Status:
TERMINATED
VAccination in Early and ADvanced Prostate caNCEr
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
Barinthus Biotherapeutics
Conditions:
Intermediate Risk Prostate Cancer
Castration-resistant Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
Brief 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 cance...
Detailed Description
The purpose of this study was to evaluate the safety and efficacy of a combination of two new vaccines (ChAdOx1.5T4 and MVA.5T4) with a monoclonal antibody (PD-1 mAb, also known as Nivolumab and Opdiv...
Eligibility Criteria
Inclusion
- 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 progression at the time of enrolment
- Suitable to continue therapy with either abiraterone or enzalutamide at the time of enrolment at discretion of their managing clinician
- Patients who have received chemotherapy following progression on androgen-targeting therapies are eligible
- Satisfactory functional status defined as ECOG Performance Status ≤ 1
Exclusion
- For all participants:
- Any prior diagnosis or clinical suspicion of autoimmune disease
- History of allergic disease or reaction likely to be exacerbated by any component of the vaccine, e.g. egg products
- Other prior malignancy with an estimated ≥ 30% chance of relapse within 2 years
- Participation in another research study involving an investigational product or investigational surgical procedure in the 30 days preceding enrolment, or planned use during the study period
- Any prior exposure to checkpoint inhibitor drugs including anti-PD-1, anti-PD-L1, or anti-CTLA-4 monoclonal antibodies or any prior treatment with investigational vaccines
- Administration of immunoglobulins and/or any blood products within the one month preceding the planned administration of the study drugs
- Seropositive for hepatitis B surface antigen (HBsAg)
- Seropositive for hepatitis C virus (antibodies to HCV)
- Any confirmed or suspected immunocompromised state
- Any history of hereditary angioedema, acquired angioedema, or idiopathic angioedema
- History of anaphylaxis in relation to vaccination or any clinically significant allergic disease likely to be exacerbated by any component of the vaccine or checkpoint inhibitor preparations
- For advanced metastatic cohort:
- The treating oncologist estimates a subject's life expectancy to be ≤ 6 months
- Any active, previously treated, or suspected intracranial or leptomeningeal metastases
Key Trial Info
Start Date :
December 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 24 2020
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT03815942
Start Date
December 10 2018
End Date
June 24 2020
Last Update
June 25 2025
Active Locations (2)
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1
Department of Oncology, The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
2
Cancer and Haematology Centre, Churchill Hospital, Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom, OX3 7LE