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Interferon infiltration of the inoculation site / Retifanlimab / SV-BR-1-GM · Phase 3 Trial
ClinicalTrials.gov · August 17, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registered Phase 3 randomized trial comparing Bria-IMT (SV-BR-1-GM plus cyclophosphamide and interferon) combined with the checkpoint inhibitor retifanlimab against physician's choice treatment in advanced metastatic breast cancer. The trial is actively recruiting and has not yet reported results; no efficacy or safety data are available to evaluate.
Phase 3, Interventional, Randomized, Parallel, Open label, Treatment purpose. Breast Cancer, Metastatic Breast Cancer, Breast Neoplasm, Breast Cancer Metastatic, End Stage Cancer; age from 18 Years. Intervention: Bria-IMT Regimen + CPI; Bria-IMT Regimen Alone. Compared with: Treatment of Physician's Choice — Active Comparator. n = 404. 79 sites: United States.
This is a registered Phase 3 randomized trial comparing Bria-IMT (SV-BR-1-GM plus cyclophosphamide and interferon) combined with the checkpoint inhibitor retifanlimab against physician's choice treatment in advanced metastatic breast cancer. The trial is actively recruiting and has not yet reported results; no efficacy or safety data are available to evaluate.
No efficacy, safety, or interim data are available in this source.
The source did not state who this applies to in practice.
This is a recruiting Phase 3 RCT registration with no reported results; the study design is sound but outcomes are not yet available, making it a planned trial rather than evidence of efficacy.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06072612). This is a study registration, not published results. Lead sponsor: BriaCell Therapeutics Corporation. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 404 participants (ESTIMATED). Conditions: Breast Cancer, Metastatic Breast Cancer, Breast Neoplasm, Breast Cancer Metastatic, End Stage Cancer. Interventions: BIOLOGICAL: SV-BR-1-GM; DRUG: Cyclophosphamide; DRUG: Interferon infiltration of the inoculation site; DRUG: Retifanlimab; DRUG: Treatment of Physician's Choice. Primary outcome measures: Overall Survival , Up to 60 months. Brief 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.