Ivonescimab with pemetrexed and platinum chemotherapy as first-line treatment for advanced malignant pleural mesothelioma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1b/2, open-label, multicenter trial evaluating safety and preliminary efficacy of ivonescimab combined with pemetrexed and a platinum agent as first-line therapy for advanced malignant pleural mesothelioma. Phase 1b identifies the recommended dose of ivonescimab to use with the chemotherapy, then Phase 2 tests the regimen for response rate while continuing ivonescimab maintenance. Participants receive ivonescimab every 3 weeks with pemetrexed and a platinum agent for 4–6 cycles, followed by maintenance with ivonescimab (with or without pemetrexed). Exploratory analyses will use blood, pleural effusion, and pleural tissue samples.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 18 to 75 years.
2. Histologically confirmed advanced or metastatic malignant pleural mesothelioma not amenable to surgery.
3. No prior systemic anticancer therapy for advanced disease.
4. ECOG PS 0-1.
5. At least one measurable lesion according to modified RECIST (mRECIST).
6. Adequate organ function for study treatment.
7. Patients with asymptomatic or stable brain metastases are eligible.
8. Able to understand the study, provide written informed consent, and comply with study procedures.

Exclusion Criteria:

1. Active autoimmune disease requiring systemic treatment or other contraindications to immunotherapy.
2. Uncontrolled hypertension, significant bleeding risk, or other contraindications to antiangiogenic therapy.
3. Active interstitial lung disease or noninfectious pneumonitis.
4. Active infection requiring systemic treatment.
5. Other active malignancies requiring anticancer treatment.
6. Severe uncontrolled medical conditions that may interfere with study treatment.
7. Pregnant or breastfeeding women.

Where it's running

• Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
  Shanghai, Shanghai Municipality, China Recruiting
• Shanghai Chest Hospital
  Shanghai, Shanghai Municipality, China Recruiting
• West China Hospital of Sichuan University
  Chengdu, Sichuan, China Recruiting

Study contacts

• Study coordinator: Yi Xiang, MD, PhD
• Email: xiangyiht@163.com
• Phone: +86-21-64370045

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.