An Investigational Immuno-therapy Study of BMS-986205 Combined With Nivolumab, Compared to Nivolumab by Itself, in Patients With Advanced Melanoma

Study Purpose

The purpose of this study is to see if BMS-986205 combined with nivolumab, compared to nivolumab by itself, is more effective in treating Melanoma that has spread or is unable to be removed by surgery, and has not previously been treated

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:

  • - 12 years and older unless not permitted by local regulations; in that case 18 years old and older.
  • - Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 1.
  • - Histologically confirmed Stage III (unresectable) or Stage IV melanoma, per the American Joint Committee on Cancer (AJCC) Staging Manual (8th edition) - Treatment-naïve participants (no prior systemic anticancer therapy for unresectable or metastatic melanoma) - Measurable disease per RECIST v1.1.

Exclusion Criteria:

  • - Active brain metastases or leptomeningeal metastases.
  • - Uveal or ocular melanoma.
  • - Participants with active, known, or suspected autoimmune disease.
  • - Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured.
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.

NCT03329846
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, Canada, Czechia, France, Germany, Greece, Ireland, Italy, Japan, Netherlands, New Zealand, Poland, Spain, Switzerland, United Kingdom, United States
Conditions

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

Melanoma, Skin Cancer
Study Website: View Trial Website
Arms & Interventions

Arms

Active Comparator: Nivolumab + Placebo

Specified dose on specified day Participants will no longer receive BMS-986205 Placebo

Experimental: Nivolumab + BMS-986205

Specified dose on specified day. Participants have the option to discontinue BMS-986205, and continue nivolumab monotherapy, at investigator discretion

Interventions

Drug: - BMS-986205

specified dose on specified day

Biological: - Nivolumab

Specified dose on specified day

Drug: - Placebo

Specified dose on specified day

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.

Angeles Clinic and Research Institute, Los Angeles, California

Status

Address

Angeles Clinic and Research Institute

Los Angeles, California, 90025

University Of Colorado, Aurora, Colorado

Status

Address

University Of Colorado

Aurora, Colorado, 80045

Mount Sinai Comprehensive Cancer Center, Miami Beach, Florida

Status

Address

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, 33140

The University of Chicago Medicine, Chicago, Illinois

Status

Address

The University of Chicago Medicine

Chicago, Illinois, 60637

Oregon Health & Science University, Portland, Oregon

Status

Address

Oregon Health & Science University

Portland, Oregon, 97239

Local Institution, Seattle, Washington

Status

Address

Local Institution

Seattle, Washington, 98109

International Sites

Local Institution, Blacktown, New South Wales, Australia

Status

Address

Local Institution

Blacktown, New South Wales, 2148

Melanoma Institute Australia, North Sydney, New South Wales, Australia

Status

Address

Melanoma Institute Australia

North Sydney, New South Wales, 2146

Local Institution, Greenslopes, Queensland, Australia

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Address

Local Institution

Greenslopes, Queensland, 4120

Local Institution, Woolloongabba, Queensland, Australia

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Address

Local Institution

Woolloongabba, Queensland, 4120

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, Montreal, Quebec, Canada

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Address

Local Institution

Montreal, Quebec, H3T 1E2

Local Institution, Quebec, Canada

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Address

Local Institution

Quebec, , G1R 2J6

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

Local Institution, Boulogne-billancourt, France

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Local Institution

Boulogne-billancourt, , 92104

Local Institution, Saint Etienne Cedex 2, France

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Local Institution

Saint Etienne Cedex 2, , 42055

Local Institution, Villejuif Cedex, France

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Address

Local Institution

Villejuif Cedex, , 94805

Elbe Klinikum Buxtehude, Buxtehude, Germany

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Address

Elbe Klinikum Buxtehude

Buxtehude, , 21614

Universitaetsklinikum Carl Gustav Carus, Dresden, Germany

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Universitaetsklinikum Carl Gustav Carus

Dresden, , 01307

Local Institution, Essen, Germany

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Address

Local Institution

Essen, , 45147

SRH Wald-Kliniken Gera GmbH, Gera, Germany

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SRH Wald-Kliniken Gera GmbH

Gera, ,

Georg August Universitaet Goettingen, Goettingen, Germany

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Address

Georg August Universitaet Goettingen

Goettingen, , 37075

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, Muenchen, Germany

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Local Institution

Muenchen, , 80337

Local Institution, Tuebingen, Germany

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Address

Local Institution

Tuebingen, , 72076

Interbalkan European Medical Center, Thessaloniki, Greece

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Address

Interbalkan European Medical Center

Thessaloniki, , 57001

Local Institution, Dooradoyle, Limerick, Ireland

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Local Institution

Dooradoyle, Limerick,

Local Institution, Dublin, Ireland

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Local Institution

Dublin, , 4

Local Institution, Dublin, Ireland

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Address

Local Institution

Dublin, , 7

Local Institution, Milano, Italy

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Local Institution

Milano, , 20133

Napoli, Italy

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Istituto Nazionale Tumori Fondazione Pascale

Napoli, , 80131

Azienda Ospedaliera Universitaria Senese, Siena, Italy

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Address

Azienda Ospedaliera Universitaria Senese

Siena, , 53100

Local Institution, Sendai-shi, Miyagi, Japan

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Local Institution

Sendai-shi, Miyagi, 9808574

Local Institution, Niigata-shi, Niigata, Japan

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Local Institution

Niigata-shi, Niigata, 9518566

Local Institution, Okayama-shi, Okayama, Japan

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Local Institution

Okayama-shi, Okayama, 7000914

Local Institution, Osaka-shi, Osaka, Japan

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Local Institution

Osaka-shi, Osaka, 5418567

Local Institution, Chuo-ku, Tokyo, Japan

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Local Institution

Chuo-ku, Tokyo, 1040045

Local Institution, Amsterdam, Netherlands

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Local Institution

Amsterdam, , 1066 CX

Local Institution, Groningen, Netherlands

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Local Institution

Groningen, , 9700RB

Local Institution, Nijmegen, Netherlands

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Local Institution

Nijmegen, , 6525 GA

Local Institution, Rotterdam, Netherlands

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Local Institution

Rotterdam, , 3008 AE

Local Institution, Christchurch, New Zealand

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Local Institution

Christchurch, ,

Local Institution, Wellington, New Zealand

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Local Institution

Wellington, , 6021

Warszawa, Poland

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Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow

Warszawa, , 02-781

Local Institution, Barcelona, Spain

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Local Institution

Barcelona, , 08036

Local Institution, Jaen, Spain

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Local Institution

Jaen, , 23007

Local Institution, Madrid, Spain

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Local Institution

Madrid, , 28007

Local Institution, Malaga, Spain

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Local Institution

Malaga, , 29010

Local Institution, Santiago Compostela, Spain

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Local Institution

Santiago Compostela, , 15706

Local Institution, Valencia, Spain

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Local Institution

Valencia, , 46026

Universitaetsspital Zuerich, Zurich, Switzerland

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Address

Universitaetsspital Zuerich

Zurich, , 8091

Local Institution, London, Greater London, United Kingdom

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Local Institution

London, Greater London, SW17 0RE

Local Institution, London, Greater London, United Kingdom

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Local Institution

London, Greater London, SW3 6JJ

Local Institution, Belfast, United Kingdom

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Local Institution

Belfast, , BT9 7AB

Local Institution, Cambridge, United Kingdom

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Local Institution

Cambridge, , CB2 0QQ

Local Institution, Cottingham, United Kingdom

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Local Institution

Cottingham, , HU16 5JQ

Local Institution, Manchester, United Kingdom

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Local Institution

Manchester, , M20 4BX

Local Institution, Tauton, United Kingdom

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Local Institution

Tauton, , TA1 5DA

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