Drug:

SV-BR-1-GM (Bria-IMT) in combination with Retifanlimab

Indication:

Breast Cancer, Breast Cancer Metastatic, Breast Neoplasm, End Stage Cancer, Metastatic Breast Cancer, Other advanced solid tumors

Region:

US

Study of the Bria-IMT Regimen and CPI vs Physicians’ Choice in Advanced Metastatic Breast Cancer. (BRIA-ABC )

A Randomized, Open-label Study Comparing the Bria-IMT regimen in combination with Check Point Inhibitor vs Physician’s Choice in Metastatic Breast Cancer

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.

Experimental:

  • Bria-IMT Regimen + CPI
  • Bria-IMT Regimen Alone

Active Comparator:

  • Treatment of Physician’s Choice

Inclusion Criteria

  • Be ≥ 18 years of age
  • You are being asked to take part in this study because you have recurrent breast cancer that has not responded to traditional treatments
  • Able to travel to one of our clinical sites listed below
  • You will not receive any compensation (payment) for participating in this study. Travel, lodging, and other reasonable expenses may be reimbursed by the sponsor when requested by the study doctor but must be pre-approved by the sponsor

Locations

    California Locations
    Bakersfield, California, United States, 93309
    Comprehensive Blood and Cancer Center
    Contact: Nicole Ward
    661-862-8548 nward@cbccusa.com
    Principal Investigator: Ravi Patel, MD

    Irvine, California, United States, 92618
    Hoag Hospital Center
    Contact: Keeva Bromley
    keeva.bromley@hoag.org
    Principal Investigator: Chaitali Nangia, MD

    Irvine, California, United States, 92618
    Hoag Hospital Irvine
    Contact:Kevva Bromey
    keeva.bromley@hoag.org
    Principal Investigator: Chaitali Nangia, MD

    San Diego, California, United States, 92037
    UC San Diego
    Contact: Odelia Ha
    858-534-8248 oha@health.ucsd.edu
    Principal Investigator: Rebecca A. Shatsky, MD

    Santa Monica, California, United States, 90404
    St. John’s Cancer Center
    Contact: Pamela Torres, CCRC
    pamela.torres@providence.org
    Principal Investigator: Parvin Peddi, MD

    Torrance, California, United States, 90505
    Torrance Memorial Cancer Center
    Contact: Jessica Yoshinaga
    310-750-3378 jyoshinaga@mednet.ucla.edu
    Contact: Crystal Taylor
    ctaylor@trio-us.org
    Principal Investigator: David Chan, MD

    Connecticut Locations
    New Haven, Connecticut, United States, 06511
    Smilow Cancer Hospital at Yale New Haven
    Contact: Carl Brown
    475-241-1065 carl.brown@yale.edu
    Principal Investigator: Adriana Kahn, MD

    Florida Locations
    Coral Gables, Florida, United States, 33146
    University of Miami-SCCC-Lennar
    Contact: Yisell Gongora
    305-270-3467 yxg780@med.miami.edu
    Contact: Irene Marino
    3052439221 idm32@med.miami.edu
    Principal Investigator: Lawrence Negret, MD
    Sub-Investigator: Carmen Calfa, MD

    Miami, Florida, United States, 33136
    University Of Miami-SCCC-Miami
    Contact: Maynela Quinones
    305-243-2457 maynela@med.miami.edu
    Contact: Irene Marino
    305-243-9221 idm32@med.miami.edu
    Principal Investigator: Lawrence Negret, MD
    Sub-Investigator: Carmen Calfa, MD

    Orlando, Florida, United States, 32804
    Advent Health – Orlando
    Contact: Ashley Young, CCRC
    407-303-2284 ashley.young@adventhealth.com
    Contact: Valeria BURKOVSKAYA, CCRC
    407-303-2283 valeria.burkovskaya@adventhealth.com
    Principal Investigator: Carlos Alemany, MD

    Plantation, Florida, United States, 33324
    University of Miami-SCCC-Plantation
    Contact: Deborah Conte, CCRC
    954-210-1171 dmc238@med.miami.edu
    Contact: Irene Marino
    3052439221 idm32@med.miami.edu
    Principal Investigator: Lawrence Negret, MD
    Sub-Investigator: Carmen Calfa, MD

    Illinois Locations
    Chicago, Illinois, United States, 60611
    Northwestern University
    Contact: Nina Garcia
    312-695-1352 nina.garcia1@northwestern.edu
    Principal Investigator: Regina Stein, MD

    Springfield, Illinois, United States, 62702
    Southern Illinois University-Simmons
    Contact: Kathy Robinson
    217-545-1946 krobinson@siumed.edu
    Principal Investigator: Krishna Rao, MD

    Urbana, Illinois, United States, 61801
    Carle Foundation Cancer Institute-Urbana
    Contact: Christine Rogers
    217-383-3394 christine.rogers@carle.com
    Principal Investigator: Kendrith Rowland, MD

    Indiana Locations
    Dyer, Indiana, United States, 46311
    Northwest Cancer Center
    Contact: Mariela Abad
    219-924-8178 ext 279 mariela.abad@usoncology.com
    Principal Investigator: Shruti Singh, MD

    Kansas Locations
    Kansas City, Kansas, United States, 66204
    AMR Kansas City Oncology
    Contact: Jennifer Ross, CCRC
    913-386-7556 jennifer.ross@amrllc.com
    Contact: Jason Huntington, Site Manager (913) 386-7556
    Principal Investigator: Jaswinder Singh, MD

    Louisiana Locations
    Marrero, Louisiana, United States, 70072
    Care Access-Marrero
    Contact: William Robinson, RN
    351-227-7173 William.robinson@careaccess.com
    Principal Investigator: Shibu Varughese, MD

    Maryland Locations
    Bethesda, Maryland, United States, 20817
    The Center for Cancer and Blood Disorders a division of American Oncology Partners, P.A.
    Contact: Jenelle Larkin, CCRC
    301-571-0019 ext 69355 Jenelle.Larkin@aoncology.com
    Contact: Natalie Bongiorno, RN, MSHS
    301-571-2016 Natalie.Bongiorno@aoncology.com
    Principal Investigator: Ralph Boccia, MD

    Nebraska Locations
    Omaha, Nebraska, United States, 68130
    Nebraska Cancer Specialists
    Contact: Heather Cordes, CCRC
    402-691-6970 hcordes@nebraskacancer.com
    Contact: Scott Degenhardt
    402-691-5257 sdegenhardt@nebraskacancer.com
    Principal Investigator: Geetha Palaniappan, MD

    New York Locations
    Babylon, New York, United States, 11702
    New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C. (Babylon)
    Contact: Lauren Gianelli
    855-528-7322 lgianelli@nycancer.com
    Principal Investigator: Richard Zuniga, MD

    Bronx, New York, United States, 10469
    New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C (Bronx)
    Contact: Lauren Gianelli
    855-528-7322 lgianelli@nycancer.com
    Principal Investigator: Richard Zuniga, MD

    New Hyde Park, New York, United States, 11042
    New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C.(New Hyde Park)
    Contact: Lauren Gianelli
    lgianelli@nycancer.com
    Principal Investigator: Richard Zuniga, MD

    New York, New York, United States, 10016
    Manhattan Hematology /Oncology Associates
    Contact: Patricia Mccullough, RN
    212-689-6791 patriciarose13@gmail.com
    Principal Investigator: Alec Goldenberg, MD

    New York, New York, United States, 10028
    New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C (NY)
    Contact: Lauren Gianelli
    lgianelli@nycancer.com
    Principal Investigator: Richard Zuniga, MD

    Patchogue, New York, United States, 11772
    New York Cancers & Blood Specialists_North Shore Hematology Oncology Assocaites P.C (Patchogue)
    Contact: Lauren Bilka, LPN
    631-675-5075 research@nycancer.com
    Principal Investigator: Richard Zuniga, MD
    Sub-Investigator: Gurmohan Syali, MD

    Port Jefferson Station, New York, United States, 11776
    New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C. (Port Jefferson Station2)
    Contact: Lauren Gianelli
    855-528-7322 lgianelli@nycancer.com
    Principal Investigator: Richard Zuniga, MD

    Port Jefferson Station, New York, United States, 11776
    New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C.(Port Jefferson Station1)
    Contact: Lauren Gianelli
    855-528-7322 lgianelli@nycancer.com
    Principal Investigator: Richard Zuniga, MD

    Port Jefferson Station, New York, United States, 11776
    New York Cancers & Blood Specialists
    Contact: Lauren Gianelli
    855-528-7322 lgianelli@nycancer.com
    Contact: Laura Brady-Parisi, LPN, LPN
    631-675-5075 lbrady@nycancer.com
    Principal Investigator: Richard Zuniga, MD

    Riverhead, New York, United States, 11901
    New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C. (Riverhead)
    Contact: Lauren Gianelli
    lgianelli@nycancer.com
    Principal Investigator:
    Richard Zuniga, MD

    Ohio Locations
    Canton, Ohio, United States, 44718
    Gabrail Cancer & Research Center
    Contact: Carrie Smith, RN
    330-492-3345 csmith@gabrailcancercenter.com
    Principal Investigator: Nashat Gabrail, MD

    Cleveland, Ohio, United States, 44195
    Cleveland Clinic
    Contact: Mariah Branem, CCRC
    866-320-4573 branemm@ccf.org
    Principal Investigator: Azka Ali, MD

    Texas Locations
    Dallas, Texas, United States, 75246
    Texas Oncology-Baylor Charles A. Sammons Cancer Center
    Contact: Melissa Melendez-Salazar, RN
    214-370-1038 melissa.melende-salazar@usoncology.com
    Contact: Jessica Medina, CCRC
    214-370-1989 jessica.medina@usoncology.com
    Principal Investigator: Joyce O’Shaughnessy, MD

    Dallas, Texas, United States, 75251
    Mary Crowley Cancer Research
    Contact: Akhil Valiyil, CCRC
    972-566-3061 avaliyil@marycrowley.org
    Contact: Angela Hotchkiss
    214-658-1958 ahotchkiss@marycrowley.org
    Principal Investigator: Minal Barve, MD

    Edinburg, Texas, United States, 78539
    DHR Health Oncology Institute
    Contact: Edgar Lopez
    956-362-2394 ed.lopez@dhr-rgv.com
    Contact: Vaney Capetillo
    v.capetillo@dhr-rgv.com
    Principal Investigator: Jose Cruz, MD

    Fredericksburg, Texas, United States, 78624
    Texas Oncology – Fredericksburg
    Contact: Brenda Travieso
    Brenda.Travieso@usoncology.com
    Principal Investigator: Emmalind Aponte, MD

    Harlingen, Texas, United States, 78550
    Texas Oncology – Harlingen
    Contact: Nereida Salinas
    nereida.salinas@usoncology.com
    Principal Investigator: Alvaro Restrepo, MD

    McAllen, Texas, United States, 78503
    Texas Oncology McAllen
    Contact: Nereida Salinas, RN
    956-687-5150 nereida.salinas@usoncology.com
    Principal Investigator: Alvaro Restrepo, MD

    New Braunfels, Texas, United States, 78130
    Texas Oncology, New Braunfels
    Contact: Brenda Travieso
    Brenda.Travieso@usoncology.com
    Principal Investigator: Emmalind Aponte, MD

    San Antonio, Texas, United States, 78216
    Texas Oncology-San Antonio Cancer Care
    Contact: Shannon Syring, RN
    210-419-2608 shannon.syring@usoncology.com
    Contact: Norma Norris, RN
    210-595-5613 norma.norris@usoncology.com
    Principal Investigator: Emmalind Aponte, MD

    San Antonio, Texas, United States, 78217
    Texas Oncology – San Antonio Northeast
    Contact: Brenda Travieso
    Brenda.Travieso@usoncology.com
    Principal Investigator: Emmalind Aponte, MD

    San Antonio, Texas, United States, 78258
    Texas Oncology – San Antonio Stone Oak
    Contact: Brenda Travieso
    Brenda.Travieso@usoncology.com
    Principal Investigator: Emmalind Aponte, MD

    Webster, Texas, United States, 77598
    Tranquil Clinical Research
    Contact: Veronica D. Mohammed, RN
    713-907-6054 veronicam@tranquilityresearch.com
    Contact: Patricia Roark, RN
    346-435-9438 patriciar@tranquilityresearch.com
    Principal Investigator: John Knecht, MD

    Weslaco, Texas, United States, 78596
    Texas Oncology – Weslaco
    Contact: Nereida Salinas, RN
    nereida.salinas@usoncology.com
    Principal Investigator: Alvaro Restrepo, MD

    Virginia Locations
    Fredericksburg, Virginia, United States, 22408
    Hematology-Oncology Associates of Fredericksburg, Inc
    Contact: Ashley Lawrence, RN, OCN
    540-371-0079 ext 149 alawrence@hoafredericksburg.com
    Contact: Amber Spurley, RN
    540-371-0079 research@hoafredericksburg.com
    Principal Investigator: Christopher N. Vaughn, MD

    Washington Locations
    Spokane Valley, Washington, United States, 99218
    Cancer Care Northwest
    Contact: Ronaye Wagner, RN, MSN
    509-228-1680 Ronaye.wagner@ccnw.net
    Contact: Bethany Giachetti, BS, CCRC
    509-228-1684 Bethany.giachetti@ccnw.net
    Principal Investigator: Kristine Rinn, MD

    Spokane, Washington, United States, 99202
    Cancer Care Northwest-1 (601 S. Sherman)
    Contact: Ronaye Wagner
    Ronaye.wagner@ccnw.net
    Principal Investigator: Kristine Rinn, MD

    Spokane, Washington, United States, 99218
    Cancer Care Northwest_2 (605 E. Holland)
    Contact: Ronaye Wagner
    Ronaye.wagner@ccnw.net
    Principal Investigator: Kristine Rinn, MD

    Wisconsin Location
    Sheboygan, Wisconsin, United States, 53081
    Sheboygan Cancer & Blood Specialists
    Contact: Maria Splittgerber
    920-452-1650 ext 318 msplittgerber@physhealthnet.com
    Principal Investigator: S. Mark Bettag, MD

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06072612

Study Sponsor: BriaCell Therapeutics Corp.

Sponsor Protocol Number: BC-IMT-04