A Randomized, Open-Label, Multicenter Phase II Study of Ipilimumab Retreatment Versus Chemotherapy for Subjects With Advanced Melanoma Who Progressed After Initially Achieving Disease Control With Ipilimumab Therapy
18 Years
N/A
Both
Melanoma
Trial Information
A Randomized, Open-Label, Multicenter Phase II Study of Ipilimumab Retreatment Versus Chemotherapy for Subjects With Advanced Melanoma Who Progressed After Initially Achieving Disease Control With Ipilimumab Therapy
Minimum age of participants is 18 years (or 16 years, if allowable per local regulatory
authority)
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:
- Histological diagnosis of unresectable stage III or IV metastatic melanoma
- Prior Ipilimumab induction treatment (3mg/kg)
- Documented disease control [Stable Disease (SD) ≥ 3 months or PR/CR] after Ipilimumab
induction
- Documented progressive disease following disease control
Exclusion Criteria:
- Subjects with brain metastasis are excluded, unless they are free of neurologic
symptoms related to metastatic brain lesions and do not receive systemic
corticosteroid therapy for the purpose of reducing intracranial inflammation in the
10 days prior to beginning retreatment with Ipilimumab
- Any intervening anticancer therapy between last dose of Ipilimumab induction and
Ipilimumab retreatment on study
- Subjects who experienced any grade 3 immune-related adverse events (irAE) (except for
endocrinopathies where clinical symptoms were controlled with appropriate hormone
replacement therapy) or any grade 4 toxicity during prior treatment with Ipilimumab
- Subjects with a prior irAE that has not improved to grade 1 or better at
randomization
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Survival rate
Outcome Description:
The survival rate at 18 months is defined as the proportion of subjects still alive at 18 months or more from randomization divided by the total number of subjects randomized. Vital status will be assessed at each study visit. Analysis of overall survival rate will be done at 18 months from LPFV
Outcome Time Frame:
At 18 months from Last Patient First Visit (LPFV)
Safety Issue:
No
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
Austria: Federal Office for Safety in Health Care
Study ID:
CA184-243
NCT ID:
NCT01709162
Start Date:
March 2013
Completion Date:
January 2020
Related Keywords:
- Melanoma
- Melanoma
Name | Location |
|---|---|
| Lehigh Valley Hospital | Allentown, Pennsylvania 18103 |
| Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756 |
| The Angeles Clinic & Research Institute | Los Angeles, California 90404 |
| Local Institution | Indianapolis, Indiana |
| Local Institution | Bronx, New York |
| Local Institution | Cincinnati, Ohio |
| Local Institution | Birmingham, Alabama |
| Local Institution | Corona, California |
| Local Institution | Aurora, Colorado |
| Local Institution | Fort Lauderdale, Florida |
| Local Institution | Wichita, Kansas |
| Local Institution | Wilmington, North Carolina |
| Local Institution | North Charleston, South Carolina |
| Local Institution | Austin, Texas |
| Comprehensive Cancer Center of Nevada | Las Vegas, Nevada 89109 |
| Baptist Cancer Institute | Jacksonville, Florida 32207 |
| Mercy Medical Research Institute | Springfield, Missouri 65807 |
