About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
Ivonescimab
DrugIvonescimab is administered IV Q3W on Day 1 of each cycle
Treatment groups
Trial outcomes
Primary outcomes
Response
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.
Sponsors and contacts
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Memorial Sloan Kettering Cancer Center
Lead sponsor
Summit Therapeutics
Collaborator