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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03329846
Recruitment Status : Completed
First Posted : November 6, 2017
Results First Posted : July 9, 2021
Last Update Posted : July 9, 2021
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Melanoma Skin Cancer Drug: BMS-986205 Biological: Nivolumab Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 30, 2017
Actual Primary Completion Date : July 2, 2020
Actual Study Completion Date : July 2, 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma
Drug Information available for: Nivolumab

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 Name: BMS-936558

Drug: Placebo
Specified dose on specified day
Other Name: 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

Drug: BMS-986205
specified dose on specified day

Biological: Nivolumab
Specified dose on specified day
Other Name: BMS-936558

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03329846

Show Show 63 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  Study Documents (Full-Text)

Documents provided by Bristol-Myers Squibb:
Study Protocol  [PDF] October 25, 2018
Statistical Analysis Plan  [PDF] July 23, 2020

Additional Information:
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Responsible Party: Bristol-Myers Squibb Identifier: NCT03329846    
Other Study ID Numbers: CA017-055
2017-002499-14 ( EudraCT Number )
First Posted: November 6, 2017    Key Record Dates
Results First Posted: July 9, 2021
Last Update Posted: July 9, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors