Trial of Zanzalintinib (XL092) in Combination With Immunotherapy in Patients Who Progress on Adjuvant Therapy in Clear Cell RCC

Part of paid clinical trials in La Jolla, California.

Sponsor
Karie Runcie
Study ID
NCT06863311
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • XL092 — DRUG
    100 mg orally
  • Nivolumab — DRUG
    480 mg intravenously.

Study Details

The study population for this Phase 2 study will include men and women ≥ 18 with confirmed renal cell carcinoma who have progressed on adjuvant anti-PD-1/PD-L1 therapy, the current standard of care. Subjects will be randomized to Arm A or Arm B. Study treatment will be given in 28-day (4 week) cycles. Arm A treatment will consist of zanzalintinib (XL092) alone and will be taken once daily continuously (Day 1-Day 28). Arm B treatment will consist of XL092 plus nivolumab. XL092 will be taken once daily continuously (Day 1-Day 28) and nivolumab will be administered every 4 weeks (Day 1). Treatment will continue until progression by RECIST 1.1, toxicity, or other reasons as appropriate.

Key Dates

Start date
Mar 13, 2026
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: XL092
    Study treatment will be given in 28-day (4 week) cycles. Arm A treatment will consist of XL092 60 mg orally alone and will be taken once daily continuously (Day 1-Day 28). Treatment will continue until progression by RECIST 1.1, toxicity, or other reasons as appropriate.
  • Experimental: Arm B: XL092 and Nivolumab
    Study treatment will be given in 28-day (4 week) cycles. Arm B treatment will consist of XL092 60 mg plus nivolumab 480 mg intravenously. XL092 will be taken once daily continuously (Day 1-Day 28) and nivolumab will be administered every 4 weeks (Day 1). Treatment will continue until progression by RECIST 1.1, toxicity, or other reasons as appropriate.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: 6 months ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of California San DiegoLa JollaCalifornia92093
Elizabeth Elmes
[email protected]
858-822-6185
Rana McKay, MD (PRINCIPAL_INVESTIGATOR)
Indiana University Melvin and Bren Simon Comprehensive Cancer CenterIndianapolisIndiana46202
Maria Burton
[email protected]
317-278-2535
Jennifer King, MD (PRINCIPAL_INVESTIGATOR)
Washington University School of MedicineSt LouisMissouri63110
Lynne Mitchell, MS CRM, MA BS
[email protected]
Melissa Reimers, MD (PRINCIPAL_INVESTIGATOR)
Columbia University Irving Medical CenterNew YorkNew York10032
Zach Leid
[email protected]
212-305-0787
Clinical Protocol and Data Management Office
[email protected]
212-305-0787
Karie Runcie, MD (PRINCIPAL_INVESTIGATOR)

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