drugset / Trial / 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
Phase 1/2
Active not recruiting
57 enrolled
University of Wisconsin, Madison
Bristol-Myers Squibb · collabNational Cancer Institute (NCI) · collabRegeneron Pharmaceuticals · collabUnited States Department of Defense · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2021-12-16
- Primary completion
- 2026-12
- Completion
- 2028-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cemiplimab | Monoclonal antibody | 350 mg | Intravenous |
| Subject | Fianlimab | Monoclonal antibody | 1600 mg | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 240 mg | Intravenous |
| Subject | pTVG-AR | Vaccine | 100 ug | Intravitreal |
| Background | Degarelix | Other / unclassified | 80 mg | Subcutaneous |