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Looking for volunteers

Testing the Safety and Feasibility of Immunotherapy Drugs, Botensilimab and Balstilimab, Before Surgery for Clear Cell Renal Cell Carcinoma, NEO RoBOT Trial

NCT07516366 · National Cancer Institute (NCI) · Updated 21 Oct 2026

What is being tested
Balstilimab; Biospecimen Collection; Botensilimab; Computed Tomography; Nephrectomy; Questionnaire Administration
For
Clear Cell Renal Cell Carcinoma; Stage II Renal Cell Cancer AJCC v8; Stage III Renal Cell Cancer AJCC v8; Stage IV Renal Cell Cancer AJCC v8
Kind of study
Tests a treatment or device on volunteers. Phase 2.
Who can join
Ages 18 years and older. About 16 people. The full rules are on the registry page.
Where
United States (5 sites)
When
Starts or started 17 May 2027, ends 31 Dec 2028. Registered 8 April 2026.
Results
None posted yet.

In the researchers' words

This phase II trial tests the effect of botensilimab and balstilimab before surgery (neoadjuvant) in treating patients with high-risk clear cell renal cell cancer that has not spread from where it first started to other areas of the body (non-metastatic). The current standard treatment for patients with non-metastatic clear cell renal cell cancer may include surgery to completely remove the tumor. This typically involves removing the kidney or part of the kidney (nephrectomy). Immunotherapy with monoclonal antibodies, such as botensilimab and balstilimab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving neoadjuvant botensilimab and balstilimab may be safe, tolerable, and/or effective in treating patients with high-risk non-metastatic clear cell renal cell cancer before undergoing a nephrectomy.
ClinicalTrials.gov, NCT07516366

Sites

  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory CareIrvine, California, United States
  • UC Irvine Health/Chao Family Comprehensive Cancer CenterOrange, California, United States
  • UF Health Cancer Institute - GainesvilleGainesville, Florida, United States
  • University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma, United States
  • University of Virginia Cancer CenterCharlottesville, Virginia, United States