Clinical Trial TitleAn open-label, randomized, controlled, multicenter, phase II study evaluating safety and efficacy of intratumorally administered intuvax pre-nephrectomy followed by sunitinib post-nephrectomy, compared to sunitinib post-nephrectomy in mRCC.
Clinical Trial Protocol Description:
To provide intratumorally administered intuvax pre-nephrectomy followed by sunitinib post-nephrectomy, compared to sunitinib post-nephrectomy in treatment for patients with advanced renal cell carcinoma (RCC) and to collect additional data on treatment safety.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have newly (<6 months) diagnosed RCC (histological/cytological verification is optional) with at least one (1) CT-verified metastasis ≥10 mm for which complete metastasectomy is not planned. US patients must have verified clear-cell tumor histology.
- Have planned resection of primary tumor.
- Have primary tumor diameter ≥40 mm.
- Are a candidate for first-line therapy with sunitinib initiated five (5) to eight (8) weeks after nephrectomy.
You will be excluded from the study if any of the following criteria apply to you:
- Have life expectancy less than 4 months.
- Have central nervous system (CNS) metastasis that is symptomatic or progressing or untreated or that requires current therapy (e.g. evidence of new or enlarging CNS metastasis or new neurological symptoms attributable to CNS metastases).
- Have active autoimmune disease which requires treatment with systemic immunosuppressive agents (e.g. inflammatory bowel disease, multiple sclerosis, sarcoidosis, psoriasis, autoimmune hemolytic anemia, rheumatoid arthritis, SLE, vasculitis, Sjögren's syndrome, scleroderma, autoimmune hepatitis, and other rheumatological diseases).
- Have been treated with per oral systemic corticosteroids exceeding 10 mg/day within 7 days before screening until nephrectomy. (Inhaled, intranasal, and local steroids acceptable irrespective of dose.)
This is a partial list of inclusion and exclusion criteria.