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NCT06863311PHASE2RECRUITING

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

EXACT: Randomized Phase II Trial of Zanzalintinib (XL092) in Combination With Immunotherapy in Patients Who Progress on Adjuvant Therapy in Clear Cell RCC

Sponsor: Karie Runcie + Exelixis, Columbia University

No open prediction endpoints

Endpoints are classified and published by ProgramSignal analysts.

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Key Facts

Study type
INTERVENTIONAL
Conditions
Advanced Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma, Clear Cell Renal Cell Carcinoma
Interventions
XL092, Nivolumab
Enrollment
70 participants
Primary completion
Dec 2027
Study completion
Dec 2028
First posted
Mar 2025
Last updated
May 2026

Primary Endpoints (CT.gov)

Overall Response Rate (ORR)

Time frame: 6 months

Secondary Endpoints

Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

Progression Free Survival (PFS)

Overall Survival (OS)

Eligibility Criteria

Inclusion Criteria: 1. Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately. 2. Age ≥ 18 years at the time of consent. 3. ECOG Performance Status of 0-1 within 28 days prior to registration. 4. Advanced or metastatic RCC with a clear cell component. 5. Prior treatment must have included an anti-PD-1. Subjects must have progressed on or after adjuvant anti-PD-1 therapy. A washout period of 14 days prior to study treatment initiation is required. Subjects must have recovered from all reversible acute toxic effects of the regimen (other than alopecia) to Grade ≤ 1 or baseline. Unresolved grade 2 or greater toxicity from prior checkpoint inhibitor therapy will exclude a subject from enrolling. Subjects that received other systemic therapy after anti-PD1 are not eligible. 6. Measurable disease per RECIST 1.1. 7. Demonstrate adequate organ fu

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✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov