Trial Outcomes & Findings for Prime-boost Immunotherapeutic Trial in Men With Biochemical Recurrence After Definitive Local Therapy for Prostate Cancer (NCT NCT05617040)
NCT ID: NCT05617040
Last Updated: 2025-11-10
Results Overview
Participants with AEs, ≥Grade 3 AEs, and serious adverse events.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
22 participants
Primary outcome timeframe
From the start of the first VTP-850 administration continuing until Month 6
Results posted on
2025-11-10
Participant Flow
Participant milestones
| Measure |
IM/IM Low
ChAdOx1-PCAQ 5\*10\^9 vp IM / MVA-PCAQ 5\*10\^7 pfu IM
|
IM/IM Full
ChAdOx1-PCAQ 2.5\*10\^10 vp IM / MVA-PCAQ 2\*10\^8 pfu IM
|
IM/IV Full
ChAdOx1-PCAQ 2.5\*10\^10 vp IM / MVA-PCAQ 2\*10\^7 pfu IV
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
10
|
9
|
|
Overall Study
COMPLETED
|
3
|
9
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
IM/IM Low
ChAdOx1-PCAQ 5\*10\^9 vp IM / MVA-PCAQ 5\*10\^7 pfu IM
|
IM/IM Full
ChAdOx1-PCAQ 2.5\*10\^10 vp IM / MVA-PCAQ 2\*10\^8 pfu IM
|
IM/IV Full
ChAdOx1-PCAQ 2.5\*10\^10 vp IM / MVA-PCAQ 2\*10\^7 pfu IV
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
|
Overall Study
Death
|
0
|
0
|
1
|
Baseline Characteristics
Prime-boost Immunotherapeutic Trial in Men With Biochemical Recurrence After Definitive Local Therapy for Prostate Cancer
Baseline characteristics by cohort
| Measure |
IM/IM Low
n=3 Participants
ChAdOx1-PCAQ 5\*10\^9 vp IM / MVA-PCAQ 5\*10\^7 pfu IM
|
IM/IM Full
n=10 Participants
ChAdOx1-PCAQ 2.5\*10\^10 vp IM / MVA-PCAQ 2\*10\^8 pfu IM
|
IM/IV Full
n=9 Participants
ChAdOx1-PCAQ 2.5\*10\^10 vp IM / MVA-PCAQ 2\*10\^7 pfu IV
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
66.0 Years
STANDARD_DEVIATION 6.93 • n=5 Participants
|
71.1 Years
STANDARD_DEVIATION 4.89 • n=20 Participants
|
68.9 Years
STANDARD_DEVIATION 9.53 • n=40 Participants
|
69.5 Years
STANDARD_DEVIATION 7.25 • n=28 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=28 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=28 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=28 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
2 Participants
n=28 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
9 Participants
n=20 Participants
|
8 Participants
n=40 Participants
|
19 Participants
n=28 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=28 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=28 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=28 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
9 Participants
n=20 Participants
|
9 Participants
n=40 Participants
|
21 Participants
n=28 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=28 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=28 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
10 Participants
n=20 Participants
|
9 Participants
n=40 Participants
|
22 Participants
n=28 Participants
|
PRIMARY outcome
Timeframe: From the start of the first VTP-850 administration continuing until Month 6Participants with AEs, ≥Grade 3 AEs, and serious adverse events.
Outcome measures
| Measure |
IM/IM Low
n=3 Participants
ChAdOx1-PCAQ 5\*10\^9 vp IM / MVA-PCAQ 5\*10\^7 pfu IM
|
IM/IM Full
n=10 Participants
ChAdOx1-PCAQ 2.5\*10\^10 vp IM / MVA-PCAQ 2\*10\^8 pfu IM
|
IM/IV Full
n=9 Participants
ChAdOx1-PCAQ 2.5\*10\^10 vp IM / MVA-PCAQ 2\*10\^7 pfu IV
|
|---|---|---|---|
|
The Safety of VTP-850 Prime-boost Regimens, With the Booster Dose Administered Either IM or IV, and the Recommended Phase 2 Regimen (RP2R)
Participants with AEs
|
3 Participants
|
9 Participants
|
9 Participants
|
|
The Safety of VTP-850 Prime-boost Regimens, With the Booster Dose Administered Either IM or IV, and the Recommended Phase 2 Regimen (RP2R)
Grade 1 (Worst Severity)
|
2 Participants
|
5 Participants
|
3 Participants
|
|
The Safety of VTP-850 Prime-boost Regimens, With the Booster Dose Administered Either IM or IV, and the Recommended Phase 2 Regimen (RP2R)
Grade 2 (Worst Severity)
|
1 Participants
|
4 Participants
|
5 Participants
|
|
The Safety of VTP-850 Prime-boost Regimens, With the Booster Dose Administered Either IM or IV, and the Recommended Phase 2 Regimen (RP2R)
Grade 5 (Worst Severity)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
The Safety of VTP-850 Prime-boost Regimens, With the Booster Dose Administered Either IM or IV, and the Recommended Phase 2 Regimen (RP2R)
Serious adverse events
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The Efficacy Evaluable Set (EES) will consist of all participants in the FAS who had one baseline measurement of PSA and at least one post-baseline measurement of PSA.
Percentage of participants with ≥50% reduction in serum PSA compared to baseline (2 consecutive measurements at least 2 weeks apart)
Outcome measures
| Measure |
IM/IM Low
n=3 Participants
ChAdOx1-PCAQ 5\*10\^9 vp IM / MVA-PCAQ 5\*10\^7 pfu IM
|
IM/IM Full
n=9 Participants
ChAdOx1-PCAQ 2.5\*10\^10 vp IM / MVA-PCAQ 2\*10\^8 pfu IM
|
IM/IV Full
n=8 Participants
ChAdOx1-PCAQ 2.5\*10\^10 vp IM / MVA-PCAQ 2\*10\^7 pfu IV
|
|---|---|---|---|
|
The PSA Response Rate to VTP-850
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
IM/IM Low
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
IM/IM Full
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
IM/IV Full
Serious events: 1 serious events
Other events: 9 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
IM/IM Low
n=3 participants at risk
ChAdOx1-PCAQ 5\*10\^9 vp IM / MVA-PCAQ 5\*10\^7 pfu IM
|
IM/IM Full
n=10 participants at risk
ChAdOx1-PCAQ 2.5\*10\^10 vp IM / MVA-PCAQ 2\*10\^8 pfu IM
|
IM/IV Full
n=9 participants at risk
ChAdOx1-PCAQ 2.5\*10\^10 vp IM / MVA-PCAQ 2\*10\^7 pfu IV
|
|---|---|---|---|
|
General disorders
Death
|
0.00%
0/3 • From the start of the first VTP-850 administration continuing until Month 6
|
0.00%
0/10 • From the start of the first VTP-850 administration continuing until Month 6
|
11.1%
1/9 • From the start of the first VTP-850 administration continuing until Month 6
|
|
Nervous system disorders
Cerebral ischaemia
|
33.3%
1/3 • From the start of the first VTP-850 administration continuing until Month 6
|
0.00%
0/10 • From the start of the first VTP-850 administration continuing until Month 6
|
0.00%
0/9 • From the start of the first VTP-850 administration continuing until Month 6
|
Other adverse events
| Measure |
IM/IM Low
n=3 participants at risk
ChAdOx1-PCAQ 5\*10\^9 vp IM / MVA-PCAQ 5\*10\^7 pfu IM
|
IM/IM Full
n=10 participants at risk
ChAdOx1-PCAQ 2.5\*10\^10 vp IM / MVA-PCAQ 2\*10\^8 pfu IM
|
IM/IV Full
n=9 participants at risk
ChAdOx1-PCAQ 2.5\*10\^10 vp IM / MVA-PCAQ 2\*10\^7 pfu IV
|
|---|---|---|---|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • From the start of the first VTP-850 administration continuing until Month 6
|
0.00%
0/10 • From the start of the first VTP-850 administration continuing until Month 6
|
11.1%
1/9 • From the start of the first VTP-850 administration continuing until Month 6
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • From the start of the first VTP-850 administration continuing until Month 6
|
10.0%
1/10 • From the start of the first VTP-850 administration continuing until Month 6
|
0.00%
0/9 • From the start of the first VTP-850 administration continuing until Month 6
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • From the start of the first VTP-850 administration continuing until Month 6
|
10.0%
1/10 • From the start of the first VTP-850 administration continuing until Month 6
|
0.00%
0/9 • From the start of the first VTP-850 administration continuing until Month 6
|
|
General disorders
Fatigue
|
0.00%
0/3 • From the start of the first VTP-850 administration continuing until Month 6
|
30.0%
3/10 • From the start of the first VTP-850 administration continuing until Month 6
|
33.3%
3/9 • From the start of the first VTP-850 administration continuing until Month 6
|
|
General disorders
Chills
|
0.00%
0/3 • From the start of the first VTP-850 administration continuing until Month 6
|
10.0%
1/10 • From the start of the first VTP-850 administration continuing until Month 6
|
11.1%
1/9 • From the start of the first VTP-850 administration continuing until Month 6
|
|
General disorders
Injection site pain
|
33.3%
1/3 • From the start of the first VTP-850 administration continuing until Month 6
|
0.00%
0/10 • From the start of the first VTP-850 administration continuing until Month 6
|
11.1%
1/9 • From the start of the first VTP-850 administration continuing until Month 6
|
|
General disorders
Injection site reaction
|
0.00%
0/3 • From the start of the first VTP-850 administration continuing until Month 6
|
10.0%
1/10 • From the start of the first VTP-850 administration continuing until Month 6
|
0.00%
0/9 • From the start of the first VTP-850 administration continuing until Month 6
|
|
General disorders
Pyrexia
|
0.00%
0/3 • From the start of the first VTP-850 administration continuing until Month 6
|
10.0%
1/10 • From the start of the first VTP-850 administration continuing until Month 6
|
0.00%
0/9 • From the start of the first VTP-850 administration continuing until Month 6
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • From the start of the first VTP-850 administration continuing until Month 6
|
20.0%
2/10 • From the start of the first VTP-850 administration continuing until Month 6
|
22.2%
2/9 • From the start of the first VTP-850 administration continuing until Month 6
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • From the start of the first VTP-850 administration continuing until Month 6
|
10.0%
1/10 • From the start of the first VTP-850 administration continuing until Month 6
|
0.00%
0/9 • From the start of the first VTP-850 administration continuing until Month 6
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/3 • From the start of the first VTP-850 administration continuing until Month 6
|
10.0%
1/10 • From the start of the first VTP-850 administration continuing until Month 6
|
0.00%
0/9 • From the start of the first VTP-850 administration continuing until Month 6
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • From the start of the first VTP-850 administration continuing until Month 6
|
20.0%
2/10 • From the start of the first VTP-850 administration continuing until Month 6
|
11.1%
1/9 • From the start of the first VTP-850 administration continuing until Month 6
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • From the start of the first VTP-850 administration continuing until Month 6
|
0.00%
0/10 • From the start of the first VTP-850 administration continuing until Month 6
|
11.1%
1/9 • From the start of the first VTP-850 administration continuing until Month 6
|
|
Psychiatric disorders
Irritability
|
33.3%
1/3 • From the start of the first VTP-850 administration continuing until Month 6
|
0.00%
0/10 • From the start of the first VTP-850 administration continuing until Month 6
|
0.00%
0/9 • From the start of the first VTP-850 administration continuing until Month 6
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • From the start of the first VTP-850 administration continuing until Month 6
|
10.0%
1/10 • From the start of the first VTP-850 administration continuing until Month 6
|
0.00%
0/9 • From the start of the first VTP-850 administration continuing until Month 6
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • From the start of the first VTP-850 administration continuing until Month 6
|
0.00%
0/10 • From the start of the first VTP-850 administration continuing until Month 6
|
11.1%
1/9 • From the start of the first VTP-850 administration continuing until Month 6
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • From the start of the first VTP-850 administration continuing until Month 6
|
0.00%
0/10 • From the start of the first VTP-850 administration continuing until Month 6
|
11.1%
1/9 • From the start of the first VTP-850 administration continuing until Month 6
|
|
Vascular disorders
Hot flush
|
33.3%
1/3 • From the start of the first VTP-850 administration continuing until Month 6
|
10.0%
1/10 • From the start of the first VTP-850 administration continuing until Month 6
|
0.00%
0/9 • From the start of the first VTP-850 administration continuing until Month 6
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • From the start of the first VTP-850 administration continuing until Month 6
|
0.00%
0/10 • From the start of the first VTP-850 administration continuing until Month 6
|
11.1%
1/9 • From the start of the first VTP-850 administration continuing until Month 6
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • From the start of the first VTP-850 administration continuing until Month 6
|
0.00%
0/10 • From the start of the first VTP-850 administration continuing until Month 6
|
11.1%
1/9 • From the start of the first VTP-850 administration continuing until Month 6
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • From the start of the first VTP-850 administration continuing until Month 6
|
10.0%
1/10 • From the start of the first VTP-850 administration continuing until Month 6
|
22.2%
2/9 • From the start of the first VTP-850 administration continuing until Month 6
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • From the start of the first VTP-850 administration continuing until Month 6
|
10.0%
1/10 • From the start of the first VTP-850 administration continuing until Month 6
|
11.1%
1/9 • From the start of the first VTP-850 administration continuing until Month 6
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • From the start of the first VTP-850 administration continuing until Month 6
|
0.00%
0/10 • From the start of the first VTP-850 administration continuing until Month 6
|
11.1%
1/9 • From the start of the first VTP-850 administration continuing until Month 6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place