TriAdeno Vaccine + N-803 for Prostate Cancer

GC
PA
Overseen ByPeter A Pinto, M.D.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new vaccine, TriAdeno, alongside the drug N-803 (an immunotherapy already used for bladder cancer), to determine if they can halt the growth of prostate tumors. It targets individuals with early-stage prostate cancer, where the cancer remains confined to the prostate. Men monitoring their early-stage prostate cancer without needing aggressive treatment might be suitable candidates. Participants will receive both treatments via injections and undergo regular tests and check-ups. As a Phase 2 trial, this research aims to measure the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial requires a 6-week break from steroid therapy before starting the study treatment. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.

Is there any evidence suggesting that TriAdeno vaccine and N-803 are likely to be safe for humans?

Previous studies have shown that the combination of the TriAdeno vaccine and N-803 is generally well-tolerated. Research indicates that patients experienced few serious side effects when these treatments were combined. N-803, already approved by the FDA for bladder cancer, has a known safety profile, providing reassurance about its use in prostate cancer trials.

For the TriAdeno vaccine, studies suggest it can be safely combined with N-803, although specific side effects were not detailed in the available data. As this trial is in phase 2, it focuses on evaluating the safety and side effects of this combination. While some evidence of safety exists, the trial aims to gather more detailed information on patient tolerance to the treatment.12345

Why are researchers excited about this study treatment for prostate cancer?

Researchers are excited about the TriAdeno vaccine combined with N-803 for prostate cancer because it offers a new approach to treatment. Unlike standard treatments like hormone therapy, surgery, or chemotherapy, this combination uses a vaccine to stimulate the immune system to target cancer cells. N-803 enhances this immune response, potentially leading to more effective targeting and elimination of cancer cells. This innovative method could offer new hope for patients by potentially providing a treatment that is both more precise and less invasive than traditional options.

What evidence suggests that TriAdeno vaccine and N-803 might be effective for prostate cancer?

Studies suggest that the combination of the TriAdeno vaccine and N-803, which trial participants will receive, may benefit prostate cancer patients. The TriAdeno vaccine helps the body identify and fight cancer by targeting three specific cancer proteins. N-803 boosts important immune cells called T cells and NK (natural killer) cells, which attack cancer cells. Previous research has shown that N-803 can enhance the effectiveness of other cancer treatments. While specific results for prostate cancer are still under investigation, these components have shown promise in treating other types of cancer, indicating they might help prevent prostate tumors from growing.12467

Who Is on the Research Team?

PA

Peter A Pinto, M.D.

Principal Investigator

National Cancer Institute (NCI)

Are You a Good Fit for This Trial?

This trial is for adults (18+) with early-stage, low- or medium-risk prostate cancer who are being closely monitored instead of treated right away. Participants need to be in good general health, have certain blood counts and PSA levels, and must provide a recent tissue sample from their prostate biopsy.

Inclusion Criteria

I am currently being monitored with active surveillance.
I am 18 years old or older.
I am fully active or have only minor physical limitations.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive TriAdeno vaccine and N-803 injections on Day 1 of each 21-day cycle for up to four cycles

12 weeks
4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including follow-up phone calls for 5 years

5 years
Follow-up calls every 3 months for 1 year, then every 6 months for 4 years

What Are the Treatments Tested in This Trial?

Interventions

  • N-803
  • TriAdeno vaccine

Trial Overview

The study tests a new vaccine (TriAdeno) that targets three cancer proteins plus an immune-boosting drug (N-803). Both are given as injections every three weeks for up to four cycles to see if they can slow down or stop the growth of prostate tumors.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Arm 1Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+

Citations

Multitargeted Recombinant Ad5 PSA/MUC-1/Brachyury ...

N-803 is an IL-15 agonist that activates and expands T cells and NK cells. N-803 enhances anti-tumor activity in combination with tumor-targeted ...

ESMO 2024: Results from the Quick Efficacy Seeking Trial ( ...

... (N-803) in castrate-resistant prostate cancer. Although novel treatment options for castrate-resistant prostate cancer (CRPC) patients have ...

NCT05445882 | N-803 Alone or in Combination With BN ...

Synergistic anti-tumor effects have been observed in vitro when combining bintrafusp alfa and N-803, and in vivo when combining these agents with tumor vaccine ...

Breaking barriers in prostate cancer: the mRNA vaccine ... - PMC

Prostate cancer (PC) treatment is evolving beyond conventional therapies. This review explores mRNA-based vaccines as a promising immunotherapy.

TriAdeno Vaccine + N-803 for Prostate Cancer

... N-803 and TriAdeno vaccine will have tolerable side effects & efficacy for patients with Prostate Cancer, Neoplasms, Lung Cancer, Cancer, Cancer, Prostate ...

Promising novel immunotherapies and combinations ... - PMC

Interestingly, the trial demonstrated an overall survival benefit favoring the treatment arm (median survival: 25.9 vs 21.4 months; p = 0.01). Additional ...

Efficacy of BN-Brachyury (BNVax) + Bintrafusp Alfa (BA ...

The QuEST1 trial was designed to rapidly interrogate the safety and efficacy of a combination of immunotherapy regiments and see the activity of immunotherapy ...