Ivonescimab for the Treatment of Thymic Cancer
UCLA L-11: A Phase II Trial of Ivonescimab for Previously Treated Thymic Carcinoma
2 other identifiers
interventional
25
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jul 2025
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2025
CompletedFirst Posted
Study publicly available on registry
May 20, 2025
CompletedStudy Start
First participant enrolled
July 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 17, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 17, 2028
October 20, 2025
May 1, 2025
1.9 years
May 12, 2025
October 16, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Overall response rate (ORR)
ORR is defined as complete response or partial response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. The ORR estimate and its associated 95% confidence interval will be calculated.
Up to 1 year
Secondary Outcomes (4)
Progression free survival
From trial initiation to cancer progression or death due to any cause, assessed up to 1 year
Duration of response
From documentation of tumor response to disease progression, assessed up to 1 year
Time to response
From treatment initiation until documentation of tumor response, assessed up to 1 year
Overall survival
From randomization to death by any cause, assessed up to 1 year
Study Arms (1)
Treatment (ivonescimab)
EXPERIMENTALPatients receive ivonescimab IV over 60-120 minutes on day 1 of each cycle. Cycles repeat Q3W for up to 24 months in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and collection of blood and urine samples throughout the study. Patients may undergo MRI throughout the study if indicated and may optionally undergo a biopsy at the end of treatment.
Interventions
Undergo biopsy
Undergo collection of blood and urine samples
Undergo CT
Given IV
Undergo MRI
Eligibility Criteria
You may qualify if:
- Male or female ≥ 18 years of age and willing and able to provide informed consent
- Cytologically or histologically confirmed thymic carcinoma, which is incurable
- Received prior systemic therapy for thymic carcinoma, or is ineligible for or refuses other therapies
- Measurable disease, as per RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L
- Platelets ≥ 100 × 10\^9/L
- Hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L
- Serum creatinine ≤ 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance (CrCl) ≥ 50 mL/min (glomerular filtration rate \[GFR\] can also be used in place of creatinine or CrCl)
- Estimated glomerular filtration rate (eGFR) value ≥ 50 mL/min for participants with creatinine levels \> 1.5 x institutional ULN
- Creatinine clearance may be calculated using the Cockcroft-Gault formula or estimated glomerular filtration rate (eGFR) may be calculated using the Modification of Diet in Renal Disease (MDRD) GFR equation
- Urine dipstick protein ˂ 2+ OR 24 hour urine protein quantification ˂ 1.0 g
- Serum total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ ULN
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) ≤ 2.5 x ULN OR ≤ 5 x ULN for participants with liver metastases
- Albumin ≥ 2.5 g/dL
- +9 more criteria
You may not qualify if:
- 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. Concurrent use of hormones for non-cancer-related conditions (eg, insulin for diabetes and hormone replacement therapy) is acceptable
- Thoracic radiation of ≥ 30 Gy within 3 months. Other radiation within 3 weeks with the following exceptions: (a) Stereotactic, palliative radiation for bone metastases is acceptable without a washout; (b) Stereotactic brain radiation for asymptomatic brain metastases is acceptable with a 7 day washout
- 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)
- If known muscle-specific kinase (MuSK) antibodies positive then excluded, otherwise additional testing not required
- 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
- Poorly controlled hypertension with repeated systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy
- Presence of angina or active cardiac ischemia, uncontrolled congestive heart failure of current ≥ class III as defined by the New York Heart Association, or unstable cardiac arrhythmia (e.g., clinically stable atrial fibrillation is permitted)
- 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 enrollment. Patients with a history of venous thromboembolism beyond 6 months prior to study enrollment can be enrolled if they are appropriately anticoagulated
- Imaging during the screening period shows that the tumor surrounds important blood vessels or has obvious necrosis and/or cavitation, and the investigator determines that entering the study is a bleeding or fistula risk. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is permitted
- +25 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jonsson Comprehensive Cancer Centerlead
- Summit Therapeuticscollaborator
Study Sites (1)
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan W Goldman
UCLA / Jonsson Comprehensive Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2025
First Posted
May 20, 2025
Study Start
July 15, 2025
Primary Completion (Estimated)
June 17, 2027
Study Completion (Estimated)
June 17, 2028
Last Updated
October 20, 2025
Record last verified: 2025-05