RecruitingPhase 2NCT06794229

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

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)

Sponsor

Qian Qin

Enrollment

69 participants

Start Date

Oct 30, 2025

Study Type

INTERVENTIONAL

Conditions

Locally Advanced Renal Cell Carcinoma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of zanzalintinib (a drug that cuts off tumor blood supply) and nivolumab (an immunotherapy drug) given before surgery in people with advanced or inoperable kidney cancer (clear cell renal cell carcinoma). The goal is to shrink the tumor so surgery becomes possible. **You may be eligible if...** - You are 18 or older with confirmed clear cell kidney cancer that is locally advanced or considered inoperable - Your cancer has not spread widely to distant organs - Your overall health is adequate (ECOG 0–1) **You may NOT be eligible if...** - You have already received treatment for this kidney cancer - You have active autoimmune disease requiring treatment - You have significant heart, liver, or other organ problems Talk to your doctor to see if this trial is right for you.

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Interventions

DRUGZanzalintinib

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

DRUGNivolumab

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).

Locations(1)

University of Texas Southwestern Medical Center

Dallas, Texas, United States

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NCT06794229

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