The study is for patients with malignant mesothelioma of the lung lining(called pleura). MedDRA version: 13.1 Level: PT Classification code 10035603 Term: Pleural mesothelioma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Trovax
Product Name: TroVax
Pharmaceutical Form: Powder for solution for injection
Sponsors
Velindre NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Signed and dated written informed consent obtained from the patient in accordance with the local regulations • Locally advanced or metastatic, histologically or cytologically proven MPM • Aged 18 years or over • WHO performance status 0-1 (Appendix I) • Life expectancy > 6months • Haemoglobin = 12 g/dl, total white cell count = 3 x 10^9/L, neutrophil count > 1.5 x 10^9/L, lymphocyte count =1 x 10^9/L, monocyte count 100 x 10^9/L and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: *Serious infections within the 28 days prior to entry to the trial. *Prior TroVax® treatment *Previous chemotherapy for MPM *Major surgery or radiation therapy completed = 4 weeks prior to enrolment *Prior radiopharmaceuticals (strontium, samarium) less than 8 weeks prior to enrolment *Participation in any other clinical trial of a licensed or unlicensed drug within the previous 30 days *History of prior malignant disease unless patient has been disease-free for at least 3 years or the tumour was a non-melanoma skin cancer or early cervical cancer *Autoimmune disease including systemic Lupus Erythematosis, Grave’s disease, Hashimoto’s thyroiditis, multiple sclerosis, insulin dependent diabetes mellitus or systemic (non-joint) manifestations of rheumatoid disease *Clinical significant cardiac failure or a measured ejection fraction of <40% *Other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgement of the investigator, would make the patient inappropriate for entry into this study. *Chronic oral corticosteroid use unless prescribed as replacement therapy in the case of adrenal insufficiency, or other immunosuppressive agents. Dexamethasone is allowed as part of trial treatment. *Cerebral metastases *History of allergic response to previous vaccine vaccinations *Known allergy to egg proteins *Known to test positive for HIV or hepatitis B or C *Pregnancy or lactation *Prior history of organ transplantation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate whether TroVax® is active in the treatment of MPM. This will be assessed by measuring the cellular or humoral anti-5T4 immune responses following treatment with TroVax® given in combination with Pem/Cis.; Secondary Objective: To investigate the safety and tolerability of TroVax® in combination with Pem/Cis To assess secondary measures of clinical efficacy, including progression-free survival (PFS), objective response rate (ORR), overall survival (OS) at 6 months and 1 year. To explore the relationship between immune response (antibody and cellular responses against the tumour 5T4 and the MVA viral vector) and clinical response (PFS, ORR, OS). To investigate the utility of (a) baseline platelet levels, (b) baseline monocyte levels and (c) baseline haemoglobin as predictors of treatment benefit. ; Primary end point(s): *Cellular response to 5T4 and MVA antigens as measured by Peripheral Blood Mononuclear Cell (ICCS) *Antibody response to 5T4 and MVA antigens as measured by ELISA | — |
Countries
United Kingdom
Outcome results
None listed