Combination Therapy for Breast Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial requires a 'washout' period (time without taking certain medications) of 3 weeks before starting, and 8 weeks for some specific drugs. You should also avoid any medications listed as prohibited in the trial protocol.
What data supports the effectiveness of the drug combination therapy for breast cancer?
Research shows that combining immune checkpoint inhibitors, like those targeting PD-1, with other treatments can enhance the immune system's ability to fight breast cancer, especially in aggressive types like triple-negative breast cancer. This approach has shown promise in improving outcomes when used alongside chemotherapy or other targeted therapies.12345
What safety data exists for the combination therapy for breast cancer?
What makes the combination therapy for breast cancer involving Retifanlimab and SV-BR-1-GM unique?
This combination therapy is unique because it involves Retifanlimab, a drug that blocks a specific protein (PD-1) on immune cells, potentially enhancing the body's immune response against cancer cells. Retifanlimab has been approved for other cancers, like Merkel cell carcinoma, and its use in combination with SV-BR-1-GM for breast cancer represents a novel approach to potentially improve treatment outcomes by targeting immune pathways.810111213
What is the purpose of this trial?
This is an open-label, phase I/II double arm study of the SV-BR-1-GM regimen in combination with retifanlimab in patients with metastatic or locally recurrent breast cancer who have failed standard therapy.Patients will receive the SV-BR-1-GM regimen with combination immunotherapy. There will be an initial evaluation of the combination of the SV-BR-1-GM regimen with retifanlimab every 3 weeks. If this is found to be safe and well tolerated in a cohort of at least 12 patients (dose-limiting toxicities (DLTs) in less than 30% of the patients evaluated), then an expansion cohort of up to 24 patients will be treated with that combination. These will be randomized to two regimens differing in the timing of checkpoint inhibitor administration.
Research Team
George E Peoples, MD, FACS
Principal Investigator
LumaBridge LLC
Eligibility Criteria
This trial is for women over 18 with Stage IV triple-negative breast cancer that can't be treated locally and who have survived past standard therapies. They must expect to live at least 4 more months, not have severe psychiatric issues or major medical conditions, no recent immunosuppressive treatments, vaccines, transplants, or autoimmune disease treatments.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the SV-BR-1-GM regimen with retifanlimab every 3 weeks, with safety evaluations and imaging studies performed periodically
Follow-up
Participants are monitored for safety and effectiveness after treatment, with survival analysis every 3 months
Treatment Details
Interventions
- Retifanlimab
- SV-BR-1-GM
Retifanlimab is already approved in United States for the following indications:
- Merkel cell carcinoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
BriaCell Therapeutics Corporation
Lead Sponsor
LumaBridge
Industry Sponsor
Cancer Insight, LLC
Industry Sponsor
LumaBridge
Collaborator