From the blog

A Phase II Trial to Assess TroVax® Plus Chemotherapy in Patients With Malignant Pleural Mesothelioma (SKOPOS)

Published: April 3, 2012

Primary Outcome Measures:

Immune response to 5T4 and MVA antigens as measured by intracellular cytokine staining (ICCS) [ Time Frame: 34 weeks ] [ Designated as safety issue: No ]
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 Outcome Measures:

Safety and tolerability [ Time Frame: 34 weeks ] [ Designated as safety issue: Yes ]
To investigate the safety and tolerability of TroVax® in combination with Pem/Cis. This will be assessed from toxicity data, SAE reports and dose of chemotherapy received
Clinical activity in terms of PFS, ORR and OS [ Time Frame: 1 year ] [ Designated as safety issue: No ]
To assess secondary measures of clinical activity, including progression-free survival (PFS), objective response rate (ORR), overall survival (OS) at 6 months and 1 year
Relationship between immune response and clinical response [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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).
Identify potential predictors of treatment benefit [ Time Frame: 1 year ] [ Designated as safety issue: No ]
To investigate the utility of (a) baseline platelet levels, (b) baseline monocyte levels and (c) baseline haemoglobin as predictors of treatment benefit.

Eligibility 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 <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
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