A Phase 3, Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab Versus Ipilimumab Monotherapy in Subjects With Previously Untreated Unresectable or Metastatic Melanoma
18 Years
N/A
Both
Unresectable or Metastatic Melanoma
Trial Information
A Phase 3, Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab Versus Ipilimumab Monotherapy in Subjects With Previously Untreated Unresectable or Metastatic Melanoma
CheckMate 067: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 067
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:
- Histologically confirmed stage III (unresectable) or stage IV melanoma
- Treatment naïve patients
- Measurable disease by computed tomography (CT) or Magnetic Resonance Imaging (MRI)
per RECIST 1.1 criteria
- Tumor tissue from an unresectable or metastatic site of disease for biomarker
analyses
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Exclusion Criteria:
- Active brain metastases or leptomeningeal metastases
- Ocular melanoma
- Subjects with active, known or suspected autoimmune disease
- Subjects with a condition requiring systemic treatment with either corticosteroids
(>10 mg daily prednisone equivalents) or other immunosuppressive medications within
14 days of treatment
- Prior treatment with an anti-Programmed Death receptor-1 (PD-1), anti-Programmed
Death-1 ligand-1 (PD-L1), anti-PD-L2, or anti-cytotoxic T lymphocyte associated
antigen-4 (anti-CTLA-4) antibody
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Endpoint of Overall Survival (OS) in all randomized subjects
Outcome Description:
OS is defined as the time between the date of randomization and the date of death due to any cause. OS will be censored on the last date a subject was known to be alive. OS data will be collected continuously while subjects are on study medication and every 3 months via in-person or phone contact after discontinuation of study medication
Outcome Time Frame:
Approximately up to 44.1 months
Safety Issue:
No
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
United States: Institutional Review Board
Study ID:
CA209-067
NCT ID:
NCT01844505
Start Date:
June 2013
Completion Date:
January 2017
Related Keywords:
- Unresectable or Metastatic Melanoma
- Melanoma
Name | Location |
|---|---|
| Duke Cancer Institute | Durham, North Carolina 27710 |
| Local Institution | Chicago, Illinois |
| Local Institution | Baltimore, Maryland |
| Local Institution | Bronx, New York |
| Local Institution | Cincinnati, Ohio |
| Local Institution | Portland, Oregon |
| Local Institution | Vancouver, Washington |
| Local Institution | Phoenix, Arizona |
| Local Institution | Corona, California |
| Local Institution | Aurora, Colorado |
| Local Institution | Hamden, Connecticut |
| Local Institution | Washington, District of Columbia |
| Local Institution | Fort Lauderdale, Florida |
| Local Institution | Springfield, Massachusetts |
| Local Institution | Albuquerque, New Mexico |
| Local Institution | Wilmington, North Carolina |
| Local Institution | Duncansville, Pennsylvania |
| Local Institution | Austin, Texas |
| Local Institution | Rome, Georgia |
| Local Institution | Chattanooga, Tennessee |
| Local Institution | Salt Lake City, Utah |
| Local Institution | Jackson, Mississippi |
| Local Institution | Columbia, Missouri |
| New York Oncology Hematology, PC | Albany, New York 12208 |
| Maine Center for Cancer Medicine | Scarborough, Maine 04074 |
| The Angeles Clinic and Research Institute | Los Angeles, California 90025 |
| Sarah Cannon Research Institute | Nashville, Tennessee 37203 |
| Local Institution | Detroit, Michigan |
| Local Institution | Las Vegas, Nevada |
| Greenville Health System | Greenville, South Carolina 29615 |
