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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.
 
ClinicalTrials.gov Identifier: NCT03329846
Recruitment Status : Active, not recruiting
First Posted : November 6, 2017
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 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 21, 2017
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
Drug Information available for: Nivolumab

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Adverse Events (AEs) [ Time Frame: Up to 19 months ]
  2. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 19 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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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
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

Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT03329846


Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03329846    
Other Study ID Numbers: CA017-055
2017-002499-14 ( EudraCT Number )
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020

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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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Melanoma
Skin Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms by Site
Skin Diseases
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents