Zanzalintinib in Combination With Ipilimumab and Nivolumab in Patients With Metastatic Soft Tissue Sarcoma
Phase I Study With Expansion Cohort of Zanzalintinib in Combination With Ipilimumab and Nivolumab in Patients With Metastatic Soft Tissue Sarcoma
Sponsor: Washington University School of Medicine + Exelixis
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Occurrence of dose-limiting toxicities (DLTs)
Time frame: Through day 42
Secondary Endpoints
Frequency and grades of treatment-emergent adverse events (TEAEs)
Rate of treatment discontinuation due to treatment-emergent adverse events (TEAEs)
Objective response rate (ORR) per RECIST 1.1 criteria
Eligibility Criteria
Inclusion Criteria: * Histologically or cytologically confirmed soft tissue sarcoma that is metastatic or unresectable. * Must have received at least one but no more than 3 lines of therapy in the metastatic setting, with progression on last line of therapy. Neoadjuvant or adjuvant therapy completed more than one year prior does not count towards as a line of therapy in the metastatic. Individuals with alveolar soft part sarcoma may enroll without being refractory to at least one line of therapy. * Measurable disease per RECIST 1.1. * At least 18 years of age. * ECOG performance status ≤ 1. * Adequate bone marrow and organ function as defined below: * Absolute neutrophil count (ANC) ≥ 1.5 K/cumm without granulocyte colony-stimulating factor support within 2 weeks prior to screening laboratory collection * Platelets ≥ 100 K/cumm without transfusion within 2 weeks prior to screening laboratory collection * Hemoglobin ≥ 9.0 g/dL without transfusion within 2 weeks prior to screenin…
Read full criteria on CT.gov →✦ Analyst Commentary
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