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

StatusRecruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 1 year 4 months later Aug 30, 2027 → Dec 31, 2028
See other at-risk trials from National Cancer Institute (NCI)

Record History

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  1. Trial sites expanded: 1 → 4 locations
  2. Study sites: 1 to 3
  3. Study sites: 2 to 1
  4. Study sites: 1 to 2
    • Eligibility criteria expanded, about 31 words
    • Secondary endpoints: details revised at 5 of 6 entries
    • Study description revised
  5. Re-verified, no change to tracked fieldsv7
  6. Primary and study completion pushed from Aug 30, 2027 to Dec 31, 2028v6 Show 5 more changesShow less
    • Recruitment opened
    • Start date: Aug 21, 2026 to May 17, 2027
    • Study sites: 0 to 1
    • Eligibility criteria expanded, about 72 words
    • Secondary endpoints: details revised at 1 of 6 entries
  7. Start date: Jun 4, 2026 to Aug 21, 2026v5
  8. 3 versions Re-verified since Apr 8, 2026, no change to tracked fieldsv2-v4
  9. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07516366
Lead Sponsor National Cancer Institute (NCI)
Conditions
(from sponsor)		 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
Related terms Carcinoma, Renal Cell
Enrollment 16 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov