MDX-010 Antibody, MDX-1379 Melanoma Vaccine, or MDX-010/MDX-1379 Combination Treatment for Patients With Unresectable or Metastatic Melanoma
Completed · Phase 3
Conditions studied: Melanoma, Metastases
In brief
The purpose of this study is to determine the safety and efficacy of MDX-010 (ipilimumab, BMS-734016) (anti-CTLA4) in combination with MDX-1379 (gp100, BMS-734019) in patients with previously treated, unresectable Stage III or IV melanoma. Survival time will be evaluated, as well as patient responses and time to disease progression. Eligible patients are those who in response to a single regimen containing interleukin-2 (IL-2), dacarbazine, and/or temozolomide, have 1) relapsed following an objective response (partial response/complete response \[PR/CR\]); 2) failed to demonstrate an objective response (PR/CR); or 3) could not tolerate such a regimen due to unacceptable toxicity. Patients will be randomized into one of three groups, and will receive one of the following treatments: MDX-010 alone, MDX-1379 alone, or MDX-010 in combination with MDX-1379.
Key facts
- Study ID
- NCT00094653
- Run by
- Bristol-Myers Squibb
- People needed
- 1783
- Starts
- 2004-09-01
- Expected to finish
- 2009-10-01
- Last updated by the study team
- 2011-07-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosed with malignant melanoma
- Measurable unresectable Stage III or IV melanoma
- HLA-A*0201 positive
- Previous treatment with \& failure/relapse/inability to tolerate IL-2, dacarbazine and/or temozolomide
- At least 4 weeks since prior treatment
- Negative pregnancy
- Life expectancy greater than 4 months
- Eastern Cooperative Oncology Group (ECOG) performance of 0 or 1
- Required lab values
- Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) negative
You may not qualify if…
- Prior malignancies which the patient has not been disease free for over 5 years, except treated and cured basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix, or any other cancer
- Ocular melanoma
- Active, untreated central nervous system (CNS) metastasis
- Prior treatment with MDX-010 (anti-CTLA4) antibody
- Prior treatment with any cancer therapeutic vaccine
- Active autoimmune disease or history of autoimmune disease
- Pregnancy or nursing
- Hypersensitivity to Incomplete Freund's Adjuvant (IFA) (Montanide ISA-51)
- Underlying medical conditions deemed hazardous if treated with study drug
- Concomitant therapy with anti-melanoma drugs, chemotherapies, other investigational therapies, chronic use of systemic corticosteroids
- Unable to provide informed consent
Where it is running
- University Medical Center — Tucson, Arizona, United States
- City of Hope National Medical Center — Duarte, California, United States
- San Diego Cancer Center — Encinitas, California, United States
- La Jolla Hematology and Oncology Medical Group — La Jolla, California, United States
- Scripps Cancer Center — La Jolla, California, United States
- Moores UCSD Cancer Center — La Jolla, California, United States
- Pacific Shores Medical Group — Long Beach, California, United States
- Cancer Institute Medical Group, Inc — Los Angeles, California, United States
- The Angeles Clinic and Research Institute — Los Angeles, California, United States
- USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States
- North County Oncology Medical Clinical, Inc. — Oceanside, California, United States
- City of Hope Medical Group — Pasadena, California, United States
- University of California, San Diego — San Diego, California, United States
- St. Mary's Medical Center - Northern California Melanoma Center — San Francisco, California, United States
- Cancer Institute Medical Group, Inc — Santa Monica, California, United States
- San Diego Cancer Center — Vista, California, United States
- Anschutz Cancer Pavilion — Aurora, Colorado, United States
- Rocky Mountain Cancer Centers — Aurora, Colorado, United States
- University of Colorado Health Sciences Center — Aurora, Colorado, United States
- Rocky Mountain Cancer Centers — Boulder, Colorado, United States
- Rocky Mountain Cancer Centers — Colorado Springs, Colorado, United States
- Rocky Mountain Cancer Centers — Denver, Colorado, United States
- University of Colorado Hospital — Denver, Colorado, United States
- Rocky Mountain Cancer Centers — Lakewood, Colorado, United States
- Arizona Cancer Center — Tucson, Arizona, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.