Trial Outcomes & Findings for A Study to Evaluate Concurrent VRP-HER2 Vaccination and Pembrolizumab for Patients With Breast Cancer (NCT NCT03632941)
NCT ID: NCT03632941
Last Updated: 2025-03-12
Results Overview
The enzyme-linked immunosorbent spot (ELISpot) assay is a quantitative method that measures the frequency of cytokine secretion in a single cell.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
up to approximately 15 weeks
Results posted on
2025-03-12
Participant Flow
Participant milestones
| Measure |
VRP-HER2 Vaccine
VRP-HER2 Vaccine 4 x 10EE8 IU given as a single injection every 2 weeks for 3 injections total (Cycle 1: Day 1 and Day 15 Cycle 2: Day 8)
VRP-HER2: VRP (alphavirus-like replicon particles) containing self amplifying replicon RNA for HER2
|
Pembrolizumab
5 administrations of Pembrolizumab 200 mg every 3 weeks for 5 total IV infusions (Day 1 of each 3 week cycle x 5 cycles)
Pembrolizumab: A humanized antibody specific for the programmed cell death 1 (PD-1) receptor.
|
VRP-HER2 Vaccine + Pembrolizumab
VRP-HER2 Vaccine 4 x 10EE8 IU given as a single injection every 2 weeks for 3 injections total (Cycle 1: Day 1 and Day 15 Cycle 2: Day 8)+ 5 administrations of Pembrolizumab 200 mg every 3 weeks for 5 total IV infusions (Day 1 of each 3 week cycle x 5 cycles)
VRP-HER2: VRP (alphavirus-like replicon particles) containing self amplifying replicon RNA for HER2
Pembrolizumab: A humanized antibody specific for the programmed cell death 1 (PD-1) receptor.
|
|---|---|---|---|
|
Overall Study
STARTED
|
1
|
2
|
5
|
|
Overall Study
COMPLETED
|
1
|
2
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate Concurrent VRP-HER2 Vaccination and Pembrolizumab for Patients With Breast Cancer
Baseline characteristics by cohort
| Measure |
VRP-HER2 Vaccine
n=1 Participants
VRP-HER2 Vaccine 4 x 10EE8 IU given as a single injection every 2 weeks for 3 injections total (Cycle 1: Day 1 and Day 15 Cycle 2: Day 8)
VRP-HER2: VRP (alphavirus-like replicon particles) containing self amplifying replicon RNA for HER2
|
Pembrolizumab
n=2 Participants
5 administrations of Pembrolizumab 200 mg every 3 weeks for 5 total IV infusions (Day 1 of each 3 week cycle x 5 cycles)
Pembrolizumab: A humanized antibody specific for the programmed cell death 1 (PD-1) receptor.
|
VRP-HER2 Vaccine + Pembrolizumab
n=5 Participants
VRP-HER2 Vaccine 4 x 10EE8 IU given as a single injection every 2 weeks for 3 injections total (Cycle 1: Day 1 and Day 15 Cycle 2: Day 8)+ 5 administrations of Pembrolizumab 200 mg every 3 weeks for 5 total IV infusions (Day 1 of each 3 week cycle x 5 cycles)
VRP-HER2: VRP (alphavirus-like replicon particles) containing self amplifying replicon RNA for HER2
Pembrolizumab: A humanized antibody specific for the programmed cell death 1 (PD-1) receptor.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
36.0 years
STANDARD_DEVIATION NA • n=5 Participants
|
52.0 years
STANDARD_DEVIATION 12.7 • n=7 Participants
|
63.8 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
57.4 years
STANDARD_DEVIATION 13.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: up to approximately 15 weeksThe enzyme-linked immunosorbent spot (ELISpot) assay is a quantitative method that measures the frequency of cytokine secretion in a single cell.
Outcome measures
| Measure |
VRP-HER2 Vaccine
n=1 Participants
VRP-HER2 Vaccine 4 x 10EE8 IU given as a single injection every 2 weeks for 3 injections total (Cycle 1: Day 1 and Day 15 Cycle 2: Day 8)
VRP-HER2: VRP (alphavirus-like replicon particles) containing self amplifying replicon RNA for HER2
|
Pembrolizumab
n=2 Participants
5 administrations of Pembrolizumab 200 mg every 3 weeks for 5 total IV infusions (Day 1 of each 3 week cycle x 5 cycles)
Pembrolizumab: A humanized antibody specific for the programmed cell death 1 (PD-1) receptor.
|
VRP-HER2 Vaccine + Pembrolizumab
n=5 Participants
VRP-HER2 Vaccine 4 x 10EE8 IU given as a single injection every 2 weeks for 3 injections total (Cycle 1: Day 1 and Day 15 Cycle 2: Day 8)+ 5 administrations of Pembrolizumab 200 mg every 3 weeks for 5 total IV infusions (Day 1 of each 3 week cycle x 5 cycles)
VRP-HER2: VRP (alphavirus-like replicon particles) containing self amplifying replicon RNA for HER2
Pembrolizumab: A humanized antibody specific for the programmed cell death 1 (PD-1) receptor.
|
|---|---|---|---|
|
Number of Participants With a Positive T Cell Response Based on ELISpot Results
|
1 Participants
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: up to approximately 15 weeksAdverse events are graded on a scale from 1 to 5. Grade 1 adverse events are mild and generally not bothersome. Grade 2 events are bothersome and may interfere with doing some activities but are not dangerous. Grade 3 events are serious and interfere with a person's ability to do basic things like eat or get dressed. Grade 3 events may also require medical intervention. Grade 4 events are usually severe enough to require hospitalization. Grade 5 events are fatal. Reported here is the number of participants with a grade 3 adverse event.
Outcome measures
| Measure |
VRP-HER2 Vaccine
n=1 Participants
VRP-HER2 Vaccine 4 x 10EE8 IU given as a single injection every 2 weeks for 3 injections total (Cycle 1: Day 1 and Day 15 Cycle 2: Day 8)
VRP-HER2: VRP (alphavirus-like replicon particles) containing self amplifying replicon RNA for HER2
|
Pembrolizumab
n=2 Participants
5 administrations of Pembrolizumab 200 mg every 3 weeks for 5 total IV infusions (Day 1 of each 3 week cycle x 5 cycles)
Pembrolizumab: A humanized antibody specific for the programmed cell death 1 (PD-1) receptor.
|
VRP-HER2 Vaccine + Pembrolizumab
n=5 Participants
VRP-HER2 Vaccine 4 x 10EE8 IU given as a single injection every 2 weeks for 3 injections total (Cycle 1: Day 1 and Day 15 Cycle 2: Day 8)+ 5 administrations of Pembrolizumab 200 mg every 3 weeks for 5 total IV infusions (Day 1 of each 3 week cycle x 5 cycles)
VRP-HER2: VRP (alphavirus-like replicon particles) containing self amplifying replicon RNA for HER2
Pembrolizumab: A humanized antibody specific for the programmed cell death 1 (PD-1) receptor.
|
|---|---|---|---|
|
Number of Participants With a Severe Adverse Event as Assessed by CTCAE v5.0
|
0 Participants
|
0 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to approximately 15 weeksPopulation: Data not collected on 1 participant in the VRP-HER2 Vaccine group and 1 participant in the Pembrolizumab group.
RECIST (Response Evaluation Criteria in Solid Tumors) defines Stable Disease as neither partial response (\>30% decrease in the sum of diameters of target lesions) or progressive disease (\<20% decrease in the sum of diameters of target lesions).
Outcome measures
| Measure |
VRP-HER2 Vaccine
n=1 Participants
VRP-HER2 Vaccine 4 x 10EE8 IU given as a single injection every 2 weeks for 3 injections total (Cycle 1: Day 1 and Day 15 Cycle 2: Day 8)
VRP-HER2: VRP (alphavirus-like replicon particles) containing self amplifying replicon RNA for HER2
|
Pembrolizumab
n=1 Participants
5 administrations of Pembrolizumab 200 mg every 3 weeks for 5 total IV infusions (Day 1 of each 3 week cycle x 5 cycles)
Pembrolizumab: A humanized antibody specific for the programmed cell death 1 (PD-1) receptor.
|
VRP-HER2 Vaccine + Pembrolizumab
n=4 Participants
VRP-HER2 Vaccine 4 x 10EE8 IU given as a single injection every 2 weeks for 3 injections total (Cycle 1: Day 1 and Day 15 Cycle 2: Day 8)+ 5 administrations of Pembrolizumab 200 mg every 3 weeks for 5 total IV infusions (Day 1 of each 3 week cycle x 5 cycles)
VRP-HER2: VRP (alphavirus-like replicon particles) containing self amplifying replicon RNA for HER2
Pembrolizumab: A humanized antibody specific for the programmed cell death 1 (PD-1) receptor.
|
|---|---|---|---|
|
Number of Participants With Stable Disease as Overall Response Based on RECIST 1.1 Criteria
|
1 Participants
|
1 Participants
|
4 Participants
|
Adverse Events
VRP-HER2 Vaccine
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Pembrolizumab
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
VRP-HER2 Vaccine + Pembrolizumab
Serious events: 1 serious events
Other events: 4 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
VRP-HER2 Vaccine
n=1 participants at risk
VRP-HER2 Vaccine 4 x 10EE8 IU given as a single injection every 2 weeks for 3 injections total (Cycle 1: Day 1 and Day 15 Cycle 2: Day 8)
VRP-HER2: VRP (alphavirus-like replicon particles) containing self amplifying replicon RNA for HER2
|
Pembrolizumab
n=2 participants at risk
5 administrations of Pembrolizumab 200 mg every 3 weeks for 5 total IV infusions (Day 1 of each 3 week cycle x 5 cycles)
Pembrolizumab: A humanized antibody specific for the programmed cell death 1 (PD-1) receptor.
|
VRP-HER2 Vaccine + Pembrolizumab
n=5 participants at risk
VRP-HER2 Vaccine 4 x 10EE8 IU given as a single injection every 2 weeks for 3 injections total (Cycle 1: Day 1 and Day 15 Cycle 2: Day 8)+ 5 administrations of Pembrolizumab 200 mg every 3 weeks for 5 total IV infusions (Day 1 of each 3 week cycle x 5 cycles)
VRP-HER2: VRP (alphavirus-like replicon particles) containing self amplifying replicon RNA for HER2
Pembrolizumab: A humanized antibody specific for the programmed cell death 1 (PD-1) receptor.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/1 • Up to approximately 15 weeks
|
0.00%
0/2 • Up to approximately 15 weeks
|
20.0%
1/5 • Up to approximately 15 weeks
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/1 • Up to approximately 15 weeks
|
0.00%
0/2 • Up to approximately 15 weeks
|
20.0%
1/5 • Up to approximately 15 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • Up to approximately 15 weeks
|
0.00%
0/2 • Up to approximately 15 weeks
|
20.0%
1/5 • Up to approximately 15 weeks
|
|
Investigations
Creatinine increased
|
0.00%
0/1 • Up to approximately 15 weeks
|
0.00%
0/2 • Up to approximately 15 weeks
|
20.0%
1/5 • Up to approximately 15 weeks
|
Other adverse events
| Measure |
VRP-HER2 Vaccine
n=1 participants at risk
VRP-HER2 Vaccine 4 x 10EE8 IU given as a single injection every 2 weeks for 3 injections total (Cycle 1: Day 1 and Day 15 Cycle 2: Day 8)
VRP-HER2: VRP (alphavirus-like replicon particles) containing self amplifying replicon RNA for HER2
|
Pembrolizumab
n=2 participants at risk
5 administrations of Pembrolizumab 200 mg every 3 weeks for 5 total IV infusions (Day 1 of each 3 week cycle x 5 cycles)
Pembrolizumab: A humanized antibody specific for the programmed cell death 1 (PD-1) receptor.
|
VRP-HER2 Vaccine + Pembrolizumab
n=5 participants at risk
VRP-HER2 Vaccine 4 x 10EE8 IU given as a single injection every 2 weeks for 3 injections total (Cycle 1: Day 1 and Day 15 Cycle 2: Day 8)+ 5 administrations of Pembrolizumab 200 mg every 3 weeks for 5 total IV infusions (Day 1 of each 3 week cycle x 5 cycles)
VRP-HER2: VRP (alphavirus-like replicon particles) containing self amplifying replicon RNA for HER2
Pembrolizumab: A humanized antibody specific for the programmed cell death 1 (PD-1) receptor.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Plantar Warts
|
100.0%
1/1 • Up to approximately 15 weeks
|
0.00%
0/2 • Up to approximately 15 weeks
|
0.00%
0/5 • Up to approximately 15 weeks
|
|
General disorders
Localized edema
|
0.00%
0/1 • Up to approximately 15 weeks
|
50.0%
1/2 • Up to approximately 15 weeks
|
0.00%
0/5 • Up to approximately 15 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1 • Up to approximately 15 weeks
|
50.0%
1/2 • Up to approximately 15 weeks
|
0.00%
0/5 • Up to approximately 15 weeks
|
|
General disorders
Edema face
|
0.00%
0/1 • Up to approximately 15 weeks
|
50.0%
1/2 • Up to approximately 15 weeks
|
0.00%
0/5 • Up to approximately 15 weeks
|
|
Skin and subcutaneous tissue disorders
Exacerbation of Psoriasis- bilateral hands
|
0.00%
0/1 • Up to approximately 15 weeks
|
0.00%
0/2 • Up to approximately 15 weeks
|
20.0%
1/5 • Up to approximately 15 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • Up to approximately 15 weeks
|
0.00%
0/2 • Up to approximately 15 weeks
|
40.0%
2/5 • Up to approximately 15 weeks
|
|
Vascular disorders
Hot flashes
|
0.00%
0/1 • Up to approximately 15 weeks
|
0.00%
0/2 • Up to approximately 15 weeks
|
20.0%
1/5 • Up to approximately 15 weeks
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/1 • Up to approximately 15 weeks
|
0.00%
0/2 • Up to approximately 15 weeks
|
20.0%
1/5 • Up to approximately 15 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/1 • Up to approximately 15 weeks
|
0.00%
0/2 • Up to approximately 15 weeks
|
20.0%
1/5 • Up to approximately 15 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/1 • Up to approximately 15 weeks
|
0.00%
0/2 • Up to approximately 15 weeks
|
60.0%
3/5 • Up to approximately 15 weeks
|
|
General disorders
Fatigue
|
0.00%
0/1 • Up to approximately 15 weeks
|
0.00%
0/2 • Up to approximately 15 weeks
|
20.0%
1/5 • Up to approximately 15 weeks
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/1 • Up to approximately 15 weeks
|
0.00%
0/2 • Up to approximately 15 weeks
|
20.0%
1/5 • Up to approximately 15 weeks
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/1 • Up to approximately 15 weeks
|
0.00%
0/2 • Up to approximately 15 weeks
|
20.0%
1/5 • Up to approximately 15 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • Up to approximately 15 weeks
|
0.00%
0/2 • Up to approximately 15 weeks
|
20.0%
1/5 • Up to approximately 15 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place