RecruitingPhase 1Phase 2NCT04989946

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


Sponsor

University of Wisconsin, Madison

Enrollment

60 participants

Start Date

Dec 16, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests different combinations of hormone-blocking therapy (androgen deprivation), an experimental prostate cancer vaccine (pTVG-AR), and immune checkpoint drugs in men with newly diagnosed high-risk prostate cancer who are candidates for surgery. **You may be eligible if...** - You have confirmed high-risk prostate cancer (Gleason score 7 with PSA above 20, or Gleason score above 7) - You are a candidate for prostate removal surgery - You are in good general health (ECOG 0–1) - You have adequate blood, kidney, and liver function - You have no history of HIV, hepatitis B, or hepatitis C - You have never received prior prostate cancer treatment **You may NOT be eligible if...** - You have had any prior prostate cancer treatment (hormone therapy, radiation, surgery) - You have active heart disease (heart attack or heart failure in last 6 months) - You have an autoimmune disease requiring treatment in the past 2 years - You have had a lung inflammation requiring steroids - You are on high-dose corticosteroids - You received a live vaccine within 14 days - You have a history of severe allergic reactions to tetanus vaccine Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGDegarelix

standard Gonadotropin-releasing hormone (GnRH) antagonist

BIOLOGICALpTVG-AR

DNA vaccine encoding androgen receptor ligand-binding domain

DRUGNivolumab

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

DRUGCemiplimab

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.

DRUGFianlimab

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.

DRUGFLT PET/CT

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


Locations(1)

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04989946


Related Trials