Testing the Addition of the Drug Nivolumab Before and After Surgery for Renal Cell Cancer

June 13, 2017
EA8143
Renal Cancer
Brian Myre, MD

Edward Cancer Center - Naperville
Edward Cancer Center - Plainfield
Nancy Knowles Cancer Center - Elmhurst

The purpose of this study is to compare good and bad effects of using nivolumab (also known as OPDIVO®), before and after kidney cancer surgery to using the usual approach of surgically removing the kidney cancer followed by standard post-operative follow-up and monitoring.

Sponsor: Eastern Cooperative Oncology Group (ECOG)

https://clinicaltrials.gov/ct2/show/NCT03055013

  • Over age of 18
  • Preoperative biopsy for confirmation of renal cell carcinoma (RCC) must be performed within four (4) months prior to randomization
  • Patients with newly diagnosed higher risk RCC of any histology including sarcomatoid or (if preoperative biopsy was uninformative) - "unknown" histology; RCC must have been confirmed by biopsy within 4 months prior to randomization; if the biopsy clearly demonstrated a benign condition or a different type of cancer
  • Clinical stage >= T2NxM0 or TanyN+ disease for which radical or partial nephrectomy is planned
  • Patients must have no clinical or radiological evidence of distant metastases (M0)
  • No concurrent or prior systemic or local anti-cancer therapy for RCC is permitted; examples of these prohibited therapies include:
    • Radical or partial nephrectomy for prior RCC
    • Metastectomy for RCC
    • Radiation therapy to the renal bed or any distant metastatic sites
    • Antineoplastic systemic therapies for RCC: i.e., chemotherapy, hormonal therapy, immunotherapy, or standard or investigational agents for treatment of RCC
    • Prior treatment with an anti-programmed cell death 1 (PD-1), anti-programmed cell death-ligand 1 (PD-L1), anti-PD-L2, anti-cluster of differentiation (CD)137, or anti-cytotoxic T-lymphocyte protein 4
    • (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

10 years

Accepting Participants
Interventional
III
Kathy Seymour, BSN
630-646-6075
630-646-6110
630-646-6072