Zanzalintinib (XL-092) Plus Durvalumab and Tremelimumab in Unresectable Hepatocellular Carcinoma (ZENOBIA)

No open prediction endpoints

Endpoints are classified and published by ProgramSignal analysts.

Key Facts

Primary Endpoints (CT.gov)

Secondary Endpoints

Eligibility Criteria

Inclusion Criteria: 1. Patients must have unresectable hepatocellular carcinoma. 2. Patients must be treatment naïve for systemic therapy in the unresectable setting. 3. ≥ 18 years and ECOG performance status 0-1 4. Recovery to baseline or ≤ Grade 1 severity (CTCAE v5) from adverse events (AEs), unless AE(s) are clinically nonsignificant and/or stable on supportive therapy (e.g., physiological replacement of mineralocorticosteroid). 5. Adequate organ and marrow function, based upon meeting all of the following laboratory criteria within 14 days before first dose of study treatment. 6. Urine protein-to-creatinine ratio (UPCR) ≤ 1 mg/mg (≤ 113.2 mg/mmol) creatinine. Tumor tissue fresh biopsies are REQUIRED for ALL study participants at screening/baseline unless an archival tumor tissue block is available and fulfills the criteria • Note that PI approval can be obtained if institution is unable to release blocks. 7. Capable of understanding and complying with the protocol requirements a…

✦ Analyst Commentary

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

Source