A Study of Two Different Dose Combinations of Nivolumab in Combination With Ipilimumab in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Melanoma

Treatments: Biological: Nivolumab 3 mg/kg IV; Biological: Nivolumab 1 mg/kg IV; Biological: Ipilimumab 1 mg/kg IV; Biological: Nivolumab 6 mg/kg IV; Biological: Ipilimumab 3 mg/kg IV

Study type: Interventional

Funder types: Industry

Identifiers

NCT02714218

CA209-511

Details and patient eligibility

About

The purpose of this study is to evaluate two different dose combinations of nivolumab and ipilimumab in the treatment of melanoma.

Enrollment: 387 patients

Sex: All

Ages: 18+ 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:

• Subject must have been diagnosed with stage III or/and stage IV histologically confirmed melanoma [per American Joint Committee on Cancer (AJCC) staging system] that is unresectable or metastatic
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• Subject has not been treated by systemic anticancer therapy for unresectable or metastatic melanoma

Exclusion Criteria:

• Subjects with active brain metastases or leptomeningeal metastases
• Subjects with ocular melanoma
• Subjects with active, known or suspected autoimmune disease

Other protocol defined inclusion/exclusion criteria could apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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387 participants in 3 patient groups

Nivolumab 3 mg/kg IV + Ipilimumab 1 mg/kg IV

Experimental group

Description:

Specified dose on specified days

Treatment:

Biological: Nivolumab 3 mg/kg IV

Biological: Ipilimumab 1 mg/kg IV

Ipilimumab 3 mg/kg IV + Nivolumab 1 mg/kg IV

Experimental group

Description:

Specified dose on specified days

Treatment:

Biological: Nivolumab 1 mg/kg IV

Biological: Ipilimumab 3 mg/kg IV

Nivolumab 6 mg/kg IV + Ipilimumab 1 mg/kg

Experimental group

Description:

Specified dose on specified days

Treatment:

Biological: Nivolumab 6 mg/kg IV

Biological: Ipilimumab 1 mg/kg IV