Actively Recruiting
A Study of Ivonescimab in People With Leiomyosarcoma
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-08
20
Participants Needed
7
Research Sites
156 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
S
Summit Therapeutics
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Ivonescimab in People With Leiomyosarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female age �3e= 18 years at the time of informed consent
- Histologically confirmed unresectable/metastatic leiomyosarcoma
- Willing and able to provide written informed consent for the trial
- Willing to comply with the treatment protocol
- Adequate performance status: ECOG 0 - 2
- Received at least 1 but not more than 3 prior lines of systemic therapy for leiomyosarcoma
- Completed radiation therapy at least 2 weeks before study drug administration if treated with radiotherapy
- Completed chemotherapy, investigational therapies, or other anti-cancer agents at least 3 weeks or 5 half-lives prior to study drug administration
- Adverse events from prior treatments must be grade 1 or less except alopecia and stable neuropathy (must be grade 2 or less or baseline)
- At least 2 weeks since estrogen modulating therapy prior to study drug administration
- Sufficient archival tumor tissue available for research, or optional pre-treatment biopsy if safe and feasible
- Presence of measurable disease per RECIST v1.1, excluding certain previously irradiated lesions without progression
- Adequate hematology, kidney, liver, and coagulation function as specified
- Negative pregnancy tests for female patients of childbearing age prior to dosing
- Agreement to use effective contraception as required during and after treatment
You will not qualify if you...
- Prior therapy with anti PD1/PDL1 and/or VEGF inhibitors
- History or evidence of symptomatic or active autoimmune disease requiring systemic treatment in past 2 years
- Clinically significant immunosuppression including primary immunodeficiency, opportunistic infection, or recent systemic immunosuppressive therapy
- Major surgery or serious trauma within 4 weeks prior to randomization
- History of bleeding tendencies or significant bleeding symptoms within 4 weeks
- Poorly controlled hypertension despite oral therapy
- Active autoimmune or lung disease requiring systemic therapy within 2 years
- History of major cardiac, gastrointestinal, thromboembolic, or pulmonary diseases as specified
- Imaging evidence of major blood vessel invasion or tumor invading critical organs
- Symptomatic or certain CNS metastases
- Recent live vaccine or planned live vaccine during study
- Severe infection within 4 weeks prior to randomization
- Pre-existing peripheral neuropathy grade 2 or higher
- Uncontrolled pleural, pericardial effusions, or ascites
- History of non-infectious pneumonia requiring systemic corticosteroids or interstitial lung disease
- Active or prior inflammatory bowel disease
- Known uncontrolled HIV infection
- Current systemic corticosteroid use above specified doses
- History of organ or stem cell transplantation
- Active hepatitis B or C infection not meeting stability criteria
- Known allergy or severe hypersensitivity to study drugs
- Any condition that might interfere with study participation or safety
- Breastfeeding or planning to breastfeed during the study
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Rockville Centre, New York, United States, 11553
Actively Recruiting
Research Team
S
Sandra D'Angelo, MD
CONTACT
S
Sujana Movva, 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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