MedTrace Logo

Study of Pembrolizumab Plus Chemotherapy With Lenvatinib for Malignant Pleural Mesothelioma

NCT06318286 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-05-25

No results posted yet for this study

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.

Conditions

  • Malignant Pleural Mesothelioma

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Kozo Kuribayashi, MD, PhD · Department of Respiratory Medicine and Hematology, Hyogo Medical University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-13
Primary Completion
2026-04-30
Completion
2026-10-30
FDA Drug
Yes

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06318286 on ClinicalTrials.gov