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.
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.
Age ≥ 18 years at the time of consent.
ECOG Performance Status of 0-1 within 28 days prior to registration.
Advanced or metastatic RCC with a clear cell component.
Prior treatment with Zanzalintinib.
Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 14 days prior to study treatment initiation.
Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) within 28 days prior to study treatment initiation unless otherwise specified.
Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.
Parallel
XL092
Drug100 mg orally
Nivolumab
Drug480 mg intravenously.
Overall Response Rate (ORR)
ORR is defined as the proportion of patients with partial response and complete response per RECIST version 1.1 criteria at any time prior to 6 months
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Safety and tolerability will be assessed based on the severity and frequency of treatment related Grade 3 or higher adverse events graded by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).
Progression Free Survival (PFS)
PFS is defined as the time from randomization to disease progression per RECIST 1.1 or death due to any cause (Arm B).
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause (Arm B)
Duration of Response (DoR)
DoR is defined as the time of response (PR or CR) until the time of progression per RECIST or death due to any cause.
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Karie Runcie
Lead sponsor
Hoosier Cancer Research Network
Sponsor institution
Exelixis
Collaborator
Columbia University
Collaborator
