Melanoma
Conditions
Keywords
metastatic,, Melanoma,, Antigen-Specific Cancer Immunotherapeutic,, ASCI, MAGE-A3, tumor antigen,
Brief summary
This study is being done to evaluate the safety and the clinical activity of MAGE-A3 Antigen-Specific Cancer Immunotherapeutic in patients with unresectable and progressive metastatic cutaneous melanoma.
Interventions
BIOLOGICALGSK Biologicals' Recombinant MAGE-A3 Antigen-Specific Cancer Immunotherapeutic (ASCI) GSK1203486A
IM administration in the deltoid or lateral regions of the thighs, alternately on the right and left sides.
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female patient with histologically proven, measurable metastatic cutaneous melanoma, and with documented progressive disease within the 12 weeks before the first administration of study treatment. * Written informed consent has been obtained from the patient before the performance of any protocol-specific procedure. * Patient is \>= 18 years of age at the time of signature of the informed consent. * The patient's tumor shows expression of MAGE-A3 gene * ECOG performance status of 0 or 1. * The patient has normal organ functions * 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 all study treatment period and for 2 months after completion of the injection series. * In the view of the investigator, the patient can and will comply with the requirements of the protocol.
Exclusion criteria
* The patient has at any time received systemic (bio-)chemotherapy (except for isolated limb perfusion, as long as this was performed at least 4 weeks before first study treatment administration). * The patient is scheduled to receive any anti-cancer specific treatment, including radiotherapy, immunotherapy, chemotherapy and immunomodulating agents. * The patient requires concomitant treatment with systemic corticosteroids, or any other immunosuppressive agents. * The patient received any cancer immunotherapeutic containing a MAGE-A3 antigen or any cancer immunotherapeutic for his/her metastatic disease. * The patient has received any investigational or non-registered drug or vaccine other than the study medication within the 30 days preceding the first ASCI injection or it is planned that (s)he will receive such a drug during the study period. * 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. * History of allergic disease or reactions likely to be exacerbated by any component of the study investigational product. * The patient has an autoimmune disease such as, but not limited to, multiple sclerosis, lupus, and inflammatory bowel disease. Patients with vitiligo are not excluded. * The patient has a family history of congenital or hereditary immunodeficiency. * The patient is known to be positive for the Human Immunodeficiency Virus (HIV). * 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. * For female patients: the patient is pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Any Antigen-Specific Cancer Immunotherapeutic (ASCI) Related Grade 3/4 Adverse Events (AE) | During the entire study, up to 2.5 years per patient | The assessment was made as per the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, where Grade refers to the severity of the AE. The CTCAE version 3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE, as follows: Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE. |
| Number of Subjects With Any Serious Adverse Events (SAEs). | During the entire study, up to 2.5 years per patient | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| The Rate of Objective Clinical Response. | At the time of analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free Survival. | At the time of analysis. |
| Progression-free Survival After Initial SPD. | At the time of analysis. |
| The Rate of Stable Disease. | At the time of analysis. |
| Immunogenicity at Defined Time Points. | At 13 defined time points. |
| Documentation of Any Toxicity. | During the entire study, up to 2.5 years per patient |
| The Rate of Mixed Response. | At the time of analysis. |
| Time to Study Treatment Failure. | At the time of analysis. |
Countries
Argentina, Greece, Norway
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GSK1203486A Group Patients received 4 cycles of MAGE-A3 product as follows: - Cycle 1: 6 doses, each given at a 2-week interval, - Cycle 2: 6 doses, each given at a 3-week interval - Cycle 3: 4 doses, each given at a 6-week interval - Cycle 4: 4 doses, each given at a 3-month interval followed by 4 doses, each given at a 6-month interval. The MAGE-A3 product was administered intramuscularly in the deltoid or lateral regions of the thighs, alternately on the right and left sides. | 5 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Disease progression | 4 |
| Overall Study | Other | 1 |
Baseline characteristics
| Characteristic | GSK1203486A Group | — |
|---|---|---|
| Age, Continuous | 67.2 Years STANDARD_DEVIATION 11.17 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 2 Participants | — |
| Sex: Female, Male Male | 3 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 5 / 5 |
| serious Total, serious adverse events | 1 / 5 |
Outcome results
Primary
Number of Subjects With Any Antigen-Specific Cancer Immunotherapeutic (ASCI) Related Grade 3/4 Adverse Events (AE)
The assessment was made as per the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, where Grade refers to the severity of the AE. The CTCAE version 3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE, as follows: Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE.
Time frame: During the entire study, up to 2.5 years per patient
Population: The Total treated cohort (TTC) included all patients who received at least one dose of the ASCI.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK1203486A Group | Number of Subjects With Any Antigen-Specific Cancer Immunotherapeutic (ASCI) Related Grade 3/4 Adverse Events (AE) | 0 Participants |
Primary
Number of Subjects With Any Serious Adverse Events (SAEs).
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: During the entire study, up to 2.5 years per patient
Population: The Total treated cohort (TTC) included all patients who received at least one dose of the ASCI.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK1203486A Group | Number of Subjects With Any Serious Adverse Events (SAEs). | 1 Participants |
Primary
The Rate of Objective Clinical Response.
Time frame: At the time of analysis.
Population: As the study was terminated before the end of recruitment, data was not collected.
Secondary
Documentation of Any Toxicity.
Time frame: During the entire study, up to 2.5 years per patient
Population: As the study was terminated before the end of recruitment, data was not collected.
Secondary
Immunogenicity at Defined Time Points.
Time frame: At 13 defined time points.
Population: As the study was terminated before the end of recruitment, data was not collected.
Secondary
Progression-free Survival.
Time frame: At the time of analysis.
Population: As the study was terminated before the end of recruitment, data was not collected.
Secondary
Progression-free Survival After Initial SPD.
Time frame: At the time of analysis.
Population: As the study was terminated before the end of recruitment, data was not collected.
Secondary
The Rate of Mixed Response.
Time frame: At the time of analysis.
Population: As the study was terminated before the end of recruitment, data was not collected.
Secondary
The Rate of Stable Disease.
Time frame: At the time of analysis.
Population: As the study was terminated before the end of recruitment, data was not collected.
Secondary
Time to Study Treatment Failure.
Time frame: At the time of analysis.
Population: As the study was terminated before the end of recruitment, data was not collected.