Dacarbazine and Ipilimumab vs. Dacarbazine With Placebo in Untreated Unresectable Stage III or IV Melanoma

This study has been completed.
Sponsor:
Collaborator:
Medarex
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00324155
First received: May 8, 2006
Last updated: October 13, 2014
Last verified: October 2014
  Purpose

The purpose of this clinical research study is to examine the safety and effectiveness (how well the drug works) of two different treatments for patients with melanoma. One treatment is an investigational compound (a drug that is not currently approved by the United States Food and Drug Administration [FDA]), know as Ipilimumab (also known as MDX-010 or BMS-734016) together with an approved chemotherapy drug called Dacarbazine


Condition Intervention Phase
Melanoma
Drug: Ipilimumab
Drug: Placebo
Drug: Dacarbazine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Double-Blind, Two-Arm, Phase III Study in Patients With Untreated Stage III (Unresectable) or IV Melanoma Receiving Dacarbazine Plus 10 mg/kg Ipilimumab (MDX-010) vs. Dacarbazine With Placebo

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: Date of randomization to 37 months through 5-year follow-up and up to approximately 76 months ] [ Designated as safety issue: No ]
    OS was defined as the time from the date of randomization until the date of death. Analysis of OS was to be done once 416 deaths had occurred (primary endpoint). However, analysis occurred at 414 deaths (February 7, 2011), due to operational timing of the study. Median number of months of OS and associated confidence interval calculated using the method of Brookmeyer and Crowley.


Secondary Outcome Measures:
  • Survival Rate at 1 Year, 18 Months, 2 Years, and 3 Years [ Time Frame: Date of randomization to 3 years following randomization ] [ Designated as safety issue: No ]
    The survival rate (percentage of participants alive) was defined as the probability that a participant is alive at 1 year (or 18 months, 2 years, or 3 years) following randomization and was estimated via the Kaplan-Meier method.

  • Disease Control Rate (DCR) [ Time Frame: First dose to last tumor assessment prior to subsequent therapy at data cutoff for Primary Endpoint (approximately 5 years) ] [ Designated as safety issue: No ]
    DCR=number whose best overall response (BOR) was partial response (PR), complete response (CR) or stable disease (SD), divided by all randomized participants (unevaluable participants included). Independent review committee assessment. BOR=date of first dose to last tumor assessment prior to subsequent cancer therapy (including tumor resection, excluding palliative local radiotherapy). Modified World Health Organization criteria: CR=disappearance of all lesions; no evidence of progressive disease (PD); PR=50% or more decrease in the sum of products of the longest diameter and greatest perpendicular diameter of all index lesions compared with baseline; SD=neither sufficient decrease to qualify for PR nor sufficient increase to qualify for PD; PD=at least 25% increase in sum of products of all index lesions and/or appearance of any new lesions; nonindex lesions: appearance of any new lesions and/or unequivocal progression of nonindex lesions.

  • Median Number of Months of Progression-free Survival (PFS) [ Time Frame: Randomization to date of progression or death to approximately 5 years ] [ Designated as safety issue: No ]
    PFS=time between randomization and date of progression or death, whichever occurs first. Participants who died without reported prior progression were considered to have progressed on date of death. For those alive and not progressed, PFS was censored on date of last evaluable tumor assessment (TA). Those who have not died and have no recorded postbaseline TA were censored at randomization. Those who died without any recorded postbaseline TA were considered to have progressed on date of death. Evaluation was conducted by both investigator and an independent review committee (IRC), who assessed radiologic imaging studies, photographs of skin lesions, and clinical data. Progressive disease defined using modified criteria of the World Health Organization: demonstration of at least a 25% increase in the sum of products of all index lesions or the appearance of any new lesions. For nonindex lesions: appearance of any any new lesions or unequivocal progression of nonindex lesions.

  • Progression-free Survival (PFS) Rate Truncated at Week 12 [ Time Frame: Day 78 ] [ Designated as safety issue: No ]
    PFS rate at Week 12=probability participant was progression-free at Day 78 posttreatment, calculated as total number of patients receiving treatment who had an overall response of stable disease (SD), partial response (PR), or complete response (CR) at Week 12, divided by total number of participants. For those alive and not progressed at or before Week 12, PFS was censored on date of the last evaluable tumor assessment (TA) at or before Week 12. Those who had an assessment of PD prior to Week 12 and subsequent assessment of SD, PR, or CR at Week 12 were censored as progression-free at Week 12. Those with no recorded postbaseline TA dated on or before Day 109, and who had not died on or before Day 109, were censored at date of randomization. PD=at least 25% increase in sum of the products of all index lesions or appearance of any new lesions; nonindex lesions: the appearance of any new lesions or unequivocal progression of nonindex lesions. IRC=independent review committee.

  • Best Overall Response Rate (BORR) [ Time Frame: First dose to last tumor assessment at data cutoff for primary endpoint (approximately 5 years) ] [ Designated as safety issue: No ]
    BORR=number with Best Overall Response (BOR) of complete response (CR) or partial response (PR), divided by total number of randomized patients. BOR=date of first dose to the last tumor assessment prior to subsequent cancer therapy (including tumor resection surgery but excluding palliative local radiotherapy for bone lesions). Independent review committee assessment. Modified criteria of the World Health Oganization (mWHO): CR=disappearance of all lesions; no evidence of progressive disease; PR=50% or greater decrease in the sum of products of the longest diameter and greatest perpendicular diameter of all index lesions compared with baseline. Immune-related (ir) response criteria (irRC) assess tumor response in patients on immunotherapy: irCR=disappearance of all lesions in 2 consecutive observations at least 4 weeks apart; irPR=50% or greater decrease in total measureable tumor burden compared with peak in 2 observations at least 4 weeks apart.

  • Duration of Response (DOR): Randomized Participants With Response of Complete Response (CR) or Partial Response (PR) [ Time Frame: Day of CR or PR to day of PD or death up to data cutoff for primary endpoint (approximately 5 years) ] [ Designated as safety issue: No ]
    DOR defined in those with Best Overall Response (BOR)=CR or PR per independent review committee (IRC) as time between date of response of confirmed CR or PR, whichever occurred first, and date of PD or death. If PR assessed before CR, DOR confirmed at earlier time-point showing PR. Modified criteria of the World Health Organization (mWHO): CR=disappearance of all lesions;no evidence of PD; PR=50% or greater decrease in the sum of products of longest and greatest perpendicular diameters (SPD) of all index lesions compared with baseline. PD=an increase of 25% or greater in SPD of index lesions compared with the smallest recorded sum, or appearance of 1 or more new lesions. Immune-related response criteria (irRC): SD=50% decrease in total measurable tumor burden compared with peak cannot be established nor 25% increase compared with nadir, in absence of unequivocal progression of nonindex lesions. Unconfirmed immune-related (ir) CR, irPR, or irPD=irSD.

  • Time to Response: All Randomized Participants With Response to Treatment [ Time Frame: First dose to date of BOR up to data cutoff for primary endpoint (approximately 5 years) ] [ Designated as safety issue: No ]
    Time to response was defined as the time between the first dose of study therapy and the date when measurement criteria were met for Best Overall Response (BOR) of partial response (PR) or complete response (CR), whichever occurred first, per independent review committee. Note that if an overall response of PR occurred before confirmation of CR, the time to response endpoint was not determined by the time that the BOR of CR was shown but rather by the earlier time point showing PR. Modified criteria of the World Health Organization: CR=disappearance of all lesions; no evidence of progressive disease (PD); PR=50% or more decrease in the sum of products of the longest and greatest perpendicular diameters (SPD) of all index lesions compared with baseline; PD=an increase of 25% or greater in the SPD of index lesions compared with the smallest recorded sum, or the appearance of 1 or more new lesions.

  • Duration of Stable Disease (SD): Randomized Participants With Stable Disease [ Time Frame: Week 12 to date of disease progression or death up to data cutoff for primary endpoint (approximately 5 years) ] [ Designated as safety issue: No ]
    Duration of SD was defined in those whose Best Overall Response (BOR) was SD, per independent review committee (IRC) as the time between Week 12 and date of progressive disease (PD) or death , whichever occurs first. For those who underwent tumor resection following Week 12 but prior to PD, duration of SD was censored on date of last evaluable tumor assessment (TA) prior to resection. For those with BOR of SD at Week 12, date of PD was used in analysis of duration of SD. For those with BOR=SD who have not subsequently progressed and who remain alive, duration of SD censored on date of last evaluable TA. Modified criteria of the World Health Organization (mWHO): SD=insufficient decrease to qualify for partial response or sufficient increase to qualify for PD; PD=an increase of 25% or more in sum of products of longest diameter and greatest perpendicular diameter of index lesions compared with smallest recorded sum, or appearance of 1 or more new lesions.

  • Percentage of Participants With Brain Metastasis-Free Survival at Time of Data Cutoff [ Time Frame: Date of randomization up to data cutoff for primary endpoint (approximately 5 years) ] [ Designated as safety issue: No ]
    Brain metastasis-free survival was defined as the time from randomization to the date of progression with a new lesion located in the brain. New brain lesions prior to Week 12 constituted a progression event (unlike main progression-free survival analysis). A participant who dies without documentation of a brain lesion was considered to have progressed with brain metastasis on the date of death. Participants who are free of brain metastasis were censored on the date of their last tumor assessment. An independent review committee evaluated images of participants with clinical symptoms to determine the number of those free of brain metastasis. The brain metastasis-free status was reported as a percent of participants (n/N), where n= participants with metastasis-free brains at data cutoff for the Primary Endpoint and N= randomized participants. A 2-sided Clopper and Pearson confidence interval was performed.

  • Number of Participants With Adverse Events (AEs), Drug-related AEs, AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Drug-related SAEs, Drug-related Hypersensitivity, Immune-related AEs/SAEs, and Inflammatory AEs/SAEs [ Time Frame: Week 1 (First Dose) to 70 days after last dose of study up to data cutoff for primary endpoint (approximately 5 years) ] [ Designated as safety issue: Yes ]
    AE=any new undesirable symptom, sign, clinically significant laboratory abnormality, or medical condition occurring after starting study treatment, even if the event was not considered to be drug-related. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Randomization=Day 1; start of treatment (first dose)=Week 1. Summarization time frame is from first dose to 70 days after last dose of study at time of 414 deaths.

  • Number of Participants With Grade 2-3 and Grade 3-4 Immune-related Adverse Events (irAEs) With Resolution Resolved [ Time Frame: Week 1 (first dose) to 70 days after last dose up to data cutoff for primary endpoint (approximately 5 years) ] [ Designated as safety issue: Yes ]
    irAEs included the categories: gastrointestinal (GI), diarrhea, liver, endocrine, and skin. Grade 2=moderate adverse events (AEs); minimal, local, or noninvasive intervention indicated. Grade 3=severe AEs, medically significant but not immediately life-threatening. Grade 4=life-threatening consequences; urgent intervention indicated. Resolution is defined as improvement to Grade 1 or less or to the Grade at baseline (prior to treatment).

  • Time to Resolution of Grade 2-3, Grade 3-4 Immune-related Adverse Events (irAEs) [ Time Frame: Week 1 (first dose) to 70 days after last dose up to database lock for primary endpoint (approximately 5 years) ] [ Designated as safety issue: Yes ]
    irAEs included the categories: gastrointestinal (GI), diarrhea, liver, endocrine, and skin. Grade 2=Moderate adverse events (AEs); minimal, local or noninvasive intervention indicated. Grade 3=severe AEs, medically significant but not immediately life-threatening. Grade 4=life-threatening consequences; urgent intervention indicated. Time to resolution is defined as improvement to Grade 1 or less or to the Grade at baseline (prior to treatment).


Enrollment: 681
Study Start Date: August 2006
Study Completion Date: October 2013
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: Ipilimumab and Dacarbazine
In Maintenance phase: Ipilimumab will be continued. Dacarbazine was given up to Week 22 and is not given in the Maintenance phase
Drug: Ipilimumab

Intravenous solution; intravenous; 10mg/kg; one dose every 3 weeks for 10 weeks then one dose every 12 weeks starting at Week 24, until disease progression, unacceptable toxicity or withdrawal of consent

In Maintenance phase: Only Ipilimumab: 10mg/kg, every 12 weeks will be continued until disease progression

Other Names:
  • MDX-010
  • BMS-734016
Drug: Dacarbazine
Intravenous solution; intravenous; 850 mg/m^2; one dose every 3 weeks for 22 weeks, until disease progression, unacceptable toxicity or withdrawal of consent
Active Comparator: Arm B: Placebo and Dacarbazine Drug: Placebo
Intravenous solution; intravenous; 0 mg; one dose every 3 weeks for 10 weeks then one dose every 12 weeks starting at Week 24; until disease progression, unacceptable toxicity or withdrawal of consent
Drug: Dacarbazine
Intravenous solution; intravenous; 850 mg/m^2; one dose every 3 weeks for 22 weeks, until disease progression, unacceptable toxicity or withdrawal of consent

Detailed Description:

For the extension phase:

Allocation: single arm study; Masking: open label; Intervention Model: Single Group

  Eligibility

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

Inclusion Criteria:

  • Informed Consent
  • Measurable Disease
  • Eastern Cooperative Oncology Group (ECOG) 0 or 1
  • Lab / imaging requirements
  • Neg for Human Immunodeficiency Virus (HIV), Hepatitis B (HepB), C
  • Men and Women > 18 years (16 were allowable)
  • Prior therapy restriction (adjuvant only)

Exclusion:

  • Pregnant / nursing
  • Inadequate contraception
  • Brain metastasis
  • Primary ocular or mucosal melanoma
  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: NCT00324155

  Hide Study Locations
Locations
United States, California
Pacific Cancer Medical Center
Anaheim, California, United States, 92801
Wilshire Oncology Medical Group Inc
La Verne, California, United States, 91750
The Angeles Clinic And Research Institute
Los Angeles, California, United States, 90025
Comprehensive Cancer Center
Palm Springs, California, United States, 92262
Sharp Clinical Oncology Research
San Diego, California, United States, 92123
United States, Connecticut
Saint Francis Hospital And Medical Center
Hartford, Connecticut, United States, 06105
Hematology Oncology, P.C.
Stamford, Connecticut, United States, 06902-3628
United States, Florida
Cancer Specialists Of North Florida Beaches
Jacksonville, Florida, United States, 32256
Orlando Health, Inc. M.D. Anderson Cancer Center Orlando
Orlando, Florida, United States, 32806
Hematology Oncology Associates Of The Treasure Coast
Port Saint Lucie, Florida, United States, 34952
United States, Illinois
University Of Chicago
Chicago, Illinois, United States, 60637
Mid-Illinois Hematology/Oncology Associates, Ltd.
Normal, Illinois, United States, 61761
Oncology Specialists, Sc
Park Ridge, Illinois, United States, 60068
United States, Indiana
Central Indiana Cancer Centers
Fishers, Indiana, United States, 46037
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Kansas
Hutchinson Clinic, Pa
Hutchinson, Kansas, United States, 67502
United States, Kentucky
Kentucky Cancer Clinic
Hazard, Kentucky, United States, 41701
United States, Maryland
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
Sinai Hospital Of Baltimore
Baltimore, Maryland, United States, 21215
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Missouri
Ellis Fischel Cancer Center
Columbia, Missouri, United States, 65203
St Joseph Oncology Inc
Saint Joseph, Missouri, United States, 64507
United States, New Mexico
University Of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, North Carolina
Blumenthal Cancer Center
Charlotte, North Carolina, United States, 28204
United States, Oregon
Providence Portland Medical Center
Portland, Oregon, United States, 97213
United States, Pennsylvania
St. Luke'S Hospital & Health Network
Bethlehem, Pennsylvania, United States, 18015
United States, South Carolina
Lowcountry Hematology & Oncology, Pa
Mount Pleasant, South Carolina, United States, 29464
United States, Tennessee
Thompson Cancer Survival Center
Knoxville, Tennessee, United States, 37916
Vanderbilt-Ingram Cancer Ctr
Nashville, Tennessee, United States, 37232
United States, Texas
Joe Arrington Cancer Research And Treatment Center
Lubbock, Texas, United States, 79410
United States, Virginia
Virginia Cancer Institute
Richmond, Virginia, United States, 23226
Argentina
Local Institution
Buenos Aires, Argentina, C1408INH
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Buenos Aires, Argentina, 1185
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Buenos Aires, Argentina, C1426ANZ
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Cordoba, Argentina, X5000AAI
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Santa Fe, Argentina, S3000FFU
Australia, New South Wales
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Coffs Harbour, New South Wales, Australia, 2450
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Newcastle, New South Wales, Australia, 2300
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Port Macquarie, New South Wales, Australia, 2444
Australia, Queensland
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South Brisbane, Queensland, Australia, 4101
Australia, Victoria
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Box Hill, Victoria, Australia, 3128
Austria
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Vienna, Austria, 1090
Belgium
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Brasschaat, Belgium, 2930
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Brussels, Belgium, 1200
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Edegem, Belgium, B-2650
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Gent, Belgium, 9000
Brazil
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Fortaleza, Ceara, Brazil, 60430-230
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Porto Alegre, Rio Grande Do Sul, Brazil, 90050-170
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Porto Alegre, Rs, Rio Grande Do Sul, Brazil, 90610-000
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Sao Paulo, Brazil, 01508-010
Canada, Alberta
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Edmonton, Alberta, Canada, T6G 1Z2
Canada, Quebec
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Montreal, Quebec, Canada, H1T 2W4
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Montreal, Quebec, Canada, H3T 1E2
Canada, Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7N 4H4
Chile
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Santiago, Chile
Czech Republic
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Olomouc, Czech Republic, 775 20
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Praha, Czech Republic, 128 08
France
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Nantes, Cedex 1, France, 44093
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Saint Etienne, Cedex 2, France, 42055
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Brest, Cedex, France, 29200
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Bordeaux, France, 33075
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Marseille, France, 13009
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Paris, France, 75010
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Pierre Benite, France, 69495
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Villejuif, France, 94805
Germany
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Berlin, Germany, 12200
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Heidelberg, Germany, 69120
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Jena, Germany, 07740
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Kiel, Germany, 24105
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Mannheim, Germany, 68167
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Muenchen, Germany, 81675
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Tubingen, Germany, 72076
Hungary
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Kaposyar, Hungary, 7400
Ireland
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Dublin, Dublin 4, Ireland
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Cork, Ireland
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Galway, Ireland
Israel
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Jerusalem, Israel, 91120
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Tel Aviv, Israel, 64239
Italy
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Genova, Italy, 16128
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Milano, Italy, 20141
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Napoli, Italy, 80131
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Padova, Italy, 35128
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Ragusa, Italy, 97100
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Rome, Italy, 00144
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Siena, Italy, 53100
Netherlands
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Eindhoven, Netherlands, 5623 EJ
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Hv Amsterdam, Netherlands, 1081
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Wurzburg, Netherlands, 97080
Norway
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Montebello, Oslo, Norway, 0310
Poland
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Gdansk, Poland, 80-219
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Lodz, Poland, 93-509
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Lublin, Poland, 20-090
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Poznan, Poland, 61-866
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Wroclaw, Poland, 51-124
Portugal
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Lisboa, Portugal, 1099-023
Russian Federation
Local Institution
Pyatigorsk, Stavropol, Russian Federation, 357502
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Moscow, Russian Federation, 115478
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Moscow, Russian Federation, 105229
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Murmansk, Russian Federation, 183047
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Ryazan, Russian Federation, 390011
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Samara, Russian Federation, 443066
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St Petersburg, Russian Federation, 198255
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St.-Petersburg, Russian Federation, 191104
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Stavropol, Russian Federation, 355047
South Africa
Local Institution
Port Elizabeth, Eastern Cape, South Africa, 6000
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Groenkloof, Gauteng, South Africa, 0181
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Pretoria, Gauteng, South Africa, 0041
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Saxonworld, Gauteng, South Africa, 2196
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Cape Town, Western Cape, South Africa, 7570
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Johannesburg, South Africa, 2199
Spain
Local Institution
Barcelona, Spain, 08036
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Canarias, Spain, 38320
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Valencia, Spain, 46014
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Zaragoza, Spain, 50009
Switzerland
Local Institution
Basel, Switzerland, CH-4031
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Geneva, Switzerland, 1211
Ukraine
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Cherkassy, Ukraine, 18009
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Dnepropetrovsk, Ukraine, 49044
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Lviv, Ukraine, 79031
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Uzhgorod, Ukraine, 88000
United Kingdom
Local Institution
Bristol, Avon, United Kingdom, BS2 8ED
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Poole, Dorset, United Kingdom, BH15 2JB
Local Institution
Chelmsford, Essex, United Kingdom, CM1 7ET
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London, Greater London, United Kingdom, SW3 6JJ
Local Institution
Wirral, Merseyside, United Kingdom, CH63 3JY
Local Institution
Guildford, Surrey, United Kingdom, GU2 7XX
Sponsors and Collaborators
Bristol-Myers Squibb
Medarex
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: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00324155     History of Changes
Other Study ID Numbers: CA184-024
Study First Received: May 8, 2006
Results First Received: January 22, 2014
Last Updated: October 13, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Stage IIIc N3 (unresectable)
Stage IV melanoma

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas

ClinicalTrials.gov processed this record on October 23, 2014