Study of the Bria-IMT Regimen and CPI vs Physicians' Choice in Advanced Metastatic Breast Cancer.
18 Years and older, Male and Female
BC-IMT-04 (primary)
NCI-2023-10928
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.
Objectives
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
- Be = 18 years of age.
- Have signed informed consent.
- 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:
- 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.
- 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.
- 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.
- 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.
- 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.
- HER2 negative tumors must be refractory to hormonal therapy (if indicated) and previously treated with at least 2 chemotherapy regimens.
- 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
- Has expected survival of at least 4 months.
- ECOG performance status of 0, 1 or 2
Treatment Sites in Georgia
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