A Phase II, Open-label, Single-arm Study of nEoadjuvant Zanzalintinib (XL092) Plus nivoLumab in Patients With lOcally Advanced and/or inopeRable clEar Cell Renal Cell Carcinoma With or Without Non-measurable Metastasis (EXPLORE-RCC)

Summary

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 standard of care systemic therapy and continue follow up per protocol if the participant has disease progression (Cohort B2).

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  Zanzalintinib

  Zanzalintinib 100mg orally (PO) once daily for 12 weeks up (all subjects) and up to 48 weeks from Cycle 1 Day 1 (Cohort B1)

• Drug
  Nivolumab

  Nivolumab will be administered at either 240mg IV every 2 weeks or 480mg IV 4 every weeks for 12 weeks (all subjects) and up to 48 weeks from Cycle 1 Day 1 (Cohort B1).

Location