Immunotherapy for Prostate Cancer

No longer recruiting at 11 trial locations

Overseen By General enquiries

Age: 18+

Sex: Male

Trial Phase: Phase 1 & 2

Sponsor: Barinthus Biotherapeutics

Must not be taking: Corticosteroids, Immunosuppressives, others

Disqualifiers: Prior malignancy, Cardiovascular, Liver, others

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new immunotherapy treatment called VTP-850 for men whose prostate cancer has returned after initial treatments like surgery or radiation. The goal is to determine if VTP-850 can help manage the cancer by harnessing the body's immune system. Men with rising prostate-specific antigen (PSA) levels after previous prostate cancer treatment, without evidence of disease spreading, might be suitable candidates. Participants should be ready to follow trial procedures and refrain from starting new prostate cancer treatments during the study. As a Phase 1 trial, this research aims to understand how VTP-850 works in people, offering participants the opportunity to be among the first to receive this new treatment.

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

The trial protocol does not specify if you need to stop taking your current medications. However, it does mention that you cannot be on certain treatments like systemic corticosteroids or immunosuppressive medications within 14 days of the first dose. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that VTP-850 is likely to be safe for humans?

Research shows that VTP-850 is an experimental treatment, meaning it is still under study and not yet approved by the FDA. Early results suggest that people generally tolerate VTP-850 well. Studies with similar treatments have found no serious side effects directly linked to the treatment. This suggests that VTP-850 might be safe, but further research is necessary to confirm this. Since VTP-850 remains in the early testing stages, researchers continue to gather safety information. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for prostate cancer, such as surgery, radiation, and hormone therapy, VTP-850 is an innovative immunotherapy that works by stimulating the body's immune system to specifically target and attack prostate cancer cells. Researchers are excited about this treatment because it uses a unique mechanism that involves a viral vector to enhance the immune response, potentially offering a more targeted and less invasive option compared to traditional therapies. This could mean fewer side effects and improved outcomes for patients, making it a promising new avenue in the fight against prostate cancer.

What evidence suggests that VTP-850 might be an effective treatment for prostate cancer?

Research shows that VTP-850 is designed to help the body's immune system fight prostate cancer by targeting specific proteins related to the cancer, including PSA. In earlier studies, VTP-850 activated strong T cell responses against these proteins, which are connected to prostate cancer cells. Initial results suggest that this treatment can lower PSA levels, a marker often used to monitor prostate cancer. Some patients showed signs of improvement without serious side effects. This indicates that VTP-850 might be effective for men whose prostate cancer has returned after initial treatment. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

Men over 18 with prostate cancer recurrence after initial treatment, no metastasis confirmed by scans, and a rising PSA level. They must have stable vital signs, normal organ function tests, agree to contraception or abstinence, and not start hormone therapy for 4 months post-trial entry. Excluded if they've had other cancers (except certain skin cancers), severe allergies to eggs or vaccines, recent vaccinations or immunotherapies, unstable health conditions or active infections.

Inclusion Criteria

Serum testosterone >75 ng/dL

PSA doubling time ≤12 months

Baseline laboratory parameters must meet specific criteria including haemoglobin, white cell count, absolute neutrophil count, lymphocytes, platelets, creatinine, total bilirubin, alanine aminotransferase, and aspartate aminotransferase levels

Exclusion Criteria

I haven't been part of any experimental treatments or surgeries in the last 3 months.

I haven't had any cancer except for skin cancer that was fully removed over 3 years ago.

I haven't received immunoglobulins or blood products in the last 28 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive ChAdOx1-PCAQ on Day 1 and MVA-PCAQ on Days 29 and 57

8 weeks

3 visits (in-person)

Short-term Follow-up

Participants are monitored for PSA response and safety for 6 months or until new therapy or metastatic PCa development

6 months

Long-term Follow-up

Participants with a PSA response are followed for an additional 18 months, up to 24 months from first dose

18 months

What Are the Treatments Tested in This Trial?

Interventions

• VTP-850

Trial Overview The trial is testing VTP-850 prime-boost immunotherapy in men who have biochemical recurrence of prostate cancer after primary treatments like surgery or radiation. It's an open-label study across multiple centers designed to evaluate the safety and efficacy of this new potential vaccine-based treatment.

How Is the Trial Designed?

Group I: IM/IV Full Experimental Treatment 2 Interventions

ChAdOx1-PCAQ 2.5\*10\^10 vp IM / MVA-PCAQ 2\*10\^7 pfu IV

Group II: IM/IM Low Experimental Treatment 2 Interventions

ChAdOx1-PCAQ 5\*10\^9 vp IM / MVA-PCAQ 5\*10\^7 pfu IM

Group III: IM/IM Full Experimental Treatment 2 Interventions

ChAdOx1-PCAQ 2.5\*10\^10 vp IM / MVA-PCAQ 2\*10\^8 pfu IM

Who Is Running the Clinical Trial?

Barinthus Biotherapeutics

Lead Sponsor

Trials

12

Recruited

3,800+

Vaccitech (UK) Limited

Lead Sponsor

Trials

11

Recruited

3,800+

Citations

1. barinthusbio.com barinthusbio.com/pipeline/cancer/

Pipeline: Cancer VTP-850 is our next-generation immunotherapeutic which encodes for multiple prostate-associated antigens including PSA. PAP, STEAP1 and 5T4 and is due to enter ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.TPS5119

Prime-boost Immunotherapy in Prostate Cancer Recurrence The results indicate that VTP-850 can elicit T cell responses to each of the 4 encoded antigens, with the responses to PSA of greatest ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05617040

NCT05617040 | Prime-boost Immunotherapeutic Trial in ... This is a multi-center Phase 1/2 clinical trial to evaluate safety, PSA response, and immunogenicity of the VTP850 prime-boost immunotherapeutic in men with ...

4. clin.larvol.com clin.larvol.com/trial-detail/NCT05617040

Prime-boost Immunotherapeutic Trial in Men with ... "Phase 1 trial of VTP-850 in patients with prostate cancer: The trial is now complete, with no treatment related SAEs reported. Data shows encouraging signs ...

5. synapse.patsnap.com synapse.patsnap.com/drug/86e2eb741b3e4deb9493e2c4ca0dff4a

VTP-850 - Drug Targets, Indications, Patents Two participants met criteria for functional cure. Two participants who discontinued NUC therapy seroconverted to HBsAb positivity. Nov. 15, 2024 -- Barinthus ...

6. jcto.weill.cornell.edu jcto.weill.cornell.edu/open_clinical_trials/a-phase-1phase-2-trial-to-evaluate-safety-immunogenicity-and-psa-response-of-vtp-850-prostate-cancer-immunotherapeutic-in-men-with-biochemical-recurrence-after-definitive-local-therapy-for-prostate-cancer

A Phase 1/Phase 2 Trial to Evaluate Safety, ... VTP-850 is considered investigational, which means it has not been approved by the U.S. Food and Drug Administration. VTP-850 consists of 2 components: ChAdOx1- ...