Trial Outcomes & Findings for Immunization With the MAGE-3.A1 Peptide Mixed With the Adjuvant CpG 7909 in Patients With Metastatic Melanoma (NCT NCT00145145)

Last Updated: 2022-10-07

Results Overview

Blood samples were collected prior to treatment and in weeks 3, 7, and 13. Specific CTL responses directed against the MAGE-3.A1 antigen were to be assessed by using restimulation in vitro, followed by staining with the A1/MAGE-3 tetramer and cloning of the tetramer-positive lymphocytes (MLPC/tetramer/cloning assay).

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

1 participants

Primary outcome timeframe

Up to 12 weeks

Results posted on

2022-10-07

Participant Flow

Participant milestones

Participant milestones
Measure	MAGE-3.A1 Peptide Mixed With CpG 7909 Patients were vaccinated every two weeks on six occasions. On each vaccination day, the MAGE-3.A1 peptide (300 mcg) mixed with CpG 7909 (5 mg) was administered twice intradermally (10% of the dose each) and twice subcutaneously (40% of the dose each) in the arms and thighs.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Immunization With the MAGE-3.A1 Peptide Mixed With the Adjuvant CpG 7909 in Patients With Metastatic Melanoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MAGE-3.A1 Peptide Mixed With CpG 7909 n=1 Participants Patients were vaccinated every two weeks on six occasions. On each vaccination day, the MAGE-3.A1 peptide (300 mcg) mixed with CpG 7909 (5 mg) was administered twice intradermally (10% of the dose each) and twice subcutaneously (40% of the dose each) in the arms and thighs.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Sex: Female, Male Female	0 Participants n=99 Participants
Sex: Female, Male Male	1 Participants n=99 Participants
Region of Enrollment Belgium	1 participants n=99 Participants

PRIMARY outcome

Timeframe: Up to 12 weeks

Population: The cytolytic T lymphocyte (CTL) response directed against the MAGE-3.A1 vaccine antigen was not analyzed due to the premature closing of this trial after only one patient was treated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 12 weeks

Population: The one patient who was entered into the study and received study treatment.

All adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale, version 3.0. DLT was defined as: * Any Grade 3 hematological or non-hematological toxicity other than skin or flu-like symptoms. * Any Grade 4 toxicity. To be dose-limiting, an adverse event must be definitely, probably, or possibly related to the administration of MAGE-3.A1 peptide mixed with CpG 7909.

Outcome measures

Outcome measures
Measure	MAGE-3.A1 Peptide Mixed With CpG 7909 n=1 Participants Patients were vaccinated every two weeks on six occasions. On each vaccination day, the MAGE-3.A1 peptide (300 mcg) mixed with CpG 7909 (5 mg) was administered twice intradermally (10% of the dose each) and twice subcutaneously (40% of the dose each) in the arms and thighs.
To Determine the Safety of the Treatment by Measuring the Number of Patients With Dose Limiting Toxicities (DLT)	0 Participants

SECONDARY outcome

Timeframe: up to 12 weeks

Population: The one patient who was entered into and treated in this study.

Computed tomography (CT) scans were performed at screening, and at week 13. Response was assessed using RECIST version 1.0 (Therasse et al, J Natl Cancer Inst 2000; 92:205-16). Per RECIST, target lesions are categorized as follows: complete response (CR): disappearance of all target lesions (no evaluable disease); partial response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; progressive disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; stable disease (SD): small changes that do not meet above criteria.

Outcome measures

Outcome measures
Measure	MAGE-3.A1 Peptide Mixed With CpG 7909 n=1 Participants Patients were vaccinated every two weeks on six occasions. On each vaccination day, the MAGE-3.A1 peptide (300 mcg) mixed with CpG 7909 (5 mg) was administered twice intradermally (10% of the dose each) and twice subcutaneously (40% of the dose each) in the arms and thighs.
To Determine the Clinical Effectiveness of the Treatment by Measuring Tumor Response in Patients With Measurable Disease. CR	0 Participants
To Determine the Clinical Effectiveness of the Treatment by Measuring Tumor Response in Patients With Measurable Disease. PR	0 Participants
To Determine the Clinical Effectiveness of the Treatment by Measuring Tumor Response in Patients With Measurable Disease. SD	0 Participants
To Determine the Clinical Effectiveness of the Treatment by Measuring Tumor Response in Patients With Measurable Disease. PD	1 Participants

Adverse Events

MAGE-3.A1 Peptide Mixed With CpG 7909

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	MAGE-3.A1 Peptide Mixed With CpG 7909 n=1 participants at risk Patients were vaccinated every two weeks on six occasions. On each vaccination day, the MAGE-3.A1 peptide (300 mcg) mixed with CpG 7909 (5 mg) was administered twice intradermally (10% of the dose each) and twice subcutaneously (40% of the dose each) in the arms and thighs.
Infections and infestations Bronchitis	100.0% 1/1 • up to 13 weeks All Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent until end of study were documented. Toxicity was reported according to the Common Terminology Criteria for Adverse Events (CTCAE) Scale of the National Cancer Institute, version 3.0.
Respiratory, thoracic and mediastinal disorders Cough	100.0% 1/1 • up to 13 weeks All Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent until end of study were documented. Toxicity was reported according to the Common Terminology Criteria for Adverse Events (CTCAE) Scale of the National Cancer Institute, version 3.0.
General disorders Pyrexia	100.0% 1/1 • up to 13 weeks All Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent until end of study were documented. Toxicity was reported according to the Common Terminology Criteria for Adverse Events (CTCAE) Scale of the National Cancer Institute, version 3.0.
General disorders Influenza-like illness	100.0% 1/1 • up to 13 weeks All Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent until end of study were documented. Toxicity was reported according to the Common Terminology Criteria for Adverse Events (CTCAE) Scale of the National Cancer Institute, version 3.0.
Nervous system disorders Headache	100.0% 1/1 • up to 13 weeks All Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent until end of study were documented. Toxicity was reported according to the Common Terminology Criteria for Adverse Events (CTCAE) Scale of the National Cancer Institute, version 3.0.
Respiratory, thoracic and mediastinal disorders Hypoventilation	100.0% 1/1 • up to 13 weeks All Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent until end of study were documented. Toxicity was reported according to the Common Terminology Criteria for Adverse Events (CTCAE) Scale of the National Cancer Institute, version 3.0.
General disorders Night sweats	100.0% 1/1 • up to 13 weeks All Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent until end of study were documented. Toxicity was reported according to the Common Terminology Criteria for Adverse Events (CTCAE) Scale of the National Cancer Institute, version 3.0.
General disorders Injection site pain	100.0% 1/1 • up to 13 weeks All Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent until end of study were documented. Toxicity was reported according to the Common Terminology Criteria for Adverse Events (CTCAE) Scale of the National Cancer Institute, version 3.0.
General disorders Injection site erythema	100.0% 1/1 • up to 13 weeks All Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent until end of study were documented. Toxicity was reported according to the Common Terminology Criteria for Adverse Events (CTCAE) Scale of the National Cancer Institute, version 3.0.
General disorders Injection site scab	100.0% 1/1 • up to 13 weeks All Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent until end of study were documented. Toxicity was reported according to the Common Terminology Criteria for Adverse Events (CTCAE) Scale of the National Cancer Institute, version 3.0.
General disorders Fatigue	100.0% 1/1 • up to 13 weeks All Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent until end of study were documented. Toxicity was reported according to the Common Terminology Criteria for Adverse Events (CTCAE) Scale of the National Cancer Institute, version 3.0.
General disorders Weakness	100.0% 1/1 • up to 13 weeks All Adverse Events (AEs) occurring during the study were to be documented in the source records and on the respective AE Case Report Form (CRF), regardless of the assumption of a causal relationship. All events, which occurred after signed informed consent until end of study were documented. Toxicity was reported according to the Common Terminology Criteria for Adverse Events (CTCAE) Scale of the National Cancer Institute, version 3.0.

Additional Information

Jonathan Skipper PhD

Ludwig Institute for Cancer Research

Phone: 12124501539

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place