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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Melanoma

Thank you

Trial Information

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


For the extension phase:

Allocation: single arm study; Masking: open label; Intervention Model: Single Group


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:



- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Time Frame:

Patient Status is assessed at every visit (Weeks 1, 4, 7, 10, 12, 13, 16, 19, 20, 22, 24 in the Induction Phase, Weeks 24, 30, 36, 42, 48 and every 12 weeks thereafter in the Maintenance Phase, and every 12 weeks in the Follow-up Phase)

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA184-024

NCT ID:

NCT00324155

Start Date:

August 2006

Completion Date:

August 2013

Related Keywords:

  • Melanoma
  • Stage IIIc N3 (unresectable)
  • Stage IV melanoma
  • Melanoma

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Sinai Hospital of BaltimoreBaltimore, Maryland  21225
Joe Arrington Cancer Research and Treatment CenterLubbock, Texas  79410-1894
Thompson Cancer Survival CenterKnoxville, Tennessee  37916
University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
Ellis Fischel Cancer CenterColumbia, Missouri  65203
Greater Baltimore Medical CenterBaltimore, Maryland  21204
Hematology Oncology, P.C.Stamford, Connecticut  06902
Comprehensive Cancer CenterGlendale, California  91204
Oncology Specialists, SCPark Ridge, Illinois  60068
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Providence Portland Medical CenterPortland, Oregon  97213-3635
University of ChicagoChicago, Illinois  60637
Blumenthal Cancer CenterCharlotte, North Carolina  28203
Virginia Cancer InstituteRichmond, Virginia  23230
Central Indiana Cancer CentersIndianapolis, Indiana  46227
Hematology Oncology Associates of the Treasure CoastPort St. Lucie, Florida  34952
Kentucky Cancer ClinicPikeville, Kentucky  41501
Sharp Clinical Oncology ResearchSan Diego, California  92123
Saint Francis Hospital and Medical CenterHartford, Connecticut  06105
The Angeles Clinic and Research InstituteLos Angeles, California  90025
Pacific Cancer Medical CenterAnaheim, California  92801
Hutchinson Clinic, PAHutchinson, Kansas  67502
Orlando Health, Inc. M.D. Anderson Cancer Center OrlandoOrlando, Florida  32806
St Joseph Oncology IncSt Joseph, Missouri  64507
Wilshire Oncology Medical Group IncLaverne, California  91750
Mid-Illinois Hematology/Oncology Associates, Ltd.Normal, Illinois  61761
St. Luke'S Hospital & Health NetworkBethlehem, Pennsylvania  18015
Lowcountry Hematology & Oncology, PaMt. Pleasant, South Carolina  29464
Vanderbilt-Ingram Cancer CtrNashville, Tennessee  37232
Cancer Specialists Of North Florida BeachesJacksonville, Florida  32256