NCT05127824 Autologous Dendritic Cell Vaccine in Kidney Cancer
| NCT ID | NCT05127824 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Jodi Maranchie |
| Condition | Carcinoma, Renal Cell |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2023-07-06 |
| Primary Completion | 2026-12 |
Trial Parameters
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Brief Summary
The purpose of this study is to estimate the probability of immune response for the combination treatment of dendritic cell vaccine with oral cabozantinib and characterize the safety profile of interventional therapy.
Eligibility Criteria
Inclusion Criteria: 1. Histologically proven clear cell renal cancer that is non-metastatic and amenable to surgical resection with no evidence of metastatic disease or lesions outside of the kidney. 2. 18 years or older (male or female) with an ECOG performance status of 0 or 1. 3. Have serotype HLA-A2+ if receiving vaccine. 4. Capable of understanding and complying with the protocol requirements and have signed the informed consent document. 5. Adequate organ and marrow function, based upon meeting all of the following laboratory criteria within 14 days before first dose of study treatment: 1. Absolute neutrophil count (ANC) ≥ 1500/µL without granulocyte colony- stimulating factor support. 2. White blood cell count ≥ 2500/µL. 3. Platelets ≥ 100,000/µL without transfusion. 4. Hemoglobin ≥ 9 g/dL (≥ 90 g/L). 5. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤ 3x upper limit of normal (ULN). ALP ≤ 5x ULN with documented bone metastases.