NCT04215146 - 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 | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

June 10, 2020

Primary Completion Date

August 1, 2022

Study Completion Date

June 30, 2025

Conditions

Breast Cancer Metastatic

Interventions

DRUG

Paclitaxel

Paclitaxel 80 mg/m\^2 1-hour IV infusion on days 1, 8, and 15 of a 28-day cycle.

BIOLOGICAL

Pelareorep

Pelareorep 4.5 x 10\^10 TCID50 1-hour IV infusion days 1, 2, 8, 9, and 15, 16 of a 28-day cycle.

DRUG

Avelumab

Avelumab 10 mg/kg (not more than 800 mg) 1-hour IV infusion days 3 and 17 of a 28-day cycle.

Trial Locations (18)

10029

Icahn School of Medicine at Mount Sinai, New York

10461

Montefiore Medical Park, The Bronx

14263

Roswell Park, Buffalo

14642

University of Rochester Medical Center, Rochester

19104

University of Pennsylvania, Philadelphia

19107

Thomas Jefferson University Hospital, Sidney Kimmel Cancer Center, Philadelphia

19111

Fox Chase Cancer Center, Philadelphia

22908

University of Virginia Cancer Center, Charlottesville

23298

VCU/Massey Cancer Center, Richmond

26506

West Virginia University, Morgantown

33136

University of Miami Sylvester Comprehensive Cancer Center, Miami

43210

Ohio State University Comprehensive Cancer Center, Columbus

44106

University Hospitals Cleveland Medical Center, Cleveland

46202

Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis

61801

Carle Cancer Center, Urbana

63110

Washington University School of Medicine, St Louis

70121

Ochsner Clinic Foundation, New Orleans

08901

Rutgers Cancer Institute of New Jersey, New Brunswick