Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07283731

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

Led by M.D. Anderson Cancer Center · Updated on 2026-04-17

20

Participants Needed

1

Research Sites

230 weeks

Total Duration

On this page

Sponsors

M

M.D. Anderson Cancer Center

Lead Sponsor

E

Exelixis

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must have histologically or cytologically confirmed undifferentiated pleomorphic sarcoma (UPS), myxofibrosarcoma (MFS), high grade pleomorphic sarcoma (HGPS), or high grade undifferentiated sarcoma (HGUS).
  • Participants must be 18 years of age or older.
  • ECOG performance status of 2 or better (Karnofsky 60% or higher).
  • Must have measurable disease with at least one lesion measurable by imaging or clinical exam.
  • At least 4 weeks since prior chemotherapy.
  • At least 2 weeks since radiation for bone metastases and 4 weeks since other radiation therapy before first dose.
  • At least 6 weeks since systemic treatment with radionuclides before first dose.
  • Adequate organ and marrow function within 14 days before first dose.
  • For chronic hepatitis B, viral load must be undetectable if on therapy.
  • Hepatitis C infection must be treated and cured or have undetectable viral load if on treatment.
  • Treated brain metastases are allowed if stable for at least 4 weeks and corticosteroids are stopped or at physiologic replacement doses.
  • New or progressive brain metastases allowed if immediate CNS treatment is not needed during first three cycles.
  • Prior or concurrent malignancies allowed if they do not interfere with study assessments.
  • Cardiac function must be New York Heart Association Functional Classification class 2B or better.
  • Women of childbearing potential and men must agree to use contraception during study and specified post-treatment periods.
  • Females must not be pregnant.
  • Must be able to understand and comply with study requirements and sign informed consent.
  • Consent to companion laboratory protocol for correlative analyses of biopsies.
Not Eligible

You will not qualify if you...

  • Prior treatment with immune checkpoint inhibitors or zanzalintinib.
  • Use of small molecule kinase inhibitors within 2 weeks before first dose.
  • Unresolved toxicities from prior anti-cancer therapy greater than Grade 1 except alopecia.
  • Clinically significant ongoing complications from prior radiation therapy.
  • Use of other investigational agents or systemic anticancer therapies within 4 weeks before study treatment.
  • Use of oral anticoagulants and platelet inhibitors except specified allowed anticoagulants.
  • Use of complementary medications to treat the studied disease within 2 weeks before first dose.
  • Uncontrolled or significant recent illness including unstable cardiovascular disorders, uncontrolled hypertension, recent stroke or thrombotic events.
  • History of myocarditis.
  • Certain gastrointestinal disorders or recent gastrointestinal surgeries.
  • Significant bleeding or pulmonary conditions within specified timeframes.
  • Active infections requiring systemic treatment.
  • Serious non-healing wounds, ulcers, or bone fractures not related to tumor skin lesions.
  • Malabsorption syndrome.
  • Symptomatic hypothyroidism not pharmacologically compensated.
  • Moderate to severe hepatic impairment.
  • Need for dialysis.
  • History of solid organ or allogeneic stem cell transplant.
  • Allergic reactions to study drugs or similar compounds.
  • Use of moderate or strong CYP3A4 inhibitors or inducers without change in regimen prior to study.
  • Psychiatric or social conditions limiting compliance.
  • Pregnant or breastfeeding women.
  • Recent major or minor surgery without complete healing prior to first dose.
  • QTc interval greater than 480 ms within 14 days before first dose.
  • Inability to swallow tablets or oral suspensions.
  • Other malignancies requiring active therapy interfering with study assessments within 2 years except certain low-risk tumors.
  • Suspected or recent autoimmune diseases except some stable or mild conditions.
  • Known positive tuberculosis with clinical or radiographic disease.
  • History or evidence of pneumonitis.
  • Free thyroxine outside normal range without approval.
  • Diagnosis of immunodeficiency or recent systemic immunosuppressive therapies.
  • Recent live vaccine administration within 30 days before first dose.
  • Any other conditions that may compromise safety or study completion as judged by the investigator.

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

M

Michael S Nakazawa, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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