Phase I Study With Expansion Cohort of Zanzalintinib in Combination With Ipilimumab and Nivolumab in Patients With Metastatic Soft Tissue Sarcoma
Washington University School of Medicine
Summary
The investigators hypothesize that zanzalintinib in combination with ipilimumab and nivolumab will be well tolerated and serve as a potential therapeutic strategy in metastatic soft tissue sarcoma (mSTS) including myxofibrosarcoma, undifferentiated pleomorphic sarcoma, dedifferentiated liposarcoma, cutaneous angiosarcoma, and undifferentiated sarcoma histologies.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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. *…
Interventions
- DrugZanzalintinib
Zanzalintinib will be supplied by Exelixis, Inc.
- DrugIpilimumab
Ipilimumab will be commercially sourced.
- DrugNivolumab
Nivolumab will be commercially sourced.
Location
- Washington University School of MedicineSt Louis, Missouri