Clinical trial · Interventional
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
Phase 2 Study of Ipilimumab in Children and Adolescents (12 to < 18 Years) With Previously Treated or Untreated, Unresectable Stage III or Stage IV Malignant Melanoma
NCT01696045CI-TRIAL-00029338terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
The purpose of the study is to comply with the Pediatric Investigation Plan requirements of Ipilimumab
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Melanoma | Melanoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ipilimumab | Biological | Ipilimumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ipilimumab 3 mg/kg
- description
- Ipilimumab (3 mg/kg) was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
- interventionNames
- Biological: Ipilimumab
- type
- EXPERIMENTAL
- label
- Ipilimumab 10 mg/kg
- description
- Ipilimumab (10 mg/kg) was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
- interventionNames
- Biological: Ipilimumab
Primary outcomes (2)
- measure
- Overall Survival (OS) Rate at 1 Year
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
- Maximum age
- 17 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDGeoerger B, Bergeron C, Gore L, Sender L, Dunkel IJ, Herzog C, Brochez L, Cruz O, Nysom K, Berghorn E, Simsek B, Shen J, Pappo A. Phase II study of ipilimumab in adolescents with unresectable stage III or IV malignant melanoma. Eur J Cancer. 2017 Nov;86:358-363. doi: 10.1016/j.ejca.2017.09.032. Epub 2017 Nov 5. PMID 29100190