio De Janeiro, , 20220-410

Local Institution, Rio de Janeiro, Brazil

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Address

Local Institution

Rio de Janeiro, , 22793-080

Local Institution, Sao Paulo, Brazil

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Address

Local Institution

Sao Paulo, , 01246-000

Local Institution, Edmonton, Alberta, Canada

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Local Institution

Edmonton, Alberta, T6G 1Z2

Local Institution, Vancouver, British Columbia, Canada

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Local Institution

Vancouver, British Columbia, V5Z 4E6

Local Institution, Ottawa, Ontario, Canada

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Address

Local Institution

Ottawa, Ontario, K1H 8L6

Princess Margaret Cancer Centre, Toronto, Ontario, Canada

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Address

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9

Local Institution, Montreal, Quebec, Canada

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Address

Local Institution

Montreal, Quebec, H2L 4M1

Local Institution, Montreal, Quebec, Canada

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Address

Local Institution

Montreal, Quebec, H3T 1E2

CHU de Quebec - Universite Laval, Quebec, Canada

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Address

CHU de Quebec - Universite Laval

Quebec, , G1R 2J6

Klinika komplexni onkologicke pece, Brno, Czechia

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Klinika komplexni onkologicke pece

Brno, , 656 53

Klinika onkologie a radioterapie, Hradec Kralove, Czechia

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Address

Klinika onkologie a radioterapie

Hradec Kralove, , 500 05

Praha 10, Czechia

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Address

Dermatovenerologicka klinika 3. LF UK a FNKV

Praha 10, , 100 34

Praha 2, Czechia

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Address

Dermatovenerologicka klinika VFN a 1. LF UK

Praha 2, , 128 08

Dijon, France

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Address

Centre Hospitalier Universitaire Dijon Bocage

Dijon, , 21079

Hopital Claude Huriez, LILLE Cedex, France

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Address

Hopital Claude Huriez

LILLE Cedex, , 59037

Hopital De La Timone, Marseille Cedex 5, France

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Address

Hopital De La Timone

Marseille Cedex 5, , 13385

Chu Nantes, Nantes, France

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Address

Chu Nantes

Nantes, , 44093

Hopital Saint Louis, Paris, France

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Address

Hopital Saint Louis

Paris, , 75475

Centre Hospitalier Lyon Sud, Pierre Benite Cedex, France

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Address

Centre Hospitalier Lyon Sud

Pierre Benite Cedex, , 69495

Institut Claudius Regaud, Toulouse Cedex 9, France

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Address

Institut Claudius Regaud

Toulouse Cedex 9, , 31059

Institut Gustave Roussy, Villejuif, France

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Address

Institut Gustave Roussy

Villejuif, , 94805

Local Institution, Berlin, Germany

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Local Institution

Berlin, , 10117

Local Institution, Buxtehude, Germany

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Address

Local Institution

Buxtehude, , 21614

Local Institution, Essen, Germany

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Address

Local Institution

Essen, , 45147

Local Institution, Gera, Germany

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Address

Local Institution

Gera, , 07548

Local Institution, Hannover, Germany

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Address

Local Institution

Hannover, , 30625

Local Institution, Heidelberg, Germany

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Address

Local Institution

Heidelberg, , 69120

Local Institution, Luebeck, Germany

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Address

Local Institution

Luebeck, , 23538

Local Institution, Muenchen, Germany

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Address

Local Institution

Muenchen, , 80337

Local Institution, Tuebingen, Germany

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Address

Local Institution

Tuebingen, , 72076

Laiko Hospital, Athens, Greece

Status

Address

Laiko Hospital

Athens, , 11527

Metropolitan Hospital, Athens, Greece

Status

Address

Metropolitan Hospital

Athens, , 18547

Local Institution, Haifa, Israel

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Address

Local Institution

Haifa, , 3109601

Local Institution, Jerusalem, Israel

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Address

Local Institution

Jerusalem, , 91120

Local Institution, Tel Hashomer, Israel

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Address

Local Institution

Tel Hashomer, , 52621

ASST Papa Giovanni XXIII, Bergamo, Italy

Status

Address

ASST Papa Giovanni XXIII

Bergamo, , 24127

Ospedale Policlinico San Martino, Genova, Italy

Status

Address

Ospedale Policlinico San Martino

Genova, , 16132

IRCCS Istituto Nazionale Tumori Milano, Milano, Italy

Status

Address

IRCCS Istituto Nazionale Tumori Milano

Milano, , 20133

Napoli, Italy

Status

Address

Istituto Nazionale Tumori Fondazione Pascale

Napoli, , 80131

Istituto Oncologico Veneto IOV, Padova, Italy

Status

Address

Istituto Oncologico Veneto IOV

Padova, , 35128

Azienda Ospedaliera Universitaria Senese, Siena, Italy

Status

Address

Azienda Ospedaliera Universitaria Senese

Siena, , 53100

Local Institution, Tauranga, BAY OF Plenty, New Zealand

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Address

Local Institution

Tauranga, BAY OF Plenty, 3143

Local Institution, Christchurch, New Zealand

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Address

Local Institution

Christchurch, ,

Local Institution, Dunedin, New Zealand

Status

Address

Local Institution

Dunedin, , 9001

Krakow, Poland

Status

Address

Klinika Nowotworow Ukladowych i Uogolnionych

Krakow, , 31-115

Warszawa, Poland

Status

Address

Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow

Warszawa, , 02-781

Bucharest, Romania

Status

Address

Institute Of Oncology "Prof.Dr.Alexandru Trestioreanu" Bucha

Bucharest, , 022328

Sf. Nectarie Oncology Center, Craiova, Romania

Status

Address

Sf. Nectarie Oncology Center

Craiova, , 200347

Local Institution, Krasnodar, Russian Federation

Status

Address

Local Institution

Krasnodar, , 350040

Local Institution, Krasnoyarsk, Russian Federation

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Address

Local Institution

Krasnoyarsk, , 660133

Local Institution, Moscow, Russian Federation

Status

Address

Local Institution

Moscow, , 115478

Badalona-barcelona, Spain

Status

Address

Hospital Universitari Germans Trias I Pujol

Badalona-barcelona, , 08916

H. Univ. Vall dHebron, Barcelona, Spain

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Address

H. Univ. Vall dHebron

Barcelona, , 08035

Hospital Clinic I Provincial, Barcelona, Spain

Status

Address

Hospital Clinic I Provincial

Barcelona, , 08036

Hospital Gral. Univ. Gregorio Maranon, Madrid, Spain

Status

Address

Hospital Gral. Univ. Gregorio Maranon

Madrid, , 28007

Malaga, Spain

Status

Address

Hospital Regional Universitario De Malaga

Malaga, , 29010

Hosp Univ Virgen Macarena, Sevilla, Spain

Status

Address

Hosp Univ Virgen Macarena

Sevilla, , 41009

Valencia, Spain

Status

Address

Hospital Universitario Y Politecnico La Fe

Valencia, , 46026

Local Institution, Lausanne, Switzerland

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Address

Local Institution

Lausanne, , 1011

Local Institution, Zurich, Switzerland

Status

Address

Local Institution

Zurich, , 8091

Local Institution, Oxford, Oxfordshire, United Kingdom

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Address

Local Institution

Oxford, Oxfordshire, OX3 7LJ

Glasgow, United Kingdom

Status

Address

The Beatson West Of Scotland Cancer Centre

Glasgow, , G12 0YN

The Royal Marsden Hospital, London, United Kingdom

Status

Address

The Royal Marsden Hospital

London, , SW3 6JJ

Christie Hospital Nhs Trust, Manchester, United Kingdom

Status

Address

Christie Hospital Nhs Trust

Manchester, , M20 4BX

Royal Marsden Hospital - Surrey, Sutton., United Kingdom

Status

Address

Royal Marsden Hospital - Surrey

Sutton., , SM25PT

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