NCT06840834

Evaluating Ivonescimab as a Potential Treatment for Pleural Mesothelioma Patients Whose Cancer Has Returned After Previous Immunotherapy and Chemotherapy

Assessment of Ivonescimab as Salvage Treatment in Relapsing Pleural Mesothelioma Patients, Previously Treated by Immunotherapy and Standard Chemotherapy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Intergroupe Francophone de Cancerologie Thoracique · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Pleural Mesotheliomas

Interventions

Type	Name	Description
DRUG	Ivonescimab	Ivonescimab is administered IV Q3W on Day 1 of each cycle. Ivonescimab is given at a dose of 20 mg/kg (a fixed dose of 3200 mg for ivonescimab should be used for patients ≥160 kg). The total duration of ivonescimab treatment is up to 24 months.

Timeline

• Start date: 2025-06-30
• Primary completion: 2026-03-24
• Completion: 2028-03-31
• First posted: 2025-02-21
• Last updated: 2026-03-16

Locations

20 sites across 1 country: France