A Randomized, Double-Blind, Multicenter Study Comparing MDX-010 Monotherapy, MDX-010 in Combination With a Melanoma Peptide Vaccine, and Melanoma Vaccine Monotherapy in HLA-A2*0201-Positive Patients With Previously Treated Unresectable Stage III or IV Melanoma
18 Years
N/A
Both
Melanoma, Metastases
Trial Information
A Randomized, Double-Blind, Multicenter Study Comparing MDX-010 Monotherapy, MDX-010 in Combination With a Melanoma Peptide Vaccine, and Melanoma Vaccine Monotherapy in HLA-A2*0201-Positive Patients With Previously Treated Unresectable Stage III or IV Melanoma
Melanoma accounts for approximately 5% of all skin cancers in the United States, but it
accounts for about 75% of all skin cancer deaths. In 2004, the expected prevalence of
melanoma is 627,252, with about 119,178 of these cases being Stage III or IV (metastatic
melanoma). First line treatments for metastatic melanoma, usually IL-2, dacarbazine and/or
temozolomide, are associated with significant toxicities. MDX-010 (anti-CTLA4) antibodies
are designed to keep the immune system running by blocking CTLA-4 from down-regulating T
cell activation. MDX-1379 is made up of two peptides that are pieces of a bigger melanoma
protein (gp100). These peptides bind to HLA-A2 which is then recognized by T cells.
Inclusion Criteria:
- Diagnosed with malignant melanoma
- Measurable unresectable Stage III or IV melanoma
- HLA-A*0201 positive
- Previous treatment with & failure/relapse/inability to tolerate IL-2, dacarbazine
and/or temozolomide
- At least 4 weeks since prior treatment
- Negative pregnancy
- Life expectancy greater than 4 months
- Eastern Cooperative Oncology Group (ECOG) performance of 0 or 1
- Required lab values
- Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV)
negative
Exclusion Criteria:
- Prior malignancies which the patient has not been disease free for over 5 years,
except treated and cured basal or squamous cell skin cancer, superficial bladder
cancer, carcinoma in situ of the cervix, or any other cancer
- Ocular melanoma
- Active, untreated central nervous system (CNS) metastasis
- Prior treatment with MDX-010 (anti-CTLA4) antibody
- Prior treatment with any cancer therapeutic vaccine
- Active autoimmune disease or history of autoimmune disease
- Pregnancy or nursing
- Hypersensitivity to Incomplete Freund's Adjuvant (IFA) (Montanide ISA-51)
- Underlying medical conditions deemed hazardous if treated with study drug
- Concomitant therapy with anti-melanoma drugs, chemotherapies, other investigational
therapies, chronic use of systemic corticosteroids
- Unable to provide informed consent
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Outcome Measure:
Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 in Combination With gp 100 Melanoma Peptide Vaccine Versus gp 100 Melanoma Peptide Vaccine Alone
Outcome Description:
OS was defined as the time from randomization until death from any cause. If a participant did not expire, the subject was censored at the time of last contact (last known alive date). 95% confidence intervals (CI) for median were computed using Brookmeyer and Crowley method.
Outcome Time Frame:
From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks)
Safety Issue:
No
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
United States: Food and Drug Administration
Study ID:
MDX010-20
NCT ID:
NCT00094653
Start Date:
September 2004
Completion Date:
October 2009
Related Keywords:
- Melanoma
- Metastases
- melanoma
- metastatic melanoma
- skin cancer
- Melanoma
- Neoplasm Metastasis
Name | Location |
|---|---|
| Arizona Cancer Center | Tucson, Arizona 85724 |
| Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
| USC/Norris Comprehensive Cancer Center | Los Angeles, California 90033-0800 |
| Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
| University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15213 |
| Fletcher Allen Health Care | Burlington, Vermont 05401 |
| Henry Ford Hospital | Detroit, Michigan 48202 |
| Huntsman Cancer Institute | Salt Lake City, Utah 84112 |
| James Graham Brown Cancer Center | Louisville, Kentucky 40202 |
| Joe Arrington Cancer Research and Treatment Center | Lubbock, Texas 79410-1894 |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
| Franklin Square Hospital Center | Baltimore, Maryland 21237 |
| Hackensack University Medical Center | Hackensack, New Jersey 07601 |
| Central Baptist Hospital | Lexington, Kentucky 40503 |
| University of Louisville Hospital | Louisville, Kentucky 40202 |
| Arlington Cancer Center | Arlington, Texas 76012 |
| City of Hope National Medical Center | Los Angeles, California 91010 |
| Cancer Centers of the Carolinas | Greenville, South Carolina 29605 |
| Mount Sinai Comprehensive Cancer Center | Miami Beach, Florida 33140 |
| Memorial Regional Cancer Center | Hollywood, Florida 33021 |
| Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
| Vanderbilt University Medical Center | Nashville, Tennessee 37232-2516 |
| Ellis Fischel Cancer Center | Columbia, Missouri 65203 |
| Pacific Shores Medical Group | Long Beach, California 90813 |
| Rocky Mountain Cancer Centers | Thornton, Colorado 80260 |
| Palm Beach Cancer Institute | West Palm Beach, Florida 33401 |
| Center for Cancer Care at Goshen Health System | Goshen, Indiana 46526 |
| City of Hope Medical Group | Pasadena, California 91105 |
| Mount Sinai Comprehensive Cancer Center at Aventura | Aventura, Florida 33180 |
| University of Colorado Health Sciences Center | Denver, Colorado 80262 |
| Scripps Cancer Center | La Jolla, California 92037 |
| Center for Oncology Research and Treatment | Dallas, Texas 75230 |
| Family Cancer Center | Collierville, Tennessee 38017 |
| H. Lee Moffitt Cancer Center & Research Institute | Tampa, Florida 33612 |
| Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
| University of Colorado Hospital | Denver, Colorado 80262 |
| Providence Portland Medical Center | Portland, Oregon 97213-3635 |
| Mount Sinai Medical Center | Miami Beach, Florida 33140 |
| The Cleveland Clinic Foundation | Cleveland, Ohio |
| University of California, San Diego | La Jolla, California 92037-1709 |
| University Medical Center | Tucson, Arizona 85724 |
| San Diego Cancer Center | Vista, California 92083 |
| Decatur Memorial Hospital | Decatur, Illinois 62526 |
| Hematology-Oncology Associates of Northern NJ, PA | Morristown, New Jersey 07962 |
| Overlook Oncology Center | Summit, New Jersey 07901 |
| The West Clinic | Memphis, Tennessee 38120 |
| The Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
| Cancer Care Specialists of Central IL | Decatur, Illinois 62526 |
| Robert Wood Johnson University Hospital | New Brunswick, New Jersey 08903 |
| Anschutz Cancer Pavilion | Aurora, Colorado |
| University of Florida/Jacksonville Faculty Clinic | Jacksonville, Florida 32209 |
| Shands Jacksonville | Jacksonville, Florida 32209 |
| New Mexico Oncology Hematology Consultants, Ltd. | Albuquerque, New Mexico 87109 |
| The Cancer Center at Hackensack University Medical Center | Hackensack, New Jersey 07601 |
| Barnes Jewish Hospital | St. Louis, Missouri 63110 |
| Cancer Institute Medical Group, Inc | Santa Monica, California 90404 |
| M.D. Anderson Cancer Center Orlando | Orlando, Florida 32806 |
| University of North Carolina at Chapel Hill | Chapel Hill, North Carolina 27599 |
| Hillman Cancer Center | Pittsburg, Pennsylvania 15232 |
| La Jolla Hematology and Oncology Medical Group | La Jolla, California 92037 |
| The Angeles Clinic and Research Institute | Los Angeles, California 90025 |
| North County Oncology Medical Clinical, Inc. | Oceanside, California 92056 |
| St. Mary's Medical Center - Northern California Melanoma Center | San Francisco, California 94109 |
| Yale University School of Medicine - Oncology Outpatient Clinic | New Haven, Connecticut 06520 |
| Jackson Memorial Hospital & Clinics | Miami, Florida 33136 |
| University of Miami Hospital & Clinics | Miami, Florida 33136 |
| Emory University Hospital-Winship Cancer Institute | Atlanta, Georgia 30322 |
| Cardinal Bernardin Cancer Center, Loyola Unv. Med. Ctr. | Maywood, Illinois 60153 |
| Indiana Oncology Hematology South | Indianapolis, Indiana 46237 |
| American Health Network of IN, LLC | Indianapolis, Indiana 46237 |
| Indiana Oncology Hematology Consultants North | Indianapolis, Indiana 46202 |
| Indiana Oncology Hematology Consutants of Noblesville | Noblesville, Indiana 46060 |
| Norton Hospital | Louisville, Kentucky 40202 |
| Brigham and Womens Hospital | Boston, Massachusetts 02115 |
| Beth Isreal Dec Medical Center | Boston, Massachusetts 02115 |
| Henry Ford Medical Center | Dearborn, Michigan 48126 |
| Henry Ford Medical Center- West Bloomfield | West Bloomfield, Michigan 48322 |
| Humphrey Cancer Center | Coon Rapids, Minnesota 55433 |
| Hubert H Humphrey Cancer Center | Robbinsdale, Minnesota 55422 |
| Family Cancer Center | Olive Branch, Mississippi 38654 |
| St. Joseph Oncology, Inc | St. Joseph, Missouri 64507 |
| Washington Unv. School of Med./ Siteman Cancer Center | St. Louis, Missouri 63110 |
| Hematology-Oncology Associates of CNY | East Syracuse, New York 13057 |
| Columbia University Medical Center, Irving Center for Clinical Research | New York, New York 10032 |
| The Christ Hospital Cancer Center | Cincinnati, Ohio 45219 |
| The Oregon Clinical | Portland, Oregon 97213 |
| Penn State Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033 |
| Thomas Jefferson University Hosptital | Philadelphia, Pennsylvania 19107 |
| Hillman Cancer Research Pavilion | Pittsburgh, Pennsylvania 15213 |
