Trial Outcomes & Findings for Phase II Study to Assess the Safety and Immunogenicity of recMAGE-A3+AS15 ASCI With or Without Poly IC:LC (NCT NCT01437605)
NCT ID: NCT01437605
Last Updated: 2019-12-20
Results Overview
Number of participants with adverse events after receiving one dose of recMAGE-A3 + AS15 ASCI or recMAGEA3 + AS15 ASCI in combination with Poly IC:LC
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
14 participants
Primary outcome timeframe
Beginning of Treatment to End of Follow Up - up to 5 years per participant
Results posted on
2019-12-20
Participant Flow
Participant milestones
| Measure |
A: recMAGE-A3 + AS15
ASCI injections without Poly IC:LC
MAGE-A3 ASCI injections without Poly IC:LC: MAGE-A3 ASCI injections without Poly IC:LC as outlined in Detailed Description
|
B: recMAGE-A3 + AS15 + Poly IC:LC
ASCI injections with Poly IC:LC
MAGE-A3 ASCI injections with Poly IC:LC: MAGE-A3 ASCI injections with Poly IC:LC as outlined in Detailed Description
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
5
|
|
Overall Study
COMPLETED
|
9
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II Study to Assess the Safety and Immunogenicity of recMAGE-A3+AS15 ASCI With or Without Poly IC:LC
Baseline characteristics by cohort
| Measure |
A: recMAGE-A3 + AS15
n=9 Participants
ASCI injections without Poly IC:LC
MAGE-A3 ASCI injections without Poly IC:LC: MAGE-A3 ASCI injections without Poly IC:LC as outlined in Detailed Description
|
B: recMAGE-A3 + AS15 + Poly IC:LC
n=5 Participants
ASCI injections with Poly IC:LC
MAGE-A3 ASCI injections with Poly IC:LC: MAGE-A3 ASCI injections with Poly IC:LC as outlined in Detailed Description
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race White / Ethnicity Non-Hispanic
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
5 participants
n=7 Participants
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Beginning of Treatment to End of Follow Up - up to 5 years per participantNumber of participants with adverse events after receiving one dose of recMAGE-A3 + AS15 ASCI or recMAGEA3 + AS15 ASCI in combination with Poly IC:LC
Outcome measures
| Measure |
A: recMAGE-A3 + AS15
n=9 Participants
ASCI injections without Poly IC:LC
MAGE-A3 ASCI injections without Poly IC:LC: MAGE-A3 ASCI injections without Poly IC:LC as outlined in Detailed Description
|
B: recMAGE-A3 + AS15 + Poly IC:LC
n=5 Participants
ASCI injections with Poly IC:LC
MAGE-A3 ASCI injections with Poly IC:LC: MAGE-A3 ASCI injections with Poly IC:LC as outlined in Detailed Description
|
|---|---|---|
|
Number of Participants With Adverse Events Related to Study Treatment
|
9 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Beginning of Treatment to End of Follow Up - up to 5 years per participantPopulation: Data not collected (likely futility from low numbers enrolled when the protocol was closed to accrual)
Laboratory Endpoint: Assessment of the immunogenicity of the two regimens. Serum antibodies (such as Anti-MAGE-A3) seropositivity status (a seropositive patient is a patient whose titre is greater than or equal to the cut-off value) will be the primary immune endpoints assessed. Seropositivity will be assessed at baseline, after 2, 4, 6, 7 and 9 administrations, post-treatment (i.e., at concluding visit) and one year after concluding visit (i.e., at follow-up visit 2).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Beginning of Treatment to End of Follow Up - up to 2 years per participantRFS, defined as the time from randomization to the date of first relapse of melanoma or of death, whichever comes first. Percentage of participants with RFS, assessed up to 2 years is reported
Outcome measures
| Measure |
A: recMAGE-A3 + AS15
n=9 Participants
ASCI injections without Poly IC:LC
MAGE-A3 ASCI injections without Poly IC:LC: MAGE-A3 ASCI injections without Poly IC:LC as outlined in Detailed Description
|
B: recMAGE-A3 + AS15 + Poly IC:LC
n=5 Participants
ASCI injections with Poly IC:LC
MAGE-A3 ASCI injections with Poly IC:LC: MAGE-A3 ASCI injections with Poly IC:LC as outlined in Detailed Description
|
|---|---|---|
|
Percentage of Participants With Relapse-Free Survival (RFS)
1 Year RFS
|
56 percentage of participants
Interval 20.0 to 80.0
|
40 percentage of participants
Interval 5.0 to 75.0
|
|
Percentage of Participants With Relapse-Free Survival (RFS)
2 Year RFS
|
33 percentage of participants
Interval 8.0 to 62.0
|
40 percentage of participants
Interval 5.0 to 75.0
|
SECONDARY outcome
Timeframe: At 5 yearsPopulation: Data not collected (likely futility from low numbers enrolled when the protocol was closed to accrual)
OS defined as the interval from randomization to the date of death, irrespective of the cause of death; patients still alive will be censored at the date of the last assessment. The primary analysis will be based on the adjusted Cox regression model.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Beginning of Treatment to End of Follow Up - up to 5 years per participantPopulation: Participants not analyzed due to low number of patients accrued to this study before closure for likely futility from other negative trials of MAGE-A3
Immunogenicity as measured by T cell responses directed against MAGE-A3 antigen.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Beginning of Treatment to End of Follow Up - up to 5 years per participantPopulation: Participants not analyzed due to low number of patients accrued to this study before closure for likely futility from other negative trials of MAGE-A3
A potential correlation between gene expression profile and treatment clinical activity (RFS) in both study arms (recMAGE-A3 + AS15 ASCI and recMAGE-A3 + AS15 ASCI in combination with Poly IC:LC).
Outcome measures
Outcome data not reported
Adverse Events
A: recMAGE-A3 + AS15
Serious events: 3 serious events
Other events: 9 other events
Deaths: 4 deaths
B: recMAGE-A3 + AS15 + Poly IC:LC
Serious events: 1 serious events
Other events: 5 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
A: recMAGE-A3 + AS15
n=9 participants at risk
ASCI injections without Poly IC:LC
MAGE-A3 ASCI injections without Poly IC:LC: MAGE-A3 ASCI injections without Poly IC:LC as outlined in Detailed Description
|
B: recMAGE-A3 + AS15 + Poly IC:LC
n=5 participants at risk
ASCI injections with Poly IC:LC
MAGE-A3 ASCI injections with Poly IC:LC: MAGE-A3 ASCI injections with Poly IC:LC as outlined in Detailed Description
|
|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/9 • 6 years and 11 months
|
20.0%
1/5 • Number of events 1 • 6 years and 11 months
|
|
Infections and infestations
Infections and Infestations - Other, Specify
|
11.1%
1/9 • Number of events 1 • 6 years and 11 months
|
0.00%
0/5 • 6 years and 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic and Mediastinal Disorders
|
11.1%
1/9 • Number of events 1 • 6 years and 11 months
|
0.00%
0/5 • 6 years and 11 months
|
|
Vascular disorders
Thromboembolic Event
|
11.1%
1/9 • Number of events 1 • 6 years and 11 months
|
0.00%
0/5 • 6 years and 11 months
|
|
Nervous system disorders
Central Nervous System Necrosis
|
11.1%
1/9 • Number of events 1 • 6 years and 11 months
|
0.00%
0/5 • 6 years and 11 months
|
Other adverse events
| Measure |
A: recMAGE-A3 + AS15
n=9 participants at risk
ASCI injections without Poly IC:LC
MAGE-A3 ASCI injections without Poly IC:LC: MAGE-A3 ASCI injections without Poly IC:LC as outlined in Detailed Description
|
B: recMAGE-A3 + AS15 + Poly IC:LC
n=5 participants at risk
ASCI injections with Poly IC:LC
MAGE-A3 ASCI injections with Poly IC:LC: MAGE-A3 ASCI injections with Poly IC:LC as outlined in Detailed Description
|
|---|---|---|
|
Investigations
Alanine Aminotransferase Increased
|
11.1%
1/9 • Number of events 1 • 6 years and 11 months
|
0.00%
0/5 • 6 years and 11 months
|
|
Investigations
Aspartate Aminotransferase Increased
|
11.1%
1/9 • Number of events 2 • 6 years and 11 months
|
0.00%
0/5 • 6 years and 11 months
|
|
Investigations
Platelet Count Decreased
|
11.1%
1/9 • Number of events 1 • 6 years and 11 months
|
0.00%
0/5 • 6 years and 11 months
|
|
Investigations
Weight Gain
|
0.00%
0/9 • 6 years and 11 months
|
20.0%
1/5 • Number of events 1 • 6 years and 11 months
|
|
Metabolism and nutrition disorders
Anorexia
|
22.2%
2/9 • Number of events 3 • 6 years and 11 months
|
20.0%
1/5 • Number of events 1 • 6 years and 11 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
11.1%
1/9 • Number of events 1 • 6 years and 11 months
|
0.00%
0/5 • 6 years and 11 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
11.1%
1/9 • Number of events 1 • 6 years and 11 months
|
0.00%
0/5 • 6 years and 11 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
55.6%
5/9 • Number of events 5 • 6 years and 11 months
|
20.0%
1/5 • Number of events 4 • 6 years and 11 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
11.1%
1/9 • Number of events 1 • 6 years and 11 months
|
20.0%
1/5 • Number of events 1 • 6 years and 11 months
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
11.1%
1/9 • Number of events 1 • 6 years and 11 months
|
0.00%
0/5 • 6 years and 11 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
3/9 • Number of events 3 • 6 years and 11 months
|
0.00%
0/5 • 6 years and 11 months
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
11.1%
1/9 • Number of events 1 • 6 years and 11 months
|
0.00%
0/5 • 6 years and 11 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms Benign, Malignant and Unspecified (includes Cysts and Polyps) - Other, Specify
|
33.3%
3/9 • Number of events 4 • 6 years and 11 months
|
20.0%
1/5 • Number of events 1 • 6 years and 11 months
|
|
Nervous system disorders
Central Nervous System Necrosis
|
11.1%
1/9 • Number of events 1 • 6 years and 11 months
|
0.00%
0/5 • 6 years and 11 months
|
|
Nervous system disorders
Dizziness
|
33.3%
3/9 • Number of events 3 • 6 years and 11 months
|
40.0%
2/5 • Number of events 3 • 6 years and 11 months
|
|
Nervous system disorders
Headache
|
66.7%
6/9 • Number of events 10 • 6 years and 11 months
|
0.00%
0/5 • 6 years and 11 months
|
|
Nervous system disorders
Memory Impairment
|
11.1%
1/9 • Number of events 1 • 6 years and 11 months
|
0.00%
0/5 • 6 years and 11 months
|
|
Nervous system disorders
Nervous System Disorders - Other, Specify
|
11.1%
1/9 • Number of events 3 • 6 years and 11 months
|
0.00%
0/5 • 6 years and 11 months
|
|
Nervous system disorders
Paresthesia
|
11.1%
1/9 • Number of events 1 • 6 years and 11 months
|
0.00%
0/5 • 6 years and 11 months
|
|
Nervous system disorders
Peripheral Motor Neuropathy
|
11.1%
1/9 • Number of events 1 • 6 years and 11 months
|
0.00%
0/5 • 6 years and 11 months
|
|
Nervous system disorders
Spasticity
|
11.1%
1/9 • Number of events 1 • 6 years and 11 months
|
0.00%
0/5 • 6 years and 11 months
|
|
Psychiatric disorders
Anxiety
|
11.1%
1/9 • Number of events 1 • 6 years and 11 months
|
0.00%
0/5 • 6 years and 11 months
|
|
Psychiatric disorders
Hallucinations
|
11.1%
1/9 • Number of events 1 • 6 years and 11 months
|
0.00%
0/5 • 6 years and 11 months
|
|
Psychiatric disorders
Insomnia
|
11.1%
1/9 • Number of events 1 • 6 years and 11 months
|
0.00%
0/5 • 6 years and 11 months
|
|
Psychiatric disorders
Suicidal Ideation
|
11.1%
1/9 • Number of events 1 • 6 years and 11 months
|
0.00%
0/5 • 6 years and 11 months
|
|
Renal and urinary disorders
Renal and Urinary Disorders - Other, Specify
|
0.00%
0/9 • 6 years and 11 months
|
20.0%
1/5 • Number of events 2 • 6 years and 11 months
|
|
Reproductive system and breast disorders
Irregular Menstruation
|
11.1%
1/9 • Number of events 1 • 6 years and 11 months
|
0.00%
0/5 • 6 years and 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
22.2%
2/9 • Number of events 2 • 6 years and 11 months
|
20.0%
1/5 • Number of events 1 • 6 years and 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
3/9 • Number of events 3 • 6 years and 11 months
|
20.0%
1/5 • Number of events 1 • 6 years and 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.1%
1/9 • Number of events 1 • 6 years and 11 months
|
0.00%
0/5 • 6 years and 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/9 • 6 years and 11 months
|
20.0%
1/5 • Number of events 1 • 6 years and 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal Drip
|
11.1%
1/9 • Number of events 1 • 6 years and 11 months
|
0.00%
0/5 • 6 years and 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
11.1%
1/9 • Number of events 1 • 6 years and 11 months
|
20.0%
1/5 • Number of events 1 • 6 years and 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic and Mediastinal Disorders - Other, Specify
|
11.1%
1/9 • Number of events 1 • 6 years and 11 months
|
0.00%
0/5 • 6 years and 11 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/9 • 6 years and 11 months
|
20.0%
1/5 • Number of events 1 • 6 years and 11 months
|
|
Skin and subcutaneous tissue disorders
Nail Loss
|
0.00%
0/9 • 6 years and 11 months
|
20.0%
1/5 • Number of events 2 • 6 years and 11 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/9 • 6 years and 11 months
|
20.0%
1/5 • Number of events 1 • 6 years and 11 months
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
22.2%
2/9 • Number of events 3 • 6 years and 11 months
|
40.0%
2/5 • Number of events 2 • 6 years and 11 months
|
|
Skin and subcutaneous tissue disorders
Scalp Pain
|
11.1%
1/9 • Number of events 1 • 6 years and 11 months
|
0.00%
0/5 • 6 years and 11 months
|
|
Skin and subcutaneous tissue disorders
Skin and Subcutaneous Tissue Disorders - Other, Specify
|
33.3%
3/9 • Number of events 3 • 6 years and 11 months
|
20.0%
1/5 • Number of events 2 • 6 years and 11 months
|
|
Vascular disorders
Hot Flashes
|
0.00%
0/9 • 6 years and 11 months
|
20.0%
1/5 • Number of events 1 • 6 years and 11 months
|
|
Vascular disorders
Hypertension
|
22.2%
2/9 • Number of events 3 • 6 years and 11 months
|
0.00%
0/5 • 6 years and 11 months
|
|
Vascular disorders
Thromboembolic Event
|
11.1%
1/9 • Number of events 1 • 6 years and 11 months
|
0.00%
0/5 • 6 years and 11 months
|
|
Blood and lymphatic system disorders
Anemia
|
11.1%
1/9 • Number of events 1 • 6 years and 11 months
|
0.00%
0/5 • 6 years and 11 months
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/9 • 6 years and 11 months
|
20.0%
1/5 • Number of events 2 • 6 years and 11 months
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/9 • 6 years and 11 months
|
20.0%
1/5 • Number of events 1 • 6 years and 11 months
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
22.2%
2/9 • Number of events 2 • 6 years and 11 months
|
0.00%
0/5 • 6 years and 11 months
|
|
Infections and infestations
Papulopustular Rash
|
11.1%
1/9 • Number of events 1 • 6 years and 11 months
|
0.00%
0/5 • 6 years and 11 months
|
|
Gastrointestinal disorders
Gastrointestinal Disorders - Other, Specify
|
11.1%
1/9 • Number of events 1 • 6 years and 11 months
|
0.00%
0/5 • 6 years and 11 months
|
|
Infections and infestations
Sinusitis
|
11.1%
1/9 • Number of events 1 • 6 years and 11 months
|
20.0%
1/5 • Number of events 1 • 6 years and 11 months
|
|
Infections and infestations
Skin Infection
|
11.1%
1/9 • Number of events 2 • 6 years and 11 months
|
0.00%
0/5 • 6 years and 11 months
|
|
Gastrointestinal disorders
Nausea
|
22.2%
2/9 • Number of events 2 • 6 years and 11 months
|
40.0%
2/5 • Number of events 5 • 6 years and 11 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9 • 6 years and 11 months
|
20.0%
1/5 • Number of events 1 • 6 years and 11 months
|
|
General disorders
Chills
|
22.2%
2/9 • Number of events 2 • 6 years and 11 months
|
0.00%
0/5 • 6 years and 11 months
|
|
General disorders
Edema Limbs
|
0.00%
0/9 • 6 years and 11 months
|
20.0%
1/5 • Number of events 2 • 6 years and 11 months
|
|
Infections and infestations
Upper Respiratory Infection
|
0.00%
0/9 • 6 years and 11 months
|
20.0%
1/5 • Number of events 1 • 6 years and 11 months
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/9 • 6 years and 11 months
|
20.0%
1/5 • Number of events 1 • 6 years and 11 months
|
|
General disorders
Fatigue
|
66.7%
6/9 • Number of events 17 • 6 years and 11 months
|
60.0%
3/5 • Number of events 6 • 6 years and 11 months
|
|
General disorders
Fever
|
77.8%
7/9 • Number of events 14 • 6 years and 11 months
|
60.0%
3/5 • Number of events 10 • 6 years and 11 months
|
|
General disorders
Flu Like Symptoms
|
55.6%
5/9 • Number of events 9 • 6 years and 11 months
|
60.0%
3/5 • Number of events 3 • 6 years and 11 months
|
|
General disorders
General Disorders and Administration Site Conditions - Other, Specify
|
33.3%
3/9 • Number of events 5 • 6 years and 11 months
|
0.00%
0/5 • 6 years and 11 months
|
|
Endocrine disorders
Cushingoid
|
11.1%
1/9 • Number of events 1 • 6 years and 11 months
|
0.00%
0/5 • 6 years and 11 months
|
|
Endocrine disorders
Endocrine Disorders - Other, Specify
|
0.00%
0/9 • 6 years and 11 months
|
20.0%
1/5 • Number of events 2 • 6 years and 11 months
|
|
Eye disorders
Blurred Vision
|
11.1%
1/9 • Number of events 1 • 6 years and 11 months
|
20.0%
1/5 • Number of events 1 • 6 years and 11 months
|
|
Eye disorders
Dry Eye
|
11.1%
1/9 • Number of events 1 • 6 years and 11 months
|
20.0%
1/5 • Number of events 1 • 6 years and 11 months
|
|
General disorders
Injection Site Reaction
|
77.8%
7/9 • Number of events 20 • 6 years and 11 months
|
80.0%
4/5 • Number of events 13 • 6 years and 11 months
|
|
General disorders
Malaise
|
11.1%
1/9 • Number of events 4 • 6 years and 11 months
|
0.00%
0/5 • 6 years and 11 months
|
|
General disorders
Pain
|
22.2%
2/9 • Number of events 2 • 6 years and 11 months
|
0.00%
0/5 • 6 years and 11 months
|
|
Infections and infestations
Infections and Infestations - Other, Specify
|
0.00%
0/9 • 6 years and 11 months
|
20.0%
1/5 • Number of events 1 • 6 years and 11 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
22.2%
2/9 • Number of events 2 • 6 years and 11 months
|
0.00%
0/5 • 6 years and 11 months
|
|
Gastrointestinal disorders
Constipation
|
22.2%
2/9 • Number of events 2 • 6 years and 11 months
|
20.0%
1/5 • Number of events 1 • 6 years and 11 months
|
|
Gastrointestinal disorders
Diarrhea
|
11.1%
1/9 • Number of events 1 • 6 years and 11 months
|
20.0%
1/5 • Number of events 1 • 6 years and 11 months
|
|
Gastrointestinal disorders
Gastritis
|
11.1%
1/9 • Number of events 1 • 6 years and 11 months
|
0.00%
0/5 • 6 years and 11 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place