OncRef

Clinical Trial: NCT04510597

Comparing the Outcome of Immunotherapy-Based Drug Combination Therapy With or Without Surgery to Remove the Kidney in Metastatic Kidney Cancer, the PROBE Trial

Status:

RECRUITING

Phase:

Phase 3

Lead Sponsor:SWOG Cancer Research Network
Information Provided By:SWOG Cancer Research Network
Last Update Posted:2026-10-08

Study Overview

Brief Summary

This phase III trial compares the effect of adding surgery to a standard of care immunotherapy-based drug combination versus a standard of care immunotherapy-based drug combination alone in treating patients with kidney cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab, pembrolizumab, and avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Surgery to remove the kidney, called a nephrectomy, is also considered standard of care; however, doctors who treat kidney cancer do not agree on its benefits. It is not yet known if the addition of surgery to an immunotherapy-based drug combination works better than an immunotherapy-based drug combination alone in treating patients with kidney cancer.

Official Title

Phase III Trial of Immunotherapy-Based Combination Therapy With or Without Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma (PROBE Trial)

Conditions

Metastatic Clear Cell Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v8

Intervention / Treatment

  • Procedure: Cytoreductive Nephrectomy
  • Drug: Active Comparator

Other Study ID Numbers

  • S1931
  • NCI-2020-04442

Start Date (Actual)

2021-03-08

Primary Completion Date (Estimated)

2033-07

Study Completion Date (Estimated)

2033-07

Enrollment (Estimated)

364

Study Type

Interventional

Phase

Phase 3