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 + Exelixis, University of Texas
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Objective response rate (ORR)
Time frame: 12 weeks
Secondary Endpoints
Conversion from inoperable to operable
Number of Participants with Adverse Events
Eligibility Criteria
Inclusion Criteria: 1. Written informed consent and Health Insurance Portability and Accountability Act (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. Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1 within 30 days prior to registration. 4. Histologically confirmed (i.e., tissue from primary kidney tumor of interest) diagnosis of clear cell renal cell carcinoma with or without sarcomatoid features. NOTE: biopsy should be performed at least 5 days before the first dose of study treatment and must be completely healed before dosing. 5. Locally advanced (cT3/T4, N0-1) OR deemed surgically challenging/inoperable per surgeon discretion. Satisfying either of the criteria allows for enrollment. NOTE: Surgically challenging/inoperable per surgeon discretion is based on one or more of the following, wh…
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