RecruitingPhase 2NCT06318286

Study of Pembrolizumab Plus Chemotherapy With Lenvatinib for Malignant Pleural Mesothelioma

First-line Pembrolizumab Plus Platinum Doublet Chemotherapy With Lenvatinib in Unresectable Malignant Pleural Mesothelioma:Multi-Institutional, Single-Arm Phase 2 Trial


Sponsor

Hyogo Medical University

Enrollment

25 participants

Start Date

Mar 13, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

In this Phase-II study, the investigators will investigate the efficacy and safety of lenvatinib in combination with pembrolizumab and chemotherapy in patients with malignant pleural mesothelioma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of three drugs — pembrolizumab (immunotherapy), chemotherapy, and lenvatinib (a targeted drug) — as a first-line treatment for malignant pleural mesothelioma, a rare and aggressive cancer of the lining of the lungs usually linked to asbestos exposure. **You may be eligible if...** - You have been diagnosed with advanced or metastatic malignant pleural mesothelioma that cannot be removed by surgery - You have not yet received any treatment for mesothelioma - Your oxygen levels at rest are 94% or above without supplemental oxygen - You have at least one tumor that can be measured on a scan - Your expected survival is more than 90 days **You may NOT be eligible if...** - You have already received treatment for mesothelioma - You have serious other illnesses, uncontrolled infections, or autoimmune disease - 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

DRUGLenvatinib

Induction treatment: lenvatinib, 8 mg QD on Day 1 of a 21-day cycle for 4-6 cycles. Maintenance treatment: Lenvatinib, 20 mg QD may be given for up to a total of 35 cycles.

DRUGPemetrexed

Pemetrexed, 500 mg/m2 will be given by intravenous (IV) infusion on Day 1 of a 21-day cycle for 4-6 cycles.

DRUGCisplatin/Carboplatin

Carboplatin (AUC 5 mg/mL/min) or Cisplatin (75 mg/m2) will be given by IV infusion on Day 1 of a 21-day cycle for 4-6 cycles.

DRUGPembrolizumab

Pembrolizumab, 200 mg will be given by IV infusion on Day 1 of a 21-day cycle for up to a total of 35 cycles.


Locations(1)

Hyogo Medical University Hospital

Nishinomiya, Hyōgo, Japan

View Full Details on ClinicalTrials.gov

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NCT06318286


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