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New treatment option for Leiomyosarcoma
Official title A Study of Ivonescimab in People With Leiomyosarcoma
ClinicalTrials.gov ID: NCT07516925
What this study is testing
What is Ivonescimab?
Ivonescimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for leiomyosarcoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to find out if Ivonescimab is an effective and safe treatment that causes few or mild side effects for people with advanced/unresectable leiomyosarcoma.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female age ≥ 18 years at the time of informed consent
- people 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
You likely can't join if
- Prior therapy with an anti PD1/PDL1 inhibitor and/or VEGF inhibitor (including multi-tyrosine kinase inhibitors with VEGF inhibition such as...
- History or evidence of symptomatic autoimmune disease (e.g., pneumonitis, glomerulonephritis, vasculitis, or other), or history of active autoimmune...
- Evidence of clinically significant immunosuppression such as the following: o Primary immunodeficiency state such as Severe Combined Immunodeficiency...
- Major surgical procedures or serious trauma within 4 weeks prior to randomization, or plans for major surgical procedures within 4 weeks after the...
- History of bleeding tendencies or coagulopathy and/or clinically significant bleeding symptoms or risk within 4 weeks prior to randomization...
- Hemoptysis (defined as coughing up ≥ 0.5 teaspoon of fresh blood or small blood clots) Note: transient hemoptysis associated with diagnostic...
See the full eligibility criteria
Who can join
- Male or female age ≥ 18 years at the time of informed consent
- people 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
- people 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...
- 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...
- 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...
- 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...
- Adequate Organ Function: a. Hematology (no blood transfusions or growth factor therapy used within 7 days of the screening CBC): i. Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L ii. Platelet count ≥ 100 × 10\^9/L iii...
- 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...
- 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...
- 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...
- 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...
What rules you out
- 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...
- 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...
- 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...
- 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:
- Hemoptysis (defined as coughing up ≥ 0.5 teaspoon of fresh blood or small blood clots) Note: transient hemoptysis associated with diagnostic bronchoscopy is allowed.
- Nasal bleeding /epistaxis (bloody nasal discharge is allowed)
- Current use of prophylactic or full-dose anticoagulants or anti-platelet agents for therapeutic purposes that is not stable prior to randomization is not allowed. The use of full-dose anticoagulants is permitted as long...
- 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...
- Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is permitted.
- Intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections is permitted
- History of major diseases before randomization, specifically:
- Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association [NYHA] classification ≥ grade 2) or unstable vascular disease (eg, aortic aneurysm at risk of rupture, Moyamoya disease) that...
- History of esophageal gastric varices, severe ulcers, wounds that do not heal, abdominal fistula, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months before randomization
- History of any grade arterial thromboembolic event, Grade 3 and above venous thromboembolic event, as specified in National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0, transient...
- Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks before randomization
- History of perforation of the gastrointestinal tract and/or fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection...
- Imaging during the screening period shows that the patient has:
- Radiologically documented evidence of major blood vessel invasion (central pulmonary artery, central pulmonary veins, aorta, brachiocephalic artery, common carotid artery, subclavian artery, superior vena cava) or tumor...
- Radiographic evidence of major blood vessel encasement with narrowing of the vessel or intratumor lung cavitation or necrosis that the investigator determines will pose a significantly increased risk of bleeding.
- 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...
- 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...
- 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 side effects for one month prior...
- 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...
- Patient is breastfeeding or plans to breastfeed during the study.
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Rockville Centre, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.