Phase 3 Study of Nivolumab or Nivolumab plus Ipilimumab Versus Ipilimumab Alone in Previously Untreated Advanced Melanoma

Phase 1

Conditions: nresectable or metastatic melanoma
MedDRA version: 21.1Level: LLTClassification code 10053571Term: MelanomaSystem Organ Class: 100000004864
MedDRA version: 20.0Level: LLTClassification code 10027481Term: Metastatic melanomaSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2012-005371-13-DE

Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1144

Inclusion Criteria

• Histologically confirmed stage III (unresectable) or stage IV melanoma
• Treatment naïve patients
• Measurable disease by CT or MRI per RECIST 1.1 criteria.
• Tumor tissue from an unresectable or metastatic site of disease for biomarker analyses.
• ECOG PS 0 or 1

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 795
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 349

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-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The purpose of this study is to show that Nivolumab and/or Nivolumab<br>in combination with Ipilimumab will extend progression free survival<br>and overall survival compared to Ipilimumab alone.;Secondary Objective: • ORR<br>• Differences in OS, PFS and ORR between experimental arms<br>• PFS and OS based on PD-L1 expression<br>• Mean changes from baseline in EORTC-QLQ-C30;Primary end point(s): -Endpoint of Overall Survival (OS) in all randomized subjects<br>-Progression Free Survival (PFS);Timepoint(s) of evaluation of this end point: OS: From the beginning of randomization period up to date of event<br>(expected to be no more than 5 years)<br>PFS : Time Frame: Baseline (Day 1), Week 12, every 6 weeks thereafter<br>up to week 49, and then every 12 weeks until disease progression is<br>documented (Approximately around 5 years)]

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: • ORR: Baseline, Week 12 every 6 weeks thereafter up to week 49, and<br>then every 12 weeks until disease progression is documented (expected<br>to be no more than 5 years)<br>• OS, PFS, and ORR at the same time points identified for the primary<br>and first secondary objectives<br>• PFS and OS at the same time points identified as the primary objective<br>and PD-L1 expression at Baseline:<br>• Baseline, every 4 weeks for 6 months, then every 6 weeks until disease<br>progression is documented, during follow-up (30 days after last dose,<br>100-114 days after last dose);Secondary end point(s): • ORR<br>• Differences in OS, PFS and ORR between experimental arms<br>• PFS and OS based on PD-L1 expression<br>• Mean changes from baseline in EORTC-QLQ-C30

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