Combination Study of SV-BR-1-GM in Combination With INCMGA00012 and Epacadostat

Summary

Participation Requirements

Description

This is an open-label, single arm study of the SV-BR-1-GM regimen in combination with INCMGA00012 and epacadostat in patients with metastatic or locally recurrent breast cancer who have failed at least two lines of therapy. Patients will receive the SV-BR-1-GM regimen with combination immunotherapy....

This is an open-label, single arm study of the SV-BR-1-GM regimen in combination with INCMGA00012 and epacadostat in patients with metastatic or locally recurrent breast cancer who have failed at least two lines of 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 INCMGA00012 every 3 weeks. If this is found to be safe and well tolerated in a cohort of at least 6 patients (dose-limiting toxicities (DLTs) in less than 30% of the patients evaluated), then a triple combination of the SV-BR-1-GM regimen with INCMGA00012 and epacadostat will be evaluated in a cohort of 6 patients. If the DLT rate remains below 30%, additional higher dose levels of epacadostat will be explored. Once a dose of epacadostat has been determined that is safe and reliably normalizes plasma kynurenine levels, the study will expand to treat an additional 36 patients. If DLTs are seen in 30% or more of patients, the dose of epacadostat will be further reduced and an additional cohort of 6 patients evaluated in a stepwise fashion until a safe dose level is determined. Once the recommended phase II dose is determined, the study will expand to treat an additional 36 patients. The SV-BR-1-GM regimen consists of: Pre- SV-BR-1-GM cyclophosphamide 2-3 days prior to SV-BR-1-GM inoculation SV-BR-1-GM inoculation Interferon-alpha-2b - at the inoculation sites 2 (±1 day) post-SV-BR-1-GM Interferon-alpha-2b - at the inoculation sites 4 (±1 day) post-SV-BR-1-GM The SV-BR-1-GM regimen will be administered with the following combination immunotherapy regimen: Combination therapy with INCMGA00012 (anti-PD-1) Combination therapy with epacadostat (IDO inhibitor) The SV-BR-1-GM regimen with INCMGA00012 will be administered every 21 days (± 3 days), except when approved by the Investigator in consultation with the medical monitor. Epacadostat will be dosed twice daily and will continue through each cycle. Note that hormonal therapy (e.g., aromatase inhibitors) is permitted if ongoing, but may be added while the patient is on this study only with the medical monitor's approval (e.g. for hormone receptor positive patients who are deriving clinical benefit but have not achieved a CR after >6 cycles of therapy).

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