Pulmonology & Critical Care
PHASE2
● Phase II
Ivonescimab Phase II Study Targets 55% DCR in Relapsed Pleural Mesothelioma
ClinicalTrials.gov
Published March 27, 2026
Intergroupe Francophone de Cancerologie Thoracique
NCT06840834 ↗
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.
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· Auto-published
This study focuses on pleural mesothelioma, a type of cancer that affects the lining of the lungs and can be difficult to treat. Researchers are investigating a new treatment called ivonescimab for patients whose cancer has returned after they have already tried immunotherapy and chemotherapy. In this study, 38 patients will receive ivonescimab every three weeks for up to two years or until their condition worsens. The goal is to see if this treatment can help control the disease in more than half of the patients within 12 weeks. If successful, this could offer new hope for patients with limited options. However, it’s important to remember that this is still an early-stage study, and the results are not guaranteed. Patients interested in this treatment should discuss it with their healthcare providers to understand the potential benefits and risks.
What this means for you: This study is exploring a new treatment for pleural mesothelioma that may help patients whose cancer has returned.
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