Comparison Study of MDX-010 (CTLA-4) Alone and Combined With DTIC in the Treatment of Metastatic Melanoma
A Randomized Study Comparing MDX-010 (CTLA-4) Alone or in Combination With DTIC in the Treatment of Patients With Chemotherapy Naїve Metastatic Melanoma.
2 other identifiers
interventional
N/A
1 country
9
Brief Summary
The objectives of this study are to determine the safety and activity profile of multiple doses of MDX-010, and to determine the whether the addition of cytotoxic chemotherapy (decarbazine \[DTIC\]) can augment the effects of MDX-010 in patients with chemotherapy naïve metastatic melanoma with a tolerable toxicity profile.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2002
Shorter than P25 for phase_2
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2002
CompletedFirst Submitted
Initial submission to the registry
November 21, 2002
CompletedFirst Posted
Study publicly available on registry
November 22, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2004
CompletedJanuary 28, 2011
January 1, 2011
1.3 years
November 21, 2002
January 20, 2011
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of unresectable metastatic melanoma.
- No prior chemotherapy for melanoma, and no chemotherapy for other malignancies within 5 years and at least 4 weeks since treatment (surgery, radiation, or immunotherapy) for melanoma.
You may not qualify if:
- Patients who exhibit any of the following conditions at screening will not be eligible for admission into the study:
- Any other prior malignancy, except for the following: adequately treated basal or squamous cell skin cancer or superficial bladder cancer, or any other cancer from which the patient has been disease-free for \>=5 years.
- Active autoimmune disease.
- Active infection requiring therapy, or chronic active HBV or HCV, or confirmed reactivity with HIV tests.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Arizona Cancer Center
Tucson, Arizona, 85724, United States
Pacific Shores Medical Group
Long Beach, California, 90813, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Northern California Melanoma Center
San Francisco, California, 94109, United States
Cancer Institute Medical Group
Santa Monica, California, 90404, United States
Indiana Oncology/ Hematology Consultants
Indianapolis, Indiana, 46237, United States
Piedmont Oncology Specialists
Charlotte, North Carolina, 28207, United States
Joe Arrington Cancer. Research & Treatment Center
Lubbock, Texas, 79410, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
Related Publications (1)
Hersh EM, O'Day SJ, Powderly J, Khan KD, Pavlick AC, Cranmer LD, Samlowski WE, Nichol GM, Yellin MJ, Weber JS. A phase II multicenter study of ipilimumab with or without dacarbazine in chemotherapy-naive patients with advanced melanoma. Invest New Drugs. 2011 Jun;29(3):489-98. doi: 10.1007/s10637-009-9376-8. Epub 2010 Jan 16.
PMID: 20082117DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 21, 2002
First Posted
November 22, 2002
Study Start
October 1, 2002
Primary Completion
February 1, 2004
Study Completion
February 1, 2004
Last Updated
January 28, 2011
Record last verified: 2011-01