UCLA L-11: A Phase II trial of Ivonescimab for Previously Treated Thymic Carcinoma
Study Description
This phase II trial tests how well ivonescimab works in treating patients with thymic carcinoma. Immunotherapy with monoclonal antibodies, such as ivonescimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Eligibility
Inclusion
-Cytologically or histologically confirmed thymic carcinoma
-Received prior systemic therapy for thymic carcinoma
-Female participants of childbearing potential must have a negative urine or serum pregnancy test.
-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 120 days after the last dose of ivonescimab.
-Measurable disease, as per RECIST 1.1
-(ECOG) performance status of 0-1
-ANC > 1.5 x 10 9 L, Platelets > 100x 10 9 / L, hemoglobin > 9g per dL or > 5.6mml per L, Serum creatinine > 1.5 x, Urine dip stick protein < 2+ or 24 hr less than 1.0, Serum total bilirubin <1.5xULN
Exclusion
-Prior treatment with an immune checkpoint inhibitor targeted PD-1 or PD-L1. Prior treatment with VEGF inhibitor is allowed
-Concurrent enrollment in another clinical study, unless enrolled only in the follow-up period or an observational study
-Any chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment in the prior 3 weeks or within 5 half-lives of the medication, whichever is shorter
-Thoracic radiation of greater than or equal to gy within 3 mos
-Use of any investigational anticancer therapy received within 21 days prior to the first dose of study drug
-The patient has a known allergy/history of hypersensitivity reaction to any of the treatment components or any other contraindication to one of the administered treatments
Active autoimmune condition currently requiring systemic immune suppressive therapy
-Positive paraneoplastic serologies, including binding, blocking and modulating antibodies to acetylcholine receptor (AChR)
-Major surgical procedures or serious trauma within 4 weeks prior to randomization
-Poorly controlled hypertension
-Presence of angina or active cardiac ischemia
-The patient has experienced myocardial infarction within 6 months prior to study enrollment
-History of arterial or venous thrombosis or thromboembolism within 6 months prior to study
-Imaging during the screening period shows that the tumor surrounds important blood vessels
-The patient has any ongoing or active infection requiring the use of parenteral anti-microbial agents
-The patient is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial
-Progressive or symptomatic brain metastases.
-History of another cancer within 2 years of study initiation
-History of bleeding tendencies or coagulopathy and/or clinically significant bleeding symptoms
-Current use of prophylactic or full-dose anticoagulants
-History of perforation of the gastrointestinal tract and/or fistula
-Active autoimmune or lung disease requiring systemic therapy
-Has pre-existing peripheral neuropathy
-Uncontrolled pleural effusions, pericardial effusions
-History of non-infectious pneumonia requiring systemic corticosteroids
-Active or prior history of inflammatory bowel disease
