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

Part of paid clinical trials in Miami, Florida.

Sponsor
Oncolytics Biotech
Study ID
NCT04215146
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Breast Cancer Metastatic

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Paclitaxel — DRUG
    Paclitaxel 80 mg/m\^2 1-hour IV infusion on days 1, 8, and 15 of a 28-day cycle.
  • Pelareorep — BIOLOGICAL
    Pelareorep 4.5 x 10\^10 TCID50 1-hour IV infusion days 1, 2, 8, 9, and 15, 16 of a 28-day cycle.
  • Avelumab — DRUG
    Avelumab 10 mg/kg (not more than 800 mg) 1-hour IV infusion days 3 and 17 of a 28-day cycle.

Study Details

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 (HR+)/Human Epidermal Growth Factor Receptor 2 negative(HER2-) 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.

Key Dates

Start date
Jun 10, 2020
Status verified
Jan 2025
Primary completion
Aug 1, 2022
Completion
Jun 30, 2025

Study Design

Enrollment
48 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Cohort 1
    Patients receive paclitaxel alone.
  • Experimental: Cohort 2
    Patients receive pelareorep + paclitaxel.
  • Experimental: Cohort 3
    Patients receive pelareorep + paclitaxel + avelumab.

Primary Outcome Measure

Overall Response Rate [ Time Frame: at week 16 ]

Locations (18)

FacilityCityStateZIPSite coordinators
University of Miami Sylvester Comprehensive Cancer CenterMiamiFlorida33136-
Carle Cancer CenterUrbanaIllinois61801-
Indiana University Melvin and Bren Simon Comprehensive Cancer CenterIndianapolisIndiana46202-
Ochsner Clinic FoundationNew OrleansLouisiana70121-
Washington University School of MedicineSt LouisMissouri63110-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08901-
Roswell ParkBuffaloNew York14263-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
University of Rochester Medical CenterRochesterNew York14642-
Montefiore Medical ParkThe BronxNew York10461-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
Thomas Jefferson University Hospital, Sidney Kimmel Cancer CenterPhiladelphiaPennsylvania19107-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
University of Virginia Cancer CenterCharlottesvilleVirginia22908-
VCU/Massey Cancer CenterRichmondVirginia23298-
West Virginia UniversityMorgantownWest Virginia26506-

Find similar trials in Miami, FL

By research site
University of Miami Sylvester Comprehensive Cancer Center· Miami, FLCarle Cancer Center· Urbana, ILIndiana University Melvin and Bren Simon Comprehensive Cancer Center· Indianapolis, INOchsner Clinic Foundation· New Orleans, LAWashington University School of Medicine· St Louis, MORutgers Cancer Institute of New Jersey· New Brunswick, NJ

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