OncoMatch/Clinical Trials/NCT05127824
Autologous Dendritic Cell Vaccine in Kidney Cancer
Is NCT05127824 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Autologous alpha-DC1/TBVA vaccine and Cabozantinib for carcinoma, renal cell.
Treatment: Autologous alpha-DC1/TBVA vaccine · Cabozantinib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Renal Cell Carcinoma
Disease stage
Excluded: Stage IV
non-metastatic and amenable to surgical resection with no evidence of metastatic disease or lesions outside of the kidney
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic immunosuppressive agents (steroids)
Exception: replacement therapy for endocrine dysfunction and do not exceed 10 mg prednisone or equivalent daily
Current (within the preceding 6 weeks) treatment with systemic immunosuppressive agents including steroids except when they are administered as replacement therapy for endocrine dysfunction and do not exceed 10 mg prednisone or equivalent daily
Cannot have received: cabozantinib (cabozantinib)
Prior treatment with cabozantinib
Cannot have received: small molecule kinase inhibitor
Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within two weeks before first dose of study treatment
Cannot have received: cytotoxic, biologic or other systemic anticancer therapy
Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) within four weeks before first dose of study treatment
Cannot have received: radiation therapy
Exception: bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before first dose of study treatment; systemic treatment with radionuclides within 6 weeks before first dose of study treatment
Radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before first dose of study treatment.
Cannot have received: blood transfusion
Blood transfusion within two weeks prior to leukapheresis
Cannot have received: major surgery
Exception: must have complete wound healing from major surgery or minor surgery before first dose of study treatment
Major surgery (e.g., laparoscopic nephrectomy, GI surgery, removal or biopsy of brain metastasis) within 2 weeks before first dose of study treatment. Minor surgeries within 10 days before first dose of study treatment.
Lab requirements
Blood counts
ANC ≥ 1500/µL without G-CSF support; WBC ≥ 2500/µL; platelets ≥ 100,000/µL without transfusion; hemoglobin ≥ 9 g/dL (≥ 90 g/L); PT/INR or PTT < 1.3x ULN
Kidney function
serum creatinine ≤ 2.0 ULN or calculated creatinine clearance ≥ 30 mL/min; urine protein/creatinine ratio ≤ 1 mg/mg or 24-h urine protein ≤ 1
Liver function
ALT, AST, and ALP ≤ 3x ULN (ALP ≤ 5x ULN with documented bone metastases); total bilirubin ≤ 1.5x ULN (≤ 3x ULN for Gilbert's disease); serum albumin ≥ 2.8 g/dl
Cardiac function
QTcF ≤ 500 ms per ECG within 14 days before first dose of study treatment
Adequate organ and marrow function, based upon meeting all of the following laboratory criteria within 14 days before first dose of study treatment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UPMC Department of Urology · Pittsburgh, Pennsylvania
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