Actively Recruiting
Zanzalintinib in Combination With Ipilimumab and Nivolumab in Patients With Metastatic Soft Tissue Sarcoma
Led by Washington University School of Medicine · Updated on 2026-01-08
18
Participants Needed
1
Research Sites
290 weeks
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
E
Exelixis
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Zanzalintinib in Combination With Ipilimumab and Nivolumab in Patients With Metastatic Soft Tissue Sarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed metastatic or unresectable soft tissue sarcoma.
- Received between 1 and 3 lines of therapy for metastatic disease, with progression on last treatment (neoadjuvant or adjuvant therapy completed over 1 year ago does not count).
- Measurable disease according to RECIST 1.1 criteria.
- At least 18 years old.
- ECOG performance status of 0 or 1.
- Adequate bone marrow and organ function including neutrophil count, platelets, hemoglobin, coagulation, liver enzymes, albumin, kidney function, and protein-to-creatinine ratio within specified limits.
- Recovery to baseline or Grade 1 from prior adverse events; some low-grade or controlled toxicities allowed.
- Agreement to use highly effective contraception during and after study treatment as specified.
- Female participants of childbearing potential must not be pregnant at screening.
- Ability to understand and willingness to sign informed consent.
You will not qualify if you...
- Translocation-driven sarcoma except alveolar soft part sarcoma.
- Previous treatment with zanzalintinib, cabozantinib, PD-1, PD-L1, or CTLA-4 inhibitors.
- Use of kinase inhibitors within 2 weeks or systemic anticancer therapy within 4 weeks before study treatment.
- Recent radiation therapy within specified timeframes or ongoing complications from prior radiation.
- Known brain metastases unless treated and stable for at least 4 weeks.
- Allergic reactions to study drugs or similar compounds.
- Use of certain anticoagulants; some anticoagulants allowed under conditions.
- Use of complementary medications for the disease within 2 weeks before treatment.
- Uncontrolled or recent significant illnesses including serious cardiovascular, gastrointestinal, bleeding, pulmonary, or other disorders.
- Major surgery within 8 weeks or minor surgery within 5 days before study treatment without complete healing.
- Prolonged QT interval on ECG.
- Psychiatric illness interfering with consent or compliance.
- Pregnant or breastfeeding women.
- Inability to swallow tablets or suspensions.
- Other active cancers requiring treatment within 2 years except certain low-risk tumors.
- Active or suspected autoimmune diseases, except some mild or controlled conditions.
- Positive tuberculosis test with disease evidence.
- History or evidence of certain lung diseases or active pneumonitis.
- Abnormal free thyroxine levels unless approved by investigator.
- Immunodeficiency or recent use of systemic immunosuppressive therapy.
- Recent live attenuated vaccine administration within 30 days before treatment.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
M
Mia Weiss, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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