The patients will be stratified, according to the Heng risk criteria, (36 high risk patients, 54 intermediate risk patients) and randomized in a 2:1 ratio to receive Intuvax+ Sunitinib or Sunitinib alone.

The high-risk patients will start Sunitinib treatment 5-8 weeks after operation, whereas the intermediate risk patients will start Sunitinib when tumour progression is verified according to Response Evaluation Criteria in Solid Tumors (RECIST).

Results from the phase I study, together with the results reported in the literature on the use of autologous dendritic cells (DCs) in combination with Sunitinib encourage Immunicum AB to further investigate the possibility of exploiting Intuvax vaccination when combined with Sunitinib for the treatment of mRCC patients.

Inclusion Criteria:

• Recent (<6 months) diagnosed RCC with at least one (1) CT-verified metastasis
• Planned resection of primary tumor
• Primary tumor diameter ≥4 cm
• Candidate for standard first-line therapy with Sunitinib
• Female or male ≥18 years of age
• Willing and able to provide informed consent
• Adequate hematological parameters, i.e:
  • B-Leukocyte count ≥4.5 x109/L
  • B-Platelet count ≥150 x109/L
  • B-Hemoglobin ≥100 g/L
• Adequate liver function, i.e. Child-Pugh maximum stage A
• Female who has been post-menopausal for more than one (1) year or female of childbearing potential using a highly efficient method of contraception (i.e. a method with less than 1% failure rate [e.g. sterilization, hormone implants, hormone injections, some intrauterine devices, or vasectomized partner or combined birth control pills]) during the study. Female of childbearing potential must have a negative blood pregnancy test at Screening, and if randomized to vaccination a negative blood or urine pregnancy test within one (1) day before each dose of Intuvax) and must not be lactating.

or Male agreeing to use condoms during the study, or male having a female partner who is using a highly efficient method of contraception as described above.

Exclusion Criteria:

• Life expectancy less than 4 months
• Active autoimmune disease which requires treatment with systemic immunosuppressive agents, e.g. inflammatory bowel disease, multiple sclerosis, sarcoidosis, psoriasis, autoimmune hemolytic anemia, rheumatoid arthritis, systemic lupus erythematosus (SLE), vasculitis, Sjögren's syndrome, scleroderma, autoimmune hepatitis, and other rheumatological diseases
• Treatment with systemic corticosteroids (inhaled, intranasal and local steroids accepted) within 7 days before Screening
• Clinical significant finding in ECG at Screening
• Karnofsky performance status <70%
• National Cancer Institute (NCI) Common Terminology criteria for Adverse Events (CTCAE) Grade 3 hemorrhage within 28 days before Screening
• Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
• Clinically significant gastrointestinal abnormalities
• Uncontrolled hypertension, cardiomyopathy, or diabetes mellitus
• Pulmonary embolism within 12 months from randomization
• Prior history of invasive malignancy, except for adequately treated in situ carcinomas or non-melanoma skin cancer
• Ongoing infection that requires parenteral treatment with antibiotics
• Active or latent virus disease (HIV, hepatitis B and hepatitis C)
• ECOG performance status >2 after optimization of analgesics
• Inadequate coagulation parameters, i.e.:
  • Prothrombin Time - International Normalized Ratio (PT-INR)
  • Activated Partial Thromboplastin Time (APTT)
• Known major adverse reaction/event in connection with previously made vaccination (e.g. asthma, anaphylaxis or other serious reaction)
• Known hypersensitivity or allergy to Intuvax, Sunitinib or to chemically related products
• Prior antitumor therapy within 28 days before Screening visit
• Exposure to other investigational products within 28 days prior to Screening
• History of alcohol or substance abuse
• Any reason that, in the opinion of the Investigator, contraindicates that the patient participates in the study