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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Melanoma; Skin Cancer

Treatments: Drug: BMS-986205; Biological: Nivolumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03329846

2017-002499-14 (EudraCT Number)

CA017-055

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Nivolumab + Placebo

Active Comparator group

Description:

Specified dose on specified day Participants will no longer receive BMS-986205 Placebo

Treatment:

Drug: Placebo

Biological: Nivolumab

Nivolumab + BMS-986205

Experimental group

Description:

Specified dose on specified day. Participants have the option to discontinue BMS-986205, and continue nivolumab monotherapy, at investigator discretion

Treatment:

Biological: Nivolumab

Drug: BMS-986205