NCT06318286

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Hyogo Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a single-arm, open-label study to evaluate the efficacy and safety of lenvatinib in combination with pembrolizumab and chemotherapy in patients with malignant pleural mesothelioma. The study will consist of a screening phase, a treatment phase, and a follow-up phase. Patients who meet the Inclusion Criteria, do not meet the Exclusion Criteria, and are judged by the investigator to be eligible for this clinical trial will be included. Subjects who meet all of the criteria listed in Criteria for Administration of Investigational Drugs may continue to receive the investigational drug. If a subject receiving investigational drugs meets any of the criteria listed in Discontinuation Criteria of Investigational Drugs, the subject will be evaluated at the end of the treatment phase (at the time of discontinuation) and moved to the post-observation phase.

Conditions

• Malignant Pleural Mesothelioma

Interventions

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

Timeline

• Start date: 2024-03-13
• Primary completion: 2026-04-30
• Completion: 2026-10-30
• First posted: 2024-03-19
• Last updated: 2025-05-25

Locations

1 site across 1 country: Japan

Regulatory

• FDA-regulated drug study