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8110 Gatehouse Road, Falls Church, VA 22042

A Phase III Randomized Study Comparing the Combination of Nivolumab and Ipilimumab Versus Placebo in Participants With Localized Renal Cell Carcinoma (CheckMate 914)

General Information

Age Group

Adult

Status

Recruiting

Protocol Number

NCT03138512

Background Information

The purpose of this study is to test the effectiveness, safety, and tolerability of an investigational drug combination of nivolumab (also known as BMS-936558) and ipilimumab (also known as BMS-734016) in subjects with localized kidney cancer that have had their tumors completely removed but are at risk of having their cancer return.

Offered At

Inova Schar Cancer Institute
8081 Innovation Park Drive
Fairfax, VA 22031
A department of Inova Fairfax Hospital

Eligibility Information

  • Participants must be 18 years of age or older
  • Kidney tumor has been completely resected with negative surgical margins obtained. The nephrectomy must occur greater than 4 weeks and less than (or equal to) 12 weeks from the date of nephrectomy. Partial nephrectomy is allowed provided all inclusion criteria are met
  • Additional eligibility in protocol

Ineligibility Information

  • A diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 14 days before the first dose of study treatment
  • Any severe or serious, acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, including ongoing or active infection requiring parental antibiotics
  • Participants must have no clinical or radiological evidence of macroscopic residual disease or distant metastases (M0) after nephrectomy
  • Uncontrolled adrenal insufficiency
  • Additional ineligibility in protocol

For more information go to: https://clinicaltrials.gov/ct2/show/NCT03138512?term=03138512&rank=1