Last updated on October 2017

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 Malignant Pleural Mesothelioma (MPM).

Detailed Study Description

Study Groups: If participant is found to be eligible to take part in this study, participant will be assigned to 1 of 2 groups. Participant's doctor will decide which group participant is in. Up to 12 participants will be enrolled in each group. If participant is enrolled in Group A, participant will have already received at least 2 cycles of chemotherapy and possibly lung-sparing surgery. Participant will then receive radiation therapy to one side of participant's chest, or thorax, a technique called "hemithoracic radiation." Participant will then receive pembrolizumab. If participant is enrolled in Group B, participant may or may not have had chemotherapy or immunotherapy. Participant will not have received surgery. Participant will receive radiation therapy over a course of 1-3 weeks to a region that does not include the entire side of participant's chest, or thorax. Participant will then receive pembrolizumab. Study Drug Administration: In both groups, participant 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 participant is not receiving radiation, participant will have these visits about every 3 weeks while participant receives immunotherapy: - Participant will have a physical exam. - Blood (about 1-2 tablespoons) will be drawn to check participant's immune system, for side effects, and to check the status of the disease. Participant 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, participant may have extra imaging. Participant will have a PFT to check participant's lung function at Cycle 7 and then every 6 cycles. End-of-Study Visit: When participant stops receiving the study drug: - Participant will have a physical exam. - Blood (about 1-2 tablespoons) will be drawn to check participant's immune system, for side effects, and to check the status of the disease. - Participant will have a PFT to check participant's lung function. Length of Study: Participant may continue taking the study drug for up to 2 years. Participant will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if participant is unable to follow study directions. If the disease appears to be getting worse or the tumors appear to be getting larger, participant may still be able to receive the study drug if participant and participant's doctor decide it is in participant's 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. Participant is 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 participant is no longer able to receive other treatments. If participant chooses to receive the study drug after the disease gets worse, participant will continue to have study visits as described above. The study doctor will discuss this option with participant. Participation on the study will be over after the follow-up visits. Follow Up: About 30 days after participant's last dose of study drug, participant will have a physical exam. About every 12 weeks after participant's last dose of pembrolizumab: - Participant will have a physical exam. - Participant may have CT or PET scans to check the status of the disease. - If participant's doctor thinks it is needed, blood (about 1 tablespoon) may be drawn for routine tests. - At Weeks 12 and 24, participant will have PFTs performed. If participant is unable to make these visits, participant will be contacted by phone to check participant's health.

Clinical Study Identifier: NCT02959463

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