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DDI - 3 Arm - Carboplatin/Paclitaxel, Dacarbazine

Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase ITreatmentActive18 and overPharmaceutical / IndustryCA184-078
NCT00796991

Trial Description

Summary

The purpose of this clinical research study is to learn the pharmacokinetics of Ipilimumab when combined with Paclitaxel/Carboplatin or Dacarbazine

Eligibility Criteria

Inclusion Criteria:

  • Histologic diagnosis of advanced malignant melanoma
  • ECOG performances status 0-1
  • Measurable/evaluable disease as per mWHO criteria

Exclusion Criteria:

  • Evidence of active brain metastases
  • Prior treatment with anti-CTLA-4 or anti-CD137 antibody
  • Total Bilirubin > 1.5 x ULN and AST or ALT > 2.5 x ULN
  • Prior Autoimmune disease
  • Use of immunosuppressing therapies

Trial Contact Information

Trial Lead Organizations/Sponsors

Bristol-Myers Squibb Company - New York

Medarex, Incorporated

Bristol-Myers SquibbStudy Director

For participation information at a USA site use a phone number below. For site information outside the USA please email:
  Email: Clinical.Trials@bms.com

First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Trial Sites

U.S.A.
California
  Los Angeles
 Angeles Clinic and Research Institute - Los Angeles
 Omid Hamid, Site 002
Florida
  Tampa
 H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
 Jeffrey Weber, Site 001
New York
  New York
 Mem Sloan-Ket Can Ctr
 Jedd D. Wolchok, Site 004
North Carolina
  Charlotte
 Carolinas Med Ctr
 Asim Amin, Site 005

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00796991
Information obtained from ClinicalTrials.gov on May 07, 2009

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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