An Investigational Immuno-therapy Study of BMS-986205 Combined With Nivolumab, Compared to Nivolumab by Itself, in Patients With Advanced Melanoma
A Phase 3, Randomized, Double-blind Study of BMS-986205 Combined With Nivolumab Versus Nivolumab in Participants With Metastatic or Unresectable Melanoma That is Previously Untreated
2 other identifiers
interventional
20
16 countries
63
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Nov 2017
Typical duration for phase_3
63 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2017
CompletedFirst Posted
Study publicly available on registry
November 6, 2017
CompletedStudy Start
First participant enrolled
November 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 2, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 2, 2020
CompletedResults Posted
Study results publicly available
July 9, 2021
CompletedJuly 9, 2021
June 1, 2021
2.6 years
October 31, 2017
June 18, 2021
June 18, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants Experiencing Adverse Events
Number of participants experiencing different types of Adverse Events, including Death, Any cause Adverse Events (AEs), Drug-related AEs, Any cause Serious Adverse Events (SAEs), Drug-related SAEs, SAEs leading to discontinuation, and Drug-related Non-serious AEs leading to discontinuation
From first dose to 30 days following last dose (up to approximately 25 months)
Study Arms (2)
Nivolumab + Placebo
ACTIVE COMPARATORSpecified dose on specified day Participants will no longer receive BMS-986205 Placebo
Nivolumab + BMS-986205
EXPERIMENTALSpecified dose on specified day. Participants have the option to discontinue BMS-986205, and continue nivolumab monotherapy, at investigator discretion
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (63)
Angeles Clinic and Research Institute
Los Angeles, California, 90025, United States
University Of Colorado
Aurora, Colorado, 80045, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140, United States
University Of Chicago
Chicago, Illinois, 60637, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Local Institution
Seattle, Washington, 98109, United States
Local Institution
Blacktown, New South Wales, 2148, Australia
Melanoma Institute Australia
North Sydney, New South Wales, 2146, Australia
Local Institution
Greenslopes, Queensland, 4120, Australia
Local Institution
Woolloongabba, Queensland, 4120, Australia
Local Institution
Box Hill, Victoria, 3128, Australia
Local Institution
Melbourne, Victoria, 3000, Australia
Local Institution
Melbourne, Victoria, 3004, Australia
Local Institution
Montreal, Quebec, H3T 1E2, Canada
Local Institution
Québec, Quebec, G1R 2J6, Canada
Klinika onkologie a radioterapie
Hradec Králové, 500 05, Czechia
Dermatovenerologicka klinika 3. LF UK a FNKV
Prague, 100 34, Czechia
Dermatovenerologicka klinika VFN a 1. LF UK
Prague, 128 08, Czechia
Local Institution
Boulogne-Billancourt, 92104, France
Local Institution
Saint-Etienne, 42055, France
Local Institution
Villejuif, 94805, France
Elbe Klinikum Buxtehude
Buxtehude, 21614, Germany
Universitaetsklinikum Carl Gustav Carus
Dresden, 01307, Germany
Local Institution
Essen, 45147, Germany
SRH Wald-Kliniken Gera GmbH
Gera, Germany
Georg August Universitaet Goettingen
Göttingen, 37075, Germany
Local Institution
Hanover, 30625, Germany
Local Institution
Heidelberg, 69120, Germany
Local Institution
München, 80337, Germany
Local Institution
Tübingen, 72076, Germany
Interbalkan European Medical Center
Thessaloniki, 57001, Greece
Local Institution
Dooradoyle, Limerick, Ireland
Local Institution
Dublin, 4, Ireland
Local Institution
Dublin, 7, Ireland
Local Institution
Milan, 20133, Italy
Istituto Nazionale Tumori Fondazione Pascale
Napoli, 80131, Italy
Azienda Ospedaliera Universitaria Senese
Siena, 53100, Italy
Local Institution
Sendai, Miyagi, 9808574, Japan
Local Institution
Niigata, Niigata, 9518566, Japan
Local Institution
Okayama, Okayama-ken, 7000914, Japan
Local Institution
Osaka, Osaka, 5418567, Japan
Local Institution
Chuo-ku, Tokyo, 1040045, Japan
Local Institution
Amsterdam, 1066 CX, Netherlands
Local Institution
Groningen, 9700RB, Netherlands
Local Institution
Nijmegen, 6525 GA, Netherlands
Local Institution
Rotterdam, 3008 AE, Netherlands
Local Institution
Christchurch, New Zealand
Local Institution
Wellington, 6021, New Zealand
Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow
Warsaw, 02-781, Poland
Local Institution
Barcelona, 08036, Spain
Local Institution
Jaén, 23007, Spain
Local Institution
Madrid, 28007, Spain
Local Institution
Málaga, 29010, Spain
Local Institution
Santiago Compostela, 15706, Spain
Local Institution
Valencia, 46026, Spain
Universitaetsspital Zuerich
Zurich, 8091, Switzerland
Local Institution
London, Greater London, SW17 0RE, United Kingdom
Local Institution
London, Greater London, SW3 6JJ, United Kingdom
Local Institution
Belfast, BT9 7AB, United Kingdom
Local Institution
Cambridge, CB2 0QQ, United Kingdom
Local Institution
Cottingham, HU16 5JQ, United Kingdom
Local Institution
Manchester, M20 4BX, United Kingdom
Local Institution
Tauton, TA1 5DA, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2017
First Posted
November 6, 2017
Study Start
November 30, 2017
Primary Completion
July 2, 2020
Study Completion
July 2, 2020
Last Updated
July 9, 2021
Results First Posted
July 9, 2021
Record last verified: 2021-06