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VAccination in Early and ADvanced Prostate caNCEr
Phase 1, PHASE2 trial testing ChAdOx1-MVA 5T4 vaccine in Intermediate Risk Prostate Cancer in 23 participants. Terminated before completion.
| Lead sponsor | University of Oxford |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 23 |
| Start date | 10 December 2018 |
| Primary completion | 24 June 2020 |
| Estimated completion | 24 June 2020 |
| Sites | 2 locations across United Kingdom |
University of Oxford
18 and older, male only, with Intermediate Risk Prostate Cancer or Castration-resistant Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. Note: All participants had one or more adverse events during the period they were monitored.
| Group | Value | 95% CI |
|---|---|---|
| Advanced Metastatic Prostate Cancer | 23 |
Evaluate the efficacy by assessing the number of participants with 50% or more change in ctDNA or PSA concentration in the blood from baseline to 12 months post treatment. Change in serum PSA was analysed for this outcome as one the two alternative methods planned. As described in the trial overview, no ctDNA analysis was done due to the trial closing prematurely because of COVID-19 - by the time the pandemic had finished, the facility to perform the ctDNA analysis option was no longer available. Because no laboratory analysis was done, there is no data to report.
| Group | Value | 95% CI |
|---|---|---|
| Advanced Metastatic Prostate Cancer | 5 |
Number of participants with peripheral 5T4-specific T cell responses secondary to treatment
| Group | Value | 95% CI |
|---|---|---|
| Advanced Metastatic Prostate Cancer | 23 |
Number of participants with intraprostatic infiltration of CD3+CD8+ T cells secondary to treatment
| Group | Value | 95% CI |
|---|---|---|
| Advanced Metastatic Prostate Cancer | 23 |
Evaluating the number of participants experiencing progression-free survival at 6 and 12 months post treatment
| Group | Value | 95% CI |
|---|---|---|
| Advanced Metastatic Prostate Cancer | 23 |
Evaluating the number of participants experiencing overall survival at 6 and 12 months post treatment
| Group | Value | 95% CI |
|---|---|---|
| Advanced Metastatic Prostate Cancer | 23 |
Time frame: For 12 months following study treatment. Note that a number of participants withdrew from the study before the 12 months had elapsed.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Intermediate Risk Prostate… | Advanced Metastatic Prosta… |
|---|---|---|---|
| Metastatic spinal cord compression | Musculoskeletal and connective tissue disorders | — | — |
| fatigue/haematura/increasing lymphoedema | Blood and lymphatic system disorders | — | — |
| Possibly urosepsis | Renal and urinary disorders | — | — |
| Worsening renal failure | Renal and urinary disorders | — | — |
| increasing back pain & right arm weakness | Musculoskeletal and connective tissue disorders | — | — |
| pyrexia and rigors | Blood and lymphatic system disorders | — | — |
| progressive lower back pain | Musculoskeletal and connective tissue disorders | — | — |
| Kidney injury | Renal and urinary disorders | — | — |
| Suspected pulmonary clots -> Chest infection (lifelong smoker) | Respiratory, thoracic and mediastinal disorders | — | — |
| Reaction | System | Intermediate Risk Prostate… | Advanced Metastatic Prosta… |
|---|---|---|---|
| Fatigue | General disorders | — | — |
| Myalgia | General disorders | — | — |
| Rash | General disorders | — | — |
| Urinary | Renal and urinary disorders | — | — |
| Anorexia | General disorders | — | — |
| Fever | General disorders | — | — |
| Arthralgia | General disorders | — | — |
| Abdominal pain | General disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Back ache | General disorders | — | — |
| Leg Ache / weakness | Musculoskeletal and connective tissue disorders | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — |
| Discomfort (right) sacrum | Musculoskeletal and connective tissue disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Abdominal discomfort | Gastrointestinal disorders | — | — |
| Chest infection | Respiratory, thoracic and mediastinal disorders | — | — |
| Itch (Local) | General disorders | — | — |
| Altered sensation right finger/thumb | Nervous system disorders | — | — |
| Bilateral lower limb oedema | Blood and lymphatic system disorders | — | — |
| Diarrhoea and vomiting | Gastrointestinal disorders | — | — |
| Sore mouth | General disorders | — | — |
| Tooth Ache | Musculoskeletal and connective tissue disorders | — | — |
| Headache | General disorders | — | — |
| Itch General | General disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Asthenia | General disorders | — | — |
| Bilateral Subconjunctival Ulcers | Eye disorders | — | — |
| Breathlessness | Respiratory, thoracic and mediastinal disorders | — | — |
| Bruising | Skin and subcutaneous tissue disorders | — | — |
| Dry mouth | General disorders | — | — |
| Fall | General disorders | — | — |
| hypotension post vaccine | Blood and lymphatic system disorders | — | — |
| pain injection site L thigh | General disorders | — | — |
| Right Iliac pain | Gastrointestinal disorders | — | — |
| Thirst | General disorders | — | — |
| Warmth | General disorders | — | — |
| acute kidney injury | Renal and urinary disorders | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — |
| Black stools | Gastrointestinal disorders | — | — |
| Bloatedness | General disorders | — | — |
Most-reported serious reactions: Metastatic spinal cord compression, fatigue/haematura/increasing lymphoedema, Possibly urosepsis, Worsening renal failure, increasing back pain & right arm weakness, pyrexia and rigors, progressive lower back pain, Kidney injury.
Data from ClinicalTrials.gov NCT03815942 adverse events section.
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.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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