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

• Conditions: nresectable or metastatic melanoma; MedDRA version: 16.0Level: LLTClassification code 10053571Term: MelanomaSystem Organ Class: 100000004864; MedDRA version: 16.0Level: LLTClassification code 10027481Term: Metastatic melanomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-005371-13-ES
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-10
• Last Update Posted: 9 September 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• 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 in combination with Ipilimumab will extend survival compared to Ipilimumab alone;Secondary Objective: ? PFS<br>? ORR<br>? Differences in OS, PFS and ORR between experimental arms<br>? OS based on PD-L1 expression<br>? Mean changes from baseline in EORTC-QLQ-C30;Primary end point(s): Improvement in Overall Survival of investigational arms versus control arm;Timepoint(s) of evaluation of this end point: OS: From the beginning of randomization period up to date of event (expected to be no more than 5 years)

Secondary Outcome Measures

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