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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Melanoma, Metastases

Thank you

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 CenterTucson, Arizona  85724
Memorial Sloan Kettering Cancer CenterNew York, New York  10021
USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
Fletcher Allen Health CareBurlington, Vermont  05401
Henry Ford HospitalDetroit, Michigan  48202
Huntsman Cancer InstituteSalt Lake City, Utah  84112
James Graham Brown Cancer CenterLouisville, Kentucky  40202
Joe Arrington Cancer Research and Treatment CenterLubbock, Texas  79410-1894
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Franklin Square Hospital CenterBaltimore, Maryland  21237
Hackensack University Medical CenterHackensack, New Jersey  07601
Central Baptist HospitalLexington, Kentucky  40503
University of Louisville HospitalLouisville, Kentucky  40202
Arlington Cancer CenterArlington, Texas  76012
City of Hope National Medical CenterLos Angeles, California  91010
Cancer Centers of the CarolinasGreenville, South Carolina  29605
Mount Sinai Comprehensive Cancer CenterMiami Beach, Florida  33140
Memorial Regional Cancer CenterHollywood, Florida  33021
Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Vanderbilt University Medical CenterNashville, Tennessee  37232-2516
Ellis Fischel Cancer CenterColumbia, Missouri  65203
Pacific Shores Medical GroupLong Beach, California  90813
Rocky Mountain Cancer CentersThornton, Colorado  80260
Palm Beach Cancer InstituteWest Palm Beach, Florida  33401
Center for Cancer Care at Goshen Health SystemGoshen, Indiana  46526
City of Hope Medical GroupPasadena, California  91105
Mount Sinai Comprehensive Cancer Center at AventuraAventura, Florida  33180
University of Colorado Health Sciences CenterDenver, Colorado  80262
Scripps Cancer CenterLa Jolla, California  92037
Center for Oncology Research and TreatmentDallas, Texas  75230
Family Cancer CenterCollierville, Tennessee  38017
H. Lee Moffitt Cancer Center & Research InstituteTampa, Florida  33612
Dana Farber Cancer InstituteBoston, Massachusetts  02115
University of Colorado HospitalDenver, Colorado  80262
Providence Portland Medical CenterPortland, Oregon  97213-3635
Mount Sinai Medical CenterMiami Beach, Florida  33140
The Cleveland Clinic FoundationCleveland, Ohio  
University of California, San DiegoLa Jolla, California  92037-1709
University Medical CenterTucson, Arizona  85724
San Diego Cancer CenterVista, California  92083
Decatur Memorial HospitalDecatur, Illinois  62526
Hematology-Oncology Associates of Northern NJ, PAMorristown, New Jersey  07962
Overlook Oncology CenterSummit, New Jersey  07901
The West ClinicMemphis, Tennessee  38120
The Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
Cancer Care Specialists of Central ILDecatur, Illinois  62526
Robert Wood Johnson University HospitalNew Brunswick, New Jersey  08903
Anschutz Cancer PavilionAurora, Colorado  
University of Florida/Jacksonville Faculty ClinicJacksonville, Florida  32209
Shands JacksonvilleJacksonville, Florida  32209
New Mexico Oncology Hematology Consultants, Ltd.Albuquerque, New Mexico  87109
The Cancer Center at Hackensack University Medical CenterHackensack, New Jersey  07601
Barnes Jewish HospitalSt. Louis, Missouri  63110
Cancer Institute Medical Group, IncSanta Monica, California  90404
M.D. Anderson Cancer Center OrlandoOrlando, Florida  32806
University of North Carolina at Chapel HillChapel Hill, North Carolina  27599
Hillman Cancer CenterPittsburg, Pennsylvania  15232
La Jolla Hematology and Oncology Medical GroupLa Jolla, California  92037
The Angeles Clinic and Research InstituteLos Angeles, California  90025
North County Oncology Medical Clinical, Inc.Oceanside, California  92056
St. Mary's Medical Center - Northern California Melanoma CenterSan Francisco, California  94109
Yale University School of Medicine - Oncology Outpatient ClinicNew Haven, Connecticut  06520
Jackson Memorial Hospital & ClinicsMiami, Florida  33136
University of Miami Hospital & ClinicsMiami, Florida  33136
Emory University Hospital-Winship Cancer InstituteAtlanta, Georgia  30322
Cardinal Bernardin Cancer Center, Loyola Unv. Med. Ctr.Maywood, Illinois  60153
Indiana Oncology Hematology SouthIndianapolis, Indiana  46237
American Health Network of IN, LLCIndianapolis, Indiana  46237
Indiana Oncology Hematology Consultants NorthIndianapolis, Indiana  46202
Indiana Oncology Hematology Consutants of NoblesvilleNoblesville, Indiana  46060
Norton HospitalLouisville, Kentucky  40202
Brigham and Womens HospitalBoston, Massachusetts  02115
Beth Isreal Dec Medical CenterBoston, Massachusetts  02115
Henry Ford Medical CenterDearborn, Michigan  48126
Henry Ford Medical Center- West BloomfieldWest Bloomfield, Michigan  48322
Humphrey Cancer CenterCoon Rapids, Minnesota  55433
Hubert H Humphrey Cancer CenterRobbinsdale, Minnesota  55422
Family Cancer CenterOlive Branch, Mississippi  38654
St. Joseph Oncology, IncSt. Joseph, Missouri  64507
Washington Unv. School of Med./ Siteman Cancer CenterSt. Louis, Missouri  63110
Hematology-Oncology Associates of CNYEast Syracuse, New York  13057
Columbia University Medical Center, Irving Center for Clinical ResearchNew York, New York  10032
The Christ Hospital Cancer CenterCincinnati, Ohio  45219
The Oregon ClinicalPortland, Oregon  97213
Penn State Milton S. Hershey Medical CenterHershey, Pennsylvania  17033
Thomas Jefferson University HosptitalPhiladelphia, Pennsylvania  19107
Hillman Cancer Research PavilionPittsburgh, Pennsylvania  15213