Clinical trial NCT00796445: 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
Official title: GSK 2132231A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Resected Melanoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Melanoma
Keywords: DERMA
Tumor antigen
Immunotherapeutic
Adjuvant cancer therapy
Melanoma
ASCI
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-11-24
Enrollment: 1351
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

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.

Primary outcomes:
measure: Disease Free Survival (DFS)
timeFrame: At Final analysis (Month 30 = Year 2.5)
measure: Disease Free Survival (DFS)
timeFrame: At follow-up analysis (up to Year 5)
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: At Final analysis (Month 30 = Year 2.5) and at follow-up analysis (up to Year 5)
measure: Disease-free Specific Survival (DFSS)
timeFrame: At Final analysis (Month 30 = Year 2.5)
measure: Distant Metastasis-free Survival (DMFS)
timeFrame: At Final analysis (Month 30 = Year 2.5)
measure: Health-related Quality of Life
timeFrame: 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
measure: Number of Subjects With Anti-MAGE-A3 Antibody Concentrations Above the Cut-off Value
timeFrame: At Weeks 0, 6, 12, 36, 48 72, 120 (Concluding visit) and at Week 120 + 6 months
measure: Anti-MAGE-A3 Antibody Geometric Mean Concentrations
timeFrame: At Weeks 0, 6, 12, 36, 48 72, 120 (Concluding visit) and at Month 120 + 6 months
measure: Number of Subjects With Anti-MAGE-A3 Antibody Response
timeFrame: At Weeks 6, 12, 36, 48 72, 120 (Concluding visit) and at Month 120 + 6 months
measure: Number of Subjects With Abnormal Haematological and Biochemical Parameters
timeFrame: Within the 31-day (Days 0-30) post-treatment period
measure: Number of Subjects With Any Adverse Events (AEs)
timeFrame: Within the 31-day (Days 0-30) follow-up period after treatment
measure: Number of Subjects With Any Serious Adverse Events (SAEs)
timeFrame: From Day 0 up to study end (up to 5 years)
measure: Number of Subjects With Potential Immune-mediated Diseases (pIMDs)
timeFrame: From Day 0 up to study end (up to 5 years)
Other outcomes:
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city: Belo Horizonte
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state: Minas Gerais
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city: Pierre-Bénite cedex
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city: Toulouse cedex 9
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city: Freiburg
country: Germany
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state: Baden-Wuerttemberg
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country: Germany
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state: Mecklenburg-Vorpommern
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facility: GSK Investigational Site
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state: Nordrhein-Westfalen
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state: Nordrhein-Westfalen
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state: Rheinland-Pfalz
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country: Germany
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country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
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country: Germany
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country: Germany
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state: Schleswig-Holstein
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country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
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country: Germany
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state: Thueringen
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city: Berlin
country: Germany
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city: Berlin
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city: Athens
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city: Athens
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city: Cork
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city: Dublin
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city: Dublin
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country: Italy
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country: Italy
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state: Nuevo León
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country: Poland
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city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Baia Mare
country: Romania
facility: GSK Investigational Site
city: Cluj-Napoca
country: Romania
facility: GSK Investigational Site
city: Craiova, Dolj
country: Romania
facility: GSK Investigational Site
city: Chelyabinsk
country: Russian Federation
facility: GSK Investigational Site
city: Kursk
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Omsk
country: Russian Federation
facility: GSK Investigational Site
city: St. Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: St. Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Stavropol
country: Russian Federation
facility: GSK Investigational Site
city: Belgrad
country: Serbia
facility: GSK Investigational Site
city: Belgrad
country: Serbia
facility: GSK Investigational Site
city: Sremska Kamenica
country: Serbia
facility: GSK Investigational Site
city: Barcelona
country: Spain
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city: Madrid
country: Spain
facility: GSK Investigational Site
city: Pamplona
country: Spain
facility: GSK Investigational Site
city: Sevilla
country: Spain
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city: Valencia
country: Spain
facility: GSK Investigational Site
city: Göteborg
country: Sweden
facility: GSK Investigational Site
city: Malmö
country: Sweden
facility: GSK Investigational Site
city: Uppsala
country: Sweden
facility: GSK Investigational Site
city: Basel
country: Switzerland
facility: GSK Investigational Site
city: Zürich
country: Switzerland
facility: GSK Investigational Site
city: Kaohsiung
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Taoyuan Hsien
country: Taiwan
facility: GSK Investigational Site
city: Dnipropetrovsk
country: Ukraine
facility: GSK Investigational Site
city: Dnipropetrovsk
country: Ukraine
facility: GSK Investigational Site
city: Donetsk
country: Ukraine
facility: GSK Investigational Site
city: Krivoy Rog
country: Ukraine
facility: GSK Investigational Site
city: Kyiv
country: Ukraine
facility: GSK Investigational Site
city: Lviv
country: Ukraine
facility: GSK Investigational Site
city: Chelmsford
country: United Kingdom
facility: GSK Investigational Site
state: Essex
city: Belfast, Northern Ireland
country: United Kingdom
facility: GSK Investigational Site
city: Colchester
country: United Kingdom
facility: GSK Investigational Site
city: Dundee
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: Poole, Dorset
country: United Kingdom
facility: GSK Investigational Site
city: Salisbury
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Dizier B, Callegaro A, Debois M, Dreno B, Hersey P, Gogas HJ, Kirkwood JM, Vansteenkiste JF, Sequist LV, Atanackovic D, Goeman J, van Houwelingen H, Salceda S, Wang F, Therasse P, Debruyne C, Spiessens B, Brichard VG, Louahed J, Ulloa-Montoya F. A Th1/IFNgamma Gene Signature Is Prognostic in the Adjuvant Setting of Resectable High-Risk Melanoma but Not in Non-Small Cell Lung Cancer. Clin Cancer Res. 2020 Apr 1;26(7):1725-1735. doi: 10.1158/1078-0432.CCR-18-3717. Epub 2019 Nov 15.