Androgen Deprivation, With or Without pTVG-AR, and With or Without T-Cell Checkpoint Blockade, in Patients With Newly Diagnosed, High-Risk Prostate Cancer

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

December 16, 2021

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2028

Conditions
Prostate Cancer
Interventions
DRUG

Degarelix

standard Gonadotropin-releasing hormone (GnRH) antagonist

BIOLOGICAL

pTVG-AR

DNA vaccine encoding androgen receptor ligand-binding domain

DRUG

Nivolumab

Nivolumab is a human programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of patients with multiple different types of cancer.

DRUG

Cemiplimab

Cemiplimab is a human PD-1 blocking antibody approved for the treatment of patients with non-small cell lung cancer, cutaneous squamous cell carcinoma, and locally advanced basal cell carcinoma.

DRUG

Fianlimab

Lymphocyte activation gene-3 (LAG-3) is a protein that is upregulated on activated CD4+ and CD8+ T cells following T-cell receptor engagement. Binding of LAG-3 to MHC II on professional antigen-presenting cells suppresses the proliferation, activation, and cytokine secretion of T cells. Fianlimab is a human IgG4 antibody to lymphocyte activation gene-3 (LAG-3) that blocks LAG-3/MHC II-mediated T-cell inhibition.

DRUG

FLT PET/CT

Arms 1-3 only, FLT PET/CT scan at baseline (within 1-6 days of Day 1) and Day 43

Trial Locations (1)

53792

RECRUITING

University of Wisconsin Carbone Cancer Center, Madison

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

United States Department of Defense

FED

collaborator

Regeneron Pharmaceuticals

INDUSTRY

collaborator

Bristol-Myers Squibb

INDUSTRY

collaborator

National Cancer Institute (NCI)

NIH

lead

University of Wisconsin, Madison

OTHER

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 | Biotech Hunter | Biotech Hunter