Study on Ivonescimab for Treating Leiomyosarcoma

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60

ClinicalTrials ID:NCT07516925

This clinical trial is testing the safety and effectiveness of Ivonescimab, a new treatment for people with advanced or inoperable leiomyosarcoma, a type of cancer.

Patient Parameters

Program Overview

The aim of this study is to determine if Ivonescimab is a safe and effective treatment option for individuals with advanced or inoperable leiomyosarcoma, a type of cancer that affects smooth muscle tissue. Researchers want to see if the drug can help manage the disease with minimal side effects.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of advanced or inoperable leiomyosarcoma.
  • Willing to provide written consent and follow the study protocol.
  • Have a performance status score of 0 to 2, indicating good overall health.
  • Have received 1 to 3 previous treatments for leiomyosarcoma, or declined standard first-line treatment.
  • Completed any prior radiation therapy at least 2 weeks before starting the study drug.
  • Completed any prior chemotherapy or investigational treatments at least 3 weeks before starting the study drug.
  • Have enough tumor tissue available for research purposes.
  • Have measurable disease according to specific criteria.
  • Have adequate organ function, including blood, kidney, and liver function.
  • Women of childbearing age must have a negative pregnancy test and agree to use effective contraception during and after the study.
  • Men must agree to use barrier contraception during and after the study.

Exclusion Criteria

  • Previous treatment with certain immune or cancer-targeting drugs.
  • History of autoimmune diseases requiring treatment in the past 2 years.
  • Significant immune system suppression or infections.
  • Recent major surgery or trauma.
  • History of bleeding disorders or significant bleeding events.
  • Poorly controlled high blood pressure.
  • Active autoimmune or lung diseases requiring treatment.
  • History of major heart or vascular diseases.
  • Recent severe lung disease or gastrointestinal issues.
  • Evidence of major blood vessel or organ invasion by the tumor.
  • Active brain metastases or recent brain radiation.
  • Recent live vaccinations.
  • Severe infections or uncontrolled medical conditions.
  • History of severe allergic reactions to study drugs.
  • Pregnant or breastfeeding women.

Locations

FACILITYZIPCITYSTATE
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)07920Basking RidgeNew Jersey
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)07748MiddletownNew Jersey
Memorial Sloan Kettering Bergen (Limited Protocol Activities)07645MontvaleNew Jersey
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)11725CommackNew York
Memorial Sloan Kettering Westchester (Limited Protocol Activities)10604HarrisonNew York
Memorial Sloan Kettering Cancer Center10065New YorkNew York
Memorial Sloan Kettering Nassau (Limited Protocol Activities)11553Rockville CentreNew York

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