RecruitingPhase 2NCT06875076

Multicenter Single-Arm Study of Ivonescimab (AK112) Combined with Chemotherapy in Pretreated Pleural Mesothelioma

Efficacy and Safety of Ivonescimab (AK112) in Combination with Chemotherapy for the Treatment of Pretreated Pleural Mesothelioma: a Phase II Multicenter, Single-Arm Clinical Trial

Sponsor

The First Hospital of Jilin University

Enrollment

25 participants

Start Date

Mar 8, 2025

Study Type

INTERVENTIONAL

Conditions

Pretreated Pleural Mesothelioma

Summary

This study is a prospective, multicenter, single-arm, Phase II clinical trial evaluating the efficacy and safety of ivonescimab (AK112) combined with chemotherapy in patients with pleural mesothelioma who failed prior immunotherapy, anti-angiogenic therapy, or chemotherapy. The regimen consists of a treatment phase (ivonescimab 20mg/kg combined with pemetrexed 500mg/m²/gemcitabine 1000mg/m²/vinorelbine 25mg/m² every 21 days for 4 cycles) followed by a maintenance phase (ivonescimab monotherapy 20mg/kg every 21 days until disease progression, intolerance, or up to 2 years).The trial plans to enroll 25 patients, with the primary endpoint being objective response rate (ORR). Secondary endpoints include progression-free survival (PFS), overall survival (OS), and safety profiles. Exploratory endpoints investigate biomarkers such as tertiary lymphoid structures, tumor-infiltrating lymphocytes, and macrophage polarization within the tumor microenvironment.

Eligibility

Min Age: 18 MonthsMax Age: 75 Months

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of ivonescimab (a dual-action immunotherapy and anti-blood vessel drug) with chemotherapy for people with malignant pleural mesothelioma — a rare cancer lining the lungs — that has progressed after prior treatment. **You may be eligible if...** - You are Asian, aged 18 to 75 - You are in good general health (ECOG 0-1) - Your mesothelioma has been confirmed by biopsy - Your cancer progressed after 1 to 2 prior treatments (such as platinum-based chemo or immunotherapy) - You have at least one measurable tumor on imaging - Your blood counts and organ function meet minimum thresholds **You may NOT be eligible if...** - You have had another cancer in the past 5 years (some skin cancers excepted) - You have active autoimmune disease - You have brain metastases - You have uncontrolled infections 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 Combined With Chemotherapy

ivonescimab 20mg/kg combined with pemetrexed 500mg/m²/gemcitabine 1000mg/m²/vinorelbine 25mg/m² every 21 days for 4 cycles followed by a maintenance phase (ivonescimab monotherapy 20mg/kg every 21 days until disease progression, intolerance, or up to 2 years)

Locations(1)

Cancer center, First Hospital of Jilin University

Changchun, Jilin, China

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NCT06875076