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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
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Connecticut
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Florida
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Kansas
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Kentucky
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Maryland
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Massachusetts
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Missouri
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Oregon
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Pennsylvania
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Cordoba
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Santa Fe
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Austria
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Vienna
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Belgium
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Brasschaat
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Belgium
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Brussels
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Belgium
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Edegem
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Gent
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Ceara
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Sao Paulo
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Heidelberg
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Jena
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Ragusa
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Rome
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Siena
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Eindhoven
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Hv Amsterdam
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Oslo
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Gdansk
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Poznan
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Wroclaw
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Portugal
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Lisboa
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Stavropol
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Moscow
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Murmansk
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Samara
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St Petersburg
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South Africa
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Eastern Cape
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South Africa
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Gauteng
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South Africa
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Western Cape
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South Africa
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Johannesburg
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Spain
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Barcelona
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Canarias
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Valencia
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Zaragoza
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Switzerland
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Basel
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Switzerland
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Geneva
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Ukraine
State/province [92] 0 0
Cherkassy
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Ukraine
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Dnepropetrovsk
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Ukraine
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Lviv
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Ukraine
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Uzhgorod
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United Kingdom
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Avon
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United Kingdom
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Dorset
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United Kingdom
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Essex
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United Kingdom
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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
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
Trial website
https://clinicaltrials.gov/study/NCT00324155
Trial related presentations / publications
Maio M, Grob JJ, Aamdal S, Bondarenko I, Robert C, Thomas L, Garbe C, Chiarion-Sileni V, Testori A, Chen TT, Tschaika M, Wolchok JD. Five-year survival rates for treatment-naive patients with advanced melanoma who received ipilimumab plus dacarbazine in a phase III trial. J Clin Oncol. 2015 Apr 1;33(10):1191-6. doi: 10.1200/JCO.2014.56.6018. Epub 2015 Feb 23.
Schadendorf D, Hodi FS, Robert C, Weber JS, Margolin K, Hamid O, Patt D, Chen TT, Berman DM, Wolchok JD. Pooled Analysis of Long-Term Survival Data From Phase II and Phase III Trials of Ipilimumab in Unresectable or Metastatic Melanoma. J Clin Oncol. 2015 Jun 10;33(17):1889-94. doi: 10.1200/JCO.2014.56.2736. Epub 2015 Feb 9.
Robert C, Thomas L, Bondarenko I, O'Day S, Weber J, Garbe C, Lebbe C, Baurain JF, Testori A, Grob JJ, Davidson N, Richards J, Maio M, Hauschild A, Miller WH Jr, Gascon P, Lotem M, Harmankaya K, Ibrahim R, Francis S, Chen TT, Humphrey R, Hoos A, Wolchok JD. Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. N Engl J Med. 2011 Jun 30;364(26):2517-26. doi: 10.1056/NEJMoa1104621. Epub 2011 Jun 5.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00324155