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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00324155




Registration number
NCT00324155
Ethics application status
Date submitted
8/05/2006
Date registered
10/05/2006
Date last updated
2/11/2014

Titles & IDs
Public title
Dacarbazine and Ipilimumab vs. Dacarbazine With Placebo in Untreated Unresectable Stage III or IV Melanoma
Scientific 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
Secondary ID [1] 0 0
CA184-024
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ipilimumab
Treatment: Drugs - Placebo
Treatment: Drugs - Dacarbazine

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

Active comparator: Arm B: Placebo and Dacarbazine -


Treatment: Drugs: 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

Treatment: Drugs: 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

Treatment: Drugs: 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Date of randomization to 37 months through 5-year follow-up and up to approximately 76 months
Secondary outcome [1] 0 0
Survival Rate at 1 Year, 18 Months, 2 Years, and 3 Years
Timepoint [1] 0 0
Date of randomization to 3 years following randomization
Secondary outcome [2] 0 0
Disease Control Rate (DCR)
Timepoint [2] 0 0
First dose to last tumor assessment prior to subsequent therapy at data cutoff for Primary Endpoint (approximately 5 years)
Secondary outcome [3] 0 0
Median Number of Months of Progression-free Survival (PFS)
Timepoint [3] 0 0
Randomization to date of progression or death to approximately 5 years
Secondary outcome [4] 0 0
Progression-free Survival (PFS) Rate Truncated at Week 12
Timepoint [4] 0 0
Day 78
Secondary outcome [5] 0 0
Best Overall Response Rate (BORR)
Timepoint [5] 0 0
First dose to last tumor assessment at data cutoff for primary endpoint (approximately 5 years)
Secondary outcome [6] 0 0
Duration of Response (DOR): Randomized Participants With Response of Complete Response (CR) or Partial Response (PR)
Timepoint [6] 0 0
Day of CR or PR to day of PD or death up to data cutoff for primary endpoint (approximately 5 years)
Secondary outcome [7] 0 0
Time to Response: All Randomized Participants With Response to Treatment
Timepoint [7] 0 0
First dose to date of BOR up to data cutoff for primary endpoint (approximately 5 years)
Secondary outcome [8] 0 0
Duration of Stable Disease (SD): Randomized Participants With Stable Disease
Timepoint [8] 0 0
Week 12 to date of disease progression or death up to data cutoff for primary endpoint (approximately 5 years)
Secondary outcome [9] 0 0
Percentage of Participants With Brain Metastasis-Free Survival at Time of Data Cutoff
Timepoint [9] 0 0
Date of randomization up to data cutoff for primary endpoint (approximately 5 years)
Secondary outcome [10] 0 0
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
Timepoint [10] 0 0
Week 1 (First Dose) to 70 days after last dose of study up to data cutoff for primary endpoint (approximately 5 years)
Secondary outcome [11] 0 0
Number of Participants With Grade 2-3 and Grade 3-4 Immune-related Adverse Events (irAEs) With Resolution Resolved
Timepoint [11] 0 0
Week 1 (first dose) to 70 days after last dose up to data cutoff for primary endpoint (approximately 5 years)
Secondary outcome [12] 0 0
Time to Resolution of Grade 2-3, Grade 3-4 Immune-related Adverse Events (irAEs)
Timepoint [12] 0 0
Week 1 (first dose) to 70 days after last dose up to database lock for primary endpoint (approximately 5 years)

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion:

* Pregnant / nursing
* Inadequate contraception
* Brain metastasis
* Primary ocular or mucosal melanoma

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2013
Sample size
Target
Accrual to date
Final
681
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Local Institution - Coffs Harbour
Recruitment hospital [2] 0 0
Local Institution - Newcastle
Recruitment hospital [3] 0 0
Local Institution - Port Macquarie
Recruitment hospital [4] 0 0
Local Institution - South Brisbane
Recruitment hospital [5] 0 0
Local Institution - Box Hill
Recruitment postcode(s) [1] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [2] 0 0
2300 - Newcastle
Recruitment postcode(s) [3] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment postcode(s) [5] 0 0
3128 - Box Hill
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
New Mexico
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Oregon
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
South Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Virginia
Country [20] 0 0
Argentina
State/province [20] 0 0
Buenos Aires
Country [21] 0 0
Argentina
State/province [21] 0 0
Cordoba
Country [22] 0 0
Argentina
State/province [22] 0 0
Santa Fe
Country [23] 0 0
Austria
State/province [23] 0 0
Vienna
Country [24] 0 0
Belgium
State/province [24] 0 0
Brasschaat
Country [25] 0 0
Belgium
State/province [25] 0 0
Brussels
Country [26] 0 0
Belgium
State/province [26] 0 0
Edegem
Country [27] 0 0
Belgium
State/province [27] 0 0
Gent
Country [28] 0 0
Brazil
State/province [28] 0 0
Ceara
Country [29] 0 0
Brazil
State/province [29] 0 0
Rio Grande Do Sul
Country [30] 0 0
Brazil
State/province [30] 0 0
Sao Paulo
Country [31] 0 0
Canada
State/province [31] 0 0
Alberta
Country [32] 0 0
Canada
State/province [32] 0 0
Quebec
Country [33] 0 0
Canada
State/province [33] 0 0
Saskatchewan
Country [34] 0 0
Chile
State/province [34] 0 0
Santiago
Country [35] 0 0
Czech Republic
State/province [35] 0 0
Olomouc
Country [36] 0 0
Czech Republic
State/province [36] 0 0
Praha
Country [37] 0 0
France
State/province [37] 0 0
Cedex 1
Country [38] 0 0
France
State/province [38] 0 0
Cedex 2
Country [39] 0 0
France
State/province [39] 0 0
Cedex
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France
State/province [40] 0 0
Bordeaux
Country [41] 0 0
France
State/province [41] 0 0
Marseille
Country [42] 0 0
France
State/province [42] 0 0
Paris
Country [43] 0 0
France
State/province [43] 0 0
Pierre Benite
Country [44] 0 0
France
State/province [44] 0 0
Villejuif
Country [45] 0 0
Germany
State/province [45] 0 0
Berlin
Country [46] 0 0
Germany
State/province [46] 0 0
Heidelberg
Country [47] 0 0
Germany
State/province [47] 0 0
Jena
Country [48] 0 0
Germany
State/province [48] 0 0
Kiel
Country [49] 0 0
Germany
State/province [49] 0 0
Mannheim
Country [50] 0 0
Germany
State/province [50] 0 0
Muenchen
Country [51] 0 0
Germany
State/province [51] 0 0
Tubingen
Country [52] 0 0
Hungary
State/province [52] 0 0
Kaposyar
Country [53] 0 0
Ireland
State/province [53] 0 0
Dublin 4
Country [54] 0 0
Ireland
State/province [54] 0 0
Cork
Country [55] 0 0
Ireland
State/province [55] 0 0
Galway
Country [56] 0 0
Israel
State/province [56] 0 0
Jerusalem
Country [57] 0 0
Israel
State/province [57] 0 0
Tel Aviv
Country [58] 0 0
Italy
State/province [58] 0 0
Genova
Country [59] 0 0
Italy
State/province [59] 0 0
Milano
Country [60] 0 0
Italy
State/province [60] 0 0
Napoli
Country [61] 0 0
Italy
State/province [61] 0 0
Padova
Country [62] 0 0
Italy
State/province [62] 0 0
Ragusa
Country [63] 0 0
Italy
State/province [63] 0 0
Rome
Country [64] 0 0
Italy
State/province [64] 0 0
Siena
Country [65] 0 0
Netherlands
State/province [65] 0 0
Eindhoven
Country [66] 0 0
Netherlands
State/province [66] 0 0
Hv Amsterdam
Country [67] 0 0
Netherlands
State/province [67] 0 0
Wurzburg
Country [68] 0 0
Norway
State/province [68] 0 0
Oslo
Country [69] 0 0
Poland
State/province [69] 0 0
Gdansk
Country [70] 0 0
Poland
State/province [70] 0 0
Lodz
Country [71] 0 0
Poland
State/province [71] 0 0
Lublin
Country [72] 0 0
Poland
State/province [72] 0 0
Poznan
Country [73] 0 0
Poland
State/province [73] 0 0
Wroclaw
Country [74] 0 0
Portugal
State/province [74] 0 0
Lisboa
Country [75] 0 0
Russian Federation
State/province [75] 0 0
Stavropol
Country [76] 0 0
Russian Federation
State/province [76] 0 0
Moscow
Country [77] 0 0
Russian Federation
State/province [77] 0 0
Murmansk
Country [78] 0 0
Russian Federation
State/province [78] 0 0
Ryazan
Country [79] 0 0
Russian Federation
State/province [79] 0 0
Samara
Country [80] 0 0
Russian Federation
State/province [80] 0 0
St Petersburg
Country [81] 0 0
Russian Federation
State/province [81] 0 0
St.-Petersburg
Country [82] 0 0
South Africa
State/province [82] 0 0
Eastern Cape
Country [83] 0 0
South Africa
State/province [83] 0 0
Gauteng
Country [84] 0 0
South Africa
State/province [84] 0 0
Western Cape
Country [85] 0 0
South Africa
State/province [85] 0 0
Johannesburg
Country [86] 0 0
Spain
State/province [86] 0 0
Barcelona
Country [87] 0 0
Spain
State/province [87] 0 0
Canarias
Country [88] 0 0
Spain
State/province [88] 0 0
Valencia
Country [89] 0 0
Spain
State/province [89] 0 0
Zaragoza
Country [90] 0 0
Switzerland
State/province [90] 0 0
Basel
Country [91] 0 0
Switzerland
State/province [91] 0 0
Geneva
Country [92] 0 0
Ukraine
State/province [92] 0 0
Cherkassy
Country [93] 0 0
Ukraine
State/province [93] 0 0
Dnepropetrovsk
Country [94] 0 0
Ukraine
State/province [94] 0 0
Lviv
Country [95] 0 0
Ukraine
State/province [95] 0 0
Uzhgorod
Country [96] 0 0
United Kingdom
State/province [96] 0 0
Avon
Country [97] 0 0
United Kingdom
State/province [97] 0 0
Dorset
Country [98] 0 0
United Kingdom
State/province [98] 0 0
Essex
Country [99] 0 0
United Kingdom
State/province [99] 0 0
Greater London
Country [100] 0 0
United Kingdom
State/province [100] 0 0
Merseyside
Country [101] 0 0
United Kingdom
State/province [101] 0 0
Surrey

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Medarex
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00324155