Personalized Dendritic Cell Vaccine with Oral Cabozantinib for Localized Clear Cell Kidney Cancer Treatment

What this Trial Is About

This research aims to estimate the likelihood of an immune response to a combination treatment involving a dendritic cell vaccine and oral cabozantinib in patients with newly diagnosed, localized clear cell renal cell carcinoma ccRCC who are planned for surgical removal of the tumor. The study also seeks to understand the safety profile of this treatment approach. The focus is on how the treatment influences tumor blood vessels and immune cell activation within the tumor. Participants who are HLA-A2 positive will receive the autologous Tumor Blood Vessel Antigen TBVA-Dendritic Cell Vaccine injected into the skin every two weeks for two doses before surgery, along with daily oral cabozantinib 20 mg for 10 days. Surgery to remove the tumor is scheduled around day 31 after starting treatment. Up to 21 additional participants who are HLA-A2 negative will be enrolled as control subjects and will not receive the vaccine or undergo study procedures beyond screening. During the study, participants will be monitored for immune responses, changes in tumor blood vessel structure, and safety outcomes including adverse events for up to 48 months. Assessments include laboratory tests, tissue analysis, and clinical evaluations. The study tracks the reduction in tumor vascularity and normalization markers over time to evaluate treatment effects. Participants will be involved in visits for vaccine administration, daily oral medication, surgery, and long-term follow-up to observe outcomes.

Autologous Dendritic Cell Vaccine in Kidney Cancer