Ignite Creation Date:
2024-05-06 @ 2:05 PM
Last Modification Date:
2024-10-26 @ 1:25 PM
Study NCT ID:
NCT04215146
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-30
First Post:
2019-12-24
Brief Title:
A Study to Assess Overall Response Rate by Inducing an Inflammatory Phenotype in Metastatic BReast cAnCEr With the Oncolytic Reovirus PeLareorEp in CombinaTion With Anti-PD-L1 Avelumab and Paclitaxel - BRACELET-1 Study
Sponsor:
Oncolytics Biotech
Organization:
Oncolytics Biotech
Study Overview
Official Title:
A Study to Assess Overall Response Rate by Inducing an Inflammatory Phenotype in Metastatic BReast cAnCEr With the Oncolytic Reovirus PeLareorEp in CombinaTion With Anti-PD-L1 Avelumab and Paclitaxel - BRACELET-1 Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to find out the possible anti-cancer effect of pelareorep in combination with chemotherapy paclitaxel and avelumab in treating a type of breast cancer called Hormone Receptor positive HRHuman Epidermal Growth Factor Receptor 2 negativeHER2- breast cancer which is either locally advanced or has metastasized cancer that has spread in your body The study will investigate if pelareorep in combination with paclitaxel and avelumab is more effective than paclitaxel alone or pelareorep and paclitaxel The safety of the combination treatments will also be evaluated
Detailed Description:
This is an open-label randomized Phase 2 3-cohort study to evaluate the safety and efficacy of pelareorep paclitaxel and avelumab in Hormone Receptor HRHuman Epidermal Growth Factor Receptor 2 negative HER2- with endocrine-refractory metastatic breast cancer
Patients will be randomized to one of three treatment cohorts paclitaxel alone pelareorep paclitaxel or pelareorep paclitaxel avelumab A three patient safety run-in will be conducted in the cohort for pelareorep paclitaxel avelumab prior to beginning randomization into all three cohorts
Patients will give mandatory blood samples and optional tumor biopsies which will be analyzed for biomarkers to determine the immunological changes within the tumor microenvironment and peripheral blood in patients treated with paclitaxel alone in combination with pelareorep and in combination with pelareorep and avelumab
Patients will be randomized to one of three treatment cohorts paclitaxel alone pelareorep paclitaxel or pelareorep paclitaxel avelumab A three patient safety run-in will be conducted in the cohort for pelareorep paclitaxel avelumab prior to beginning randomization into all three cohorts
Patients will give mandatory blood samples and optional tumor biopsies which will be analyzed for biomarkers to determine the immunological changes within the tumor microenvironment and peripheral blood in patients treated with paclitaxel alone in combination with pelareorep and in combination with pelareorep and avelumab
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PrE0113 | OTHER | PrECOG LLC | None |