A Phase 2, Multi-Center, Randomized, Open-Label Study of Two Dose Levels of IMOxine® (IMO-2055 for Injection) in Patients With Metastatic or Locally Recurrent Clear Cell Renal Carcinoma
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the best overall objective response (Complete Response [CR] + Partial Response [PR]), by RECIST in patients with clear cell metastatic or locally recurrent renal cell carcinoma treated with IMO-2055.
every 2 cycles
Alice Bexon, MD
United States: Food and Drug Administration
|Georgetown University, Lombardi Cancer Center||Washington, District of Columbia 20007|