OncoMatch/Clinical Trials/NCT04989946
Androgen Deprivation, With or Without pTVG-AR, and With or Without T-Cell Checkpoint Blockade, in Patients With Newly Diagnosed, High-Risk Prostate Cancer
Is NCT04989946 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments for prostate cancer.
Treatment: Degarelix · pTVG-AR · Nivolumab · Cemiplimab · Fianlimab · FLT PET/CT — The current protocol will examine the use of a plasmid DNA vaccine encoding AR, alone or with T-cell checkpoint blockade, to induce and/or augment therapeutic T-cells following androgen deprivation in patients with newly diagnosed prostate cancer scheduled to undergo prostatectomy. Patients without evidence of metastatic disease, with tissue remaining from a pre-treatment biopsy, and who are being considered for standard treatment by prostatectomy, will be invited to participate and will be on study for up to 15 months.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: androgen deprivation therapy
Prior treatment for prostate cancer, including androgen deprivation therapy (ADT), orchiectomy, antiandrogens, ketoconazole, abiraterone acetate or enzalutamide
Cannot have received: radiation therapy
Prior radiation to the prostate
Lab requirements
Blood counts
ANC > 1000 / mm3; HgB > 9.0 gm/dL independent of transfusion; Platelets > 100,000 / mm3
Kidney function
Creatinine < 2.0 mg/dL
Liver function
AST, ALT < 2.5 x institutional ULN; total bilirubin < 2x institutional ULN (Gilbert's syndrome exception: if direct bilirubin is within normal range, subject may be eligible)
Adequate hematologic, renal and liver function as evidenced by the following within 4 weeks of day 1: Absolute neutrophil count (ANC) > 1000 / mm3; HgB > 9.0 gm/dL independent of transfusion; Platelets > 100,000 / mm3; Creatinine < 2.0 mg/dL; AST, ALT < 2.5 x institutional ULN; Total bilirubin < 2x institutional ULN (NOTE: in subjects with Gilbert's syndrome, if total bilirubin is >2x ULN, measure direct and indirect bilirubin and if direct bilirubin is within normal range, subject may be eligible)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Wisconsin Carbone Cancer Center · Madison, Wisconsin
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