H. Lee Moffitt Cancer Center and Research Institute
The purpose of this study is to learn about the effects of the study treatment, Dendritic Cell Vaccine (DCV), in combination with trastuzumab or nivolumab to confirm the highest dose of the study treatment that can be given safely to participants with Breast Cancer (BC) with Leptomeningeal Disease (LMD).
Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of BC by ASCO/CAP guidelines (Wolff et al, 2018), or radiographically definite LMD from BC. * Trial participants must have a diagnosis of LMD. They must have the presence of malignant cells in the CSF (CSF+; note now cytology is considered diagnostic of LMD if the cytology is read as positive or suspicious; \[Chamberlain et al., 2017\] OR characteristic radiographic abnormalities of LMD). Signs and symptoms of LMD in and of themselves are not sufficient for inclusion. * Patients must have an ECOG performance scale of ≤2…
Autologous peptide-pulsed cDC1 vaccine administered intrathecally.
150 mg intrathecal weekly for HER2-positive participants.
50 mg intrathecal every 2 weeks for HER2-negative participants.
Arctuva estimate
Verify or correct the compensation shown for this listing.