A Phase II Trial to Assess TroVax® Plus Chemotherapy in Patients With Malignant Pleural Mesothelioma
A Phase II Trial to Assess the Safety, Immunological Activity of TroVax® Plus Pemetrexed/Cisplatin in Patients With Malignant Pleural Mesothelioma
  • Phase

    Phase 2
  • Study Type

  • Status

    Unknown status
  • Study Participants

This study is for patients with malignant mesothelioma of the lung lining (called pleura) who are planning to have pemetrexed-cisplatin chemotherapy.

We are investigating whether giving a vaccine called TroVax® with pemetrexed-cisplatin chemotherapy is both safe and potentially beneficial in patients with mesothelioma. This vaccine has been used in combination with chemotherapy in other types of cancer and has been shown to be safe. Cancer vaccines work by stimulating the person's immune system to fight the disease, in a similar way to the immune system fighting infection. In laboratory experiments, the vaccine has been shown to stimulate an immune response to a particular protein widely found on mesothelioma cells called 5T4. In patients with mesothelioma it is hoped that the vaccine will stimulate the immune system to attack mesothelioma cells carrying the 5T4 protein.

Pemetrexed-cisplatin chemotherapy is currently seen as the best treatment for patients with mesothelioma, and this is why we plan to combine it with the vaccine. It is hoped that the combination of the TroVax® vaccine and chemotherapy is more beneficial than chemotherapy alone.

Pemetrexed-cisplatin will be given into a vein in the arm (intravenously) every 3 weeks. The TroVax® vaccine will be given as an injection into the shoulder muscle (intramuscularly) 3 weeks before chemotherapy starts, one week before chemotherapy starts, then every 3 weeks. Each participant will receive 4 chemotherapy and 9 vaccine treatments if they complete the planned trial schedule. We aim to recruit 26 patients into the trial over a two year period. If this study shows that pemetrexed-cisplatin chemotherapy plus the TroVax® vaccine is safe and beneficial in terms of stimulating the immune system, the combination will be tested further in larger clinical trials.
Study Started
Dec 31
Primary Completion
Jun 30
Study Completion
Dec 31
Last Update
Mar 12

Biological TroVax®

Dose of 1 x 10^9 TCID 50/ml, in 1ml, given on day 1 of weeks 1, 3, 6, 9, 12, 15, 18, 21, 24.

Drug Pemetrexed

500 mg/m^2 over 10 mins, given on day 3 of weeks 4, 7, 10, 13.

Drug Cisplatin

75mg/m^2 over 1 hour, given on day 3 of weeks 4, 7, 10, 13

Dietary Supplement Vitamin B12

1000μg intramuscular, Day 2 of weeks 3 and 12

Dietary Supplement Folic Acid

400μg oral daily from Day 2 of week 3 to Day 2 of week 16

Drug Dexamethasone

4mg BD, Days 2-6 of weeks 4, 7, 10, 13

TroVax® Experimental

In this single-arm study, all participants will receive 9 injections of the TroVax® vaccine, plus standard cisplatin and pemetrexed chemotherapy.


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 <0.8 x 10^9/L platelet count >100 x 10^9/L and <400 x 10^9/L. Blood transfusion is allowed.
Adequate renal function: Creatinine ≥ 50 mL/min as measured by EDTA or 60mL/min as measured by the Cockcroft-Gault formula
Adequate liver function: ALT, AST and bilirubin < 2 times the upper limit of normal
At least four weeks from any previous therapy including surgery, or radiotherapy
Able to comply with the protocol
Women must be either post-menopausal, or rendered surgically sterile or, if of child-bearing potential, must have a negative pregnancy test prior to trial entry. Two reliable forms of contraception (oral contraception and a barrier method) must be used by all participants while they are being treated with the TroVax® vaccine. Females must continue to use this level of contraception for 3 months following the last trial treatment, and male patients must continue for 1 month.

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 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
No Results Posted