NCT02432846

Trial name or title	An Open‐Label, Randomised, Controlled, Multicenter, Phase II Study Evaluating Safety and Efficacy of Intratumourally Administered Intuvax Pre‐nephrectomy Followed by Sunitinib Post‐Nephrectomy, Compared to Sunitinib Post‐Nephrectomy in Metastatic Renal Cell Carcinoma Patients (MERECA).
Methods	Study design: 2‐arm, parallel‐group, open‐label RCT, 2:1 randomization. Setting: multicentre, phase II. Countries: Sweden.
Participants	Main inclusion criteria: aged ≥ 18 years, either gender, informed consent, recent (< 6 months) diagnosed RCC with at least 1 CT‐verified metastasis, planned resection of primary tumour, primary tumour diameter ≥ 4 cm, candidate for standard first‐line therapy with sunitinib, adequate haematological parameters and liver function. Main exclusion criteria: life expectancy < 4 months; active autoimmune disease requiring treatment with systemic immunosuppressive agents, e.g. inflammatory bowel disease, multiple sclerosis, sarcoidosis, psoriasis, autoimmune haemolytic anaemia, rheumatoid arthritis, systemic lupus erythematosus, vasculitis, Sjögren's syndrome, scleroderma and autoimmune hepatitis; treatment with systemic corticosteroids within 7 days before screening, known cardiomyopathy or clinical significant finding in electrocardiography at screening (or both); KPS < 70%. Sample size planned:90.
Interventions	Group 1: intuvax + nephrectomy + sunitinib. Group 0: nephrectomy + sunitinib.
Outcomes	Primary outcome: median OS from randomization for high‐risk patients, 18‐month OS in the intermediate‐risk mRCC patients. Secondary outcomes: safety, PFS.
Starting date	April 2015.
Contact information	henrik.elofsson@immunicum.com.
Notes	Estimated primary completion date: February 2018.