Ivonescimab Phase II Study Targets 55% DCR in Relapsed Pleural Mesothelioma
Photo by CNordic Nordic / Unsplash
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.
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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