Ivonescimab for Thymoma

Overseen By Lia R. Ethridge

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Jonsson Comprehensive Cancer Center

Must not be taking: Immune checkpoint inhibitors

Disqualifiers: Autoimmune disease, Hypertension, Cardiac issues, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 24 months

25 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Jonathan W Goldman

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Eligibility Criteria

This trial is for patients with thymic carcinoma, a type of cancer in the thymus gland. Participants must be suitable for MRI and CT scans, willing to undergo biopsy procedures and biospecimen collection, and able to complete questionnaires.

Inclusion Criteria

My kidney function is okay even with high creatinine levels.

Satisfactory blood counts: ANC ≥ 1.5 × 10^9/L, Platelets ≥ 100 × 10^9/L, Hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L

Satisfactory urine dipstick protein and 24-hour urine protein quantification

Exclusion Criteria

Positive paraneoplastic serologies

I have had a heart attack recently.

I have had blood clots in the past.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ivonescimab intravenously over 60-120 minutes on day 1 of each cycle, with cycles repeating every 3 weeks for up to 24 months

24 months

1 visit every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment completion, with follow-up every 6 weeks through week 24, and then every 12 weeks thereafter for up to 1 year

1 year

Every 6 weeks through week 24, then every 12 weeks

Treatment Details

Interventions

• Ivonescimab

Trial Overview The study is testing ivonescimab's effectiveness against thymic carcinoma. It involves immunotherapy using this monoclonal antibody to boost the immune system's fight against cancer and prevent tumor growth.

Participant Groups

Group I: Treatment (ivonescimab) Experimental Treatment 6 Interventions

Patients 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.

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials

373

Recruited

35,200+

Summit Therapeutics PLC

Collaborator

Summit Therapeutics

Industry Sponsor

Trials

18

Recruited

4,500+