An International, Randomised, Double Blind, Placebo Controlled, Parallel Group Study to Investigate Whether TroVax, Added to First-line Standard of Care Therapy, Prolongs the Survival of Patients With Locally Advanced or Metastatic Clear Cell Renal Adenocarcinoma.

Inclusion Criteria:

- Signed informed consent. The patient must be competent to give written informed
consent and comply with the protocol requirements.

- Locally advanced or metastatic, histologically proven clear cell renal carcinoma.

- Primary tumour surgically removed (some residual advanced primary tumour may remain).

- At least four weeks post surgery or radiotherapy.

- First-line. No prior therapy for renal cancer except surgery or radiotherapy.

- Measurable disease.

- Aged 18 years or more.

- Patient expected to survive a minimum of 12 weeks (i.e. in the opinion of the
investigator there is a >90% probability that the patient will survive >12 weeks if
treated with the selected standard of care).

- Free of clinically apparent autoimmune disease (including no prior confirmed
diagnosis or treatment for autoimmune disease including Systemic Lupus Erythematosis,
Grave's disease, Hashimoto's thyroiditis, multiple sclerosis, insulin dependant
diabetes mellitus or systemic (non-joint) manifestations of rheumatoid disease).

- Total white cell count ≥ 3 x 109/L and lymphocyte count ≥1 x 109/L.

- Serum creatinine ≤1.5 times the upper limit of normal.

- Bilirubin ≤ 2 times the upper limit of normal and an SGPT of ≤ 4 times the upper
limit of normal.

- Women must be either post menopausal, or rendered surgically sterile or, if of child
bearing potential, must have been practising a reliable form of contraception (oral
contraception + a barrier method) for at least three months prior to the first dose
of TroVax® and must continue while they are being treated with TroVax®. Men must
practise a reliable form of contraception (barrier or vasectomy) while they are being
treated with TroVax®.

- No acute changes on 12-lead ECG.

- Ejection fraction documented as not less than 45% or no clinical suspicion that
cardiac ejection fraction is less than 45%.(If clinical suspicion exists the ejection
fraction should be measured according to local site procedures).

- Karnofsky performance status of ≥ 80%.

Exclusion Criteria:

- Cerebral metastases. (Known from previous investigations or clinically detectable).

- Previous exposure to TroVax®.

- Serious infections within the 28 days prior to entry to the trial.

- Known to test positive for HIV or hepatitis B or C.

- Life threatening illness unrelated to cancer.

- History of allergic response to previous vaccinia vaccinations.

- Known allergy to egg proteins.

- Known hypersensitivity to neomycin.

- Participation in any other clinical trial of a licensed or unlicensed drug within the
previous 30 days or during the course of this trial.

- Previous malignancies within the last 10 years other than successfully treated
squamous carcinoma of the skin or in situ carcinoma of the cervix treated with cone
biopsy.

- Previous history of major psychiatric disorder requiring hospitalization or any
current psychiatric disorder that would impede the patient's ability to provide
informed consent or to comply with the protocol.

- Oral corticosteroid use unless prescribed as replacement therapy in the case of
adrenal insufficiency.

- Ongoing use of agents listed in locally approved prescribing information as causing
immunosuppression.

- Prior history of organ transplantation.

- Pregnancy or lactation.