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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00796445




Registration number
NCT00796445
Ethics application status
Date submitted
21/11/2008
Date registered
24/11/2008

Titles & IDs
Public title
A Phase III Study to Test the Benefit of a New Kind of Anti-cancer Treatment in Patients With Melanoma, After Surgical Removal of Their Tumor
Scientific title
GSK 2132231A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Resected Melanoma
Secondary ID [1] 0 0
2008-002447-16
Secondary ID [2] 0 0
111482
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 - GSK 2132231A
Treatment: Drugs - Placebo

Experimental: MAGE-A3 Group - Patients who received up to 13 doses of recMAGE-A3 + AS15 ASCI. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of ASCI product at 3-week intervals, followed by 8 doses of ASCI product at 12-week intervals.

Placebo comparator: Placebo Group - Patients who received up to 13 doses of placebo. Study products were administered as intramuscular (IM) injections in the deltoid or the lateral region of the thigh (not in anatomical regions where lymph nodes had been excised): 5 doses of placebo at 3-week intervals, followed by 8 doses of placebo at 12-week intervals.


Treatment: Drugs: GSK 2132231A
IM solution, a course of 13 injections administered over 27 months

Treatment: Drugs: Placebo
IM solution, a course of 13 injections administered over 27 months
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disease Free Survival (DFS)
Timepoint [1] 0 0
At Final analysis (Month 30 = Year 2.5)
Primary outcome [2] 0 0
Disease Free Survival (DFS)
Timepoint [2] 0 0
At follow-up analysis (up to Year 5)
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
At Final analysis (Month 30 = Year 2.5) and at follow-up analysis (up to Year 5)
Secondary outcome [2] 0 0
Disease-free Specific Survival (DFSS)
Timepoint [2] 0 0
At Final analysis (Month 30 = Year 2.5)
Secondary outcome [3] 0 0
Distant Metastasis-free Survival (DMFS)
Timepoint [3] 0 0
At Final analysis (Month 30 = Year 2.5)
Secondary outcome [4] 0 0
Health-related Quality of Life
Timepoint [4] 0 0
At Weeks 0, 6, 12 [on the day of and the day after treatment administration (TA)], at Month 6, 9, 12, 24, at the Concluding visit (Month 30) + 6 months and +12 Months and at disease recurrence
Secondary outcome [5] 0 0
Number of Subjects With Anti-MAGE-A3 Antibody Concentrations Above the Cut-off Value
Timepoint [5] 0 0
At Weeks 0, 6, 12, 36, 48 72, 120 (Concluding visit) and at Week 120 + 6 months
Secondary outcome [6] 0 0
Anti-MAGE-A3 Antibody Geometric Mean Concentrations
Timepoint [6] 0 0
At Weeks 0, 6, 12, 36, 48 72, 120 (Concluding visit) and at Month 120 + 6 months
Secondary outcome [7] 0 0
Number of Subjects With Anti-MAGE-A3 Antibody Response
Timepoint [7] 0 0
At Weeks 6, 12, 36, 48 72, 120 (Concluding visit) and at Month 120 + 6 months
Secondary outcome [8] 0 0
Number of Subjects With Abnormal Haematological and Biochemical Parameters
Timepoint [8] 0 0
Within the 31-day (Days 0-30) post-treatment period
Secondary outcome [9] 0 0
Number of Subjects With Any Adverse Events (AEs)
Timepoint [9] 0 0
Within the 31-day (Days 0-30) follow-up period after treatment
Secondary outcome [10] 0 0
Number of Subjects With Any Serious Adverse Events (SAEs)
Timepoint [10] 0 0
From Day 0 up to study end (up to 5 years)
Secondary outcome [11] 0 0
Number of Subjects With Potential Immune-mediated Diseases (pIMDs)
Timepoint [11] 0 0
From Day 0 up to study end (up to 5 years)

Eligibility
Key inclusion criteria
* Written informed consent signed.
* Male or female patient with histologically proven stage IIIB or IIIC cutaneous melanoma presenting with macroscopic lymph node involvement suitable for surgery.
* The patient must have been surgically rendered free of disease before the randomization.
* Patient is = 18 years old at the time of signing the informed consent form.
* The patient's lymph node tumor shows expression of the MAGE-A3 gene.
* The patient has fully recovered from surgery.
* ECOG performance status of 0 or 1 at the time of randomization.
* The patient must have adequate organ functions as assessed by standard laboratory criteria.
* If the patient is female, she must be of non-childbearing potential, or practice adequate contraception.
* In the opinion of the investigator, the patient can and will comply with all the requirements of the protocol.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* The patient suffers from a mucosal or ocular melanoma.
* The patient has or has had any history of in-transit metastases
* The patient has been treated or is scheduled to be treated with an adjuvant anticancer therapy after the surgery that qualifies the patient for inclusion in the present trial.
* The patient requires concomitant chronic treatment with systemic corticosteroids or any other immunosuppressive agents.
* Use of any investigational or non-registered product (drug or vaccine) other than the study treatment.
* The patient has a history of autoimmune disease.
* The patient has a family history of congenital or hereditary immunodeficiency.
* The patient is known to be positive for Human Immunodeficiency Virus (HIV) or has another confirmed or suspected immunosuppressive or immunodeficient condition.
* History of allergic disease or reactions likely to be exacerbated by any component of the treatments.
* The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent or to comply with the trial procedures.
* The patient has concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.
* The patient has previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers or carcinoma in situ of the cervix or effectively treated malignancy that has been in remission for over 5 years and is highly likely to have been cured.
* The patient has an uncontrolled bleeding disorder.
* For female patients: the patient is pregnant or lactating.

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 assessing the outcomes
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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/01/2016
Sample size
Target
Accrual to date
Final
1351
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Camperdown
Recruitment hospital [2] 0 0
GSK Investigational Site - North Sydney
Recruitment hospital [3] 0 0
GSK Investigational Site - Waratah
Recruitment hospital [4] 0 0
GSK Investigational Site - Westmead
Recruitment hospital [5] 0 0
GSK Investigational Site - Brisbane
Recruitment hospital [6] 0 0
GSK Investigational Site - Adelaide
Recruitment hospital [7] 0 0
GSK Investigational Site - Hobart
Recruitment hospital [8] 0 0
GSK Investigational Site - East Melbourne
Recruitment hospital [9] 0 0
GSK Investigational Site - Heidelberg
Recruitment postcode(s) [1] 0 0
2060 - Camperdown
Recruitment postcode(s) [2] 0 0
2060 - North Sydney
Recruitment postcode(s) [3] 0 0
2298 - Waratah
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment postcode(s) [5] 0 0
4102 - Brisbane
Recruitment postcode(s) [6] 0 0
5000 - Adelaide
Recruitment postcode(s) [7] 0 0
7000 - Hobart
Recruitment postcode(s) [8] 0 0
3002 - East Melbourne
Recruitment postcode(s) [9] 0 0
3084 - Heidelberg
Recruitment outside Australia
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United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
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Indiana
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Barcelona
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Uppsala
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Basel
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Switzerland
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Zürich
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Taoyuan Hsien
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Ukraine
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Dnipropetrovsk
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Ukraine
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Donetsk
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Ukraine
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Krivoy Rog
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Ukraine
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Kyiv
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Ukraine
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Lviv
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United Kingdom
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Essex
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United Kingdom
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Belfast, Northern Ireland
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Colchester
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Dundee
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London
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Poole, Dorset
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United Kingdom
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Salisbury

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

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
IPD is available via the Clinical Study Data Request site (click on the link provided below)

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Available to whom?
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.clinicalstudydatarequest.com/Posting.aspx?ID=16038


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/NCT00796445