Conditions: Renal Cell Carcinoma
Keywords: renal cell renal carcinoma metastatic recurrent treatment naive
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 92
Healthy volunteers: no

Brief summary:
* Multi-Center
* Randomized
* Open-Label Study of single agent IMO-2055
* Patients who have Metastatic or Locally Recurrent Clear Cell Renal Carcinoma (RCC)

Detailed description:
This is a study of 2 dose levels (0.16 or 0.64 mg/kg) of IMO-2055 administered by weekly subcutaneous (SC) injections in two patient populations, treatment naïve or previously treated patients. Each dose group (treatment naive or previously treated) will be randomized to receive one of the 2 doses being studied.

Arms:
arm 1: Patients will have clear cell renal carcinoma with previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.16mg/kg arm 2: Patients will have clear cell renal carcinoma with previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.64mg/kg arm 3: Patients will have clear cell renal carcinoma without previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.16mg/kg arm 4: Patients will have clear cell renal carcinoma without previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.64mg/kg

Interventions: intervention 1: IMO-2055
Intervention descriptions: intervention 1: immunostimulatory oligonucleotide

Protocol document: