Imagine facing pleural mesothelioma, a tough lung cancer, and finding out that your previous treatments aren't working anymore. This situation is a harsh reality for many patients, as the disease can be stubborn and resistant to standard therapies like chemotherapy and immunotherapy. Now, there's a new glimmer of hope: a drug called ivonescimab is being tested for patients whose cancer has returned after these treatments. In this study, 38 patients will receive ivonescimab every three weeks for up to two years. The goal is to see if this drug can help control the disease better than previous options. If it works, it could mean fewer patients experiencing disease progression and more time with their loved ones. However, it's important to remember that this is still in the testing phase, and we won't know the full results for a while. Patients should stay informed and discuss all available options with their healthcare team as this research unfolds.
Ivonescimab Phase II Study Targets 55% DCR in Relapsed Pleural MesotheliomaCould This New Drug Offer Hope for Patients with Returning Pleural Mesothelioma?
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Key Takeaway
Consider ivonescimab for relapsed PM if DCR ≥55% is achieved at 12 weeks.
This multicentre, open-label, single-arm Phase II study investigates the efficacy of ivonescimab, a bispecific antibody targeting VEGF and PD-1, in patients with pleural mesothelioma (PM) who have relapsed after prior immunotherapy and standard chemotherapy. The trial plans to enroll 38 participants across approximately 20 centers, administering ivonescimab at a dose of 20 mg/kg every 3 weeks. The primary endpoint is to achieve a disease control rate (DCR) of at least 55% at 12 weeks, challenging the null hypothesis of a DCR of 30% or less. Secondary outcomes and safety profiles will be monitored, although specific adverse event data is not yet available. The study's design allows treatment continuation for up to 2 years or until disease progression or unacceptable toxicity occurs. This trial could potentially establish ivonescimab as a viable second or third-line treatment option, pending results.
What this means for you:
A new drug may offer renewed hope for patients with returning pleural mesothelioma, opening doors to better treatment options. More on Pleural Mesothelioma
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View Original Abstract ↓
Status: RECRUITING | Phase: PHASE2
Condition(s): Pleural Mesotheliomas
Intervention(s): Ivonescimab (DRUG)
Multicentre, open-label, single arm phase II study for patients with PM previously treated by immunotherapy and standard chemotherapy. 38 patients will be given second or third-line treatment with ivonescimab 20mg/kg every 3 weeks.
An estimated 38 patients will be enrolled in approximately 20 centres. Patients will be treated for a maximum of 2 years, until disease progression, unacceptable toxicity, withdrawal of consent or another discontinuation criterion is met.
The null hypothesis is disease control rate (DCR) at 12 weeks ≤ 30%. The alternative hypothesis is DCR ≥ 55% at 12 weeks.
Primary Outcome(s): To assess the therapeutic value of the bispecific antibody anti-VEGF / anti-PD-1 ivonescimab as 2nd/3rd line treatment in relapsing PM patients
Enrollment: 38 (ESTIMATED)
Lead Sponsor: Intergroupe Francophone de Cancerologie Thoracique
Start: 2025-06-30 | Primary Completion: 2026-03-24
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