Trial Outcomes & Findings for Examining Bioactivity of PVSRIPO in Invasive Breast Cancer (NCT NCT03564782)
NCT ID: NCT03564782
Last Updated: 2024-02-08
Results Overview
To describe the change in the amount of tumor infiltrating immune cells in tumor tissue pre- and post-injection of PVSRIPO
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
5 participants
Primary outcome timeframe
10-20 days post-Injection of PVSRIPO
Results posted on
2024-02-08
Participant Flow
Participant milestones
| Measure |
All Participants Treated
All participants received a single lerapolturev dose
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Examining Bioactivity of PVSRIPO in Invasive Breast Cancer
Baseline characteristics by cohort
| Measure |
All Participants Treated
n=5 Participants
All participants received a single lerapolturev dose
|
|---|---|
|
Age, Continuous
|
53.8 years
STANDARD_DEVIATION 5.2 • n=99 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 10-20 days post-Injection of PVSRIPOPopulation: participants tumor tissue available pre- and post-treatment with PVSRIPO
To describe the change in the amount of tumor infiltrating immune cells in tumor tissue pre- and post-injection of PVSRIPO
Outcome measures
| Measure |
All Participants Treated
n=3 Participants
All participants received a single lerapolturev dose.
|
|---|---|
|
Change in Tumor Infiltrating Immune Cells
|
2.6 fold-change of % CD45+ cells
Standard Deviation 1.3
|
Adverse Events
All Participants Treated
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All Participants Treated
n=5 participants at risk
All participants received a single lerapolturev dose
|
|---|---|
|
Infections and infestations
COVID-19 infection
|
20.0%
1/5 • Number of events 1 • From treatment until study discontinuation, an average of 5 months
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
20.0%
1/5 • Number of events 1 • From treatment until study discontinuation, an average of 5 months
|
|
Injury, poisoning and procedural complications
Bruising
|
20.0%
1/5 • Number of events 1 • From treatment until study discontinuation, an average of 5 months
|
|
General disorders
Injection Site Reaction
|
20.0%
1/5 • Number of events 1 • From treatment until study discontinuation, an average of 5 months
|
|
Investigations
Aspartate Aminotransferase Increase
|
20.0%
1/5 • Number of events 1 • From treatment until study discontinuation, an average of 5 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60