A Study of Ivonescimab for Leiomyosarcoma
This study is testing a drug called Ivonescimab to see if it is a safe and effective treatment for people with advanced leiomyosarcoma (a rare type of cancer that grows in smooth muscles). You may be able to join if you are 18 or older, have leiomyosarcoma that cannot be removed by surgery or has spread, and have tried 1 to 3 other treatments. The main goal is to see how well Ivonescimab works to shrink the cancer, with results measured for up to two years. The study plans to enroll 20 people, but its current status is unclear.
- Study design
- This study is testing Ivonescimab in about 20 participants. It is an interventional study, meaning participants will receive the study drug.
- What's involved
- You would receive Ivonescimab through an IV every three weeks on Day 1 of each cycle. You would also need to be willing to follow the study's treatment plan.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure your response to treatment for up to two years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07516925
A Study of Ivonescimab in People With Leiomyosarcoma
Recruiting
PHASE2Ages 18+InterventionalTreatmentMemorial Sloan Kettering Cancer CenterInvestigator-initiated
~20 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:Ivonescimab
At a glance
Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Response
Measured over up to two years
Conditions
Where it's being run
7 sites across 2 statesNew York4
New Jersey3
Study leadership
- Sandra D'Angelo, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Male or female age ≥ 18 years at the time of informed consent
Subjects must have a histologically confirmed unresectable/metastatic LMS
Be willing and able to provide written informed consent/assent for the trial
Be willing to comply with treatment protocol
Adequate performance status: ECOG 0 - 2
Subjects must have had at least 1 but not more than 3 prior lines of systemic therapy for their LMS. Patients who decline the standard of care first-line systemic therapy will be eligible for this trial. Prior adjuvant therapy will not count provided it was completed more than 6 months previously.
Patients who were treated with radiotherapy must have completed radiation therapy at least 2 weeks before the study drug administration.
Patients who were treated with chemotherapy or any investigational therapies or other anti-cancer agent, if eligible, must have been completed at least 3 weeks or at least 5 half-lives (whichever is longer, but no less than 3 weeks) before the study drug administration. All AEs must be ≤ NCI CTCAE v5 Grade 1, except alopecia and stable neuropathy, which must have resolved to Grade ≤ 2 or baseline. Patients who were treated with estrogen modulating therapies (aromatase inhibitors, tamoxifen, GnRH agonists etc.) must have been treated at least 2 weeks prior to study drug administration.
Participants must have sufficient archival tumor tissue available (most recently procured sample where tissue is available) for research purposes. If archival tumor tissue is insufficient, a pre-treatment research biopsy will be optional but strongly encouraged, if safe and feasible, in the opinion of the Investigator. If biopsy is not feasible and no sufficient archival tissue is available, discussion is required with the Principal Investigator.
Presence of measurable disease per RECIST v1.1. Target lesions must not be chosen from a previously irradiated field unless there has been radiographically and/or pathologically documented tumor progression in that lesion prior to enrollment.
Adequate Organ Function:
Coagulation: prothrombin time (PT) or international normalized ratio (INR) ≤ 1.5 × ULN, and partial prothrombin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (unless abnormalities are unrelated to coagulopathy). This applies only to patients who are not on therapeutic anti-coagulation. Patients receiving therapeutic anti-coagulation should be on a stable dose.
Female patients of childbearing age must have negative serum pregnancy test results before randomization or per region-specific guidance documented in the informed consent and a negative urine pregnancy test on the day of first dose prior to dosing.
Female patient of childbearing potential having sex with an unsterilized male partner must agree to use a highly effective method of contraception from the beginning of screening until 90 days after the last dose of the ivonescimab.
Unsterilized male patients having sex with a female partner of childbearing potential, or a pregnant or breastfeeding partner must agree to use barrier contraception (male condom) for the duration of the treatment period until 90 days after the last dose of ivonescimab. Male patients with female partners of childbearing potential must have the female partner agree to use at least 1 form of highly effective contraception for the duration of the treatment period until 90 days after the last dose of ivonescimab.
Exclusion
Prior therapy with an anti PD1/PDL1 inhibitor and/or VEGF inhibitor (including multi-tyrosine kinase inhibitors with VEGF inhibition such as pazopanib/cabozantinib/sunitinib).
History or evidence of symptomatic autoimmune disease (e.g., pneumonitis, glomerulonephritis, vasculitis, or other), or history of active autoimmune disease that has required systemic treatment (i.e., use of corticosteroids, immunosuppressive drugs or biological agents used for treatment of autoimmune diseases) in past 2 years prior to enrollment. Replacement therapy (e.g., thyroxine for hypothyroidism, insulin for diabetes or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment for autoimmune disease.
Evidence of clinically significant immunosuppression such as the following: o Primary immunodeficiency state such as Severe Combined Immunodeficiency Disease o Concurrent opportunistic infection o Receiving systemic immunosuppressive therapy (\> 2 weeks) including oral steroid doses \> 10 mg/day of prednisone or equivalent within 7 days prior to enrollment. However, in the setting of non-immune mediated indications for steroid use, chronic/active low dose steroid use may be permitted at the discretion of the principal investigator. The dose of steroid allowed in this setting is also at the discretion of the principal investigator. (Use of inhaled or topical steroids is permitted.)
Major surgical procedures or serious trauma within 4 weeks prior to randomization, or plans for major surgical procedures within 4 weeks after the first dose (as determined by the investigator). Minor local procedures (excluding central venous catheterization and port implantation) within 3 days prior to randomization.
History of bleeding tendencies or coagulopathy and/or clinically significant bleeding symptoms or risk within 4 weeks prior to randomization, including but not limited to:
Active autoimmune or lung disease requiring systemic therapy (eg, with disease modifying drugs, prednisone \>10 mg daily or equivalent, immunosuppressant therapy) within 2 years prior to randomization, however the following will be allowed:
History of major diseases before randomization, specifically:
Imaging during the screening period shows that the patient has:
Symptomatic CNS metastases, CNS metastases with hemorrhagic features, CNS metastasis ≥ 1.5 cm, CNS radiation within 7 days prior to randomization, potential need for CNS radiation within the first cycle, or leptomeningeal disease.
Live vaccine or live attenuated vaccine within 4 weeks prior to planned randomization, or if scheduled to receive a live vaccine or live attenuated vaccine during the study period. Inactivated vaccines are permitted.
Severe infection within 4 weeks prior to randomization, including but not limited to comorbidities requiring hospitalization, sepsis, or severe pneumonia; active infection (as determined by the investigator) requiring systemic anti-infective therapy within 2 weeks prior to randomization (excluding antiviral therapy for hepatitis B or C)
Has pre-existing peripheral neuropathy that is ≥ Grade 2 by CTCAE version 5
Uncontrolled pleural effusions, pericardial effusions, or ascites that is clinically symptomatic Note: Patients managed with indwelling catheters (eg, PleurX) are allowed.
History of non-infectious pneumonia requiring systemic corticosteroids, or current interstitial lung disease
Active or prior history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)
Known history of human immunodeficiency virus (HIV) whose viral load is not controlled.
Current use of systemic corticosteroids (\>10 mg daily prednisone or equivalent)
Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
Patients with active hepatitis B are required to have stable or declining levels of hepatitis B DNA by polymerase chain reaction (PCR) on appropriate anti-viral therapy with acceptable tolerability for one month prior to randomization. All patients with active hepatitis C (hepatitis C virus \[HCV\] antibody positive with HCV RNA levels above the lower limit of detection) are excluded.
Known allergy to any component of any study drug; known history of severe hypersensitivity to other monoclonal antibodies
History or current evidence of any condition (medical \[including adverse events from prior anticancer therapy, disorders secondary to tumor\], surgical or psychiatric \[including substance abuse\]), or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, might lead to higher medical risk and/or is not in the best interest of the patient to participate, in the opinion of the treating investigator.
Patient is breastfeeding or plans to breastfeed during the study.
What this trial measures
- Responseup to two years
Response and progression will be evaluated in this study using the international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline, version 1.1. Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria.