Last updated: 09/14/2020 08:00:04
MAGE-A3 Antigen-Specific Cancer Immunotherapeutic in patients with progressive metastatic cutaneous melanoma
EudraCT ID
EU CT Number
Not applicable
Trial status
Terminated (halted prematurely)
Terminated (halted prematurely)
Trial overview
Official title: Study of GSK1203486A Antigen-Specific Cancer Immunotherapeutic in patients with unresectable and progressive metastatic cutaneous melanoma
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Number of subjects with any Antigen-Specific Cancer Immunotherapeutic (ASCI) related grade 3/4 adverse events (AE)
Timeframe: During the entire study, up to 2.5 years per patient
Number of subjects with any serious adverse events (SAEs).
Timeframe: During the entire study, up to 2.5 years per patient
The rate of objective clinical response.
Timeframe: At the time of analysis.
Secondary outcomes:
The rate of stable disease.
Timeframe: At the time of analysis.
The rate of mixed response.
Timeframe: At the time of analysis.
Time to study treatment failure.
Timeframe: At the time of analysis.
Progression-free survival.
Timeframe: At the time of analysis.
Progression-free survival after initial SPD.
Timeframe: At the time of analysis.
Documentation of any toxicity.
Timeframe: During the entire study, up to 2.5 years per patient
Immunogenicity at defined time points.
Timeframe: At 13 defined time points.
Interventions:
Biological/vaccine: GSK Biologicals' Recombinant MAGE-A3 Antigen-Specific Cancer Immunotherapeutic (ASCI) GSK1203486A
Enrollment:
5
Observational study model:
Not applicable
Primary completion date:
2011-19-01
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Melanoma
Product
GSK1203486A
Collaborators
Not applicable
Study date(s)
September 2008 to January 2011
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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.
- 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.
Inclusion and exclusion criteria
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.
Trial location(s)
Location
GSK Investigational Site
CABA, Buenos Aires, Argentina, C1425DTG
Status
Study Complete
Location
GSK Investigational Site
Quilmes, Buenos Aires, Argentina, 1878
Status
Study Complete
Location
GSK Investigational Site
Rosario, Santa Fe, Argentina, S2000KZE
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Terminated (halted prematurely)
Actual primary completion date
2011-19-01
Actual study completion date
2011-19-01
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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