Trial Outcomes & Findings for MAGE-A3 Antigen-Specific Cancer Immunotherapeutic in Patients With Progressive Metastatic Cutaneous Melanoma (NCT NCT00706238)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

During the entire study, up to 2.5 years per patient

Results posted on

2020-10-08

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	5
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Disease progression	4
Overall Study Other	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSK1203486A Group n=5 Participants 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.
Age, Continuous	67.2 Years STANDARD_DEVIATION 11.17 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	GSK1203486A Group n=5 Participants 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.
Number of Subjects With Any Antigen-Specific Cancer Immunotherapeutic (ASCI) Related Grade 3/4 Adverse Events (AE)	0 Participants

PRIMARY outcome

Timeframe: 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.

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Outcome measures
Measure	GSK1203486A Group n=5 Participants 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.
Number of Subjects With Any Serious Adverse Events (SAEs).	1 Participants

Adverse Events

GSK1203486A Group

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	GSK1203486A Group n=5 participants at risk 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.
Metabolism and nutrition disorders Diabetes Mellitus	20.0% 1/5 • All adverse events were collected during the entire study, from Month 0 to early termination date, up to 2.5 years per patient.

Other adverse events

Other adverse events
Measure	GSK1203486A Group n=5 participants at risk 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.
Skin and subcutaneous tissue disorders Inflammation	20.0% 1/5 • All adverse events were collected during the entire study, from Month 0 to early termination date, up to 2.5 years per patient.
General disorders Injection site pain	60.0% 3/5 • All adverse events were collected during the entire study, from Month 0 to early termination date, up to 2.5 years per patient.
General disorders Injection site reaction	40.0% 2/5 • All adverse events were collected during the entire study, from Month 0 to early termination date, up to 2.5 years per patient.
General disorders Pyrexia	40.0% 2/5 • All adverse events were collected during the entire study, from Month 0 to early termination date, up to 2.5 years per patient.
Infections and infestations Urinary tract infection	20.0% 1/5 • All adverse events were collected during the entire study, from Month 0 to early termination date, up to 2.5 years per patient.
Metabolism and nutrition disorders Diabetes mellitus	20.0% 1/5 • All adverse events were collected during the entire study, from Month 0 to early termination date, up to 2.5 years per patient.
Metabolism and nutrition disorders Hyperglycaemia	20.0% 1/5 • All adverse events were collected during the entire study, from Month 0 to early termination date, up to 2.5 years per patient.
Musculoskeletal and connective tissue disorders Myalgia	20.0% 1/5 • All adverse events were collected during the entire study, from Month 0 to early termination date, up to 2.5 years per patient.
General disorders Pain in extremity	20.0% 1/5 • All adverse events were collected during the entire study, from Month 0 to early termination date, up to 2.5 years per patient.
Skin and subcutaneous tissue disorders Exfoliative rash	20.0% 1/5 • All adverse events were collected during the entire study, from Month 0 to early termination date, up to 2.5 years per patient.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER