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-DK
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-15
• Last Update Posted: 8 July 2024

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