Trial Outcomes & Findings for PSMA and TARP Peptide Vaccine With Poly IC-LC Adjuvant in HLA-A2 (+) Patients With Elevated PSA After Initial Definitive Treatment (NCT NCT00694551)
NCT ID: NCT00694551
Last Updated: 2019-10-04
Results Overview
Number of participants with related Grade 3 or higher adverse events. Establish the safety and toxicity of varying doses of polypeptide vaccines PSMA and TARP administered with a fixed dose of Poly IC-LC as an adjuvant.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
29 participants
Primary outcome timeframe
Up to 48 months
Results posted on
2019-10-04
Participant Flow
Participant milestones
| Measure |
A. Level 100 mcg Peptide Vaccine
Peptide vaccine dose level 100 mcg
Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment.
|
B. Level 300 mcg Peptide Vaccine
Peptide vaccine dose level 300 mcg
Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment.
|
C. Level 1 mg Peptide Vaccine
Peptide vaccine dose level 1 mg
Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment.
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
9
|
|
Overall Study
COMPLETED
|
9
|
10
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
A. Level 100 mcg Peptide Vaccine
Peptide vaccine dose level 100 mcg
Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment.
|
B. Level 300 mcg Peptide Vaccine
Peptide vaccine dose level 300 mcg
Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment.
|
C. Level 1 mg Peptide Vaccine
Peptide vaccine dose level 1 mg
Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment.
|
|---|---|---|---|
|
Overall Study
Disease Progression
|
1
|
0
|
1
|
Baseline Characteristics
PSMA and TARP Peptide Vaccine With Poly IC-LC Adjuvant in HLA-A2 (+) Patients With Elevated PSA After Initial Definitive Treatment
Baseline characteristics by cohort
| Measure |
A. Peptide Vaccine
n=10 Participants
Peptide vaccine dose Level 100 mcg
Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment.
|
B. Peptide Vaccine
n=10 Participants
Peptide vaccine dose level 300 mcg
Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment.
|
C. Peptide Vaccine
n=9 Participants
Peptide vaccine dose level 1 mg
Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
69 years
n=99 Participants
|
69.5 years
n=107 Participants
|
69 years
n=206 Participants
|
69.5 years
n=157 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
9 Participants
n=157 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
20 Participants
n=157 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
29 Participants
n=157 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
10 participants
n=107 Participants
|
9 participants
n=206 Participants
|
29 participants
n=157 Participants
|
PRIMARY outcome
Timeframe: Up to 48 monthsPopulation: All participants who received treatment.
Number of participants with related Grade 3 or higher adverse events. Establish the safety and toxicity of varying doses of polypeptide vaccines PSMA and TARP administered with a fixed dose of Poly IC-LC as an adjuvant.
Outcome measures
| Measure |
A. Level 100 mcg Peptide Vaccine
n=10 Participants
Peptide vaccine dose Level 100 mcg
Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment.
|
B. Level 300 mcg Peptide Vaccine
n=10 Participants
Peptide vaccine dose level 300 mcg
Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment.
|
C. Level 1 mg Peptide Vaccine
n=9 Participants
Peptide vaccine dose level 1 mg
Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment.
|
|---|---|---|---|
|
Occurrence of Related Adverse Events - Grade 3 or Higher
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Up to 48 monthsPopulation: 29 patients who had serial PSA data, normalized by date and PSA.
Number of Participants Who Had a Doubling of the PSA or Proceeded to Another Therapy. Assess the impact of the vaccine on the pattern of PSA change in patients with castrate testosterone level and in patients with non-suppressed testosterone level not on hormone therapy.
Outcome measures
| Measure |
A. Level 100 mcg Peptide Vaccine
n=10 Participants
Peptide vaccine dose Level 100 mcg
Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment.
|
B. Level 300 mcg Peptide Vaccine
n=10 Participants
Peptide vaccine dose level 300 mcg
Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment.
|
C. Level 1 mg Peptide Vaccine
n=9 Participants
Peptide vaccine dose level 1 mg
Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment.
|
|---|---|---|---|
|
Number of Participants With Prostatic Specific Antigen (PSA) Doubling
|
8 participants
|
6 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Up to 48 monthsPopulation: 29 patients who had serial PSA data, normalized by date and PSA.
Number of participants who did not have a PSA doubling before their last study visit, median 458 days from baseline PSA (55-613).
Outcome measures
| Measure |
A. Level 100 mcg Peptide Vaccine
n=10 Participants
Peptide vaccine dose Level 100 mcg
Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment.
|
B. Level 300 mcg Peptide Vaccine
n=10 Participants
Peptide vaccine dose level 300 mcg
Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment.
|
C. Level 1 mg Peptide Vaccine
n=9 Participants
Peptide vaccine dose level 1 mg
Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment.
|
|---|---|---|---|
|
Number of Participants Who Did Not Have PSA Doubling
|
2 participants
|
4 participants
|
4 participants
|
Adverse Events
A. Peptide Vaccine
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
B. Peptide Vaccine
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
C. Peptide Vaccine
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
A. Peptide Vaccine
n=10 participants at risk
Peptide vaccine dose Level 100 mcg
Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment.
|
B. Peptide Vaccine
n=10 participants at risk
Peptide vaccine dose level 300 mcg
Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment.
|
C. Peptide Vaccine
n=9 participants at risk
Peptide vaccine dose level 1 mg
Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough - Grade 2 -
|
0.00%
0/10 • 2 years, 9 months
|
10.0%
1/10 • Number of events 1 • 2 years, 9 months
|
0.00%
0/9 • 2 years, 9 months
|
Other adverse events
| Measure |
A. Peptide Vaccine
n=10 participants at risk
Peptide vaccine dose Level 100 mcg
Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment.
|
B. Peptide Vaccine
n=10 participants at risk
Peptide vaccine dose level 300 mcg
Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment.
|
C. Peptide Vaccine
n=9 participants at risk
Peptide vaccine dose level 1 mg
Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment.
|
|---|---|---|---|
|
General disorders
Fatigue
|
50.0%
5/10 • Number of events 24 • 2 years, 9 months
|
50.0%
5/10 • Number of events 15 • 2 years, 9 months
|
66.7%
6/9 • Number of events 29 • 2 years, 9 months
|
|
General disorders
Feverr (in the absence of neutropenia)
|
60.0%
6/10 • Number of events 17 • 2 years, 9 months
|
50.0%
5/10 • Number of events 22 • 2 years, 9 months
|
44.4%
4/9 • Number of events 6 • 2 years, 9 months
|
|
General disorders
Rigors/chills
|
40.0%
4/10 • Number of events 10 • 2 years, 9 months
|
60.0%
6/10 • Number of events 18 • 2 years, 9 months
|
22.2%
2/9 • Number of events 2 • 2 years, 9 months
|
|
General disorders
Pain - Head/headache
|
30.0%
3/10 • Number of events 15 • 2 years, 9 months
|
60.0%
6/10 • Number of events 29 • 2 years, 9 months
|
77.8%
7/9 • Number of events 22 • 2 years, 9 months
|
|
General disorders
Pain - Muscle
|
40.0%
4/10 • Number of events 11 • 2 years, 9 months
|
40.0%
4/10 • Number of events 19 • 2 years, 9 months
|
44.4%
4/9 • Number of events 14 • 2 years, 9 months
|
|
General disorders
Pain - Back
|
0.00%
0/10 • 2 years, 9 months
|
20.0%
2/10 • Number of events 2 • 2 years, 9 months
|
33.3%
3/9 • Number of events 3 • 2 years, 9 months
|
|
General disorders
Pain - Joint
|
30.0%
3/10 • Number of events 3 • 2 years, 9 months
|
10.0%
1/10 • Number of events 2 • 2 years, 9 months
|
0.00%
0/9 • 2 years, 9 months
|
|
General disorders
Pain - Neck
|
0.00%
0/10 • 2 years, 9 months
|
20.0%
2/10 • Number of events 2 • 2 years, 9 months
|
11.1%
1/9 • Number of events 2 • 2 years, 9 months
|
|
Skin and subcutaneous tissue disorders
Injection site reaction/extravasation changes
|
70.0%
7/10 • Number of events 34 • 2 years, 9 months
|
90.0%
9/10 • Number of events 46 • 2 years, 9 months
|
77.8%
7/9 • Number of events 38 • 2 years, 9 months
|
|
Gastrointestinal disorders
Anorexia
|
20.0%
2/10 • Number of events 3 • 2 years, 9 months
|
0.00%
0/10 • 2 years, 9 months
|
22.2%
2/9 • Number of events 3 • 2 years, 9 months
|
|
Gastrointestinal disorders
Nausea
|
20.0%
2/10 • Number of events 4 • 2 years, 9 months
|
0.00%
0/10 • 2 years, 9 months
|
11.1%
1/9 • Number of events 2 • 2 years, 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other
|
0.00%
0/10 • 2 years, 9 months
|
20.0%
2/10 • Number of events 2 • 2 years, 9 months
|
44.4%
4/9 • Number of events 9 • 2 years, 9 months
|
|
General disorders
Flu-like syndrome
|
20.0%
2/10 • Number of events 5 • 2 years, 9 months
|
10.0%
1/10 • Number of events 1 • 2 years, 9 months
|
44.4%
4/9 • Number of events 8 • 2 years, 9 months
|
|
Nervous system disorders
Dizziness
|
20.0%
2/10 • Number of events 4 • 2 years, 9 months
|
30.0%
3/10 • Number of events 9 • 2 years, 9 months
|
0.00%
0/9 • 2 years, 9 months
|
|
Blood and lymphatic system disorders
Lymphatics - Other
|
0.00%
0/10 • 2 years, 9 months
|
30.0%
3/10 • Number of events 3 • 2 years, 9 months
|
11.1%
1/9 • Number of events 2 • 2 years, 9 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other
|
10.0%
1/10 • Number of events 1 • 2 years, 9 months
|
20.0%
2/10 • 2 years, 9 months
|
0.00%
0/9 • 2 years, 9 months
|
|
Endocrine disorders
Hot flashes/flushes
|
20.0%
2/10 • Number of events 2 • 2 years, 9 months
|
10.0%
1/10 • Number of events 1 • 2 years, 9 months
|
0.00%
0/9 • 2 years, 9 months
|
Additional Information
Mayer Fishman, M.D., Ph.D.
H. Lee Moffitt Cancer Center and Research Institute
Phone: 813-745-4398
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place