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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00257205




Registration number
NCT00257205
Ethics application status
Date submitted
18/11/2005
Date registered
22/11/2005
Date last updated
2/07/2012

Titles & IDs
Public title
CP-675,206 Versus Either Dacarbazine Or Temozolomide In Patients Without Prior Therapy
Scientific title
A Phase 3, Open Label, Randomized, Comparative Study Of CP-675,206 And Either Dacarbazine Or Temozolomide In Patients With Advanced Melanoma
Secondary ID [1] 0 0
A3671009
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 - dacarbazine
Treatment: Drugs - CP-675,206
Treatment: Drugs - temozolomide

Active comparator: B - Choice of one or the other Dacarbazine or Temozolomide(CP-675,206) (choice)

Experimental: A -


Treatment: Drugs: dacarbazine
decarbazine 1000 mg/m2 IV Q 21 days x 12

Treatment: Drugs: CP-675,206
CP-675,206 15 mg/kg IV Q 90 days x 4

Treatment: Drugs: temozolomide
temozolomide 200 mg/m2 orally on Days 1-5 every 28 days x 12
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
overall survival
Timepoint [1] 0 0
August 2010
Secondary outcome [1] 0 0
adverse events
Timepoint [1] 0 0
1 year
Secondary outcome [2] 0 0
PFS at 6 months
Timepoint [2] 0 0
6 months
Secondary outcome [3] 0 0
objective tumor response
Timepoint [3] 0 0
1 year
Secondary outcome [4] 0 0
Durable response
Timepoint [4] 0 0
6 months
Secondary outcome [5] 0 0
pharmacokinetics endpoints
Timepoint [5] 0 0
15 months
Secondary outcome [6] 0 0
pharmacogenomic endpoints
Timepoint [6] 0 0
1 year
Secondary outcome [7] 0 0
HQol
Timepoint [7] 0 0
1 year
Secondary outcome [8] 0 0
healthcare resource utilization and loss of productivity
Timepoint [8] 0 0
1 year
Secondary outcome [9] 0 0
human antihuman antibody response for patients in Arm A
Timepoint [9] 0 0
15 months

Eligibility
Key inclusion criteria
* Surgically incurable melanoma, either Stage IV or IIIC with N3 status for regional lymph nodes and in-transit or satellite lesions.
* Serum lactic acid dehydrogenase (LDH) <= 2 x ULN
* ECOG performance status of 0 or 1
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Received any systemic therapy for metastatic melanoma except post-surgical adjuvant treatment with cytokines (eg, alpha-interferon or GM-CSF) or with vaccines after complete resection of melanoma.
* History of brain metastases

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
Open (masking not used)
Who is / are masked / blinded?



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
1/03/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2010
Sample size
Target
Accrual to date
Final
655
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
Recruitment hospital [1] 0 0
Research Site - Waratah
Recruitment hospital [2] 0 0
Research Site - Westmead
Recruitment hospital [3] 0 0
Research Site - Woolloongabba
Recruitment hospital [4] 0 0
Research Site - Adelaide
Recruitment hospital [5] 0 0
Research Site - Launceston
Recruitment hospital [6] 0 0
Research Site - East Melbourne
Recruitment postcode(s) [1] 0 0
2300 - Waratah
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
7250 - Launceston
Recruitment postcode(s) [6] 0 0
3002 - East Melbourne
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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Utah
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Washington
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Argentina
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Buenos Aires
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Turnhout
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Cape Town
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Pretoria
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Barcelona
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Navarra
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Madrid
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Goteborg
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Lund
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Switzerland
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Zurich
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Cornwall
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Middlesex
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Surrey
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London
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Manchester
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Newcastle upon Tyne
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Newcastle Upon Tyne
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United Kingdom
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Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a Phase 3, multi-national, open-label, 2-arm randomized study in patients with surgically incurable metastatic melanoma who have received no prior chemotherapy, or biochemotherapy for the treatment of metastatic disease. The primary objective of this trial is to compare overall survival for patients with advanced melanoma who are randomized to receive CP-675,206 with that of patients who are randomized to receive either dacarbazine or temozolomide (investigator choice)
Trial website
https://clinicaltrials.gov/study/NCT00257205
Trial related presentations / publications
Friedlander P, Wood K, Wassmann K, Christenfeld AM, Bhardwaj N, Oh WK. A whole-blood RNA transcript-based gene signature is associated with the development of CTLA-4 blockade-related diarrhea in patients with advanced melanoma treated with the checkpoint inhibitor tremelimumab. J Immunother Cancer. 2018 Sep 18;6(1):90. doi: 10.1186/s40425-018-0408-9.
Ribas A, Kefford R, Marshall MA, Punt CJ, Haanen JB, Marmol M, Garbe C, Gogas H, Schachter J, Linette G, Lorigan P, Kendra KL, Maio M, Trefzer U, Smylie M, McArthur GA, Dreno B, Nathan PD, Mackiewicz J, Kirkwood JM, Gomez-Navarro J, Huang B, Pavlov D, Hauschild A. Phase III randomized clinical trial comparing tremelimumab with standard-of-care chemotherapy in patients with advanced melanoma. J Clin Oncol. 2013 Feb 10;31(5):616-22. doi: 10.1200/JCO.2012.44.6112. Epub 2013 Jan 7.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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/NCT00257205