National Cancer Institute (NCI)
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.
PRIMARY OBJECTIVE: I. To investigate the safety and feasibility of neoadjuvant botensilimab and balstilimab in high-risk (T2a-T4Nany M0 or Tany N1M0) non-metastatic clear cell renal cell carcinoma via assessment of ability to undergo timely nephrectomy. SECONDARY OBJECTIVES: I. To investigate the safety of neoadjuvant botensilimab and balstilimab in high-risk (T2a-T4Nany M0 or Tany N1M0) non-metastatic clear cell renal cell carcinoma via assessment of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. II. To investigate the surgical morbidit…
Inclusion Criteria: * Patients must have biopsy-confirmed, non-metastatic, high-risk renal cell carcinoma (RCC) with a clear cell component, defined as clinical stage T2N0, T3N0, T4N0, or any T stage with N1 disease (i.e., T2a-T4NanyM0 or TanyN1M0), and no evidence of metastatic disease * Participants with resectable RCC are eligible, including those who have previously undergone surgical resection for RCC and subsequently developed resectable recurrent disease. Patients must be candidates for further curative-intent surgical resection. Prior systemic therapy for RCC (including VEGF-targeted…
Given IV
Undergo blood sample collection
Given IV
Undergo CT
Undergo nephrectomy
Ancillary studies
Arctuva estimate
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