NCT07283731

Phase 2 Trial of Zanzalintinib and Pembrolizumab in Select Subtypes of Advanced/Metastatic Soft-tissue Sarcoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To learn if zanzalintinib and pembrolizumab can help to control select subtypes of advanced/metastatic soft-tissue sarcoma (UPS, MFS, HGPS, and HGUS

Detailed 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 zanzalintinib and pembrolizumab, defined by the rate of Grade 3 or higher adverse events by CTCAE v5 criteria

Conditions

• Phase 2
• Zanzalintinib
• Pembrolizumab
• Advanced/Metastatic
• Soft-Tissue Sarcoma

Interventions

Type	Name	Description
DRUG	Zanzalintinib	Given by po
DRUG	Pembrolizumab	Given by iv

Timeline

• Start date: 2026-06-02
• Primary completion: 2028-11-01
• Completion: 2030-11-01
• First posted: 2025-12-16
• Last updated: 2026-04-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study