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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 30, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 2, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 2, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 31, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 6, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 9, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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