Comparison Study of MDX-010 (CTLA-4) Alone and Combined With DTIC in the Treatment of Metastatic Melanoma

NCT ID: NCT00050102

Last Updated: 2011-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2004-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Melanoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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MDX-010 (CTLA-4)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Bristol-Myers Squibb

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Arizona Cancer Center

Tucson, Arizona, United States

Site Status

Pacific Shores Medical Group

Long Beach, California, United States

Site Status

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status

Northern California Melanoma Center

San Francisco, California, United States

Site Status

Cancer Institute Medical Group

Santa Monica, California, United States

Site Status

Indiana Oncology/ Hematology Consultants

Indianapolis, Indiana, United States

Site Status

Piedmont Oncology Specialists

Charlotte, North Carolina, United States

Site Status

Joe Arrington Cancer. Research & Treatment Center

Lubbock, Texas, United States

Site Status

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 20082117 (View on PubMed)

Other Identifiers

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CA184-013

Identifier Type: OTHER

Identifier Source: secondary_id

MDX010-08

Identifier Type: -

Identifier Source: org_study_id

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