Phase 2 Study of Ipilimumab in Children and Adolescents (12 to < 18 Years) With Previously Treated or Untreated, Unresectable Stage III or Stage lV Malignant Melanoma

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 2

Conditions: Malignant Melanoma

Treatments: Biological: Ipilimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01696045

CA184-178

2012-002249-39 (EudraCT Number)

Details and patient eligibility

About

The purpose of the study is to comply with the Pediatric Investigation Plan requirements of Ipilimumab

Enrollment: 14 patients

Sex: All

Ages: 12 to 17 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:

• 12 < 18 years of age
• Previously treated or untreated, unresectable Stage III or Stage IV malignant melanoma
• Karnofsky Performance Status (KPS) or Lansky Score ≥ 50

Exclusion Criteria:

• Primary Ocular Melanoma
• Prior therapy with a Cytotoxic T Lymphocyte Antigen 4 (CTLA-4) or Programmed death- 1 (PD-1) antagonist, or Programmed cell death- ligand 1 (PD-L1) or CD137 agonists
• Symptomatic brain metastases
• History of autoimmune diseases

Trial design

14 participants in 2 patient groups

Ipilimumab 3 mg/kg

Experimental group

Description:

Ipilimumab (3 mg/kg) was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.

Treatment:

Biological: Ipilimumab

Ipilimumab 10 mg/kg

Experimental group

Description:

Ipilimumab (10 mg/kg) was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.

Treatment:

Biological: Ipilimumab