Dacarbazine and Ipilimumab vs. Dacarbazine With Placebo in Untreated Unresectable Stage III or IV Melanoma
Completed · Phase 3 · Has a placebo group
Conditions studied: Melanoma
In brief
The purpose of this clinical research study is to examine the safety and effectiveness (how well the drug works) of two different treatments for patients with melanoma. One treatment is an investigational compound (a drug that is not currently approved by the United States Food and Drug Administration \[FDA\]), know as Ipilimumab (also known as MDX-010 or BMS-734016) together with an approved chemotherapy drug called Dacarbazine
Key facts
- Study ID
- NCT00324155
- Run by
- Bristol-Myers Squibb
- People needed
- 681
- Starts
- 2006-08-01
- Expected to finish
- 2013-10-01
- Last updated by the study team
- 2014-11-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Informed Consent
- Measurable Disease
- Eastern Cooperative Oncology Group (ECOG) 0 or 1
- Lab / imaging requirements
- Neg for Human Immunodeficiency Virus (HIV), Hepatitis B (HepB), C
- Men and Women > 18 years (16 were allowable)
- Prior therapy restriction (adjuvant only)
- Exclusion:
- Pregnant / nursing
- Inadequate contraception
- Brain metastasis
- Primary ocular or mucosal melanoma
Where it is running
- Wilshire Oncology Medical Group Inc — La Verne, California, United States
- The Angeles Clinic And Research Institute — Los Angeles, California, United States
- Comprehensive Cancer Center — Palm Springs, California, United States
- Sharp Clinical Oncology Research — San Diego, California, United States
- Saint Francis Hospital And Medical Center — Hartford, Connecticut, United States
- Hematology Oncology, P.C. — Stamford, Connecticut, United States
- Cancer Specialists Of North Florida Beaches — Jacksonville, Florida, United States
- Orlando Health, Inc. M.D. Anderson Cancer Center Orlando — Orlando, Florida, United States
- Hematology Oncology Associates Of The Treasure Coast — Port Saint Lucie, Florida, United States
- University Of Chicago — Chicago, Illinois, United States
- Mid-Illinois Hematology/Oncology Associates, Ltd. — Normal, Illinois, United States
- Oncology Specialists, Sc — Park Ridge, Illinois, United States
- Central Indiana Cancer Centers — Fishers, Indiana, United States
- Indiana University Cancer Center — Indianapolis, Indiana, United States
- Hutchinson Clinic, Pa — Hutchinson, Kansas, United States
- Kentucky Cancer Clinic — Hazard, Kentucky, United States
- Greater Baltimore Medical Center — Baltimore, Maryland, United States
- Sinai Hospital Of Baltimore — Baltimore, Maryland, United States
- Dana Farber Cancer Institute — Boston, Massachusetts, United States
- Ellis Fischel Cancer Center — Columbia, Missouri, United States
- St Joseph Oncology Inc — Saint Joseph, Missouri, United States
- University Of New Mexico Cancer Center — Albuquerque, New Mexico, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- Blumenthal Cancer Center — Charlotte, North Carolina, United States
- Pacific Cancer Medical Center — Anaheim, California, 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.