RecruitingPhase IIEN originalKidney cancer

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

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This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the 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 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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • •Potwierdzony biopsją rak nerki typu jasnokomórkowego, który nie rozprzestrzenił się na inne narządy
  • •Wiek co najmniej 18 lat
  • •Możliwość usunięcia guza poprzez operację w celu wyleczenia
  • •Dotychczas bez leczenia immunoterapią lub innymi lekami przeciwnowotworowymi
  • •Zadowalający ogólny stan zdrowia (sprawność do pracy minimum 60%)
  • •Prawidłowe wyniki badań krwi (liczba płytek i białych krwinek)
  • •Prawidłowa funkcja wątroby i nerek
  • •Pacjenci z HIV mogą być włączeni jeśli wirusowe obciążenie jest niewykrywalne

✗ Disqualifies

  • •Wiek poniżej 18 lat
  • •Poprzednie leczenie immunoterapią lub innymi lekami systemowymi na raka nerki
  • •Guz rozszerzony do węzłów chłonnych poza możliwością usunięcia operacyjnego
  • •Przerzuty raka do innych organów

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
October 15, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (4)

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, United States

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, United States

University of Oklahoma Health Sciences Center

Oklahoma City, United States

University of Virginia Cancer Center

Charlottesville, United States

Trial contact

Site Public Contact

Michael Daneshvar

PRINCIPAL_INVESTIGATOR

Adanma Anji Ayanambakkam Attanathi

PRINCIPAL_INVESTIGATOR

Jack Masur

PRINCIPAL_INVESTIGATOR

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/5/2026.

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