Phase II Study of Ivonescimab Given by IV to Treat Adults With Relapsed Pleural Mesothelioma After Immunotherapy and Chemotherapy

What this Trial Is About

Researchers are evaluating ivonescimab as a potential treatment for patients with pleural mesothelioma whose cancer has returned after previous immunotherapy and standard chemotherapy. This is an open-label, single-arm phase II study involving about 38 patients who have relapsed after up to two prior lines of treatment, including immunotherapy with nivolumab 1 ipilimumab and standard chemotherapy. The trial aims to assess the disease control rate at 12 weeks after starting treatment with ivonescimab. Participants receive ivonescimab intravenously at a dose of 20 mgkg every three weeks, with a fixed dose of 3200 mg for patients weighing 160 kg or more. Treatment may continue for up to 24 months, or until disease progression, unacceptable side effects, withdrawal of consent, or other reasons for stopping. This study is conducted at approximately 20 centers and is designed as a single-group trial without a placebo or comparator group. During the study, participants will undergo regular assessments including CT scans to measure disease progression and response. Researchers will monitor safety and side effects from the start of treatment through up to 90 days after the last dose. They will also evaluate progression-free survival, overall survival, best response rate, and duration of response over a period of up to about 45 months. Participants are expected to comply with scheduled visits, treatment schedules, and laboratory tests throughout the study.

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