Trial Outcomes & Findings for Determine Toxicity and Antibody Responses With a KLH Conjugated Bivalent Vaccine Containing GD2 Lactone, GD3 Lactone With Immunological Adjuvant QS-DG or OPT-821 in Patients With Disease Free AJCC Stage III or IV Cutaneous Melanoma (NCT NCT00597272)
NCT ID: NCT00597272
Last Updated: 2016-09-20
Results Overview
Toxicity will be graded in accordance with Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
34 participants
Primary outcome timeframe
2 years
Results posted on
2016-09-20
Participant Flow
Participant milestones
| Measure |
Cohort 1A
Cohort 1A: 50mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
|
Cohort 1B
Cohort 1B: 75mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
|
Cohort 1C
Cohort 1C: 100mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
|
Cohort 2A
Cohort 2A: 50mcg QS-DG weeks 1, 2, 3, 8, 20, 32
|
Cohort 2B
Cohort 2B: 75mcg QS-DG weeks 1, 2, 3, 8, 20 ,32
|
Cohort 2C
Cohort 2C: 100mcg QS-DG weeks 1, 2, 3, 8, 20 ,32
|
Cohort 3
Cohort 3: 150mcg OPT-821 for first 5 vaccines with a 50 mcg increase in dose for the final vaccine.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
10
|
1
|
1
|
10
|
10
|
|
Overall Study
COMPLETED
|
1
|
1
|
10
|
1
|
1
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Determine Toxicity and Antibody Responses With a KLH Conjugated Bivalent Vaccine Containing GD2 Lactone, GD3 Lactone With Immunological Adjuvant QS-DG or OPT-821 in Patients With Disease Free AJCC Stage III or IV Cutaneous Melanoma
Baseline characteristics by cohort
| Measure |
Cohort 1A
n=1 Participants
Cohort 1A: 50mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
|
Cohort 1B
n=1 Participants
Cohort 1B: 75mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
|
Cohort 1C
n=10 Participants
Cohort 1C: 100mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
|
Cohort 2A
n=1 Participants
Cohort 2A: 50mcg QS-DG weeks 1, 2, 3, 8, 20, 32
|
Cohort 2B
n=1 Participants
Cohort 2B: 75mcg QS-DG weeks 1, 2, 3, 8, 20 ,32
|
Cohort 2C
n=10 Participants
Cohort 2C: 100mcg QS-DG weeks 1, 2, 3, 8, 20 ,32
|
Cohort 3
n=10 Participants
Cohort 3: 150mcg OPT-821 for first 5 vaccines with a 50 mcg increase in dose for the final vaccine.
|
Total
n=34 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
27 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
7 Participants
n=24 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
11 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
23 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
10 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
10 participants
n=10 Participants
|
10 participants
n=115 Participants
|
34 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: 2 yearsToxicity will be graded in accordance with Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Outcome measures
| Measure |
Cohort 1A
n=1 Participants
Cohort 1A: 50mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
|
Cohort 1B
n=1 Participants
Cohort 1B: 75mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
|
Cohort 1C
n=10 Participants
Cohort 1C: 100mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
|
Cohort 2A
n=1 Participants
Cohort 2A: 50mcg QS-DG weeks 1, 2, 3, 8, 20, 32
|
Cohort 2B
n=1 Participants
Cohort 2B: 75mcg QS-DG weeks 1, 2, 3, 8, 20 ,32
|
Cohort 2C
n=10 Participants
Cohort 2C: 100mcg QS-DG weeks 1, 2, 3, 8, 20 ,32
|
Cohort 3
n=10 Participants
Cohort 3: 150mcg OPT-821 for first 5 vaccines with a 50 mcg increase in dose for the final vaccine.
|
|---|---|---|---|---|---|---|---|
|
Toxicity
|
1 participants
|
1 participants
|
6 participants
|
1 participants
|
1 participants
|
7 participants
|
10 participants
|
Adverse Events
Cohort 1A
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 1B
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 1C
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 2A
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 2B
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 2C
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 3
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1A
n=1 participants at risk
Cohort 1A: 50mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
|
Cohort 1B
n=1 participants at risk
Cohort 1B: 75mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
|
Cohort 1C
n=10 participants at risk
Cohort 1C: 100mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
|
Cohort 2A
n=1 participants at risk
Cohort 2A: 50mcg QS-DG weeks 1, 2, 3, 8, 20, 32
|
Cohort 2B
n=1 participants at risk
Cohort 2B: 75mcg QS-DG weeks 1, 2, 3, 8, 20 ,32
|
Cohort 2C
n=10 participants at risk
Cohort 2C: 100mcg QS-DG weeks 1, 2, 3, 8, 20 ,32
|
Cohort 3
n=10 participants at risk
Cohort 3: 150mcg OPT-821 for first 5 vaccines with a 50 mcg increase in dose for the final vaccine.
|
|---|---|---|---|---|---|---|---|
|
Investigations
Blood bilirubin increased
|
100.0%
1/1 • Number of events 2
|
0.00%
0/1
|
10.0%
1/10 • Number of events 1
|
0.00%
0/1
|
100.0%
1/1 • Number of events 1
|
0.00%
0/10
|
10.0%
1/10 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
100.0%
1/1 • Number of events 4
|
0.00%
0/1
|
10.0%
1/10 • Number of events 5
|
100.0%
1/1 • Number of events 1
|
100.0%
1/1 • Number of events 4
|
20.0%
2/10 • Number of events 2
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Injection site reaction
|
100.0%
1/1 • Number of events 2
|
0.00%
0/1
|
0.00%
0/10
|
0.00%
0/1
|
0.00%
0/1
|
20.0%
2/10 • Number of events 4
|
90.0%
9/10 • Number of events 32
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/1
|
0.00%
0/1
|
10.0%
1/10 • Number of events 1
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/10
|
0.00%
0/1
|
0.00%
0/1
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin, other
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/10
|
0.00%
0/1
|
0.00%
0/1
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Investigations
INR increased
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/10
|
0.00%
0/1
|
0.00%
0/1
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Infections and infestations
Inf unknown ANC-Pneumonia(lung)
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/10
|
0.00%
0/1
|
0.00%
0/1
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Infections and infestations
Infection w/ Gr 3/4 neut, Dental-tooth
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/10
|
0.00%
0/1
|
0.00%
0/1
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Investigations
White blood cell decreased
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/10
|
0.00%
0/1
|
0.00%
0/1
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/10
|
0.00%
0/1
|
0.00%
0/1
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/10
|
0.00%
0/1
|
0.00%
0/1
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Muscular Pain
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/10
|
0.00%
0/1
|
0.00%
0/1
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/10
|
0.00%
0/1
|
0.00%
0/1
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/10
|
0.00%
0/1
|
0.00%
0/1
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/1
|
100.0%
1/1 • Number of events 1
|
0.00%
0/10
|
0.00%
0/1
|
100.0%
1/1 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1
|
0.00%
0/1
|
10.0%
1/10 • Number of events 1
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/10
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
100.0%
1/1 • Number of events 1
|
0.00%
0/1
|
10.0%
1/10 • Number of events 1
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/10
|
0.00%
0/10
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/1
|
0.00%
0/1
|
10.0%
1/10 • Number of events 1
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/10
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/10
|
0.00%
0/1
|
100.0%
1/1 • Number of events 1
|
0.00%
0/10
|
0.00%
0/10
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/10
|
0.00%
0/1
|
100.0%
1/1 • Number of events 4
|
0.00%
0/10
|
0.00%
0/10
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/10
|
0.00%
0/1
|
100.0%
1/1 • Number of events 3
|
0.00%
0/10
|
0.00%
0/10
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/10
|
0.00%
0/1
|
100.0%
1/1 • Number of events 2
|
0.00%
0/10
|
0.00%
0/10
|
|
Investigations
Platelet count decreased
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/10
|
0.00%
0/1
|
100.0%
1/1 • Number of events 3
|
0.00%
0/10
|
0.00%
0/10
|
|
Gastrointestinal disorders
Oral pain
|
100.0%
1/1 • Number of events 1
|
0.00%
0/1
|
0.00%
0/10
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/10
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
100.0%
1/1 • Number of events 1
|
0.00%
0/1
|
0.00%
0/10
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/10
|
0.00%
0/10
|
Additional Information
Dr. Paul Chapman
Memorial Sloan Kettering Cancer Center
Phone: 646-888-4162
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place