Research & Clinical Trials

Memorial Sloan Kettering Opening New Mesothelioma Clinical Trial

Written By:
May 26, 2021
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Written By: Tim Povtak,
May 26, 2021

Memorial Sloan Kettering Cancer Center in New York City will begin recruiting soon for its latest clinical trial involving patients with malignant pleural mesothelioma and the expanded use of immunotherapy.

The single-center, phase I study will explore the effectiveness of pembrolizumab in combination with intensity-modulated pleural radiation therapy, known as IMPRINT, in treating unresectable disease.

Pembrolizumab, also known by the brand name Keytruda, was approved by the U.S. Food and Drug Administration in 2020 for treatment of a small subset of mesothelioma patients.

As a well-known immunotherapy drug, pembrolizumab is being used today with mixed success for mesothelioma treatment, but mostly under special access programs by manufacturer Merck & Co., or in clinical trials.

It has been approved also for several other types of cancers, the latest of which is gastric cancers, which was approved earlier in May.

Immunotherapy in Combination Is Key

Although immunotherapy alone has not been the answer for tough-to-treat cancers such as mesothelioma, researchers have been seeking new combinations to better maximize its potential.

Memorial Sloan Kettering is one of America’s leading mesothelioma treatment centers, with an extensive research department. Investigators declined to discuss expectations or provide additional details regarding the trial with The Mesothelioma Center at Asbestos.com.

The cancer center already is in the midst of eight active clinical trials for pleural mesothelioma, including its most celebrated one involving CAR T-Cell therapy that has shown impressive potential and eventually could change the way the disease is treated. It involves genetically modifying a patient’s T-cells.

There currently is no cure for mesothelioma, the rare and aggressive cancer caused almost exclusively by exposure to asbestos fibers.

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MSK Conducting Several Mesothelioma Clinical Trials

Memorial Sloan Kettering’s other mesothelioma clinical trials include:

  • Phase I trial involving immunotherapy drug nivolumab in combination with chemotherapy before aggressive surgery.
  • Phase I trial combining galinpepimut-S, a targeted cancer vaccine for patients expressing high levels of the protein WT-1, with nivolumab.
  • Phase II study using intensity-modulated radiation therapy and chemotherapy after pleurectomy and decortication surgery.
  • Phase III study adding ADI-PEG 20, a drug designed to restrict an enzyme that fuels cancer cells, in combination with standard chemotherapy.

This latest clinical trial involving Keytruda is scheduled to begin in July. It is designed as a dose-escalation study using a modified, continuous reassessment method.

The goal is finding the highest possible radiation dose without harmful toxicities and determining its effectiveness when combined with pembrolizumab.

Radiation Treatment Has Changed

The use of radiation with pleural mesothelioma in the past has not been extensive, and mostly palliative in nature. Only a small number of mesothelioma specialty centers have been using the more precise IMPRINT version as part of a multidisciplinary approach to treatment designed to stop or slow tumor growth.

High-dose radiation has been used most effectively to decrease the risk of regional tumor recurrence after aggressive extrapleural pneumonectomy surgery, which removes an entire lung. The use of the EPP surgery, though, has fallen dramatically.

Princess Margaret Cancer Center in Toronto is one of the few treatment centers using high-dose radiation before EPP surgery, and has discovered unprecedented success with the technique.

The theory behind the unusual practice is that the radiation-first procedure better stimulates the patient’s immune system and decreases the cancer’s ability to seed during surgery.

With lung-sparing surgery, or no surgery at all, the potential for adverse side effects has limited its use at many cancer centers, beyond the palliative nature.

This clinical trial, which combines the most precise radiotherapy possible with pembrolizumab, could change that perception.

Estimated enrollment for the trial is 24 patients over the next two years. The mesothelioma must be deemed unresectable by a thoracic surgeon for a patient to be accepted.

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