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OpenTrials
Completed

NCT Number: NCT03329846

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

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

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Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Cancer Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution, Blacktown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-986205

Drug

specified dose on specified day

Nivolumab

Biological

Specified dose on specified day

Other names: BMS-936558

Placebo

Drug

Specified dose on specified day

Other names: BMS-986205 matching placebo

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Nov 6, 2017
Registry last updated
Jul 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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