Comparison Study of MDX-010 (CTLA-4) Alone and Combined With DTIC in the Treatment of Metastatic Melanoma
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Inclusion Criteria
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Clinical diagnosis of unresectable metastatic melanoma.
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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.
Exclusion Criteria
Patients who exhibit any of the following conditions at screening will not be eligible for admission into the study:
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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.
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Active autoimmune disease.
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Active infection requiring therapy, or chronic active HBV or HCV, or confirmed reactivity with HIV tests.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Arizona Cancer Center | Tucson | Arizona | United States | 85724 |
2 | Pacific Shores Medical Group | Long Beach | California | United States | 90813 |
3 | USC/Norris Comprehensive Cancer Center | Los Angeles | California | United States | 90033 |
4 | Northern California Melanoma Center | San Francisco | California | United States | 94109 |
5 | Cancer Institute Medical Group | Santa Monica | California | United States | 90404 |
6 | Indiana Oncology/ Hematology Consultants | Indianapolis | Indiana | United States | 46237 |
7 | Piedmont Oncology Specialists | Charlotte | North Carolina | United States | 28207 |
8 | Joe Arrington Cancer. Research & Treatment Center | Lubbock | Texas | United States | 79410 |
9 | Huntsman Cancer Institute | Salt Lake City | Utah | United States | 84112 |
Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MDX010-08
- CA184-013