RecruitingPhase 1NCT06968988

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

Enrollment

18 participants

Start Date

Jan 5, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three drugs — zanzalintinib (which targets blood vessel growth in tumors), ipilimumab, and nivolumab (both immune checkpoint inhibitors) — for people with soft tissue sarcoma that has spread or cannot be removed surgically. **You may be eligible if...** - You have been diagnosed with soft tissue sarcoma confirmed by biopsy or lab analysis, and it has spread or cannot be surgically removed - You have already received between 1 and 3 prior treatments for advanced disease and your cancer has progressed - Your overall health is good enough to tolerate treatment (measured by standard performance criteria) - Your organ function (kidneys, liver, blood counts) is within acceptable ranges **You may NOT be eligible if...** - You have certain types of sarcoma that respond to other specific treatments (such as GIST or Ewing sarcoma, depending on protocol) - You have active autoimmune disease requiring systemic treatment - You have uncontrolled brain metastases - You have had prior immune checkpoint therapy and experienced severe side effects - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGZanzalintinib

Zanzalintinib will be supplied by Exelixis, Inc.

DRUGIpilimumab

Ipilimumab will be commercially sourced.

DRUGNivolumab

Nivolumab will be commercially sourced.


Locations(1)

Washington University School of Medicine

St Louis, Missouri, United States

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NCT06968988


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