Immunotherapy for Prostate Cancer

Recruiting at 10 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

22 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a multi-centre, Phase 1/2, open-label clinical trial of the VTP-850 prime-boost immunotherapeutic in men with biochemical recurrence after definitive local therapy for prostate cancer.

Eligibility Criteria

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

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

PSA doubling time ≤12 months

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

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

Treatment Details

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.

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+