Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Study of GSK2132231A Antigen-Specific Cancer Immunotherapeutic in Patients With Inoperable Metastatic Cutaneous Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00896480
Recruitment Status : Completed
First Posted : May 11, 2009
Results First Posted : September 27, 2019
Last Update Posted : September 27, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
The clinical objective of this clinical trial is to examine the clinical activity in terms of tumor response and time to treatment failure of the immunotherapeutic product GSK2132231A when given to patients with unresectable and progressive metastatic cutaneous melanoma. The safety of the treatment will also be assessed just as its immunogenicity in terms of the humoral and cellular immune response induced by the GSK2132231A immunotherapeutic. Translational research objectives are to assess the effects of the study treatment in terms of various biological variables.

Condition or disease Intervention/treatment Phase
Melanoma Biological: Immunotherapeutic GSK2132231A Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Activity, Safety and Immunogenic Properties of Cancer Immunotherapeutic GSK2132231A in Patients With Unresectable and Progressive Metastatic Cutaneous Melanoma
Actual Study Start Date : May 19, 2009
Actual Primary Completion Date : November 3, 2014
Actual Study Completion Date : November 3, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: GSK2132231A Group
Subjects, male or female, 18 years of age or older, received up to 24 doses of GSK2132231A intramuscularly in 4 cycles. In Cycle 1 (ending Week 13) 6 doses were administered at 2-week intervals; in Cycle 2 (ending Week 32) 6 doses at 3-week intervals; in Cycle 3 (ending Week 54) 4 doses at 6-week intervals and in Cycle 4 4 doses at 12-week intervals, starting 12 weeks after end of Cycle 3, followed by, after an interruption of treatment of 6 months, 4 doses at 24-week intervals.
Biological: Immunotherapeutic GSK2132231A
Administration by intramuscular injection
Other Name: MAGE-A3 ASCI




Primary Outcome Measures :
  1. Number of Patients With Objective Tumor Response (OR) to GSK2132231A Study Treatment [ Time Frame: From Pre-treatment (up to 4 weeks before first treatment) to study end (Year 4), each patient being censored out of the analysis at 1st report of disease progression in assessed lesions ]
    OR was defined as the best Overall Response (OR) in a patient. OR = Complete Response (CR) + Partial Response (PR). Responses were categorized as CR, PR, stable disease (SD), SD/PR, progressive disease (PD) and non-evaluable (NE). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR) = disappearance of all target lesions; Partial Response (PR) = ≥30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD) = neither sufficient shrinkage to be PR, not sufficient increase to qualify for Progressive Disease (PD); PD = ≥20% increase in the sum of largest diameter for target lesions. Best objective response = PR or CR. Disease control = CR, or PR, or SD, or SD/PR.

  2. Number of Patients With Mixed Response (MR) to GSK2132231A [ Time Frame: From Pre-treatment (up to 4 weeks before first treatment) to study end (Year 4), each patient being censored out of the analysis at 1st report of disease progression in assessed lesions ]
    Assessment was done based on a set of MLs identified at baseline as TLs and non-TLs (NTL) followed up until disease progression. MLs were assessed as regards matching below MR definitions. In case of evaluability per RECIST: a) MR Type 1= at least (a.l.) 30% decrease in LD in a.l. one TL measured at baseline. Such response occurring in SD/PD status of LD of TL and without appearance of one or more new lesions (= SD/PD with TL regression); b) MR Type 2: appearance of one or more new lesions occurring in SD/PR status of LD of TL (= SD/PR with new lesion). In case of non-evaluability per RECIST (due to LD<20mm): a) MR Type 1 = a clear decrease in diameters occurring in a.l. one TL measured at baseline. Such response occurring in SD/PD status of LD of (baseline) TL and without appearance of one or more new lesions (= SD/PD with TL regression); b) MR Type 2 = appearance of one or more new lesions occurring in SD/PR status of LD of TL (= SD/PR with new lesion).

  3. Time to Treatment Failure (TTF), by Gene Signature [ Time Frame: From Pre-treatment (up to 4 weeks before first treatment) to study end (Year 4), each patient being censored out of the analysis at 1st report of disease progression or death ]
    TTF was defined as withdrawal from treatment with the GSK2132231A study product due to disease progression or death. TTF analysis was performed using the non-parametric Kaplan-Meier method.

  4. Anti-MAGE-A3 Antibody Concentrations [ Time Frame: From Pre-treatment (up to 4 weeks before first treatment) to Concluding visit (CCL: at Week 196 + 30 to 37 days for patients completing the treatment, 1 month after the last Dose administered for patients withdrawn from study treatment before completion ]
    Anti-MAGE-A3 antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per millilitre (EL.U/mL). A seropositive patient was defined as a patient whose anti-MAGE-A3 antibody concentration was greater than or equal to 27 EL.U/mL. D=Day W=Week

  5. Number of Seroconverted Patients for Anti-MAGE-A3 [ Time Frame: From Pre-treatment (up to 4 weeks before first treatment) to Concluding visit (CCL: at Week 196 + 30 to 37 days for patients completing the treatment, 1 month after the last Dose administered for patients withdrawn from study treatment before completion ]
    Seroconversion was defined as a concentration of antibodies assessed that was greater than the cut-off value for a patient whose concentration of such antibodies was below the cut-off level before the initiation of treatment. Seroconverted patients were those patients with anti-MAGE-A3 antibody concentrations ≥ 27 EL.U/mL.

  6. Number of Patients With Treatment Response for Anti-MAGE-A3 Antibodies [ Time Frame: From Day 2 to Concluding visit (CCL:at Week 196 + 30 to 37 days for patients completing the treatment, 1 month after the last Dose administered for patients withdrawn from study treatment before completion ]
    For initially seronegative patients: post-administration antibody concentration ≥ 27 EL.U/mL For initially seropositive patients: post-administration antibody concentration ≥ 2 fold the pre-vaccination antibody concentration

  7. Geometric Mean Titers of Anti-MAGE-A3 Specific CD4+ and CD8+ T-cells Concentrations After Immunization [ Time Frame: From Pre-treatment (up to 4 weeks before first treatment) to Concluding visit (CCL: at Week 196 + 30 to 37 days for patients completing the treatment, 1 month after the last Dose administered for patients withdrawn from study treatment before completion ]
    This endpoint presents the geometric mean concentration, expressed in titers, of anti-MAGE-A3 specific CD4+ and CD8+ T-cells. These specific T-cells included the cluster of differentiation 4+ (CD4+) and CD8+ T-cells producing cytokines Tumor Necrosis Factor-alpha (TNF-α) and/or Interferon-gamma (INF-γ).

  8. Number of Patients With CD4+ and CD8+ T Cell Frequency ≥ 1.24 Cut-off [ Time Frame: From Pre-treatment (up to 4 weeks before first treatment) to Concluding visit (CCL: at Week 196 + 30 to 37 days for patients completing the treatment, 1 month after the last Dose administered for patients withdrawn from study treatment before completion ]
    A patient was considered as a cellular mediated immune (CMI) responder if there was an increased amount of antigen-specific T-cells after immunization as compared to the patient's baseline value. These specific T-cells included the cluster of differentiation 4+ (CD4+) and CD8+ T-cells producing cytokines Tumor Necrosis Factor-alpha (TNF-α) and/or Interferon-gamma (INF-γ).

  9. Number of Patients With a Cellular Response (Anti-MAGE-A3 Specific CD4+ and CD8+ T-cells Concentrations After Immunization) [ Time Frame: From Week 5 to Concluding visit (CCL: at Week 196 + 30 to 37 days for patients completing the treatment, 1 month after the last Dose administered for patients withdrawn from study treatment before completion ]
    A patient was considered as a cellular mediated immune (CMI) responder if there was an increased amount of antigen-specific T-cells after immunization as compared to the patient's baseline value. These specific T-cells included the cluster of differentiation 4+ (CD4+) and CD8+ T-cells producing cytokines Tumor Necrosis Factor-alpha (TNF-α) and/or Interferon-gamma (INF-γ).

  10. Number of Patients Reported With Antigen Specific Cancer Immunotherapeutics (ASCI)-Related grade3/4 Adverse Events (AEs) According to the Common Terminology Criteria (CTCAE) Version 3.0. [ Time Frame: Within the 31-day (Days 0-30) post-administration periods ]
    The assessed AEs were ASCI-related grade 3/4 adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. An unsolicited AE covers any untoward medical occurrence in a clinical investigation patient temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. AEs may include pre- or post-treatment events that occur as a result of protocol-mandated procedures (i.e. invasive procedures, modification of patient's previous therapeutic regimen).

  11. Number of Patients Reported With Serious Adverse Events (SAEs) [ Time Frame: During the entire study period (from Day 0 to CCL: at Week 196 + 30 to 37 days for patients completing the treatment, 1 month after the last Dose administered for patients withdrawn from study treatment before completion ]
    Serious adverse events (SAEs) include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a patient, is a Grade 4 AE according to the CTCAE, version3.0. Events which were part of the natural course of the disease under study were captured as part of the clinical activity outcome variables in this study; therefore did not need to be reported as SAEs. Progression/recurrence of the tumor was recorded as part of the clinical assessment data collection, and deaths due to progressive disease was recorded on a specific form, but not as an SAE. However, if the investigator considered that there was a causal relationship between treatment or protocol design/procedures and the disease progression/recurrence, then the event was reported as an SAE. Any new primary cancer (non-related to the cancer under study) was reported as an SAE.

  12. Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade [ Time Frame: From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) ]

    The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK).

    The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. ALT - SCR G0; SE G3 = ALT with no abnormality/normal value at screening and with Severe abnormality at study end].


  13. Number of Patients With Abnormal Aspartate Aminotransferase (AST) Values by Maximum Grade [ Time Frame: From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) ]

    The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK).

    The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. AST - SCR G0; SE G3 = AST with no abnormality/normal value at screening and with Severe abnormality at study end].


  14. Number of Patients With Abnormal Alkaline Phosphatase (ALK) Values by Maximum Grade [ Time Frame: From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) ]

    The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK).

    The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. ALK - SCR G0; SE G3 = ALK with no abnormality/normal value at screening and with Severe abnormality at study end].


  15. Number of Patients With Abnormal Bilirubine (BIL) Values by Maximum Grade [ Time Frame: From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) ]

    The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK).

    The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. BIL - SCR G0; SE G3 = BIL with no abnormality/normal value at screening and with Severe abnormality at study end].


  16. Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade [ Time Frame: From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) ]

    The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK).

    The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. CREA - SCR G0; SE G3 = CREA with no abnormality/normal value at screening and with Severe abnormality at study end].


  17. Number of Patients With Abnormal Gamma-glutamyl Transpeptidase (GGT) Values by Maximum Grade [ Time Frame: From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) ]

    The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK).

    The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. GGT - SCR G0; SE G3 = GGT with no abnormality/normal value at screening and with Severe abnormality at study end].


  18. Number of Patients With Abnormal Hemoglobin (HGB) Values by Maximum Grade [ Time Frame: From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) ]

    The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK).

    The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. HGB - SCR G0; SE G3 = HGB with no abnormality/normal value at screening and with Severe abnormality at study end].


  19. Number of Patients With Abnormal Hypercalcemia (HCA) Values by Maximum Grade [ Time Frame: From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) ]

    The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK).

    The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. HCA - SCR G0; SE G3 = HCA with no abnormality/normal value at screening and with Severe abnormality at study end].


  20. Number of Patients With Abnormal Hyperkalemia (HKA) Values by Maximum Grade [ Time Frame: From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) ]

    The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK).

    The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. HKA - SCR G0; SE G3 = HKA with no abnormality/normal value at screening and with Severe abnormality at study end].


  21. Number of Patients With Abnormal Hypernatremia (HNA) Values by Maximum Grade [ Time Frame: From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) ]

    The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK).

    The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. HNA - SCR G0; SE G3 = HNA with no abnormality/normal value at screening and with Severe abnormality at study end].


  22. Number of Patients With Abnormal Hypoalbuminemia (hAL) Values by Maximum Grade [ Time Frame: From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) ]

    The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK).

    The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. hAL - SCR G0; SE G3 = hAL with no abnormality/normal value at screening and with Severe abnormality at study end].


  23. Number of Patients With Abnormal Hypocalcemia (hCA) Values by Maximum Grade [ Time Frame: From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) ]

    The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK).

    The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. hCA - SCR G0; SE G3 = hCA with no abnormality/normal value at screening and with Severe abnormality at study end].


  24. Number of Patients With Abnormal Hypokalemia (hKA) Values by Maximum Grade [ Time Frame: From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) ]

    The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK).

    The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. hKA - SCR G0; SE G3 = hKA with no abnormality/normal value at screening and with Severe abnormality at study end].


  25. Number of Patients With Abnormal Hyponatremia (hNA) Values by Maximum Grade [ Time Frame: From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) ]

    The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK).

    The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. hNA - SCR G0; SE G3 = hNA with no abnormality/normal value at screening and with Severe abnormality at study end].


  26. Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade [ Time Frame: From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) ]

    The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK).

    The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. LEU - SCR G0; SE G3 = LEU with no abnormality/normal value at screening and with Severe abnormality at study end].


  27. Number of Patients With Abnormal Lymphopenia (LYM) Values by Maximum Grade [ Time Frame: From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) ]

    The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK).

    The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. LYM - SCR G0; SE G3 = LYM with no abnormality/normal value at screening and with Severe abnormality at study end].


  28. Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade [ Time Frame: From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) ]

    The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK).

    The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. NEU - SCR G0; SE G3 = NEU with no abnormality/normal value at screening and with Severe abnormality at study end].


  29. Number of Patients With Abnormal Platelets (PLT) Values by Maximum Grade [ Time Frame: From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) ]

    The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK).

    The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. PLT - SCR G0; SE G3 = PLT with no abnormality/normal value at screening and with Severe abnormality at study end].


  30. Number of Patients With Any Adverse Events (AEs) and With AEs by Maximum Grade [ Time Frame: Within the 31-day (Day 0-30) follow-up period post treatment administration. ]
    An AE was any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs reported are here below tabulated irrespective of grade (any), as well as graded by maximum grade reported according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. Maximum grade reported and tabulated were Grade 1 (G1) - Mild AE, G2 - Moderate AE, G3 - Severe AE, G4 - Life threatening/Disabling AE and G5 - Death related to AE.

  31. Number of Patients With Any AE(s) and With AEs by Maximum Grade, Related to Treatment Administration [ Time Frame: Within the 31-day (Day 0-30) follow-up period post treatment administration. ]
    An AE was any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs reported are here below tabulated irrespective of grade (any), as well as graded by maximum grade reported according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. Maximum grade reported and tabulated were Grade 1 (G1) - Mild AE, G2 - Moderate AE, G3 - Severe AE, G4 - Life threatening/Disabling AE and G5 - Death related to AE.

  32. Number of Patients With Any Serious Adverse Events (SAEs) [ Time Frame: Within the 31-day (Day 0-30) follow-up period post treatment administration. ]
    SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a patient. SAEs reported are here below tabulated irrespective of grade (any), as well as graded by maximum grade reported according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. Maximum grade reported and tabulated were Grade 1 (G1) - Mild SAE, G2 - Moderate SAE, G3 - Severe SAE, G4 - Life threatening/Disabling SAE and G5 - Death related to SAE.

  33. Number of Patients With Any Serious Adverse Events (SAEs) Related to Treatment Administration [ Time Frame: Within the 31-day (Day 0-30) follow-up period post treatment administration. ]
    SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a patient. SAEs reported are here below tabulated irrespective of grade (any), related to study treatment, as well as graded by maximum grade reported according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. Maximum grade reported and tabulated were Grade 1 (G1) - Mild SAE, G2 - Moderate SAE, G3 - Severe SAE, G4 - Life threatening/Disabling SAE and G5 - Death related to SAE.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The patient (male or female) has histologically proven, measurable metastatic cutaneous melanoma in one of the following stages according to the American Joint Committee on Cancer classification of 2002:

    • Stage III in transit, or
    • Stage III unresectable, or
    • Stage IV M1a.
  2. There has been documented progression of the patient's disease within the 12 weeks before the first administration of study treatment.
  3. The patient presents at screening with at least 3 tumor lesions of diameter >= 0.5 mm.
  4. Written informed consent has been obtained from the patient before the performance of any protocol-specific procedure.
  5. The patient is >= 18 years of age at the time of signature of informed consent.
  6. The patient's tumor shows expression of MAGE-A3 gene in at least one of the two tumor biopsies performed at baseline.
  7. The patient's ECOG performance status is 0 or 1.
  8. The patient has normal organ functions, as assessed by standard laboratory criteria.
  9. If the patient is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to administration of study treatment, have a negative pregnancy test and continue such precautions during the entire study treatment period and for 2 months after completion of the treatment injection series.
  10. In the view of the investigator, the patient can and will comply with the requirements of the protocol.

Exclusion Criteria:

  1. The patient has at any time received systemic (bio)-chemotherapy
  2. The patient is scheduled to receive any anti-cancer specific treatment, including radiotherapy, immunotherapy, chemotherapy and immunomodulating agents.
  3. The patient requires concomitant treatment with systemic corticosteroids, or any other immunosuppressive agents.
  4. The patient has received any cancer immunotherapeutic containing a MAGE A3 antigen or any cancer immunotherapeutic for his/her metastatic disease.
  5. Use of any investigational or non-registered product (drug or vaccine) other than the study treatment within the 30 days preceding the first dose of study treatment, or planned use during the study period.
  6. The patient has (or has had) previous or concomitant malignancies at other sites, except effectively treated malignancy that is considered by the investigator highly likely to have been cured.
  7. History of allergic disease or reactions likely to be exacerbated by any component of the study investigational product.
  8. The patient has an autoimmune disease such as, but not limited to, neuroinflammatory autoimmune diseases, systemic lupus erythematosus, and inflammatory bowel disease
  9. The patient has a family history of congenital or hereditary immunodeficiency.
  10. The patient is known to be positive for the human immunodeficiency virus (HIV).
  11. The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent, or to comply with the study procedures.
  12. 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.
  13. For female patients: the patient is pregnant or lactating.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00896480


Locations
Layout table for location information
Belgium
GSK Investigational Site
Brussels, Belgium, 1200
GSK Investigational Site
Brussel, Belgium, 1090
GSK Investigational Site
Wilrijk, Belgium, 2610
France
GSK Investigational Site
Caen, France, 14033
GSK Investigational Site
Lille, France, 59037
GSK Investigational Site
Paris Cedex 10, France, 75475
GSK Investigational Site
Reims, France, 51092
GSK Investigational Site
Villejuif, France, 94805
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Layout table for investigator information
Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Publications:
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00896480    
Other Study ID Numbers: 111473
2008-001301-42 ( EudraCT Number )
First Posted: May 11, 2009    Key Record Dates
Results First Posted: September 27, 2019
Last Update Posted: September 27, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access Criteria: 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.
URL: https://clinicalstudydatarequest.com

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlaxoSmithKline:
ASCI (Antigen-Specific Cancer Immunotherapeutic)
MAGE-A3
Malignant melanoma
Cancer immunotherapeutic
Additional relevant MeSH terms:
Layout table for MeSH terms
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas