RecruitingPhase 2NCT06840834

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


Sponsor

Intergroupe Francophone de Cancerologie Thoracique

Enrollment

38 participants

Start Date

Jun 30, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called ivonescimab for people with pleural mesothelioma — a rare and aggressive cancer that lines the chest cavity, often linked to asbestos exposure. Ivonescimab is a dual-action antibody that targets both the immune checkpoint (PD-1) and blood vessel growth (VEGF) to attack cancer from two angles at once. **You may be eligible if...** - You have been diagnosed with pleural mesothelioma confirmed by a surgical biopsy (thoracoscopy recommended) - You have not received prior systemic treatment for mesothelioma - Your general health (ECOG) is adequate - You have measurable disease on scans **You may NOT be eligible if...** - Your diagnosis was made only by fluid cytology (not a proper tissue biopsy) - You have had prior cancer treatments for mesothelioma - You have serious autoimmune or cardiac conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIvonescimab

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.


Locations(20)

Besançon - CHU

Besançon, France

Brest - CHU

Brest, France

Caen - CHU

Caen, France

Clermont-Ferrand - Centre Jean Perrin

Clermont-Ferrand, France

Créteil - CHI

Créteil, France

Grenoble - CHU

Grenoble, France

Le Mans - CHG

Le Mans, France

Lille - CHU

Lille, France

Marseille - APHM

Marseille, France

Montpellier - CHU

Montpellier, France

Mulhouse - GHRMSA

Mulhouse, France

Nantes - Hôpital Laennec

Nantes, France

Paris - Bichat

Paris, France

Bordeaux - CHU

Pessac, France

Lyon - HCL

Pierre-Bénite, France

Strasbourg - Nouvel Hôpital Civil

Strasbourg, France

Toulon - CHI

Toulon, France

Toulouse - CHU

Toulouse, France

Tours - CHU

Tours, France

Metz - Hôpital Robert Schuman

Vantoux, France

View Full Details on ClinicalTrials.gov

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NCT06840834