Phase 2 Trial of Zanzalintinib and Pembrolizumab in Select Subtypes of Advanced/Metastatic Soft-tissue Sarcoma
M.D. Anderson Cancer Center
Summary
To learn if zanzalintinib and pembrolizumab can help to control select subtypes of advanced/metastatic soft-tissue sarcoma (UPS, MFS, HGPS, and HGUS
Description
Primary Objectives 1\. To estimate the progression free survival (PFS), defined as the time from enrollment to time of first event (progressive disease per RECIST v.1.1 criteria or death from any cause) after receiving zanzalintinib and pembrolizumab or date of last contact for participants without an event Secondary Objectives 1. To estimate the progression free rate (progressive disease per RECIST v.1.1 criteria70 or death from any cause after first drug) at 6 months and 1 year 2. To estimate the overall response rate (ORR) as measured by RECIST v1.1 a 3. To describe the toxicity of zanza…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Eligibility Criteria * Participants must have histologically or cytologically confirmed undifferentiated pleomorphic sarcoma (UPS), myxofibrosarcoma (MFS), high grade pleomorphic (HGPS) or undifferentiated sarcoma (HGUS). * Participant ≥ 18 years of age. Because no dosing or adverse event data are currently available on the use of zanzalintinib in combination with pembrolizumab in participants \<18 years of age, children are excluded from this study. * ECOG performance status ≤2 (Karnofsky ≥60%). * Participants must have measurable disease, defined as at least one lesion that can be accuratel…
Interventions
- DrugZanzalintinib
Given by po
- DrugPembrolizumab
Given by iv
Location
- MD Anderson Cancer CenterHouston, Texas