Pembrolizumab And Lenvatinib In Leptomeningeal Metastases

Solid Tumor Clinical Trial

Official title: Phase II Trial of Pembrolizumab and Lenvatinib for Leptomeningeal Metastases

Status Terminated

Clinical Trial Summary

The purpose of this research is to examine if an experimental drug combination impacts the survival rate of individuals with Leptomeningeal Metastases

This research study involves an experimental drug combination.

The names of the study drugs involved in this study are:

• Pembrolizumab

• Lenvatinib

Clinical Trial Description

This is a single arm Phase 2 study of pembrolizumab in combination with lenvatinib in patients with leptomeningeal metastases from any solid tumor.

The research study procedures include screening for eligibility and study treatment, including evaluations and follow up visits.

• The names of the study drugs involved in this study are:

• Pembrolizumab

• Lenvatinib

The study treatment will last for up to 35 cycles (a cycle is 21 days long), or until the disease gets worse or unacceptable side effects. Participants will be followed for up to 90 days after the end of the study treatment.

It is expected that about 19 people will take part in this research study.

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug combination to learn whether the drug combination works in treating a specific disease. "Investigational" means that the drug combination is being studied.

The U.S. Food and Drug Administration (FDA) has not approved pembrolizumab or lenvatinib for this specific disease but each has been approved for other uses.

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Related Conditions & MeSH terms

• Leptomeningeal Metastasis
• Meningeal Carcinomatosis
• Neoplasm Metastasis
• Neoplasms
• Solid Tumor
• Solid Tumor, Adult

• NCT number: NCT04729348
• Study type: Interventional
• Source: Massachusetts General Hospital
• Status: Terminated
• Phase: Phase 2
• Start date: March 8, 2021
• Completion date: January 17, 2024