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VAccination in Early and ADvanced Prostate caNCEr

NCT03815942 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2025-06-25

Study results available
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Summary

This is a clinical trial of a new treatment for prostate cancer that is a type of vaccine that could be a new way to treat cancer. A vaccine that could alert the immune system to the presence of cancer cells in the body may enable the immune system to target and kill those cells effectively. This vaccine is intended to work by making the immune system kill cells that have a special protein (called 5T4) that is present on the surface of cancer cells. The vaccine is made up of two recombinant viruses ("ChAdOx1"- chimpanzee adenovirus Ox1 and "MVA" - modified vaccinia Ankara) that have been designed to produce the 5T4 protein and have been modified so that they are weakened and cannot reproduce themselves within the body like normal viruses. Once injected into the body, these viruses make the 5T4 protein and help the body's immune system to learn to target this protein and destroy cancer cells.

This vaccine will be used in combination with the immunotherapy drug called nivolumab which is an anti-PD-1 (Programmed Death protein-1) monoclonal antibody. This is a molecule that releases the brakes on the immune system and helps the immune system to kill cancer cells more efficiently. Nivolumab as a monotherapy was approved for treatment of several tumour types but not for the prostate cancer.

This study will evaluate the safety and efficacy of ChAdOx1-MVA 5T4 vaccine in combination with nivolumab in low and intermediate risk prostate cancer patients who have elected to have their prostate removed and in patients with advanced metastatic prostate cancer.

Conditions

  • Intermediate Risk Prostate Cancer
  • Castration-resistant Prostate Cancer

Interventions

BIOLOGICAL

ChAdOx1-MVA 5T4 vaccine

ChAdOx1.5T4 will be administered intramuscularly in an extremity (e.g. thigh) at a dose of 2.5 x10\^10 virus particles followed by MVA.5T4 administered via the same route at the dose of 2x10\^8 plaque forming units

DRUG

Nivolumab Infusion [Opdivo]

Nivolumab is to be administered as a flat dose of 480 mg over approximately 60-minutes via IV infusion

Sponsors & Collaborators

  • Barinthus Biotherapeutics

    collaborator INDUSTRY

  • University of Oxford

    lead OTHER

Principal Investigators

  • Adrian VS Hill · University of Oxford

  • Freddie Hamdy · Nuffield Department of Surgical Sciences, Oxford University Hospitals NHS Foundation Trust

  • Andrew Protheroe · Nuffield Department of Surgical Sciences, Oxford University Hospitals NHS Foundation Trust

  • Peter Hoskin · Department of Oncology, The Christie NHS Foundation Trust

  • Mark Tuthill · Oxford Cancer and Haematology Centre, Oxford University Hospitals NHS Foundation Trust

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-10
Primary Completion
2020-06-24
Completion
2020-06-24

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03815942 on ClinicalTrials.gov