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Hormone Therapy

Vaccine +/− Nivolumab for Prostate Cancer

Phase 1 & 2
Recruiting
Led By Christos Kyriakopoulos, MD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No known history of specific infections
Histologically confirmed adenocarcinoma of the prostate
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 months on study (1 year after prostatectomy)
Awards & highlights

Study Summary

This trial is testing a new vaccine for prostate cancer. The vaccine is given with or without a drug called nivolumab. The trial will last up to 15 months.

Who is the study for?
Men with newly diagnosed, high-risk prostate cancer who are scheduled for prostatectomy can join. They should have a Gleason score of 7 or higher and PSA > 20 ng/mL, be in good physical condition (ECOG 0-1), and have adequate organ function. Participants must consent to blood draws, use barrier contraception if sexually active, and not have HIV, HTLV-1, Hepatitis B/C or other cancers.Check my eligibility
What is being tested?
The trial is testing the effectiveness of a DNA vaccine targeting the Androgen Receptor (pTVG-AR) alone or combined with Nivolumab after initial hormone therapy in patients undergoing surgery for prostate cancer. The goal is to boost T-cells that fight cancer.See study design
What are the potential side effects?
Potential side effects include typical immune-related reactions from Nivolumab such as fatigue, skin issues, inflammation of organs like intestines or lungs; possible injection site reactions from pTVG-AR; hormonal changes due to Degarelix may cause hot flashes or sexual dysfunction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have no history of specific infections.
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My prostate cancer has been confirmed by a tissue examination.
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My blood, kidney, and liver tests are normal.
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I can follow all study rules and lie on my back for 2 hours during scans.
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I have enough tissue left from my initial prostate cancer biopsy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 months on study (1 year after prostatectomy)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 months on study (1 year after prostatectomy) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Adverse Events
Minimal Residual Disease (MRD) Rate
Pathological Complete Response Rate (pCR)
+1 more
Secondary outcome measures
Progression-Free Survival (PSA) at 1-year
Residual Cancer Burden (RCB)
Other outcome measures
Change in levels of AR-specific tumor-infiltrating CD8+T cells
Change in levels of prostate tissue-infiltrating CD8+T cells
FLT-PET imaging endpoints: SUVmax
+4 more

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: Arm 5: Degarelix and pTVG-AR and Cemiplimab and FianlimabExperimental Treatment4 Interventions
Degarelix 240 mg s.c. day 29, 80 mg s.c. day 57 pTVG-AR (100 µg) administered intradermally (i.d.) at days 1, 8, 15, 22, 29, 43, 57 and 71 Cemiplimab 350 mg IV administered at days 1, 22, 43 and 64 Fianlimab 1600 mg IV administered at days 1, 22, 43 and 64
Group II: Arm 4: Degarelix and pTVG-AR and CemiplimabExperimental Treatment3 Interventions
Degarelix 240 mg s.c. day 29, 80 mg s.c. day 57 pTVG-AR (100 µg) administered intradermally (i.d.) at days 1, 8, 15, 22, 29, 43, 57 and 71 Cemiplimab 350 mg IV administered at days 1, 22, 43 and 64
Group III: Arm 3: Degarelix and pTVG-AR and NivolumabExperimental Treatment4 Interventions
Degarelix 240 mg s.c. day 29, 80 mg s.c. day 57 pTVG-AR (100 µg) administered intradermally (i.d.) at days 1, 8, 15, 22, 29, 43, 57 and 71 Nivolumab 240 mg IV administered at days 29, 43, 57 and 71
Group IV: Arm 2: Degarelix and pTVG-ARExperimental Treatment3 Interventions
Degarelix 240 mg s.c. day 29, 80 mg s.c. day 57 pTVG-AR (100 µg) administered intradermally (i.d.) at days 1, 8, 15, 22, 29, 43, 57 and 71
Group V: Arm 1: DegarelixActive Control2 Interventions
- Degarelix 240 mg s.c. day 29, 80 mg s.c. day 57
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FLT PET/CT
2014
N/A
~10
Cemiplimab
2015
Completed Phase 3
~1340
pTVG-AR
2015
Completed Phase 1
~40
Nivolumab
2014
Completed Phase 3
~4750
Degarelix
2002
Completed Phase 3
~3600

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,794 Total Patients Enrolled
560 Trials studying Prostate Cancer
507,035 Patients Enrolled for Prostate Cancer
Bristol-Myers SquibbIndustry Sponsor
2,640 Previous Clinical Trials
4,129,404 Total Patients Enrolled
41 Trials studying Prostate Cancer
5,387 Patients Enrolled for Prostate Cancer
Regeneron PharmaceuticalsIndustry Sponsor
620 Previous Clinical Trials
380,325 Total Patients Enrolled
2 Trials studying Prostate Cancer
176 Patients Enrolled for Prostate Cancer

Media Library

Degarelix (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04989946 — Phase 1 & 2
Prostate Cancer Research Study Groups: Arm 4: Degarelix and pTVG-AR and Cemiplimab, Arm 2: Degarelix and pTVG-AR, Arm 3: Degarelix and pTVG-AR and Nivolumab, Arm 1: Degarelix, Arm 5: Degarelix and pTVG-AR and Cemiplimab and Fianlimab
Prostate Cancer Clinical Trial 2023: Degarelix Highlights & Side Effects. Trial Name: NCT04989946 — Phase 1 & 2
Degarelix (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04989946 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical condition is pTVG-AR routinely employed to manage?

"PTVG-AR is a viable treatment option for malignancies, unresectable melanoma, and squamous cell carcinoma."

Answered by AI

Are there past experiments with pTVG-AR that have been documented?

"Presently, there are 746 active clinical trials exploring pTVG-AR. Of these studies, 90 have reached phase 3. While the majority of these investigations take place in Duarte, California; a whopping 41755 locations worldwide are running further research into this therapeutic option."

Answered by AI

Is this experimentation unprecedented in its field?

"Currently, there are 746 active pTVG-AR trials in 2372 cities dispersed across 49 countries. Ferring Pharmaceuticals was the sponsor of the inaugural trial which launched in 2012 with 41 participants. Subsequent to this initial study, a further 314 experiments have been completed."

Answered by AI

Is recruitment for this experiment still ongoing?

"This clinical trial is currently recruiting volunteers, as noted on the listing hosted by clinicaltrials.gov. It was first published on December 16th 2021 and most recently edited on July 6th 2022."

Answered by AI

How many participants has this clinical trial recruited?

"Affirmative. Data posted on clinicaltrials.gov reveals that this medical trial is currently recruiting individuals, with the initial posting being made December 16th 2021 and last edited July 6th 2022. At present, 39 patients are needed for one location of the study."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Androgen Deprivation, With or Without pTVG-AR, and With or Without T-Cell Checkpoint Blockade, in Patients With Newly Diagnosed, High-Risk Prostate Cancer
2021. "Androgen Deprivation, With or Without pTVG-AR, and With or Without T-Cell Checkpoint Blockade, in Patients With Newly Diagnosed, High-Risk Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04989946.
~32 spots leftby Dec 2026
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