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

• Register: ClinicalTrials.gov
• Last refreshed on: 29 March 2021
• Main ID: NCT03329846
• Date of registration: 31/10/2017
• Prospective Registration: Yes
• Primary sponsor: Bristol-Myers Squibb
• Public title: An Investigational Immuno-therapy Study of BMS-986205 Combined With Nivolumab, Compared to Nivolumab by Itself, in Patients With Advanced Melanoma
• Scientific 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
• Date of first enrolment: November 30, 2017
• Target sample size: 77
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03329846
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Australia, Brazil, Canada, Chile, Czechia, France, Germany, Greece, Ireland, Italy, Japan, Mexico, Netherlands, New Zealand, Poland, Russian Federation, Spain, Switzerland, United Kingdom, United States

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion 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



Age minimum: 12 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Skin Cancer

Melanoma

Intervention(s)

Drug: BMS-986205

Drug: Placebo

Biological: Nivolumab

Primary Outcome(s)

Incidence of Serious Adverse Events (SAEs) [Time Frame: Up to 19 months]

Incidence of Adverse Events (AEs) [Time Frame: Up to 19 months]

Secondary ID(s)

2017-002499-14

CA017-055

Source(s) of Monetary Support

Please refer to primary and secondary sponsors