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
| Parameter | Options |
|---|
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
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) | 07920 | Basking Ridge | New Jersey |
| Memorial Sloan Kettering Monmouth (Limited Protocol Activities) | 07748 | Middletown | New Jersey |
| Memorial Sloan Kettering Bergen (Limited Protocol Activities) | 07645 | Montvale | New Jersey |
| Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) | 11725 | Commack | New York |
| Memorial Sloan Kettering Westchester (Limited Protocol Activities) | 10604 | Harrison | New York |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
| Memorial Sloan Kettering Nassau (Limited Protocol Activities) | 11553 | Rockville Centre | New York |
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