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A Randomized Study Comparing MDX-010 (CTLA-4) Alone or in Combination With DTIC in the Treatment of Patients With Chemotherapy Naїve Metastatic Melanoma.


Phase 2
18 Years
N/A
Not Enrolling
Both
Melanoma

Thank you

Trial Information

A Randomized Study Comparing MDX-010 (CTLA-4) Alone or in Combination With DTIC in the Treatment of Patients With Chemotherapy Naїve Metastatic Melanoma.

Inclusion Criteria


Inclusion Criteria

- 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.

Exclusion Criteria

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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

MDX010-08

NCT ID:

NCT00050102

Start Date:

October 2002

Completion Date:

February 2004

Related Keywords:

  • Melanoma
  • Melanoma

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800
Huntsman Cancer InstituteSalt Lake City, Utah  84112
Pacific Shores Medical GroupLong Beach, California  90813
Cancer Institute Medical GroupLos Angeles, California  90025
Northern California Melanoma CenterSan Francisco, California  94109
Indiana Oncology/ Hematology ConsultantsIndianapolis, Indiana  46237
Piedmont Oncology SpecialistsCharlotte, North Carolina  28207
Joe Arrington Cancer. Research & Treatment CenterLubbock, Texas  79410