Neoadjuvant Zanzalintinib Plus Nivolumab in Patients With Locally Advanced and/or Inoperable Clear Cell Renal Cell Carcinoma With or Without Non-measurable Metastasis

All subjects will receive zanzalintinib 100mg orally (PO) once daily plus nivolumab standard of care dosing (i.e., 240mg IV every 2 weeks or 480mg IV every 4 weeks) for a total of 12 weeks, followed by restaging scan/evaluation for surgical operability and an adaptive approach that includes (1) surgical resection if the participant is eligible for surgery (Cohort A), (2) up to 48 weeks total (from Cycle 1 Day 1) of zanzalintinib plus nivolumab if the participant has partial response or stable disease but remains inoperable (Cohort B1), or (3) stopping protocol mandated treatment to receive sta

Trial Details

NCT ID
NCT06794229
Phase
PHASE2
Sponsor
Qian Qin
Status
RECRUITING
Cancer Type
Kidney Cancer
Interventions
  • Zanzalintinib
  • Nivolumab
Locations (sample)
  • St Louis, Missouri, United States|38.62727,-90.19789
  • Dallas, Texas, United States|32.78306,-96.80667
  • Richmond, Virginia, United States|37.55376,-77.46026

Key Eligibility Criteria

  • Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information p…
  • Age ≥ 18 years at the time of consent.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1 within 30 days prior to registration.
  • Histologically confirmed (i.e., tissue from primary kidney tumor of interest) diagnosis of clear cell renal cell carcinoma with or without sarcomat…

For full eligibility, visit ClinicalTrials.gov.

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