A Phase I Study of Pembrolizumab Immunotherapy and Radiation Therapy in People with Inoperable Pleural Mesothelioma

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Full Title

Phase I Dose Escalation and Local Control Study of Pembrolizumab + Intensity-Modulated Pleural Radiation Therapy (IMPRINT) for Malignant Pleural Mesothelioma

Purpose

The purpose of this study is to learn if intensity-modulated pleural radiation therapy (IMPRINT) in combination with pembrolizumab immunotherapy is a safe treatment for people with malignant pleural mesothelioma, a cancer of the lining of the lungs. IMPRINT is a type of radiation therapy that specifically targets the lining of the lungs and the inner side of the ribs to stop cancer from growing. Pembrolizumab works by taking the brakes off the immune response, enhancing the ability of the immune system to find and kill cancer cells. It is given intravenously (by vein).

In this study, researchers will look for the highest dose of IMPRINT that can be given safely in combination with pembrolizumab. Once that dose is found, they will test it in combination with pembrolizumab in future participants to determine the effectiveness of the treatment.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have inoperable malignant pleural mesothelioma.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Andreas Rimner at 646-608-2449

Protocol

21-197

Phase

I

Disease Status

Newly Diagnosed

Investigator