Actively Recruiting
Vonescimab for the Treatment of Previously Treated Advanced or Unresectable Leiomyosarcoma - a Phase II Trial
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-06-03
20
Participants Needed
7
Research Sites
N/A
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
Researchers are studying Ivonescimab as a potential treatment for people with advanced or unresectable leiomyosarcoma who have already received previous therapy. This Phase II trial aims to evaluate whether Ivonescimab is effective and safe while causing only mild or few side effects. The study is sponsored by Memorial Sloan Kettering Cancer Center and focuses on patients with this specific type of cancer who meet certain health and treatment history criteria. Participants will receive Ivonescimab through an intravenous (IV) infusion every three weeks on the first day of each cycle. Treatment with Ivonescimab may continue for up to 24 months. The study does not involve any placebo or comparison treatment groups, and the dosing schedule is consistent throughout the treatment period. During the trial, participants will be closely monitored through regular assessments, including measuring tumor response according to RECIST criteria over a period of up to two years. Researchers will track side effects, organ function, and overall health through blood tests and other clinical evaluations. Participants will also provide tumor tissue samples for research. Safety and treatment effects will be observed throughout the study duration until the end of participation, which may last up to two years or more depending on treatment continuation.
CONDITIONS
Brief Title
A Study of Ivonescimab in People With Leiomyosarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female age 63 18 years at the time of informed consent
- Histologically confirmed unresectable or metastatic leiomyosarcoma
- Willing and able to provide written informed consent
- Willing to comply with the treatment protocol
- Adequate performance status (ECOG 0-2)
- Have had between 1 and 3 prior systemic therapies for leiomyosarcoma
- Completed radiation therapy at least 2 weeks before study drug administration if previously treated
- Completed chemotherapy, investigational therapies, or anti-cancer agents at least 3 weeks prior to study drug administration
- Sufficient archival tumor tissue available for research or willing to undergo optional biopsy
- Presence of measurable disease per RECIST v1.1
- Adequate organ function, including hematology, kidney, liver, and coagulation parameters
- Negative pregnancy test for females of childbearing potential
- Use of effective contraception for females and males with partners of childbearing potential during and 90 days after treatment
You will not qualify if you...
- Prior therapy with anti PD1/PDL1 or VEGF inhibitors
- Symptomatic or active autoimmune disease requiring systemic treatment within past 2 years
- Clinically significant immunosuppression or systemic immunosuppressive therapy within 7 days prior to enrollment
- Major surgery or serious trauma within 4 weeks prior to randomization
- History of bleeding risks or unstable anticoagulant use
- Poorly controlled hypertension despite therapy
- Active autoimmune or lung disease requiring systemic therapy within 2 years prior to randomization
- History of serious cardiac, gastrointestinal, or vascular diseases within specified time frames
- Radiologic evidence of major blood vessel invasion or tumor invading critical organs
- Symptomatic or large CNS metastases or recent CNS radiation
- Recent live vaccine administration or plans for live vaccines during study
- Severe infection or active infection requiring systemic therapy within 2 weeks prior to randomization
- Pre-existing peripheral neuropathy Grade 62
- Uncontrolled pleural, pericardial effusions, or ascites
- History of interstitial lung disease or non-infectious pneumonia requiring systemic corticosteroids
- Active or prior inflammatory bowel disease
- Uncontrolled HIV infection
- Current systemic corticosteroid use exceeding 10 mg prednisone or equivalent
- History of allogeneic organ or stem cell transplantation
- Active hepatitis B not controlled or active hepatitis C infection
- Known allergies or severe hypersensitivity to monoclonal antibodies
- Medical or psychiatric conditions that may interfere with study participation
- Breastfeeding or planning to breastfeed during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 24 months
Participants receive ivonescimab intravenously every 3 weeks on Day 1 of each cycle.
Visits every 3 weeks for drug administration
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
S
Sujana Movva, MD
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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