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ECOG-ACRIN EA8143

 

Status:

Recruiting | Phase III 

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.

Interventions:   

  • Chemotherapy: Nivolumab
  • Quality of Life questionnaires
  • Arm I: Standard of care nephrectomy followed by oberservation.
  • 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.

Key Participation Requirements:

Gender:

Male or Female

Age:

19 years and older

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.

Methodist Health System Trial Code:

ECOG-ACRIN EA8143

For more information, visit the U.S. National Library of Medicine clinical trial database.

To learn more about this clinical trial please contact us today!