Ivonescimab for Thymoma

Overseen By Kim Nahyun

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests ivonescimab, a monoclonal antibody, to evaluate its effectiveness in helping the immune system combat thymic carcinoma, a cancer found in the thymus gland. Ivonescimab may inhibit the growth and spread of cancer cells. Individuals with thymic carcinoma that cannot be cured, have tried other treatments, or cannot or choose not to try other therapies might be suitable for this trial. Participants will receive ivonescimab through an IV every three weeks and will undergo regular check-ups, such as CT scans and blood tests, to monitor progress. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in cancer treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot have had 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. You can continue using hormones for non-cancer-related conditions like insulin for diabetes.

Is there any evidence suggesting that ivonescimab is likely to be safe for humans?

Research shows that ivonescimab may help treat certain cancers. In a study on non-small cell lung cancer, ivonescimab proved effective, but 20.8% of patients experienced serious side effects. This indicates that some patients had significant reactions.

Another study found that ivonescimab has a generally acceptable and manageable safety profile. While side effects can occur, they can usually be handled with proper care.

This trial is a phase 2 study, indicating that the treatment has already been tested for basic safety in humans. However, more information is needed to fully understand its safety in treating thymic carcinoma. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Ivonescimab is unique because it combines an anti-PD-1 antibody with an anti-VEGF antibody, offering a dual mechanism of action that targets both immune checkpoints and tumor blood vessel growth. Unlike traditional treatments for thymoma, such as surgery, radiation, or chemotherapy, this approach aims to enhance the immune response while simultaneously inhibiting tumor angiogenesis. Researchers are excited about ivonescimab because this dual-targeting strategy has the potential to improve treatment efficacy and reduce tumor progression more effectively than current options.

What evidence suggests that ivonescimab might be an effective treatment for thymic carcinoma?

Research shows that ivonescimab, the investigational treatment in this trial, yields promising results for cancer patients. Studies have demonstrated that ivonescimab helps patients live longer without cancer progression. It targets two proteins, PD-1 and VEGF, which contribute to cancer growth, enabling the immune system to more effectively attack cancer cells. Earlier trials successfully treated non-small cell lung cancer, suggesting potential effectiveness for thymic carcinoma as well. These findings offer hope for ivonescimab's potential in treating thymic cancer. ^{1 3 6 7 8}

Who Is on the Research Team?

Jonathan W Goldman

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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

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

Satisfactory coagulation parameters: INR or PT ≤ 1.5 x ULN, aPTT ≤ 1.5 x ULN

Exclusion Criteria

Positive paraneoplastic serologies

I have had a heart attack recently.

I have had blood clots in the past.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

jto.org

jto.org/article/S1556-0864(25)02148-3/fulltext

P3.18.83 Efficacy and Safety of Ivonescimab Plus ...

Ivonescimab, a novel bispecific antibody targeting PD-1 and VEGF, has demonstrated promising results in non-small cell lung cancer. This study aims to evaluate ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06980077

Ivonescimab for the Treatment of Thymic Cancer

This phase II trial tests how well ivonescimab works in treating patients with thymic carcinoma. Immunotherapy with monoclonal antibodies, ...

3.

app.trialscreen.org

app.trialscreen.org/trials/phase-2-ivonescimab-combined-chemotherapy-first-line-treatment-relapsed-trial-nct06750952

Ivonescimab Combined with Chemotherapy As First-line ...

A Phase 2 study of Ivonescimab plus chemotherapy in thymic cancer. Evaluating the effectiveness and safety of Ivonescimab combined with ...

4.

iaslc.org

iaslc.org/iaslc-news/press-release/ivonescimab-outperforms-pembrolizumab-phase-3-study-first-line-treatment

Ivonescimab Outperforms Pembrolizumab in Phase 3 ...

Data from a Phase 3 study revealed that ivonescimab demonstrates a statistically significant and clinically meaningful improvement in progression-free survival.

5.

withpower.com

withpower.com/trial/phase-2-thymus-carcinoma-5-2025-d8396

Ivonescimab for Thymoma

This phase II trial tests how well ivonescimab works in treating patients with thymic carcinoma. Immunotherapy with monoclonal antibodies, ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06980077

Ivonescimab for the Treatment of Thymic Cancer

This phase II trial tests how well ivonescimab works in treating patients with thymic carcinoma. Immunotherapy with monoclonal antibodies, ...

7.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT06750952/ivonescimab-combined-with-chemotherapy-as-first-line-treatment-of-relapsed-or-metastatic-thymic-cancer-a-prospective-single-arm-phase-ii-trial

Ivonescimab Combined with Chemotherapy As First-line ...

This study is a prospective, single arm phase II clinical trial ,aimed at exploring the efficacy and safety of the combination therapy of ...

8.

smmttx.com

smmttx.com/wp-content/uploads/2025/11/2025_PR_1107-SITC-HARMONi-A-Data-_-FINAL-v2.pdf

Ivonescimab Plus Chemotherapy Demonstrates a ...

Ivonescimab continues to demonstrate an acceptable and manageable safety profile in the HARMONi-A study with this additional follow-up time, ...