NCT06968988

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Soft-tissue Sarcoma

Interventions

Type	Name	Description
DRUG	Zanzalintinib	Zanzalintinib will be supplied by Exelixis, Inc.
DRUG	Ipilimumab	Ipilimumab will be commercially sourced.
DRUG	Nivolumab	Nivolumab will be commercially sourced.

Timeline

• Start date: 2026-01-05
• Primary completion: 2026-08-12
• Completion: 2031-07-31
• First posted: 2025-05-13
• Last updated: 2026-01-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study