pTVG-HP Vaccine + Nivolumab for Prostate Cancer

Overseen By Cancer Connect

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: University of Wisconsin, Madison

Must not be taking: Chemotherapy, Corticosteroids, Androgen deprivation

Disqualifiers: Immunosuppression, HIV, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an experimental vaccine called pTVG-HP combined with nivolumab (an immunotherapy) to determine if they can enhance the immune system's ability to fight prostate cancer. Researchers aim to discover if this combination can shrink or eliminate metastatic tumors in prostate cancer that has recurred and spread to a few locations. The trial also includes radiation therapy. Men who have undergone prostate surgery, have recurring cancer with specific tumor spread, and exhibit a rising PSA (a protein level in the blood) may be suitable candidates for this study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications with hormonal effects, like finasteride or Saw Palmetto, and any other medications with possible anti-cancer effects must be discussed with the study doctor. If you've been on other experimental prostate cancer treatments, you need to stop them at least 4 weeks before starting this trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the pTVG-HP DNA vaccine has been safe in past studies. One study combined it with nivolumab and found it to be safe, with no harmful effects reported even years later.

For nivolumab, other studies have demonstrated that it is generally well-tolerated. In studies involving patients with a similar type of prostate cancer, most did not experience serious side effects. Some reported common side effects, such as fatigue or rash.

Overall, previous research has used both treatments safely. Safety remains a key focus, especially in early-stage trials like this one, where researchers closely monitor participants. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of the pTVG-HP DNA vaccine and Nivolumab for prostate cancer because it represents a novel approach to treatment. Unlike traditional options like hormone therapy, which aim to reduce testosterone levels, this combination leverages the body's immune system to target cancer cells. The pTVG-HP vaccine is designed to trigger an immune response specifically against prostate cancer cells, while Nivolumab is an immune checkpoint inhibitor that enhances the immune system's ability to detect and destroy cancer. This dual strategy potentially offers a more targeted and effective treatment for patients with recurrent, oligometastatic prostate cancer.

What evidence suggests that this trial's treatments could be effective for prostate cancer?

Research has shown that combining the pTVG-HP DNA vaccine with nivolumab, which participants in this trial will receive, may help treat prostate cancer. Studies have found that using these treatments together is safe and enhances the immune system's ability to fight cancer. This combination can delay cancer progression. Another study suggested that this method might outperform other prostate cancer treatments. While more research is needed, these findings suggest possible benefits for patients with recurring prostate cancer. ^{6 7 8 9 10}

Who Is on the Research Team?

Douglas McNeel, MD, PhD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

This trial is for individuals with non-castrate, recurrent, oligometastatic prostate cancer. Participants should have a small number of metastatic tumors and be able to receive radiation therapy. Specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

I had another cancer but was treated successfully and have been cancer-free for over three years.

Participants must be informed of the experimental nature of the study and its potential risks and must sign an IRB-approved written informed consent form indicating such an understanding

My blood, kidney, and liver tests are normal.

Exclusion Criteria

Serum testosterone at screening < 50 ng/dL

My prostate cancer is of a specific type, not the most common form.

I have HIV, HBV, or HCV.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a combination of the DNA vaccine pTVG-HP and nivolumab, along with radiation therapy

12 months

Follow-up

Participants are monitored for safety, effectiveness, and adverse events after treatment

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Nivolumab
• pTVG-HP DNA vaccine
• Radiation Therapy

Trial Overview The study tests if combining an experimental vaccine (pTVG-HP) with Nivolumab (an anti-PD-1 monoclonal antibody) can boost the immune system's ability to fight prostate cancer when followed by targeted radiation therapy.

How Is the Trial Designed?

Group I: Participants with non-castrate, recurrent, oligometastatic prostate cancer Experimental Treatment 2 Interventions

Participants will receive a combination of vaccine and immunotherapy.

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Citations

1. cancer.gov cancer.gov/clinicaltrials/NCI-2018-01474

pTVG-HP and Nivolumab in Treating Patients with High- ... Giving pTVG-HP and nivolumab may work better in treating patients with prostate cancer. Eligibility Criteria ...

2. tandfonline.com tandfonline.com/doi/full/10.1080/21645515.2024.2395680

Long-term follow up of patients treated with a DNA vaccine ... Patients with nmCSPC had a median overall survival of 12.3 y, with 5/22 (23%) alive at 15 y. 8/22 (36%) died due to prostate cancer with a ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38101860/

Phase 2 trial of a DNA vaccine (pTVG-HP) and nivolumab in ... Conclusions: In this population, combining nivolumab with pTVG-HP vaccination was safe, and immunologically active, prolonged the time to ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10729272/

Phase 2 trial of a DNA vaccine (pTVG-HP) and nivolumab ... 9/19 (47%) patients in the current trial developed immune-related adverse effects. This is similar to the frequency (28/66, 42%) of individuals ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03600350

pTVG-HP and Nivolumab in Patients With Non-Metastatic ... The purpose of this study is to evaluate the safety of an investigational DNA vaccine, pTVG-HP, a plasmid DNA encoding human prostatic acid phosphatase ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5808411/

Oligometastatic prostate cancer: definitions, clinical outcomes ... The overall rates of complications, readmission, and reoperation were 20.8%, 3.8%, and 1.9%, respectively, versus 19.4%, 3.0%, and 2.3%, ...

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.5018

CA209-8TY trial, a randomized phase 2 trial of nivolumab ... The co-primary endpoints were prostate specific antigen (PSA) response rate, defined as a ≥50% decline in PSA compared to baseline, confirmed ...

8. annalsofoncology.org annalsofoncology.org/article/S0923-7534(24)03999-1/fulltext

Ipilimumab with nivolumab in molecularly selected patients ... Ipilimumab and nivolumab induced a 6-month DCR of 38% in patients with molecularly selected mCRPC. Durable benefit was particularly high in patients with dMMR.

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39293514/

primary analysis of the phase II INSPIRE trial This trial of dual ICIs in molecularly selected mCRPC met its primary endpoint, showing DCR > 6 in 38% of patients.

10. aacrjournals.org aacrjournals.org/clincancerres/article/30/23/5342/750186/Nivolumab-in-Patients-with-Metastatic-Castration

Nivolumab in Patients with Metastatic Castration-Resistant ... This trial illuminates the nuanced landscape of nivolumab's efficacy in metastatic castration-resistant prostate cancer (mCRPC), underscoring ...