MDX-010 Antibody, MDX-1379 Melanoma Vaccine, or MDX-010/MDX-1379 Combination Treatment for Patients With Unresectable or Metastatic Melanoma

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00094653
First received: October 21, 2004
Last updated: June 29, 2011
Last verified: June 2011
  Purpose

The purpose of this study is to determine the safety and efficacy of MDX-010 (ipilimumab, BMS-734016) (anti-CTLA4) in combination with MDX-1379 (gp100, BMS-734019) in patients with previously treated, unresectable Stage III or IV melanoma. Survival time will be evaluated, as well as patient responses and time to disease progression. Eligible patients are those who in response to a single regimen containing interleukin-2 (IL-2), dacarbazine, and/or temozolomide, have 1) relapsed following an objective response (partial response/complete response [PR/CR]); 2) failed to demonstrate an objective response (PR/CR); or 3) could not tolerate such a regimen due to unacceptable toxicity. Patients will be randomized into one of three groups, and will receive one of the following treatments: MDX-010 alone, MDX-1379 alone, or MDX-010 in combination with MDX-1379.


Condition Intervention Phase
Melanoma
Metastases
Drug: MDX-010 (anti-CTLA4) monoclonal antibody
Biological: MDX-1379 (gp100) Melanoma Peptide Vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 [ Time Frame: From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 Monotherapy Versus gp100 Melanoma Peptide Vaccine Alone and MDX-010 in Combination With gp100 Melanoma Peptide Vaccine Versus MDX-010 Monotherapy [ Time Frame: From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks) ] [ Designated as safety issue: No ]
    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.

  • 12-, 18-, and 24-Month Survival Rates [ Time Frame: Month 12, Month 18, Month 24 ] [ Designated as safety issue: No ]
    The probability that a subject is alive at 12 months, 18 months, and 24 months following randomization, estimated via the non-parametric method (Kaplan-Meier method). For calculating 95% CI, bootstrap method was used with 20000 simulated trials.

  • Progression Free Survival (PFS) [ Time Frame: From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks) ] [ Designated as safety issue: No ]
    PFS was defined as the number of days between the date of randomization and the date of the progression or the date of death. A subject who died without prior progression was considered to have progressed on the date of death. PFS was determined by investigator. 95% confidence intervals (CI) for median were computed using Brookmeyer and Crowley method.

  • Percentage of Participants With Progression Free Survival (PFS) at Week 12 and Week 24 [ Time Frame: Week 12, Week 24 ] [ Designated as safety issue: No ]
    PFS at Week 12 was defined as the probability that the subject was progression-free at 12 weeks and 24 weeks following the start of randomization. It was computed via Kaplan-Meier method, truncated at Week 12 and Week 24. PFS was determined by investigator. 95% confidence intervals (CI) for median were computed using Brookmeyer and Crowley method.

  • Time to Progression (TTP) [ Time Frame: from time of randomization to date of PD or death due to PD (end of the study was defined as the time at which 481 deaths were observed [264 weeks]) ] [ Designated as safety issue: No ]
    TTP was defined as the number of days between the date of the randomization and date of PD or death due to PD. For subjects who had not progression and remained alive, TTP was censored on the date of last assessment; those who remained alive and had no recorded post-baseline assessment, TTP was censored on the date of randomization; those who remained alive and had randomized but were not treated, TTP was censored at the date of randomization; for those who died without reported disease progression, TTP was censored on the date of death.

  • Best Overall Response (BOR): Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressed Disease (PD) [ Time Frame: BOR was determined between Weeks 12 and Week 24 confirmation at least 4 weeks later at Cycle 1. ] [ Designated as safety issue: No ]
    Investigator's assessment, modified World Health Organization criteria. CR: disappearance of all lesions by 2 consecutive observations >=4 weeks apart, no evidence of PD. PR: >=50% ↓ in sum of products of longest diameter & greatest perpendicular diameter of all target lesions compared to baseline by 2 observations >=4 weeks apart. SD: Neither sufficient ↓ to qualify for PR nor sufficient ↑ to qualify for PD. PD: ↑ >=25% in sum of products of longest diameter & greatest perpendicular diameter of target lesions compared to smallest recorded sum during study, or appearance of >= 1 new lesion.

  • Determination of Best Overall Response Rate (BORR) [ Time Frame: Up to week 24 ] [ Designated as safety issue: No ]
    Response was based on the investigators' assessment using modified WHO criteria. BORR is defined as the number of subjects whose BOR is complete or partial response (CR or PR) divided by the total number of subjects in the group. BORR was comprised of responder and non-responder. The definition of a responder in BORR was either confirmed CR or PR, and a non-responder was defined as stable disease (SD), progressed disease (PD), unconfirmed CR (uCR), unconfirmed PR (uPR), and not evaluated.

  • Time to Response [ Time Frame: From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks) ] [ Designated as safety issue: No ]
    Time to response was defined as the number of days from the date of randomization to the date when measurement criteria are met for BOR of CR or PR, as determined by investigator.

  • Duration of Response [ Time Frame: from time of initial drug administration to date of PD or death due to PD (the end of the study was defined as the time at which 481 deaths were observed [264 weeks]) ] [ Designated as safety issue: No ]
    Kaplan-Meier medians along with Brookmeyer and Crowley 95% confidence intervals (CI) for were computed. Duration of response was defined in subjects whose BOR was CR or PR as the number of days between the date of response (CR or PR) and the date of PD or the date of death (whichever occurs first).

  • Disease Control Rate (DCR) [ Time Frame: Up to week 24 ] [ Designated as safety issue: No ]
    Response was based on the investigators' assessment using modified WHO criteria. DCR is defined as the number of subjects whose BOR is CR, PR, or SD divided by the total number of subjects in the group.

  • Delayed Response (Response Beyond Week 24) [ Time Frame: from Week 24 to end of study (the end of the study was defined as the time at which 481 deaths were observed [264 weeks]) ] [ Designated as safety issue: No ]
    Response was based on the investigators' assessment using modified World Health Organization (WHO) criteria. Delayed response is defined as post Week 24 overall response for the subjects who have PD before or at Week 24. Evaluation of delayed overall response is compared to baseline assessment. Delayed response includes delayed late CR, delayed late PR, delayed late SD, continued PD, unknown, and missing after Week 24. The delayed response of CR and PR also must have been confirmed.

  • Change From Baseline in Health-Related Quality of Life (QOL) as Measured by the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Instrument at Week 12 [ Time Frame: Baseline (Day 1, Cycle1), Week 12 ] [ Designated as safety issue: No ]
    The 30 items were grouped into the following: 1 global QOL scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). All scores were linearly transformed to a 0 to 100 scale. For global QOL and functional items, a higher score represents a better level of functioning (100=best/0=worst). For symptom items, a higher score represents a higher level of symptoms (0=no symptom at all/100=very much severe).

  • Percentage of Participants With On-Study Adverse Events (AEs) and AEs With an Outcome of Death [ Time Frame: On-study adverse events include all AEs reported between the first dose and 70 days after the last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]). ] [ Designated as safety issue: Yes ]
    An AE was defined as any undesirable sign, symptom, clinically significant laboratory abnormality, or medical condition occurring after starting study treatment, even if the event was not considered to be treatment-related. Adverse events are graded using the Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0. If CTCAE grading does not exist for an adverse event, the intensity of mild (1), moderate (2), severe (3), and life-threatening (4) were used.

  • Percentage of Participants With Immune-Related Adverse Events (irAEs) [ Time Frame: On-study adverse events include all AEs reported between the first dose and 70 days after the last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]). ] [ Designated as safety issue: Yes ]
    An immune related adverse event (irAE) was defined as an adverse event of unknown etiology, associated with study drug exposure and consistent with an immune phenomenon. The irAEs were programmatically determined from a predefined list of MedDRA version 12.0 high-level group terms, high-level terms and preferred terms of all ipilimumab related adverse event. The category of "Other irAEs" includes blood, eye, immune, infections, renal, and respiratory systems.

  • Percentage of Participants With Worst On-Study Hematological Abnormalities [ Time Frame: On-study laboratory results are results reported after the first dose date and within 70 days of last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]). ] [ Designated as safety issue: Yes ]
    ANC=Absolute Neutrophil Count. CTCAE v3.0 Grades 0 through 4 of severity for each AE based on this general guideline: Grade 0=Normal, Grade 1=Mild AE, Grade 2=Moderate AE, Grade 3=Severe AE, Grade 4=Life-threatening or disabling AE.

  • Percentage of Participants With Worst On-Study Liver Abnormalities [ Time Frame: On-study adverse events include all AEs reported between the first dose and 70 days after the last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]). ] [ Designated as safety issue: Yes ]
    ALT=alanine aminotransferase; AST=aspartate aminotransferase. CTCAE v3.0 Grades 0 through 4 of severity for each AE based on this general guideline: Grade 0=Normal, Grade 1=Mild AE, Grade 2=Moderate AE, Grade 3=Severe AE, Grade 4=Life-threatening or disabling AE.

  • Percentage of Participants With Worst On-Study Renal Abnormalities [ Time Frame: On-study adverse events include all AEs reported between the first dose and 70 days after the last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]). ] [ Designated as safety issue: Yes ]
    CTCAE v3.0 Grades 0 through 4 of severity for each AE based on this general guideline: Grade 0=Normal, Grade 1=Mild AE, Grade 2=Moderate AE, Grade 3=Severe AE, Grade 4=Life-threatening or disabling AE.

  • Clinically Meaningful Changes in Vital Signs and Physical Examinations [ Time Frame: vital signs and physical examination were evaluated at screening and at Weeks 1, 4, 7, 10, 12, 16, 20, 24, 28, 36, and every 3 months thereafter ] [ Designated as safety issue: Yes ]
    Clinically meaningful changes were according to investigator. Vital sign measurements include height, weight, temperature, pulse, and resting systolic and diastolic blood pressure.


Enrollment: 1783
Study Start Date: September 2004
Study Completion Date: October 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Melanoma Peptide Vaccine (MDX-1379) (gp100) + Placebo
Biological: MDX-1379 (gp100) Melanoma Peptide Vaccine
2mL (2 subcutaneous injections of 2 mL each, 1 to each thigh), every 3 weeks for 4 doses.
Other Name: melanoma peptide vaccine
Experimental: 2
MDX-010 (ipilimumab) + MDX-1379 (gp100) (Melanoma Peptide Vaccine)
Drug: MDX-010 (anti-CTLA4) monoclonal antibody
3mg/kg (intravenous [iv] infusion over 90 minutes), every 3 weeks for 4 doses
Other Name: ipilimumab
Biological: MDX-1379 (gp100) Melanoma Peptide Vaccine
2mL (2 subcutaneous injections of 2 mL each, 1 to each thigh), every 3 weeks for 4 doses.
Other Name: melanoma peptide vaccine
Active Comparator: 3
MDX-010 (ipilimumab) + Placebo
Drug: MDX-010 (anti-CTLA4) monoclonal antibody
3mg/kg (intravenous [iv] infusion over 90 minutes), every 3 weeks for 4 doses
Other Name: ipilimumab

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00094653

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Locations
United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724
University Medical Center
Tucson, Arizona, United States, 85724
United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010
San Diego Cancer Center
Encinitas, California, United States, 92024
Scripps Cancer Center
La Jolla, California, United States, 92037
Moores UCSD Cancer Center
La Jolla, California, United States, 92093
La Jolla Hematology and Oncology Medical Group
La Jolla, California, United States, 92037
Pacific Shores Medical Group
Long Beach, California, United States, 90813
The Angeles Clinic and Research Institute
Los Angeles, California, United States, 90025
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Cancer Institute Medical Group, Inc
Los Angeles, California, United States, 90025
North County Oncology Medical Clinical, Inc.
Oceanside, California, United States, 92056
City of Hope Medical Group
Pasadena, California, United States, 91105
University of California, San Diego
San Diego, California, United States, 92103
St. Mary's Medical Center - Northern California Melanoma Center
San Francisco, California, United States, 94109
Cancer Institute Medical Group, Inc
Santa Monica, California, United States, 90404
San Diego Cancer Center
Vista, California, United States, 92081
United States, Colorado
Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80010
Rocky Mountain Cancer Centers
Aurora, Colorado, United States, 80012
University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80045
Rocky Mountain Cancer Centers
Boulder, Colorado, United States, 80304
Rocky Mountain Cancer Centers
Colorado Springs, Colorado, United States, 80909
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80218
University of Colorado Hospital
Denver, Colorado, United States, 80262
Rocky Mountain Cancer Centers
Lakewood, Colorado, United States, 80228
Rocky Mountain Cancer Centers
Littleton, Colorado, United States, 80120
Rocky Mountain Cancer Centers
Lone Tree, Colorado, United States, 80124
Rocky Mountain Cancer Centers
Longmont, Colorado, United States, 80501
United States, Connecticut
Yale University School of Medicine - Oncology Outpatient Clinic
New Haven, Connecticut, United States, 06520
United States, Florida
Mount Sinai Comprehensive Cancer Center at Aventura
Aventura, Florida, United States, 33180
Memorial Regional Cancer Center
Hollywood, Florida, United States, 33021
Shands Jacksonville
Jacksonville, Florida, United States, 32209
University of Florida/Jacksonville Faculty Clinic
Jacksonville, Florida, United States, 32209
Jackson Memorial Hospital & Clinics
Miami, Florida, United States, 33136
University of Miami Hospital & Clinics
Miami, Florida, United States, 33136
Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States, 33140
M.D. Anderson Cancer Center Orlando
Orlando, Florida, United States, 32806
Palm Beach Cancer Institute
Palm Beach Gardens, Florida, United States, 33410
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
Palm Beach Cancer Institute
Wellington, Florida, United States, 33414
Palm Beach Cancer Institute
West Palm Beach, Florida, United States, 33401
United States, Georgia
Emory University Hospital-Winship Cancer Institute
Atlanta, Georgia, United States, 30322
United States, Illinois
Cancer Care Specialists of Central IL
Decatur, Illinois, United States, 62526
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Cancer Care Specialists of Central IL
Effingham, Illinois, United States, 62401
Cardinal Bernardin Cancer Center, Loyola Unv. Med. Ctr.
Maywood, Illinois, United States, 60153
United States, Indiana
Center for Cancer Care at Goshen Health System
Goshen, Indiana, United States, 46526
Indiana Oncology Hematology South
Indianapolis, Indiana, United States, 46237
American Health Network of IN, LLC
Indianapolis, Indiana, United States, 46237
Indiana Oncology Hematology Consultants North
Indianapolis, Indiana, United States, 46202
Indiana Oncology Hematology Consutants of Noblesville
Noblesville, Indiana, United States, 46060
United States, Kentucky
Central Baptist Hospital
Lexington, Kentucky, United States, 40503
James Graham Brown Cancer Center
Louisville, Kentucky, United States, 40202
University of Louisville Hospital
Louisville, Kentucky, United States, 40202
Norton Hospital
Louisville, Kentucky, United States, 40202
United States, Maryland
Franklin Square Hospital Center
Baltimore, Maryland, United States, 21237
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lutherville, Maryland, United States, 21093
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Brigham and Womens Hospital
Boston, Massachusetts, United States, 02115
Beth Isreal Dec Medical Center
Boston, Massachusetts, United States, 02115
United States, Michigan
Henry Ford Medical Center
Dearborn, Michigan, United States, 48126
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Henry Ford Medical Center- West Bloomfield
West Bloomfield, Michigan, United States, 48322
United States, Minnesota
Humphrey Cancer Center
Coon Rapids, Minnesota, United States, 55433
Humphrey Cancer Center
Fridley, Minnesota, United States, 55432
Hubert H Humphrey Cancer Center
Robbinsdale, Minnesota, United States, 55422
United States, Mississippi
Family Cancer Center
Olive Branch, Mississippi, United States, 38654
United States, Missouri
Ellis Fischel Cancer Center
Columbia, Missouri, United States, 65203
St. Joseph Oncology, Inc
St. Joseph, Missouri, United States, 64507
Washington Unv. School of Med./ Siteman Cancer Center
St. Louis, Missouri, United States, 63110
Barnes Jewish Hospital
St. Louis, Missouri, United States, 63110
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
The Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Hematology-Oncology Associates of Northern NJ, PA
Morristown, New Jersey, United States, 07962
The Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08901
Overlook Oncology Center
Summit, New Jersey, United States, 07901
United States, New Mexico
New Mexico Oncology Hematology Consultants, Ltd.
Albuquerque, New Mexico, United States, 87109
United States, New York
Hematology-Oncology Associates of CNY
East Syracuse, New York, United States, 13057
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
Columbia University Medical Center, Irving Center for Clinical Research
New York, New York, United States, 10032
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7050
United States, Ohio
The Christ Hospital Cancer Center
Cincinnati, Ohio, United States, 45219
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Oregon
Providence Portland Medical Center
Portland, Oregon, United States, 97213
The Oregon Clinical
Portland, Oregon, United States, 97213
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Thomas Jefferson University Hosptital
Philadelphia, Pennsylvania, United States, 19107
Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232
Hillman Cancer Research Pavilion
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Cancer Centers of the Carolinas
Easley, South Carolina, United States, 29640
Cancer Centers of the Carolinas
Greenville, South Carolina, United States, 29615
Cancer Centers of the Carolinas
Seneca, South Carolina, United States, 29672
Cancer Centers of the Carolinas
Spartanburg, South Carolina, United States, 29307
United States, Tennessee
Family Cancer Center
Bartlett, Tennessee, United States, 38133
Family Cancer Center
Collierville, Tennessee, United States, 38017
The West Clinic
Memphis, Tennessee, United States, 38120
Family Cancer Center
Memphis, Tennessee, United States, 38119
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Arlington Cancer Center
Arlington, Texas, United States, 76012
Center for Oncology Research and Treatment
Dallas, Texas, United States, 75230
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States, 79410
Center for Oncology Research and Treatment
Richardson, Texas, United States, 75080
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112-5550
United States, Vermont
Fletcher Allen Health Care
Burlington, Vermont, United States, 05405
Argentina
Hospital Municipal de Oncoligia Maria Curie
Ciudad de Buenos Aires, Buenos Aires, Argentina
Instituto Medico Platense
La Plata, Provincia de Buenos Aires, Argentina, 1900
Hospital Militar Central
Buenos Aires, Argentina
Instituto Medico Especializado Alexander Fleming
Buenos Aires, Argentina
Hospital Militar Central
Ciudad de Buenos Aires, Argentina, C1426BOS
Instituto Alexander Fleming
Ciudad de Buenos Aires, Argentina, C1426DRB
Hospital Britanico de Buenos Aires
Ciudad de Buenos Aires, Argentina, C1280AEB
Hospital Municipal de Oncologia Maria Curie
Ciudad de Buenos Aires, Argentina, C1405BWU
Instituto de Oncologia Angel H. Roffo
Ciudad de Buenos Aires, Argentina, C1417DTB
Hospital General de Agudos Carlos G. Durand
Ciudad de Buenos Aires, Argentina, C1405DCS
Hospital Privado Centro Medico de Cordoba S.A.
Cordoba, Argentina
Hospital Privado de Cordoba S.A.
Cordoba, Argentina, X5016KEH
ISIS Clinica Especializada
Santa Fe, Argentina, S3000FFU
ISIS Clinica Especializada
Santa Fe, Argentina
Belgium
Erasme Hospital
Brussels, Belgium, 1070
Institut Jules Bordet
Brussels, Belgium, 1000
Erasme Hospital, Free Universtiy of Brussels
Brussels, Belgium, 1070
U.Z. Gent
Gent, Belgium, 9000
Universitair Ziekenhuis Gasthuisberg
Leuven, Belgium, 3000
Cliniques Universitaires UCL de Mont-Godinne
Yvoir, Belgium, 5530
Brazil
Hospital Araujo Jorge da Associacoa de Combate ao Cancer em Goias
Goiania, GO, Brazil
Pro Onco Centro Tratamento Oncologico
Londrina, PR, Brazil
Hospital Sao Lucas da PUCRS
Porto Alegre, RS, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos
Barretos, SP, Brazil
Fundacoa Hospital Amaral Carvalho
Jau, SP, Brazil
Santo Andre Diagnosticos aTratamentos
Santo Andre, SP, Brazil
Sociedade Beneficante de Sennores - Hospital Sino Libante
Sao Paulo, SP, Brazil
Hospital de Cancer de Barretos - Fundacao Pio XII
Barretos - SP, Brazil, 14784-400
Biocor - Hosp. de Doencas Cardiovasculares Ltda.
Belo Horizonte - MG, Brazil, 34000-000
Hospital Araujo Jorge
Goiania - GO, Brazil, 74605-070
Pro Onco Centro Tratemento Oncologico
Londrina - PR, Brazil, 86050-190
Fundacao Central Sul-Americana para o Desenvolvimento de Drogas Anticancer-SOAD
Porto Alegre, Brazil, 90035-003
Fund. SOAD / HC de Porto Alegre
Porto Alegre - RS, Brazil, 90035-003
Hospital Sao Lucas - PUCRS
Porto Alegre - RS, Brazil, 90610-000
Santo Andre Diagnosticos e Tratamentos Ltda.
Santo Andre-SP, Brazil, 09090-780
HC-FMUSP
Sao Paulo - SP, Brazil, 05403-000
Hospital Sirio Labanes
Sao Paulo-SP, Brazil, 01308-050
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Newfoundland and Labrador
Dr. H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Ontario
Cancer Centre of Southeastern Ontario at KGH
Kingston, Ontario, Canada, K7L 5P9
London Regional Cancer Program
London, Ontario, Canada, N6A 4L6
The Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Sir Mortimer B. Davis - Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Chile
Instituto Nacional del Cancer
Independencia, Santiago, Chile
Clinica Davila
Recoleta, Santiago, Chile
Clinica Renaca
Renaca, Vina Del Mar, Chile
Fundacion Arturo Lopez Perez
Santiago, Chile
Hospital Barros Luco
Santiago, Chile
France
Centre Oscar Lambret
Lille, France, 59020 Cedex
Centre Leon Berard
Lyon, France, 69373 Cedex 08
Hopital Sainte-Marguerite
Marseille, France, 13009
Hopital Saint-Eloi
Montpellier, France, 34295 Cedex 5
Hotel Dieu
Nantes, France, 44093 Cedex 1
Centre Antoine Lacassagne
Nice cedex 2, France, 06189
Hopital Saint-Louis
Paris, France, 75010 10
Centre Eugene Marquis
Rennes, France, 35042 Cedex
Centre-Hospitalier Universitaire de Saint-Etienne
Saint-Etienne, France, 42055 Cedex 2
Centre Alexis Vautrin
Vandoeuvre les Nancy, France, 54511 Cedex
Institut Gustave Roussy (IGR)
Villejuif, France, 94805 Cedex
Germany
Klinik fur und Poliklinik fur Dermatologie, Venerologie und Allergologie
Hufelandstr. 55, Essen, Germany, 45122
Klinikum Augsburg
Augsburg, Germany, 86156
Charite-Universitaetsmedizin Berlin, Campus Benjamin Franklin
Berlin, Germany, 12200
Charite Universitaets medizin Berlin
Berlin, Germany, 10117
Universitaetsklinikum Dusseldorf
Duesseldorf, Germany, 40225
Universitaetsklinikum Erlangen
Erlangen, Germany, 91052
Universitaetsklinikum Essen
Essen, Germany, 45122
Universitaetsklinikum Heidelberg
Heidelburg, Germany, 69115
Klinikum der Friedrich-Schiller-Universitaet Jena
Jena, Germany, 07740
University of Mannheim
Mannheim, Germany
Klinikum Mannheim gGmbH
Mannheim, Germany, 68167
Klinikum Rechts der Isar / TU Muenchen
Muenchen, Germany, 81675
Universitaetsklinikum Tuebingen
Tuebingen, Germany, 72076
Universitaetsklinikum Wuerzburg
Wuerzburg, Germany, 97080
Hungary
National Institute of Oncology
Budapest, Hungary, H-1122
University of Debrecen, Medical and Health Sciences Center
Debrecen, Hungary, H-4012
Semmelweis Hospital
Miskolc, Hungary, H-3529
University of Szeged, Albert Szent-Gyorgyi Medical and Pharmaceutical Center
Szeged, Hungary, H-6720
Netherlands
Antoni Van Leeuwenhoek Ziekenhuis
Amsterdam, Netherlands, 1066 CX
Vrije Universiteit Medisch Centrum (VUMC)
Amsterdam, Netherlands, 1081 HV
Academisch Ziekenhuis Maastricht
Maastricht, Netherlands, 6229 HX
South Africa
Mary Potter Oncology Centre
Groenkloof, South Africa, 0181
GVI Oncology
Panorama, South Africa, 7500
Mary Potter Oncology Centre
Pretoria, South Africa, 0181
Sandton Onocology Medical Research
Sandton, South Africa, 2199
Switzerland
Centre Hospitalier Universitaire Vaudois - CHUV
Lausanne, Rue du Bugnon 46, Switzerland, CH-1011
Centre Hospitalier Universitaire Vaudois - CHUV
Lausanne, Switzerland, CH-1011
Dermatologische Klinik Universitatsspital Zurich
Zurich, Switzerland, 8091
United Kingdom
St. Luke's Cancer Center, The Royal Surrey County Hospital
Guildford, Surry, United Kingdom, GU2 7XX
Velindre Hospital
Cardiff, United Kingdom, CF14 2TL
Ninewells Hospital
Dundee, United Kingdom, DD1 9SY
Christie Hospital
Manchester, United Kingdom, M20 4BX
Nottingham City Hospital
Nottingham, United Kingdom, NG5 1PB
Churchill Hospital
Oxford, United Kingdom, OX3 7LJ
Poole Hospital
Poole, United Kingdom, BH15 2JB
Weston Park Hospital
Sheffield, United Kingdom, S10 2SJ
Southampton General
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00094653     History of Changes
Other Study ID Numbers: MDX010-20, CA184-002
Study First Received: October 21, 2004
Results First Received: April 22, 2011
Last Updated: June 29, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
melanoma
metastatic melanoma
skin cancer

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014