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Sponsors and Collaborators: |
Bristol-Myers Squibb Medarex |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00324155 |
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
Condition | Intervention | Phase |
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Melanoma |
Drug: Ipilimumab and Dacarbazine Drug: Placebo and Dacarbazine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Multi-Center, Randomized, Double-Blind, Two-Arm, Phase III Study in Patients With Untreated Stage III (Unresectable) or IV Melanoma Receiving Dacarbazine Plus 10 mg/kg Ipilimumab (MDX-010) vs. Dacarbazine With Placebo |
Estimated Enrollment: | 500 |
Study Start Date: | August 2006 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental |
Drug: Ipilimumab and Dacarbazine
Intravenous solution; ipilimumab - intravenous; dacarbazine - intravenouse, Ipilimumab 10mg/kg; dacarbazine and 850 mg/m2, Ipilimumab - one dose every 3 wks for 10wks then one dose every 12 wks starting at Wk24; dacarbazine - one dose every 3 wks for 22 wks, until disease progression, unacceptable toxicity or withdrawl of consent
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B: Active Comparator |
Drug: Placebo and Dacarbazine
Intravenous solution; intravenous; Placebo - 0 mg; dacarbazine - 850 mg/m2, Placebo - one dose every 3 wks for 10 wks then one dose every 12w ks starting at Wk24; dacarbazine - one dose every 3 wks for 22 wks, until disease progression, unacceptable toxicity or withdrawl of consent
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion:
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb ( Study Director ) |
Study ID Numbers: | CA184-024 |
Study First Received: | May 8, 2006 |
Last Updated: | May 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00324155 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Stage IIIc N3 (unresectable) Stage IV melanoma |
Neuroectodermal Tumors Dacarbazine Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Antineoplastic Agents, Alkylating Nevus Alkylating Agents Neuroendocrine Tumors Melanoma |
Neoplasms by Histologic Type Dacarbazine Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Pharmacologic Actions Melanoma Neuroendocrine Tumors |
Neuroectodermal Tumors Neoplasms Therapeutic Uses Neoplasms, Germ Cell and Embryonal Nevi and Melanomas Antineoplastic Agents, Alkylating Alkylating Agents |