Ignite Creation Date:
2024-05-06 @ 1:42 PM
Last Modification Date:
2024-10-26 @ 1:18 PM
Study NCT ID:
NCT04102618
Status:
TERMINATED
Last Update Posted:
2022-08-15
First Post:
2019-09-23
Brief Title:
A Window-of-opportunity Study of Pelareorep in Early Breast Cancer
Sponsor:
Oncolytics Biotech
Organization:
Oncolytics Biotech
Study Overview
Official Title:
A Window-of-opportunity Study of Pelareorep in Early Breast Cancer AWARE-1
Status:
TERMINATED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Enrollment into AWARE cohorts1-4 have concluded and the primary objective and core goals for the study were met
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AWARE-1
Brief Summary:
The purpose of this study is to find out if pelareorep in combination with different therapies helps to reduce the growth of breast cancer cells and increase the immune systems response to cancer This study will also help to understand what this treatment does to the tumor In addition the safety of the combination treatments with pelareorep will be evaluated
Detailed Description:
This is a window of opportunity non-randomized exploratory study to evaluate the safety and anti-tumor immunogenicity of pelareorep - atezolizumab in five different cohorts in women with operable early breast cancer
After enrollment pelareorep will be administered at 45 1010 TCID50 intravenously on days 1 2 8 9 Other therapies will be administered according to the assigned treatment cohort
After an initial biopsy diagnostic biopsy in most cases a second biopsy will be performed on Day 3 Patients will continue the planned treatment until day 215 when a third biopsy will be performed This third biopsy can be the surgical specimen if patient was scheduled for primary surgery or a core biopsy if patient will undergo neoadjuvant treatment
Blood samples will be collected throughout the study at three time points Day 1 Day 3 and End of Treatment
Patients will receive treatment for 3 weeks prior to surgery or neoadjuvant therapy Thereafter patients will either be considered for definitive surgery or primary medical treatment eg neoadjuvant chemotherapy at the discretion of the treating physician Surgery or biopsy prior to neoadjuvant chemotherapy should be done within 3 weeks 5 days from the start of the study treatment
The end of study visit will be performed at the day of surgery A safety follow-up the end of study visit will be done at 28 days 7 days after the last dose of treatment received
After enrollment pelareorep will be administered at 45 1010 TCID50 intravenously on days 1 2 8 9 Other therapies will be administered according to the assigned treatment cohort
After an initial biopsy diagnostic biopsy in most cases a second biopsy will be performed on Day 3 Patients will continue the planned treatment until day 215 when a third biopsy will be performed This third biopsy can be the surgical specimen if patient was scheduled for primary surgery or a core biopsy if patient will undergo neoadjuvant treatment
Blood samples will be collected throughout the study at three time points Day 1 Day 3 and End of Treatment
Patients will receive treatment for 3 weeks prior to surgery or neoadjuvant therapy Thereafter patients will either be considered for definitive surgery or primary medical treatment eg neoadjuvant chemotherapy at the discretion of the treating physician Surgery or biopsy prior to neoadjuvant chemotherapy should be done within 3 weeks 5 days from the start of the study treatment
The end of study visit will be performed at the day of surgery A safety follow-up the end of study visit will be done at 28 days 7 days after the last dose of treatment received
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None