Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000010594
Ethics application status
Approved
Date submitted
4/01/2006
Date registered
4/01/2006
Date last updated
6/02/2019
Date data sharing statement initially provided
6/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Phase II Study to Determine Predictive Markers of Response to MDX-010 (BMS-734016)
Scientific title
Phase II Study to Determine Predictive Markers of Response to MDX-010 (BMS-734016) in Patients with Unresectable Stage III or IV Malignant Melanoma
Secondary ID [1] 297317 0
nil known
Universal Trial Number (UTN)
Trial acronym
CA184-004
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unresectable Stage III or IV Malignant Melanoma 971 0
Condition category
Condition code
Cancer 1045 1045 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
During the Induction Phase, each patient will receive MDX-010 (BMS-734016) at either a dose of 3 or 10 mg/kg intravenous (IV) administered as 4 single doses every three weeks (Weeks 1, 4, 7 and 10). During the Maintenance Phase, non-progressing patients who have not experienced toxicities requiring discontinuation in the Induction Phase are eligible to receive additional single doses of MDX-010 (BMS-734016) every 12 Weeks (i.e. Week 24, 36, 48 in the first year) until progression, toxicities requiring discontinuation or withdrawal of consent. At the time of progression, patients who continue to have performance status ECOG 0-1, no history of prohibitive toxicity, and a best objective response of stable disease or better at Week 12 will be offered, at Investigator’s discretion, entry onto a separate companion study which examines the safety and efficacy of re-induction and maintenance at the time of progression. Progressing patients who are not eligible or
choose not to enroll onto the companion study will enter the Follow-Up Phase with no further dosing
Intervention code [1] 822 0
Treatment: Drugs
Comparator / control treatment
Nil
Control group
Dose comparison

Outcomes
Primary outcome [1] 1399 0
To identify candidate markers predictive of response and/or serious toxicity to MDX-010 (BMS-734016).
Timepoint [1] 1399 0
Tumour response measured starting at week 12 through week 24. Those continuing on therapy after week 24 have tumour responses evaluated every 3 months.
Secondary outcome [1] 2469 0
Safety & tumour response.
Timepoint [1] 2469 0
Safety evaluated on a continuous and ongoing basis.

Eligibility
Key inclusion criteria
Histologic or cytologic diagnosis of unresectable Stage III or IV malignant melanoma (excluding ocular melanoma). A pre- and post-treatment fresh core or excision tumour biopsy must be provided.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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)
Central randomisation to numbered containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Interactive voice response system (IVRS) to assign patient to dose group based on randomisation schedule computer generated and maintained by sponsor. Randomisation using a permuted block procedure and stratification.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Study halted prematurely, prior to enrolment of first participant in Australia, Completed Study is listed on ClinTrials.gov - refer to record # NCT00261365.
Date of first participant enrolment
Anticipated
15/03/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 21257 0
United States of America
State/province [1] 21257 0

Funding & Sponsors
Funding source category [1] 1143 0
Commercial sector/Industry
Name [1] 1143 0
Bristol-Myers Squibb Pty Ltd
Country [1] 1143 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb Pty Ltd.
Address
Bristol-Myers Squibb
PO Box 1080
Mt Waverley VIC 3149
Country
United States of America
Secondary sponsor category [1] 1000 0
None
Name [1] 1000 0
None
Address [1] 1000 0
Country [1] 1000 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302572 0
Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 302572 0
Ethics committee country [1] 302572 0
Australia
Date submitted for ethics approval [1] 302572 0
Approval date [1] 302572 0
15/02/2006
Ethics approval number [1] 302572 0

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

Contacts
Principal investigator
Name 35420 0
Dr Anne Hamilton
Address 35420 0
RPA Sydney Cancer Centre
Country 35420 0
Australia
Phone 35420 0
+61 2 95156902
Fax 35420 0
Email 35420 0
NA@com.au
Contact person for public queries
Name 10011 0
Mr Richard Wykes
Address 10011 0
Department of Medical Oncology
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Country 10011 0
Australia
Phone 10011 0
+61 2 95156902
Fax 10011 0
+61 2 95155063
Email 10011 0
richard.wykes@email.cs.nsw.gov.au
Contact person for scientific queries
Name 939 0
Mr Richard Wykes
Address 939 0
Department of Medical Oncology
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Country 939 0
Australia
Phone 939 0
+61 2 95156902
Fax 939 0
+61 2 95155063
Email 939 0
richard.wykes@email.cs.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Trial withdrawn


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.