Last updated on July 2018

Adjuvant Pembrolizumab After Radiation Therapy for Lung-Intact Malignant Pleural Mesothelioma


Brief description of study

The goal of this clinical research study is to assess the safety of pembrolizumab (also called MK-3475) after radiation therapy (with or without surgery and/or chemotherapy) in patients with MPM.

This is an investigational study. Radiation therapy is delivered using FDA-approved and commercially available methods for local control of metastatic and primary tumors. Pembrolizumab is FDA approved and commercially available for the treatment of unresectable or metastatic melanoma, and for lung cancer. Its use in this study is investigational.

Up to 24 participants will take part in this study. All will be enrolled at MD Anderson.

Detailed Study Description

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to 1 of 2 groups. Your doctor will decide which group you are in. Up to 12 participants will be enrolled in each group.

If you are enrolled in Group A, you will have already received at least 2 cycles of chemotherapy and possibly lung-sparing surgery. You will then receive radiation therapy to one side of your chest, or thorax, a technique called "hemithoracic radiation." You will then receive pembrolizumab.

If you are enrolled in Group B, you may or may not have had chemotherapy or immunotherapy. You will not have received surgery. You will receive radiation therapy over a course of 1-3 weeks to a region that does not include the entire side of your chest, or thorax. You will then receive pembrolizumab.

Study Drug Administration:

In both groups, you will receive pembrolizumab by vein over about 30 minutes on Day 1 of each 3-week cycle after radiation therapy, for up to 2 years.

Study Visits:

When you are not receiving radiation, you will have these visits about every 3 weeks while you receive immunotherapy:

  • You will have a physical exam.
  • Blood (about 1-2 tablespoons) will be drawn to check your immune system, for side effects, and to check the status of the disease.

You will have a CT and/or PET scan to check the status of the disease before radiation therapy, at Cycle 4, and then every 3 cycles thereafter. If the doctor thinks it is needed, you may have extra imaging.

You will have a PFT to check your lung function at Cycle 7 and then every 6 cycles.

End-of-Study Visit:

When you stop receiving the study drug:

  • You will have a physical exam.
  • Blood (about 1-2 tablespoons) will be drawn to check your immune system, for side effects, and to check the status of the disease.
  • You will have a PFT to check your lung function.

Length of Study:

You may continue taking the study drug for up to 2 years. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

If the disease appears to be getting worse or the tumors appear to be getting larger, you may still be able to receive the study drug if you and your doctor decide it is in your best interest. Sometimes the disease appears to get worse but the study drug is actually working.

However, there are risks of continuing to receive the study drug because the disease may actually be getting worse. You are still at risk for side effects due to the study drug. This could also delay starting other treatments. The disease may get worse to the point that you are no longer able to receive other treatments.

If you choose to receive the study drug after the disease gets worse, you will continue to have study visits as described above. The study doctor will discuss this option with you.

Your participation on the study will be over after the follow-up visits.

Follow Up:

About 30 days after your last dose of study drug, you will have a physical exam.

About every 12 weeks after your last dose of pembrolizumab:

  • You will have a physical exam.
  • You may have CT or PET scans to check the status of the disease.
  • If your doctor thinks it is needed, blood (about 1 tablespoon) may be drawn for routine tests.
  • At Weeks 12 and 24, you will have PFTs performed.

If you are unable to make these visits, you will be contacted by phone to check your health.

Clinical Study Identifier: NCT02959463

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University of Texas MD Anderson Cancer Center
Houston, TX United States
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