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

June 18, 2021 updated by: Bristol-Myers Squibb

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
        • Local Institution
      • North Sydney, New South Wales, Australia, 2146
        • Melanoma Institute Australia
    • Queensland
      • Greenslopes, Queensland, Australia, 4120
        • Local Institution
      • Woolloongabba, Queensland, Australia, 4120
        • Local Institution
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Local Institution
      • Melbourne, Victoria, Australia, 3004
        • Local Institution
      • Melbourne, Victoria, Australia, 3000
        • Local Institution
  • Canada
      • Quebec, Canada, G1R 2J6
        • Local Institution
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Local Institution
  • Czechia
      • Hradec Kralove, Czechia, 500 05
        • Klinika onkologie a radioterapie
      • Praha 10, Czechia, 100 34
        • Dermatovenerologicka klinika 3. LF UK a FNKV
      • Praha 2, Czechia, 128 08
        • Dermatovenerologicka klinika VFN a 1. LF UK
  • France
      • Boulogne-billancourt, France, 92104
        • Local Institution
      • Saint Etienne Cedex 2, France, 42055
        • Local Institution
      • Villejuif Cedex, France, 94805
        • Local Institution
  • Germany
      • Buxtehude, Germany, 21614
        • Elbe Klinikum Buxtehude
      • Dresden, Germany, 01307
        • Universitaetsklinikum Carl Gustav Carus
      • Essen, Germany, 45147
        • Local Institution
      • Gera, Germany
        • SRH Wald-Kliniken Gera GmbH
      • Goettingen, Germany, 37075
        • Georg August Universitaet Goettingen
      • Hannover, Germany, 30625
        • Local Institution
      • Heidelberg, Germany, 69120
        • Local Institution
      • Muenchen, Germany, 80337
        • Local Institution
      • Tuebingen, Germany, 72076
        • Local Institution
  • Greece
      • Thessaloniki, Greece, 57001
        • Interbalkan European Medical Center
  • Ireland
      • Dublin, Ireland, 4
        • Local Institution
      • Dublin, Ireland, 7
        • Local Institution
    • Limerick
      • Dooradoyle, Limerick, Ireland
        • Local Institution
  • Italy
      • Milano, Italy, 20133
        • Local Institution
      • Napoli, Italy, 80131
        • Istituto Nazionale Tumori Fondazione Pascale
      • Siena, Italy, 53100
        • Azienda Ospedaliera Universitaria Senese
  • Japan
    • Miyagi
      • Sendai-shi, Miyagi, Japan, 9808574
        • Local Institution
    • Niigata
      • Niigata-shi, Niigata, Japan, 9518566
        • Local Institution
    • Okayama
      • Okayama-shi, Okayama, Japan, 7000914
        • Local Institution
    • Osaka
      • Osaka-shi, Osaka, Japan, 5418567
        • Local Institution
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 1040045
        • Local Institution
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Local Institution
      • Groningen, Netherlands, 9700RB
        • Local Institution
      • Nijmegen, Netherlands, 6525 GA
        • Local Institution
      • Rotterdam, Netherlands, 3008 AE
        • Local Institution
  • New Zealand
      • Christchurch, New Zealand
        • Local Institution
      • Wellington, New Zealand, 6021
        • Local Institution
  • Poland
      • Warszawa, Poland, 02-781
        • Klinika Nowotworów Tkanek Miękkich, Kości i Czerniaków
  • Spain
      • Barcelona, Spain, 08036
        • Local Institution
      • Jaen, Spain, 23007
        • Local Institution
      • Madrid, Spain, 28007
        • Local Institution
      • Malaga, Spain, 29010
        • Local Institution
      • Santiago Compostela, Spain, 15706
        • Local Institution
      • Valencia, Spain, 46026
        • Local Institution
  • Switzerland
      • Zürich, Switzerland, 8091
        • Universitaetsspital Zuerich
  • United Kingdom
      • Belfast, United Kingdom, BT9 7AB
        • Local Institution
      • Cambridge, United Kingdom, CB2 0QQ
        • Local Institution
      • Cottingham, United Kingdom, HU16 5JQ
        • Local Institution
      • Manchester, United Kingdom, M20 4BX
        • Local Institution
      • Tauton, United Kingdom, TA1 5DA
        • Local Institution
    • Greater London
      • London, Greater London, United Kingdom, SW17 0RE
        • Local Institution
      • London, Greater London, United Kingdom, SW3 6JJ
        • Local Institution
  • United States
    • California
      • Los Angeles, California, United States, 90025
        • Angeles Clinic and Research Institute
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado
    • Florida
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Comprehensive Cancer Center
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
    • Washington
      • Seattle, Washington, United States, 98109
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Nivolumab + Placebo

Specified dose on specified day

Participants will no longer receive BMS-986205 Placebo
Biological: Nivolumab
Specified dose on specified day
Other Names:
  • BMS-936558
Drug: Placebo
Specified dose on specified day
Other Names:
  • BMS-986205 matching 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
Biological: Nivolumab
Specified dose on specified day
Other Names:
  • BMS-936558
Drug: BMS-986205
specified dose on specified day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Experiencing Adverse Events
Time Frame: From first dose to 30 days following last dose (up to approximately 25 months)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2017

Primary Completion (Actual)

July 2, 2020

Study Completion (Actual)

July 2, 2020

Study Registration Dates

First Submitted

October 31, 2017

First Submitted That Met QC Criteria

October 31, 2017

First Posted (Actual)

November 6, 2017

Study Record Updates

Last Update Posted (Actual)

July 9, 2021

Last Update Submitted That Met QC Criteria

June 18, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA017-055
  • 2017-002499-14 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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