RecruitingRecruiting
Study of the Bria-IMT Regimen and CPI vs Physicians' Choice in Advanced Metastatic Breast Cancer.
NCT06072612 · BriaCell Therapeutics Corporation
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Randomized, Open-Label Study of the Bria-IMT Regimen and Check Point Inhibitor vs Physicians' Choice in Advanced Metastatic Breast Cancer.
About this study
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
Inclusion Criteria:
1. Be ≥ 18 years of age.
2. Have signed informed consent.
3. Have histological confirmation of breast cancer with either locally recurrent unresectable and/or metastatic lesions, and have failed prior therapy:
* Patients with persistent disease and local recurrence must not be amenable to local treatment.
* For patients with metastatic disease, late-stage MBC with no meaningful alternative therapies available and the following class specific treatment histories:
1. Human epidermal growth factor 2 (HER2) positive must be previously treated with at least 3 regimens containing at least two anti-HER2 and at least one chemotherapy containing regimen.
2. Estrogen receptor (ER), progesterone receptor (PR) positive tumors: must be refractory to hormonal therapy demonstrated by progression on at least 2 hormonal agents in 2 separate lines of hormone directed therapy.
3. Triple Negative tumors: Must have exhausted all curative intent therapies including at least 2 prior chemotherapy regimens, which can include regimens in neoadjuvant and adjuvant settings.
4. Cancers with known germline or genomic actionable targets, e.g. g/mBRCA, must have been treated with all tumor directed indicated treatment e.g. PARPi, if tolerated.
5. HER2 low patients, in addition to the appropriate therapies based on ER/PR status and germline or genomic actionable targets, must also have received at least one HER2-targeted agent approved for treatment of HER2 low patients.
6. HER2 negative tumors must be refractory to hormonal therapy (if indicated) and previously treated with at least 2 chemotherapy regimens.
7. Patients with new or progressive breast cancer metastatic to the brain will be eligible provided:
* The brain metastases must be clinically stable (without evidence of progressive disease by imaging for at least 4 weeks prior to first dose)
* There is no need for steroids and patients have not had steroids for at least 2 weeks prior to the first dose
* Tumor is not impinging on Middle Cerebral Artery/speech-motor strip
* If surgically debulked, must be healed with at least 3 weeks since surgery prior to the first dose
4. Has expected survival of at least 4 months.
5. ECOG performance status of 0, 1 or 2
Exclusion Criteria:
1. Concurrent or recent chemotherapy, immunotherapy or major surgery within 21 days prior to the first dose.
2. Radiotherapy within 14 days of the first dose of study treatment.
3. Toxicity of prior therapy that has not recovered to ≤ Grade 1 or baseline (with the exception of any grade of alopecia and anemia not requiring transfusion support).
4. Any toxicity to prior CPI that was grade 3 or higher unless it has been successfully treated (e.g. hypothyroidism or hypopituitarism treated with replacement therapy), .
5. Toxicity to prior CPI that has not resolved to grade 1 or less except for stable asymptomatic endocrinopathies.
6. History of clinical hypersensitivity to the designated therapy as specified in the protocol, including the proposed TPC, beef, or to any components used in the preparation of SV- BR-1-GM.
7. History of hypersensitivity to any of the therapies proposed for treatment in this study.
8. Serum creatinine OR Measured OR calculated Creatinine Clearance (CrCl) (GFR can also be used in place of creatinine or CrCl) \>2.0 × ULN or \<30 mL/min for participants with creatinine levels \>2.0 × institutional ULN.
9. Absolute granulocyte count \<1000; platelets \<80,000; hemoglobin ≤ 7 g/L.
10. Bilirubin ≥ 2 × ULN unless conjugated bilirubin ≤ ULN; alkaline phosphatase \>5x upper limit of normal (ULN); ALT/AST \>3x ULN. For patients with hepatic metastases, ALT/AST \>5x ULN is exclusionary.
11. INR or PT or aPTT \> 1.8 × ULN, unless the participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants.
12. Receiving any medication listed in the prohibited medication section of the protocol.
13. Proteinuria \>2+ on urinalysis
14. A history or presence of an abnormal electrocardiogram (ECG) that, in the Investigator's opinion, is clinically meaningful. Screening corrected QT interval (QTc) interval \>480 milliseconds is excluded (corrected by Fridericia or Bazett formula). In the event that a single QTc is \>480 milliseconds, the participant may enroll if the average QTc for the 3 ECGs is \<480 milliseconds.
15. New York Heart Association stage 3 or 4 cardiac disease.
16. A pericardial effusion of moderate severity or worse.
17. Symptomatic pleural effusion or ascites. A participant who is clinically stable following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible.
18. Any woman of childbearing potential (i.e., has had a menstrual cycle within the past year and has not been surgically sterilized), unless she agrees to take appropriate precautions to avoid becoming pregnant during the study and has a negative serum pregnancy test within 7 days prior to starting treatment.
19. Men must have been sterile or, if they were potentially fertile/reproductively competent, should take appropriate precautions to avoid fathering a child for the duration of the study.
20. Women who are pregnant or nursing.
21. Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of study entry with the exception of cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy, or cancers from which the participant has been disease-free for \> 1 year, after treatment with curative intent.
22. Patients who have uncontrolled HIV or have clinical or laboratory features indicative of AIDS.
23. Have a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
24. Have an active autoimmune disease that has required systemic treatment in past year (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is allowed.
25. Known active HAV, HBV, or HCV infection, as defined by elevated transaminases with the following serology: positivity for HAV IgM antibody, anti-HCV, anti-HBc IgG or IgM, or HBsAg (in the absence of prior immunization).
26. Active infections requiring systemic therapy within the past 14 days.
27. Patients with severe psychiatric disease (e.g., schizophrenia, bipolar, or borderline personality disorder) or other clinically progressive major medical problems, unless approved by the Investigator in consultation with the Medical Monitor.
28. Has received a live vaccine within 28 days of the first dose of study drug.
29. Patients may not be on a concurrent clinical trial, unless approved by the Investigator.
Study design
Enrollment target: 404 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-12-05
Estimated completion: 2028-06
Last updated: 2026-04-07
Interventions
Biological: SV-BR-1-GMDrug: CyclophosphamideDrug: Interferon infiltration of the inoculation siteDrug: RetifanlimabDrug: Treatment of Physician's Choice
Primary outcomes
- • Overall Survival (Up to 60 months)
Sponsor
BriaCell Therapeutics Corporation · industry
Contacts & investigators
ContactSue Torchio, CPM · contact · sue.torchio@PrevailinfoWorks.com · 267-797-2061
ContactMarcela Salgado, MD · contact · MSalgado@briacell.com · 1-888-309-1868
InvestigatorGiuseppe Del Priore, MD MPH · study_director, BriaCell Therapeutics
All locations (79)
Mayo Clinic-Comprehensive Cancer Center-Breast ClinicRecruiting
Phoenix, Arizona, United States
University of Arizona-Cancer CenterRecruiting
Tucson, Arizona, United States
Los Angeles cancer Network_AnaheimRecruiting
Anaheim, California, United States
Comprehensive Blood and Cancer CenterRecruiting
Bakersfield, California, United States
Cedars-Sinai Cancer Beverly HillsRecruiting
Beverly Hills, California, United States
Los Angeles Cancer Network_CoronaRecruiting
Corona, California, United States
Los Angeles cancer Network_Fountain VallleyRecruiting
Fountain Valley, California, United States
Los Angeles Cancer Network_GlendaleRecruiting
Glendale, California, United States
Hoag Hospital CenterRecruiting
Irvine, California, United States
Hoag Hospital IrvineRecruiting
Irvine, California, United States
Los Angeles Cancer NetworkRecruiting
Los Angeles, California, United States
Cedars-Sinai Cancer at Cedars-Sinai Medical FacilityRecruiting
Los Angeles, California, United States
Los Angeles Cancer Network_Century CityRecruiting
Los Angeles, California, United States
UCLA-Hematology/Oncology Medical PlazaRecruiting
Los Angeles, California, United States
UCLA-Hematology/Oncology_LA 2Recruiting
Los Angeles, California, United States
UCLA-Hematology/Oncology_LARecruiting
Los Angeles, California, United States
Los Angeles Cancer Network_PasadenaRecruiting
Pasadena, California, United States
Los Angeles cancer Network_RiversideRecruiting
Riverside, California, United States
UC San DiegoRecruiting
San Diego, California, United States
St. John's Cancer CenterRecruiting
Santa Monica, California, United States
UCLA-Department of Medicine Hematology/Oncology-ParksideRecruiting
Santa Monica, California, United States
UCLA-Hetamtology/Oncology_S MonicaRecruiting
Santa Monica, California, United States
Torrance Memorial Cancer CenterRecruiting
Torrance, California, United States
Los Angeles Cancer Network_Valley PresRecruiting
Van Nuys, California, United States
Cedars-Sinai Breast Health Services BuildingRecruiting
West Hollywood, California, United States
Smilow Cancer Hospital at Yale New HavenRecruiting
New Haven, Connecticut, United States
University of Miami _SCCC - AventuraRecruiting
Aventura, Florida, United States
University of Miami-SCCC-LennarRecruiting
Coral Gables, Florida, United States
University of Miami_SCCC-Coral SpringsRecruiting
Coral Springs, Florida, United States
University of Miami Hospital and Clinics - Deerfield BeachRecruiting
Deerfield Beach, Florida, United States
University of Miami_SCCC-HollywoodRecruiting
Hollywood, Florida, United States
Mayo Clinic Florida-Comprehensive Cancer CenterRecruiting
Jacksonville, Florida, United States
University Of Miami-SCCC-MiamiRecruiting
Miami, Florida, United States
University of Miami_SCCC - KendallRecruiting
Miami, Florida, United States
Advent Health - OrlandoRecruiting
Orlando, Florida, United States
University of Miami-SCCC-PlantationRecruiting
Plantation, Florida, United States
Winship Cancer Institute of Emory UniversityRecruiting
Atlanta, Georgia, United States
Northwestern UniversityRecruiting
Chicago, Illinois, United States
Southern Illinois University-SimmonsRecruiting
Springfield, Illinois, United States
Carle Foundation Cancer Institute-UrbanaRecruiting
Urbana, Illinois, United States
Northwest Cancer CenterRecruiting
Dyer, Indiana, United States
AMR Kansas City OncologyRecruiting
Kansas City, Kansas, United States
Care Access-MarreroRecruiting
Marrero, Louisiana, United States
The Center for Cancer and Blood Disorders a division of American Oncology Partners, P.A.Recruiting
Bethesda, Maryland, United States
Mayo Clinic-Comprehensive Cancer Center-Breast ClinicRecruiting
Rochester, Minnesota, United States
Nebraska Cancer SpecialistsRecruiting
Omaha, Nebraska, United States
Dartmouth Hitchcock Medical CenterRecruiting
Lebanon, New Hampshire, United States
Hunterdon Medical CenterRecruiting
Flemington, New Jersey, United States
New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C. (Babylon)Recruiting
Babylon, New York, United States
NYU Langone's Perlmutter Cancer CenterRecruiting
Manhattan, New York, United States
New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C.(New Hyde Park)Recruiting
New Hyde Park, New York, United States
Manhattan Hematology /Oncology AssociatesRecruiting
New York, New York, United States
New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C (NY)Recruiting
New York, New York, United States
New York Cancers & Blood Specialists_North Shore Hematology Oncology Assocaites P.C (Patchogue)Recruiting
Patchogue, New York, United States
New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C. (Port Jefferson Station2)Recruiting
Port Jefferson Station, New York, United States
New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C.(Port Jefferson Station1)Recruiting
Port Jefferson Station, New York, United States
New York Cancers & Blood SpecialistsRecruiting
Port Jefferson Station, New York, United States
New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C. (Riverhead)Recruiting
Riverhead, New York, United States
New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C (Brox)Recruiting
The Bronx, New York, United States
Regional Medical Oncology Center_WlsonRecruiting
Wilson, North Carolina, United States
Gabrail Cancer & Research CenterRecruiting
Canton, Ohio, United States
Cleveland ClinicRecruiting
Cleveland, Ohio, United States
Texas Oncology-Baylor Charles A. Sammons Cancer CenterRecruiting
Dallas, Texas, United States
Mary Crowley Cancer ResearchRecruiting
Dallas, Texas, United States
DHR Health Oncology InstituteRecruiting
Edinburg, Texas, United States
Texas Oncology - FredericksburgRecruiting
Fredericksburg, Texas, United States
Texas Oncology - HarlingenRecruiting
Harlingen, Texas, United States
Texas Oncology McAllenRecruiting
McAllen, Texas, United States
Texas Oncology, New BraunfelsRecruiting
New Braunfels, Texas, United States
Texas Oncology-San Antonio Cancer CareRecruiting
San Antonio, Texas, United States
Texas Oncology - San Antonio NortheastRecruiting
San Antonio, Texas, United States
Texas Oncology - San Antonio Stone OakRecruiting
San Antonio, Texas, United States
Tranquil Clinical ResearchRecruiting
Webster, Texas, United States
Texas Oncology - WeslacoRecruiting
Weslaco, Texas, United States
Hematology-Oncology Associates of Fredericksburg, IncRecruiting
Fredericksburg, Virginia, United States
Cancer Care Northwest-1 (601 S. Sherman)Recruiting
Spokane, Washington, United States
Cancer Care Northwest_2 (605 E. Holland)Recruiting
Spokane, Washington, United States
Cancer Care NorthwestRecruiting
Spokane Valley, Washington, United States
Sheboygan Cancer & Blood SpecialistsRecruiting
Sheboygan, Wisconsin, United States