Phase 3 Study of Nivolumab or Nivolumab Plus Ipilimumab Versus Ipilimumab Alone in Previously Untreated Advanced Melanoma (CheckMate 067)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Unresectable or Metastatic Melanoma

Treatments: Biological: Placebo for Ipilimumab; Biological: Placebo for Nivolumab; Biological: Ipilimumab; Biological: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01844505

2012-005371-13 (EudraCT Number)

CA209-067

Details and patient eligibility

About

The purpose of this study is to show that Nivolumab and/or Nivolumab in combination with Ipilimumab will extend progression free survival and overall survival compared to Ipilimumab alone.

Enrollment: 1,296 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Histologically confirmed stage III (unresectable) or stage IV melanoma
• Treatment naïve patients
• Measurable disease by computed tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST 1.1 criteria
• Tumor tissue from an unresectable or metastatic site of disease for biomarker analyses
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

Exclusion Criteria:

• Active brain metastases or leptomeningeal metastases
• Ocular melanoma
• Subjects with active, known or suspected autoimmune disease
• Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of treatment
• Prior treatment with an anti-Programmed Death receptor-1 (PD-1), anti-Programmed Death-1 ligand-1 (PD-L1), anti-PD-L2, or anti-cytotoxic T lymphocyte associated antigen-4 (anti-CTLA-4) antibody

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,296 participants in 3 patient groups

Arm A: Nivolumab+Placebo for Ipilimumab+Placebo for Nivolumab

Experimental group

Description:

Nivolumab 3 mg/kg solution intravenously every 2 weeks plus Placebo matching with Ipilimumab 0 mg/kg solution intravenously on weeks 1, 4 and Placebo matching with Nivolumab on weeks 4 for cycles 1 and 2, until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Treatment:

Biological: Nivolumab

Biological: Placebo for Nivolumab

Biological: Placebo for Ipilimumab

Arm B: Nivolumab+Ipilimumab+Placebo for Nivolumab

Experimental group

Description:

Nivolumab 1 mg/kg solution intravenously combined with Ipilimumab 3 mg/kg solution intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solution intravenously every 2 weeks plus Placebo matching with Nivolumab on weeks 3 and 5 for cycles 1 and 2, until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Treatment:

Biological: Nivolumab

Biological: Ipilimumab

Biological: Placebo for Nivolumab

Arm C: Ipilimumab+Placebo for Nivolumab

Experimental group

Description:

Ipilimumab 3 mg/kg solution intravenously every 3 weeks for a total of 4 doses plus Placebo matching with Nivolumab 0 mg/kg solution intravenously on weeks 3 and 5 for cycles 1 and 2, until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends (Placebo matching with Nivolumab is no longer required)

Treatment:

Biological: Ipilimumab

Biological: Placebo for Nivolumab