TerminatedPhase 1/2

VAccination in Early and ADvanced Prostate caNCEr

Stopped: COVID stopped all trials - and ADVANCE could not restart again after the pandemic

United Kingdom23 participantsStarted 2018-12-10

Plain-language 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.

Who can participate

Age range18 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: For all participants: * Histologically confirmed adenocarcinoma of the prostate cancer * Any antineoplastic therapy must have been completed a minimum of 28 days prior to enrolment * Systemic antimicrobial therapy must have been completed a minimum of 7 days prior to enrolment * An archival specimen of tumour tissue should be available * Baseline laboratory parameters must meet the following criteria: Haemoglobin ≥ 80 g/L, White cell count ≥ 2.0 x10\^9/L, Neutrophils ≥ 1.5 x10\^9/L, Lymphocytes ≥ 0.5 x10\^9/L, Platelets ≥ 100 x10\^9/L, Creatinine Clearance ≥ 40 ml/min by Cockcroft Gault formulation, Total Bilirubin ≤ 1.5 ULN, Alanine Aminotransferase ≤ 1.5 ULN, Amylase ≤ 1.5 ULN For surgical cohort: * Clinically localised or locally advanced disease deemed operable by the treating consultant urological surgeon i.e.: Gleason score ≤ 7, local tumour stage ≤T3c and deemed operable, no evidence of metastases (Nx/N0 and Mx/M0), no evidence of high grade Gleason 5 disease, PSA ≤ 20 ng/ml * Scheduled for and considered fit for radical prostatectomy For advanced metastatic cohort: * Evidence of at least one distant metastasis based on MRI, CT, PET or bone scintigraphy * Established on and suitable to continue with androgen deprivation therapy (ADT) using any luteinizing hormone releasing hormone (LHRH) agonist * On treatment with anti-androgen therapy using either abiraterone (Zytiga®) or enzalutamide (Xtandi®) and demonstrating evidence of disease progress…

What they're measuring

Safety - Incidence of Treatment-related Adverse Events.

Timeframe: From baseline to 12 months

Efficacy - Measure Composite Response Rate Defined as One of the Following: 1) Change in Circulating Tumour DNA 2) Change in Serum PSA

Timeframe: From baseline to 12 months

Trial details

NCT IDNCT03815942

SponsorUniversity of Oxford

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-06-24

Results submitted2023-11-30