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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00796445
Ethics application status
Date submitted
21/11/2008
Date registered
24/11/2008
Date last updated
5/03/2021

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) - DFS = time to event from randomization to the date of first disease recurrence (as assessed by investigator) or the date of death (whatever cause), whichever occurred first. DFS was expressed as the person-year rate i.e. the number of patients with at least one event (n) over the sum of the follow-up periods in years (T), until the first occurrence of a recurrence/death. Types of recurrence to be considered as an event included loco-regional and distant metastases. Any death occurring without prior documentation of tumor recurrence was considered as an event (not censored in the stat. analysis) as this approach was less prone to introduce bias. If no event occurred by the time of analysis, then the time to event was censored at the last assessment date (tumor assessment/visit) of the patient. Any new primary cancer at another site, including second primary melanoma, was not considered as a recurrence and had to be reported as a Serious Adverse Event (SAE).
Timepoint [1] 0 0
At Final analysis (Month 30 = Year 2.5)
Primary outcome [2] 0 0
Disease Free Survival (DFS) - DFS = time to event from randomization to the date of first disease recurrence (as assessed by investigator) or the date of death (whatever cause), whichever occurred first. DFS was expressed as the person-year rate i.e. the number of patients with at least one event (n) over the sum of the follow-up periods in years (T), until the first occurrence of a recurrence/death. Types of recurrence to be considered as an event included loco-regional and distant metastases. Any death occurring without prior documentation of tumor recurrence was considered as an event (not censored in the stat. analysis) as this approach was less prone to introduce bias. If no event occurred by the time of analysis, then the time to event was censored at the last assessment date (tumor assessment/visit) of the patient. Any new primary cancer at another site, including second primary melanoma, was not considered as a recurrence and had to be reported as a Serious Adverse Event (SAE).
Timepoint [2] 0 0
At follow-up analysis (up to Year 5)
Secondary outcome [1] 0 0
Overall Survival (OS) - Overall Survival (OS) was defined as the time to event from randomization to the date of death, irrespective of the cause of death. OS was expressed as the person-year rate i.e. the number of patients with death (n) over the sum of the follow-up periods in years (T). Patients alive at the time of the analysis were censored on the date last known to be alive.
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) - Disease Free Specific Survival (DFSS) was defined as the time to event from randomization to the date of first recurrence of disease or date of death due to melanoma (cause as assessed by investigator), whichever occurred first. DFSS was expressed as the person-year rate i.e. the number of patients with at least one event (n) over the sum of the follow-up periods in years (T), until the first occurrence of a recurrence/death. Patients who died due to a cause other than the disease under study and patients alive at the time of analysis were censored on the date of last assessment (visit or tumor assessment).
Timepoint [2] 0 0
At Final analysis (Month 30 = Year 2.5)
Secondary outcome [3] 0 0
Distant Metastasis-free Survival (DMFS) - Distant Metastasis Free Survival (DMFS) was defined as the time to event from randomization to the date of first distant metastasis or date of death, whichever occurred first. DMFS was expressed as the person-year rate i.e. the number of patients with at least one event (n) over the sum of the follow-up periods in years (T), until the first occurrence of distant metastasis/death. Patients alive and without distant metastases were censored at the date of last assessment (visit or tumor assessment, or date of last tumor assessment as documented during the yearly contact follow-up period).
Timepoint [3] 0 0
At Final analysis (Month 30 = Year 2.5)
Secondary outcome [4] 0 0
Health-related Quality of Life - The assessment of health-related quality of life was restricted to patients who consented to study participation after Protocol Amendment 1 became effective at their study site, and for whom a validated version of the Euro Quality of Life-5D (EQ-5D) questionnaire was available in their native language. The EQ-5D comprises a 5-dimensional descriptive system (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), where each item has 3 levels and together they define 243 possible health states. For each health state, a value (utility) was determined by using an additive algorithm. These utility scores were calculated for each patient at each timepoint at which an EQ-5D questionnaire was completed. The score had a maximum value of 1.0 corresponding to full health level, while lower scores, down to a minimum value of 0.0 reflected degradation in the 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 - The cut-off value was 27 Enzyme-Linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL).
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 - Anti-MAGE-A3 antibody concentrations were presented as geometric mean concentrations (GMC) and expressed in EL.U/mL.
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 - Treatment response defined as: - For initially seronegative patients: post-treatment antibody concentration = 27 EL.U/mL; - For initially seropositive patients: post-treatment antibody concentration = 2 fold the pre-treatment antibody concentration.
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 - Laboratory abnormalities belong to hematological and biochemical parameters such as: alanine aminotransferase [ALT], asparatate aminostransferase [AST], alkaline phoshatase [AP], bilirubin [BIL], creatinine [CREA], hemoglobin [HGB], leukocytes [LEU], lymphopenia [LYMPH], neutrophils [NEU], platelets [PLA]. Parameter grades (Grade [G] 0, 1, 2, 3, 4, Unknown) were compared to each baseline parameter grade (G Unknown, 0, 1, 2, 3), as defined by the Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 of August 9, 2006.
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) - An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
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) - Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
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) - Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
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
Gender
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
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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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Hessen
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Slupsk
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Baia Mare
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Cluj-Napoca
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Romania
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Craiova, Dolj
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Russian Federation
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Russian Federation
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Kursk
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Russian Federation
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Moscow
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Russian Federation
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Omsk
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Russian Federation
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St. Petersburg
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Russian Federation
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Stavropol
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Serbia
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Belgrad
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Serbia
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Sremska Kamenica
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Spain
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Barcelona
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Pamplona
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Göteborg
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State/province [147] 0 0
Uppsala
Country [148] 0 0
Switzerland
State/province [148] 0 0
Basel
Country [149] 0 0
Switzerland
State/province [149] 0 0
Zürich
Country [150] 0 0
Taiwan
State/province [150] 0 0
Kaohsiung
Country [151] 0 0
Taiwan
State/province [151] 0 0
Taipei
Country [152] 0 0
Taiwan
State/province [152] 0 0
Taoyuan Hsien
Country [153] 0 0
Ukraine
State/province [153] 0 0
Dnipropetrovsk
Country [154] 0 0
Ukraine
State/province [154] 0 0
Donetsk
Country [155] 0 0
Ukraine
State/province [155] 0 0
Krivoy Rog
Country [156] 0 0
Ukraine
State/province [156] 0 0
Kyiv
Country [157] 0 0
Ukraine
State/province [157] 0 0
Lviv
Country [158] 0 0
United Kingdom
State/province [158] 0 0
Essex
Country [159] 0 0
United Kingdom
State/province [159] 0 0
Belfast, Northern Ireland
Country [160] 0 0
United Kingdom
State/province [160] 0 0
Colchester
Country [161] 0 0
United Kingdom
State/province [161] 0 0
Dundee
Country [162] 0 0
United Kingdom
State/province [162] 0 0
London
Country [163] 0 0
United Kingdom
State/province [163] 0 0
Poole, Dorset
Country [164] 0 0
United Kingdom
State/province [164] 0 0
Salisbury

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this clinical trial is to evaluate the benefit of the immunotherapeutic
product GSK 2132231A in preventing disease relapse when given to melanoma patients, after
surgical removal of their tumor.

This Protocol Posting has been updated following Amendments 1 of the Protocol, March 2010.
The impacted sections are outcome measures and entry criteria.
Trial website
https://clinicaltrials.gov/show/NCT00796445
Trial related presentations / publications
Dreno B, Thompson JF, Smithers BM, Santinami M, Jouary T, Gutzmer R, Levchenko E, Rutkowski P, Grob JJ, Korovin S, Drucis K, Grange F, Machet L, Hersey P, Krajsova I, Testori A, Conry R, Guillot B, Kruit WHJ, Demidov L, Thompson JA, Bondarenko I, Jaroszek J, Puig S, Cinat G, Hauschild A, Goeman JJ, van Houwelingen HC, Ulloa-Montoya F, Callegaro A, Dizier B, Spiessens B, Debois M, Brichard VG, Louahed J, Therasse P, Debruyne C, Kirkwood JM. MAGE-A3 immunotherapeutic as adjuvant therapy for patients with resected, MAGE-A3-positive, stage III melanoma (DERMA): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2018 Jul;19(7):916-929. doi: 10.1016/S1470-2045(18)30254-7. Epub 2018 Jun 13.
Dizier B et al. (2019) A T-helper 1/interferon-? gene signature is prognostic in the adjuvant setting of resectable high-risk melanoma but not in non-small cell lung cancer. Clin Cancer Res. pii: clincanres.3717.2018. doi: 10.1158/1078-0432.CCR-18-3717. [Epub ahead of print].
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

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00796445