Trial Outcomes & Findings for Evaluation of the Impact of Adjuvants Accompanying Peptide Immunization in High-Risk Melanoma (NCT NCT00273910)
NCT ID: NCT00273910
Last Updated: 2012-10-19
Results Overview
Comparison of six different preparations of the gp100:209-217 (210M) melanoma antigen peptide. The arm with the greater number of immunologic responses will be the one most likely to be selected for future study on the basis of immunization alone. Evidence of immunization consist of at least 10 Elispots/100,000 cells above background. An injection site reaction is not an immune response.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
104 participants
Primary outcome timeframe
48 months
Results posted on
2012-10-19
Participant Flow
104 subjects were enrolled in this trial.
Participant milestones
| Measure |
Adj-3 A2 gp209(2M) in IFA SQ (Vortex)
gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
|
Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (Vortex)
gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
|
Adj-3 A2 gp209(2M) in Saline ID
gp100:209-217(210M) in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
|
Adj-3 A2 gp209(2M) in Saline ID + Imiquimod
gp100:209-217(210M) peptide in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of the injection daily for 5 days.
|
Adj-3 A2 gp209(2M) in IFA SQ (2 Syringe)
gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
|
Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (2 Syringe)
gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
19
|
19
|
18
|
19
|
15
|
14
|
|
Overall Study
COMPLETED
|
19
|
19
|
18
|
19
|
15
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of the Impact of Adjuvants Accompanying Peptide Immunization in High-Risk Melanoma
Baseline characteristics by cohort
| Measure |
Adj-3 A2 gp209(2M) in IFA SQ (Vortex)
n=19 Participants
gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
|
Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (Vortex)
n=19 Participants
gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
|
Adj-3 A2 gp209(2M) in Saline ID
n=18 Participants
gp100:209-217(210M) in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
|
Adj-3 A2 gp209(2M) in Saline ID + Imiquimod
n=19 Participants
gp100:209-217(210M) peptide in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of the injection daily for 5 days.
|
Adj-3 A2 gp209(2M) in IFA SQ (2 Syringe)
n=15 Participants
gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
|
Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (2 Syringe)
n=14 Participants
gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
|
Total
n=104 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=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
102 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Age Continuous
|
46.9 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
42.8 years
STANDARD_DEVIATION 10.4 • n=7 Participants
|
48.8 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
48.1 years
STANDARD_DEVIATION 10.2 • n=4 Participants
|
51.7 years
STANDARD_DEVIATION 13.2 • n=21 Participants
|
47.7 years
STANDARD_DEVIATION 8.3 • n=8 Participants
|
47.6 years
STANDARD_DEVIATION 10.65 • n=8 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
37 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
67 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Natives
|
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=8 Participants
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian or Pacific Islander
|
1 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=8 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian
|
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=8 Participants
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black of non-Hispanic Origin
|
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=8 Participants
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
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=8 Participants
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White of non-Hispanic Origin
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
103 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Other or Unknown
|
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=8 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
19 participants
n=7 Participants
|
18 participants
n=5 Participants
|
19 participants
n=4 Participants
|
15 participants
n=21 Participants
|
14 participants
n=8 Participants
|
104 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 48 monthsPopulation: The number of participants analyzed and results are correct. We do not have the immunologic response rate data for all patients.
Comparison of six different preparations of the gp100:209-217 (210M) melanoma antigen peptide. The arm with the greater number of immunologic responses will be the one most likely to be selected for future study on the basis of immunization alone. Evidence of immunization consist of at least 10 Elispots/100,000 cells above background. An injection site reaction is not an immune response.
Outcome measures
| Measure |
Adj-3 A2 gp209(2M) in IFA SQ (Vortex)
n=14 Participants
gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
|
Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (Vortex)
n=10 Participants
gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
|
Adj-3 A2 gp209(2M) in Saline ID
n=12 Participants
gp100:209-217(210M) in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
|
Adj-3 A2 gp209(2M) in Saline ID + Imiquimod
n=15 Participants
gp100:209-217(210M) peptide in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of the injection daily for 5 days.
|
Adj-3 A2 gp209(2M) in IFA SQ (2 Syringe)
n=5 Participants
gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
|
Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (2 Syringe)
n=5 Participants
gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
|
|---|---|---|---|---|---|---|
|
Immunologic Response Rate
|
2 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 48 monthsHere are the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.
Outcome measures
| Measure |
Adj-3 A2 gp209(2M) in IFA SQ (Vortex)
n=19 Participants
gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
|
Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (Vortex)
n=19 Participants
gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
|
Adj-3 A2 gp209(2M) in Saline ID
n=18 Participants
gp100:209-217(210M) in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
|
Adj-3 A2 gp209(2M) in Saline ID + Imiquimod
n=19 Participants
gp100:209-217(210M) peptide in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of the injection daily for 5 days.
|
Adj-3 A2 gp209(2M) in IFA SQ (2 Syringe)
n=15 Participants
gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
|
Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (2 Syringe)
n=14 Participants
gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events
|
19 Participants
|
19 Participants
|
18 Participants
|
19 Participants
|
15 Participants
|
14 Participants
|
Adverse Events
Adj-3 A2 gp209(2M) in IFA SQ (Vortex)
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (Vortex)
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Adj-3 A2 gp209(2M) in Saline ID
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Adj-3 A2 gp209(2M) in Saline ID + Imiquimod
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Adj-3 A2 gp209(2M) in IFA SQ (2 Syringe)
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (2 Syringe)
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Adj-3 A2 gp209(2M) in IFA SQ (Vortex)
n=19 participants at risk
gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
|
Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (Vortex)
n=19 participants at risk
gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
|
Adj-3 A2 gp209(2M) in Saline ID
n=18 participants at risk
gp100:209-217(210M) in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
|
Adj-3 A2 gp209(2M) in Saline ID + Imiquimod
n=19 participants at risk
gp100:209-217(210M) peptide in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of the injection daily for 5 days.
|
Adj-3 A2 gp209(2M) in IFA SQ (2 Syringe)
n=15 participants at risk
gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
|
Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (2 Syringe)
n=14 participants at risk
gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leukocyte count decreased
|
5.3%
1/19 • Number of events 1 • 48 months
|
0.00%
0/19 • 48 months
|
5.6%
1/18 • Number of events 1 • 48 months
|
0.00%
0/19 • 48 months
|
0.00%
0/15 • 48 months
|
0.00%
0/14 • 48 months
|
|
General disorders
Chills
|
10.5%
2/19 • Number of events 2 • 48 months
|
0.00%
0/19 • 48 months
|
0.00%
0/18 • 48 months
|
0.00%
0/19 • 48 months
|
0.00%
0/15 • 48 months
|
7.1%
1/14 • Number of events 1 • 48 months
|
|
General disorders
Fatigue
|
21.1%
4/19 • Number of events 6 • 48 months
|
5.3%
1/19 • Number of events 1 • 48 months
|
0.00%
0/18 • 48 months
|
0.00%
0/19 • 48 months
|
0.00%
0/15 • 48 months
|
7.1%
1/14 • Number of events 2 • 48 months
|
|
General disorders
Sweating
|
5.3%
1/19 • Number of events 1 • 48 months
|
0.00%
0/19 • 48 months
|
0.00%
0/18 • 48 months
|
0.00%
0/19 • 48 months
|
0.00%
0/15 • 48 months
|
0.00%
0/14 • 48 months
|
|
Skin and subcutaneous tissue disorders
Injection site reaction
|
100.0%
19/19 • Number of events 56 • 48 months
|
100.0%
19/19 • Number of events 48 • 48 months
|
100.0%
18/18 • Number of events 47 • 48 months
|
100.0%
19/19 • Number of events 55 • 48 months
|
100.0%
15/15 • Number of events 35 • 48 months
|
100.0%
14/14 • Number of events 36 • 48 months
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
26.3%
5/19 • Number of events 5 • 48 months
|
5.3%
1/19 • Number of events 1 • 48 months
|
0.00%
0/18 • 48 months
|
0.00%
0/19 • 48 months
|
6.7%
1/15 • Number of events 1 • 48 months
|
14.3%
2/14 • Number of events 2 • 48 months
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
10.5%
2/19 • Number of events 2 • 48 months
|
5.3%
1/19 • Number of events 1 • 48 months
|
0.00%
0/18 • 48 months
|
0.00%
0/19 • 48 months
|
6.7%
1/15 • Number of events 1 • 48 months
|
0.00%
0/14 • 48 months
|
|
Gastrointestinal disorders
Diarrhea
|
10.5%
2/19 • Number of events 2 • 48 months
|
0.00%
0/19 • 48 months
|
0.00%
0/18 • 48 months
|
0.00%
0/19 • 48 months
|
0.00%
0/15 • 48 months
|
0.00%
0/14 • 48 months
|
|
Gastrointestinal disorders
Nausea
|
5.3%
1/19 • Number of events 1 • 48 months
|
0.00%
0/19 • 48 months
|
0.00%
0/18 • 48 months
|
0.00%
0/19 • 48 months
|
0.00%
0/15 • 48 months
|
0.00%
0/14 • 48 months
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
1/19 • Number of events 1 • 48 months
|
0.00%
0/19 • 48 months
|
0.00%
0/18 • 48 months
|
0.00%
0/19 • 48 months
|
0.00%
0/15 • 48 months
|
0.00%
0/14 • 48 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.5%
2/19 • Number of events 2 • 48 months
|
0.00%
0/19 • 48 months
|
0.00%
0/18 • 48 months
|
0.00%
0/19 • 48 months
|
0.00%
0/15 • 48 months
|
7.1%
1/14 • Number of events 1 • 48 months
|
|
Psychiatric disorders
Headache
|
0.00%
0/19 • 48 months
|
5.3%
1/19 • Number of events 1 • 48 months
|
0.00%
0/18 • 48 months
|
0.00%
0/19 • 48 months
|
0.00%
0/15 • 48 months
|
0.00%
0/14 • 48 months
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/19 • 48 months
|
0.00%
0/19 • 48 months
|
0.00%
0/18 • 48 months
|
0.00%
0/19 • 48 months
|
0.00%
0/15 • 48 months
|
0.00%
0/14 • 48 months
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
0.00%
0/19 • 48 months
|
0.00%
0/19 • 48 months
|
0.00%
0/18 • 48 months
|
0.00%
0/19 • 48 months
|
0.00%
0/15 • 48 months
|
7.1%
1/14 • Number of events 1 • 48 months
|
Additional Information
Steven A. Rosenberg, M.D.
National Cancer Institute, National Institutes of Health
Phone: 301-496-4164
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place