Nivolumab in Treating Patients With Localized Kidney Cancer Undergoing Nephrectomy

Brief description of study

This randomized phase III trial compares nephrectomy (surgery to remove a kidney or part of a kidney) with or without nivolumab in treating patients with kidney cancer that is limited to a certain part of the body (localized). Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Giving nivolumab before nephrectomy may make the tumor smaller and reduce the amount of normal tissue that needs to be removed, and after nephrectomy to increase survival. It is not yet known whether nivolumab and nephrectomy is more effective than nephrectomy alone in treating patients with kidney cancer.

Clinical Study Identifier: NCT03055013

Detailed Study Description

PRIMARY OBJECTIVES: I. To compare recurrence-free survival (RFS) between patients with locally advanced renal cell carcinoma randomly assigned to perioperative nivolumab in conjunction with radical or partial nephrectomy with patients randomized to surgery alone. SECONDARY OBJECTIVES: I. To evaluate for differences in recurrence-free survival associated with perioperative nivolumab compared to surgery alone among the subset of patients with clear cell histology. II. To compare the overall survival between patients randomized to perioperative nivolumab in addition to resection to patients randomized to primary tumor resection alone. III. To describe the safety and tolerability of perioperative nivolumab. TERTIARY OBJECTIVES: I. To correlate the primary tumor's expression of programmed cell death 1 ligand 1 (PD-L1) with outcome. II. To correlate the expression of PD-L1 on tumor tissue at recurrence with outcome. III. To archive images for central confirmation of recurrence and for future correlative work with American College of Radiology Imaging Network (ACRIN), including markers predicting outcome or response. IV. To prospectively collect tumor and biologic specimens (e.g., serum, peripheral blood mononuclear cells [PBMCs]) for future correlative studies. V. To characterize the pharmacokinetics of nivolumab and explore exposure response relationships with respect to safety and efficacy. VI. To characterize the immunogenicity of nivolumab. VII. To evaluate differences in change from baseline in patient-reported symptoms and toxicities among patients randomized to treatment with nivolumab compared to surgery alone. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive nivolumab intravenously (IV) over 60 minutes on day 1. Treatment repeats every 14 days for 2 courses. Patients then undergo partial or radical nephrectomy. Patient then receive nivolumab IV on day 1. Treatment repeats every 14 days for 6 courses, and then every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. ARM II: Patients undergo partial or radical nephrectomy followed by observation. After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and every 12 months for 5 years.

Contact research investigator to learn more about this study by filling out the form below.


To: Research Study Investigator
Subject: I am interested in participating in your Research Study
Dear Investigator,
I'm interested in learning more about and participating in your research study named: Nivolumab in Treating Patients With Localized Kidney Cancer Undergoing Nephrectomy
Included below is some of my health information:
  1. Condition = Renal Cell Carcinoma
I am hoping to hear back from you and discuss details of the study

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