Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06318286

Study of Pembrolizumab Plus Chemotherapy With Lenvatinib for Malignant Pleural Mesothelioma

Led by Hyogo Medical University · Updated on 2025-05-25

25

Participants Needed

1

Research Sites

137 weeks

Total Duration

On this page

Sponsors

H

Hyogo Medical University

Lead Sponsor

M

Merck Sharp & Dohme LLC

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Study of Pembrolizumab Plus Chemotherapy With Lenvatinib for Malignant Pleural Mesothelioma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older with unresectable advanced or metastatic malignant pleural mesothelioma
  • No prior treatment for malignant pleural mesothelioma
  • Expected survival longer than 90 days
  • Resting oxygen saturation of 94% or higher without oxygen support within 7 days before enrollment
  • Provided written informed consent or consent by a surrogate
  • At least one measurable tumor lesion on CT or MRI within 28 days before enrollment, with specific conditions if lesion is pleural and history of pleurodesis
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 7 days before first treatment
  • Confirmed diagnosis of malignant pleural mesothelioma by tissue examination
  • Adequate organ function based on laboratory tests within 10 days before starting treatment
Not Eligible

You will not qualify if you...

  • Severe allergic reactions to drugs or antibody preparations
  • Women of childbearing potential with positive pregnancy test within 72 hours before registration
  • Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or other immune checkpoint agents
  • Systemic anti-cancer therapy or investigational agents within 4 weeks before registration
  • Live vaccine within 30 days before first treatment
  • Participation in another investigational study within 4 weeks before first treatment
  • Immunodeficiency or use of high-dose steroids or immunosuppressive therapy within 7 days before first treatment
  • Active or progressing additional cancers needing treatment within 3 years, with some exceptions
  • Active brain metastases or carcinomatous meningitis unless stable for at least 4 weeks
  • Severe hypersensitivity to pembrolizumab or its ingredients
  • Active autoimmune disease requiring systemic treatment in past 2 years
  • History or current pneumonitis or interstitial lung disease needing steroids
  • Active infection needing treatment
  • Known HIV, active Hepatitis B or C infection
  • Conditions or treatments that may interfere with study participation or results
  • Psychiatric or substance abuse disorders affecting trial cooperation
  • Pregnancy, breastfeeding, or plans to conceive during study and 120 days after last dose
  • History of allogenic tissue or solid organ transplant
  • Diverticulitis or symptomatic gastrointestinal ulcers
  • Frequent pleural effusions needing drainage more than every 2 weeks
  • Pericardial or ascitic effusions requiring treatment
  • Uncontrolled tumor-related pain
  • Recent serious cardiovascular events or uncontrolled heart conditions
  • Use of anticoagulation therapy excluding low-dose aspirin
  • Uncontrolled diabetes
  • Recent surgical treatments with local or general anesthesia within specified timeframes
  • Recent pleurodesis or pericardial/peritoneal adhesions within specified timeframes
  • Recent radiation therapy for pain relief or radiopharmaceuticals within specified timeframes
  • Use of unapproved drugs or combinations within specified timeframes
  • Prolonged QT interval over 480 msec
  • Significant proteinuria or active bleeding
  • Tumor involvement near major blood vessels increasing bleeding risk

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Hyogo Medical University Hospital

Nishinomiya, Hyōgo, Japan, 6638501

Actively Recruiting

Loading map...

Research Team

K

Kozo Kuribayashi, MD, PhD

CONTACT

T

Tetsuya Takagawa, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here