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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 Center New York, New York  10021
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
Sinai Hospital of Baltimore Baltimore, Maryland  21225
Joe Arrington Cancer Research and Treatment Center Lubbock, Texas  79410-1894
Thompson Cancer Survival Center Knoxville, Tennessee  37916
University of New Mexico Cancer Center Albuquerque, New Mexico  87131-5636
Ellis Fischel Cancer Center Columbia, Missouri  65203
Greater Baltimore Medical Center Baltimore, Maryland  21204
Hematology Oncology, P.C. Stamford, Connecticut  06902
Comprehensive Cancer Center Glendale, California  91204
Oncology Specialists, SC Park Ridge, Illinois  60068
Dana Farber Cancer Institute Boston, Massachusetts  02115
Providence Portland Medical Center Portland, Oregon  97213-3635
University of Chicago Chicago, Illinois  60637
Blumenthal Cancer Center Charlotte, North Carolina  28203
Virginia Cancer Institute Richmond, Virginia  23230
Central Indiana Cancer Centers Indianapolis, Indiana  46227
Hematology Oncology Associates of the Treasure Coast Port St. Lucie, Florida  34952
Kentucky Cancer Clinic Pikeville, Kentucky  41501
Sharp Clinical Oncology Research San Diego, California  92123
Saint Francis Hospital and Medical Center Hartford, Connecticut  06105
The Angeles Clinic and Research Institute Los Angeles, California  90025
Pacific Cancer Medical Center Anaheim, California  92801
Hutchinson Clinic, PA Hutchinson, Kansas  67502
Orlando Health, Inc. M.D. Anderson Cancer Center Orlando Orlando, Florida  32806
St Joseph Oncology Inc St Joseph, Missouri  64507
Wilshire Oncology Medical Group Inc Laverne, California  91750
Mid-Illinois Hematology/Oncology Associates, Ltd. Normal, Illinois  61761
St. Luke'S Hospital & Health Network Bethlehem, Pennsylvania  18015
Lowcountry Hematology & Oncology, Pa Mt. Pleasant, South Carolina  29464
Vanderbilt-Ingram Cancer Ctr Nashville, Tennessee  37232
Cancer Specialists Of North Florida Beaches Jacksonville, Florida  32256