MelanomaPhase 2NCT00706238
MAGE-A3 Antigen-Specific Cancer Immunotherapeutic in Patients With Progressive Metastatic Cutaneous Melanoma
A Phase 2 study testing GSK Biologicals' Recombinant MAGE-A3 Antigen-Specific Cancer Immunotherapeutic (ASCI) GSK1203486A in people with Melanoma, run by GlaxoSmithKline at 6 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- GSK Biologicals' Recombinant MAGE-A3 Antigen-Specific Cancer Immunotherapeutic (ASCI) GSK1203486A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 29 Sep 2008to 19 Jan 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Argentina3 sites
GSK Investigational Site
CABA, Buenos Aires, C1425DTG
GSK Investigational Site
Quilmes, Buenos Aires, 1878
GSK Investigational Site
Rosario, Santa Fe Province, S2000KZE
Greece2 sites
GSK Investigational Site
Athens, 11527
GSK Investigational Site
Athens, 185 47
About this study
Official title: Study of GSK1203486A Antigen-Specific Cancer Immunotherapeutic in Patients With Unresectable and Progressive Metastatic Cutaneous Melanoma
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.
- Conditions
- Melanoma
- Being tested
- GSK Biologicals' Recombinant MAGE-A3 Antigen-Specific Cancer Immunotherapeutic (ASCI) GSK1203486A
- Keywords
- metastatic,, Melanoma,, Antigen-Specific Cancer Immunotherapeutic,, ASCI, MAGE-A3, tumor antigen,
- Medical subject headings
- Melanoma, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK Biologicals' Recombinant MAGE-A3 Antigen-Specific Cancer Immunotherapeutic (ASCI) GSK1203486ABiological
IM administration in the deltoid or lateral regions of the thighs, alternately on the right and left sides.
| Study group | Role | What they receive |
|---|---|---|
| GSK1203486A Group | Experimental | 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. Receives: Biological: GSK Biologicals' Recombinant MAGE-A3 Antigen-Specific Cancer Immunotherapeutic (ASCI) GSK1203486A |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the entire study, up to 2.5 years per patient
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.
Measured: During the entire study, up to 2.5 years per patient
The Rate of Objective Clinical Response.
Measured: At the time of analysis.
Secondary outcomes (7)
The Rate of Stable Disease.
Measured: At the time of analysis.
The Rate of Mixed Response.
Measured: At the time of analysis.
Time to Study Treatment Failure.
Measured: At the time of analysis.
Progression-free Survival.
Measured: At the time of analysis.
Progression-free Survival After Initial SPD.
Measured: At the time of analysis.
Documentation of Any Toxicity.
Measured: During the entire study, up to 2.5 years per patient
Immunogenicity at Defined Time Points.
Measured: At 13 defined time points.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2008 (estimated)
- Study start29 Sep 2008
- Primary completion19 Jan 2011
- Study completion19 Jan 2011
Why it stopped: The study was terminated early due to difficulties in recruiting subjects, not following concerns for the safety or absence of clinical activity in patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00706238
- Sponsor's protocol ID
- 110551
- Other IDs
- 2007-005203-18
- Status last verified
- Sep 2020
- First submitted
- 25 Jun 2008
- Last updated
- 8 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of GSK1203486A Antigen-Specific Cancer Immunotherapeutic in Patients With Unresectable and Progressive Metastatic Cutaneous Melanoma
- ClinicalTrials.gov ID
- NCT00706238
- Acronym / sponsor ID
- 110551
- Conditions
- Melanoma
- Keywords
- metastatic,, Melanoma,, Antigen-Specific Cancer Immunotherapeutic,, ASCI, MAGE-A3, tumor antigen,
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early due to difficulties in recruiting subjects, not following concerns for the safety or absence of clinical activity in patients.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 29 Sep 2008 (actual)
- Primary completion
- 19 Jan 2011 (actual)
- Study completion
- 19 Jan 2011 (actual)
- First posted
- 27 Jun 2008 (estimated)
- Results
- Posted 3 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GSK1203486A Group | Experimental | Biological: GSK Biologicals' Recombinant MAGE-A3 Antigen-Specific Cancer Immunotherapeutic (ASCI) GSK1203486APatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSK Biologicals' Recombinant MAGE-A3 Antigen-Specific Cancer Immunotherapeutic (ASCI) GSK1203486AIM administration in the deltoid or lateral regions of the thighs, alternately on the right and left sides. | Biological | GSK1203486A Group |
Primary outcome
Number of Subjects With Any Antigen-Specific Cancer Immunotherapeutic (ASCI) Related Grade 3/4 Adverse Events (AE)
Time frame: 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).
Time frame: 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.
Time frame: At the time of analysis.
7 secondary outcomes
The Rate of Stable Disease.
Time frame: At the time of analysis.
The Rate of Mixed Response.
Time frame: At the time of analysis.
Time to Study Treatment Failure.
Time frame: At the time of analysis.
Progression-free Survival.
Time frame: At the time of analysis.
Progression-free Survival After Initial SPD.
Time frame: At the time of analysis.
Documentation of Any Toxicity.
Time frame: During the entire study, up to 2.5 years per patient
Immunogenicity at Defined Time Points.
Time frame: At 13 defined time points.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GSK Biologicals' Recombinant MAGE-A3 Antigen-Specific Cancer Immunotherapeutic (ASCI) GSK1203486A in people with Melanoma, run by GlaxoSmithKline at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Argentina, Greece, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With Any Antigen-Specific Cancer Immunotherapeutic (ASCI) Related Grade 3/4 Adverse Events (AE) (time frame: During the entire study, up to 2.5 years per patient). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.