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
12 Years
17 Years
Both
Malignant Melanoma
Trial Information
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
For additional information, please contact the BMS oncology clinical trial information
service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit
www.BMSStudyConnect.com for more information on clinical trial participation.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall Survival Rate at 1-Year
Outcome Description:
Overall Survival Rate at 1-Year is defined as the probability that a subject is alive at one year following start of treatment. The time frame for this endpoint is from Day 1 of first patient first treatment to Day 365 from the last patient first treatment
Outcome Time Frame:
Up to 1 year after last patient first treatment (LPFT)
Safety Issue:
Yes
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
United States: Food and Drug Administration
Study ID:
CA184-178
NCT ID:
NCT01696045
Start Date:
April 2013
Completion Date:
July 2017
Related Keywords:
- Malignant Melanoma
- Melanoma
Name | Location |
|---|---|
| Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
| Mayo Clinic | Rochester, Minnesota 55905 |
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
| Children's Hospital of Orange County | Orange, California 92668 |
| St. Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |
| Phoenix Children's Hospital | Phoenix, Arizona 85016-7710 |
| Primary Children's Medical Center | Salt Lake City, Utah 84113-1100 |
| H. Lee Moffitt Cancer Center & Research Institute | Tampa, Florida 33612 |
| Local Institution | Baltimore, Maryland |
| Local Institution | Austin, Texas |
| Children's Hospital Colorado | Aurora, Colorado 80045 |
| Childrens hospital of LA | Los Angeles, California 90033 |
