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ECOG-ACRIN EA8143

Trial Overview

Official Title

A Phase 3 Randomized Study Comparing Perioperative Nivolumab vs. Observation in Patients With Localized Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)

Study Purpose

To compare the rate that cancer returns in patients who have locally advanced renal cell carcinoma who either get standard of care observation after kidney removal or patients who receive nivolumab before and after surgery.

Diagnosis

Newly diagnosed locally advanced renal cell carcinoma (kidney cancer).

Eligibility

Prior therapy: No prior therapy for this cancer.

Patients are not eligible if they have evidence of metastatic cancer.

No prior history of renal cell carcinoma in the last 5 years.

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Intervention

  • Chemotherapy: Nivolumab
  • Quality of Life questionnaires
  • Arm I: Standard of care nephrectomy followed by observation
  • Arm II: 2 doses of nivolumab 2 weeks apart.  Then nephrectomy followed by nivolumab every 2 weeks for 6 doses then every four weeks for six doses

For more information, visit ClinicalTrials.gov

Key Participation Requirements
Gender
Male or Female
Age
19 years and older
Phase
Phase III
Methodist Health System Trial Code
EA8143
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