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

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 atta

Trial Details

NCT ID
NCT07516366
Phase
PHASE2
Sponsor
National Cancer Institute (NCI)
Status
RECRUITING
Cancer Type
Kidney Cancer
Interventions
  • Balstilimab
  • Biospecimen Collection
  • Botensilimab
  • Computed Tomography
  • Nephrectomy
  • Questionnaire Administration
Locations (sample)
  • Irvine, California, United States|33.66946,-117.82311
  • Orange, California, United States|33.78779,-117.85311
  • Gainesville, Florida, United States|29.65163,-82.32483
  • Oklahoma City, Oklahoma, United States|35.46756,-97.51643
  • Charlottesville, Virginia, United States|38.02931,-78.47668

Key Eligibility Criteria

  • Patients must have biopsy-confirmed, non-metastatic, high-risk renal cell carcinoma (RCC) with a clear cell component, defined as clinical stage T2…
  • Participants with resectable RCC are eligible, including those who have previously undergone surgical resection for RCC and subsequently developed …
  • Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of botensilimab in combination with balstilimab in patie…
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (or Karnofsky ≥ 60%)

For full eligibility, visit ClinicalTrials.gov.

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