Phase 2 Study of Ipilimumab in Children and Adolescents (12<18 years) with Previously Treated or Untreated, Unresectable Stage III or Stage IV Malignant Melanoma

Phase 1

• Conditions: Malignant Melanoma; MedDRA version: 16.0Level: PTClassification code 10025650Term: Malignant melanomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-002249-39-ES
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-08
• Last Update Posted: 29 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

- 12 < 18 years of age
- Previously Treated or Untreated, Unresectable - Stage III or Stage IV Malignant Melanoma
KPS or Lansky Score of ? 50
Are the trial subjects under 18? yes
Number of subjects for this age range: 40
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Primary Ocular Melanoma
- Prior therapy with CTLA-4 or PD-1 antagonist, or PD-L1 or CD137 agonists
- Symptomatic brain metastases
- History of autoimmune disease

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified