Study of the Bria-IMT Regimen and CPI vs Physicians' Choice in Advanced Metastatic Breast Cancer.
Start Date
12/5/2023
Completion Date
6/1/2028
Summary
This is a multicenter randomized, open label study to evaluate overall survival with the Bria-IMT regimen in combination with Checkpoint Inhibitor \[Retifanlimab\], versus Treatment of Patients'/Physicians' Choice (TPC) in advanced metastatic or locally recurrent breast cancer (aMBC) patients with no approved alternative therapies available.
Detailed Description
This is a multicenter randomized, open label study to evaluate overall survival with the Bria-IMT regimen in combination with Checkpoint Inhibitor \[Retifanlimab\], versus Treatment of Patients'/Physicians' Choice (TPC) in advanced metastatic or locally recurrent breast cancer (aMBC) patients with no approved alternative therapies available. A secondary objective will be to evaluate the activity of the Bria-IMT regimen alone in comparison with the Bria-IMT regimen in combination with CPI. Initial randomization will be 1:1:1 to the Bria-IMT regimen + CPI (combination therapy), TPC, and the Bria-IMT regimen alone (monotherapy). After the first 150 patients have enrolled in the study, the monotherapy arm will be discontinued and patients allowed to cross over to the combination therapy if needed. Randomization will continue 1:1 between the combination therapy vs TPC. For the Bria regimen +/- CPI arms, treatment cycles occur every 3 weeks. TPC cycle details will be according to the site's SOC. In the absence of progressive disease or major safety issues, the patient will continue with therapy cycles, with imaging assessment every 6 weeks x2 then every 8 weeks thereafter. The Bria-IMT regimen includes: Day -2 or -3 Cyclophosphamide 300mg/m2 Day 0 SV-BR-1-GM given intradermally divided into 4 inoculations Day 1-3 CPI infusion plus interferon intra-dermally within each Bria-IMT inoculation site
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
SV-BR-1-GM
Cyclophosphamide
Interferon infiltration of the inoculation site
Retifanlimab
Treatment of Physician's Choice
Conditions
Locations
Mayo Clinic-Comprehensive Cancer Center-Breast Clinic
Phoenix, Arizona 85054
United States
University of Arizona-Cancer Center
Tucson, Arizona 85719
United States
Los Angeles cancer Network_Anaheim
Anaheim, California 92801
United States
Comprehensive Blood and Cancer Center
Bakersfield, California 93309
United States
Cedars-Sinai Cancer Beverly Hills
Beverly Hills, California 90211
United States
Los Angeles Cancer Network_Corona
Corona, California 92879
United States
Los Angeles cancer Network_Fountain Vallley
Fountain Valley, California 92708
United States
Los Angeles Cancer Network_Glendale
Glendale, California 91206
United States
Hoag Hospital Center
Irvine, California 92618
United States
Hoag Hospital Irvine
Irvine, California 92618
United States
Los Angeles Cancer Network
Los Angeles, California 90017
United States
Cedars-Sinai Cancer at Cedars-Sinai Medical Facility
Los Angeles, California 90048
United States
Los Angeles Cancer Network_Century City
Los Angeles, California 90067
United States
UCLA-Hematology/Oncology Medical Plaza
Los Angeles, California 90095
United States
UCLA-Hematology/Oncology_LA 2
Los Angeles, California 90095
United States
UCLA-Hematology/Oncology_LA
Los Angeles, California 90095
United States
Los Angeles Cancer Network_Pasadena
Pasadena, California 91105
United States
Los Angeles cancer Network_Riverside
Riverside, California 92501
United States
UC San Diego
San Diego, California 92037
United States
St. John's Cancer Center
Santa Monica, California 90404
United States
UCLA-Department of Medicine Hematology/Oncology-Parkside
Santa Monica, California 90404
United States
UCLA-Hetamtology/Oncology_S Monica
Santa Monica, California 90404
United States
Torrance Memorial Cancer Center
Torrance, California 90505
United States
Los Angeles Cancer Network_Valley Pres
Van Nuys, California 91405
United States
Cedars-Sinai Breast Health Services Building
West Hollywood, California 90048
United States
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut 06511
United States
University of Miami _SCCC - Aventura
Aventura, Florida 33180
United States
University of Miami-SCCC-Lennar
Coral Gables, Florida 33146
United States
University of Miami_SCCC-Coral Springs
Coral Springs, Florida 33065
United States
University of Miami Hospital and Clinics - Deerfield Beach
Deerfield Beach, Florida 33442
United States
University of Miami_SCCC-Hollywood
Hollywood, Florida 33021
United States
Mayo Clinic Florida-Comprehensive Cancer Center
Jacksonville, Florida 32224
United States
University Of Miami-SCCC-Miami
Miami, Florida 33136
United States
University of Miami_SCCC - Kendall
Miami, Florida 33176
United States
Advent Health - Orlando
Orlando, Florida 32804
United States
University of Miami-SCCC-Plantation
Plantation, Florida 33324
United States
Winship Cancer Institute of Emory University
Atlanta, Georgia 30322
United States
Northwestern University
Chicago, Illinois 60611
United States
Southern Illinois University-Simmons
Springfield, Illinois 62702
United States
Carle Foundation Cancer Institute-Urbana
Urbana, Illinois 61801
United States
Northwest Cancer Center
Dyer, Indiana 46311
United States
AMR Kansas City Oncology
Kansas City, Kansas 66204
United States
Care Access-Marrero
Marrero, Louisiana 70072
United States
The Center for Cancer and Blood Disorders a division of American Oncology Partners, P.A.
Bethesda, Maryland 20817
United States
Mayo Clinic-Comprehensive Cancer Center-Breast Clinic
Rochester, Minnesota 55905
United States
Nebraska Cancer Specialists
Omaha, Nebraska 68130
United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire 03756
United States
Hunterdon Medical Center
Flemington, New Jersey 08822
United States
New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C. (Babylon)
Babylon, New York 11702
United States
NYU Langone's Perlmutter Cancer Center
Manhattan, New York 10016
United States
New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C.(New Hyde Park)
New Hyde Park, New York 11042
United States
Manhattan Hematology /Oncology Associates
New York, New York 10016
United States
New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C (NY)
New York, New York 10028
United States
New York Cancers & Blood Specialists_North Shore Hematology Oncology Assocaites P.C (Patchogue)
Patchogue, New York 11772
United States
New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C. (Port Jefferson Station2)
Port Jefferson Station, New York 11776
United States
New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C.(Port Jefferson Station1)
Port Jefferson Station, New York 11776
United States
New York Cancers & Blood Specialists
Port Jefferson Station, New York 11776
United States
New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C. (Riverhead)
Riverhead, New York 11901
United States
New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C (Brox)
The Bronx, New York 10469
United States
Regional Medical Oncology Center_Wlson
Wilson, North Carolina 27893
United States
Gabrail Cancer & Research Center
Canton, Ohio 44718
United States
Cleveland Clinic
Cleveland, Ohio 44195
United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas 75246
United States
Mary Crowley Cancer Research
Dallas, Texas 75251
United States
DHR Health Oncology Institute
Edinburg, Texas 78539
United States
Texas Oncology - Fredericksburg
Fredericksburg, Texas 78624
United States
Texas Oncology - Harlingen
Harlingen, Texas 78550
United States
Texas Oncology McAllen
McAllen, Texas 78503
United States
Texas Oncology, New Braunfels
New Braunfels, Texas 78130
United States
Texas Oncology-San Antonio Cancer Care
San Antonio, Texas 78216
United States
Texas Oncology - San Antonio Northeast
San Antonio, Texas 78217
United States
Texas Oncology - San Antonio Stone Oak
San Antonio, Texas 78258
United States
Tranquil Clinical Research
Webster, Texas 77598
United States
Texas Oncology - Weslaco
Weslaco, Texas 78596
United States
Hematology-Oncology Associates of Fredericksburg, Inc
Fredericksburg, Virginia 22408
United States
Cancer Care Northwest-1 (601 S. Sherman)
Spokane, Washington 99202
United States
Cancer Care Northwest_2 (605 E. Holland)
Spokane, Washington 99218
United States
Cancer Care Northwest
Spokane Valley, Washington 99218
United States
Sheboygan Cancer & Blood Specialists
Sheboygan, Wisconsin 53081
United States