M7824 Related Adverse Effects in Adults With Cancer

Summary

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Description

Immunotherapy agents utilize the immune system to help fight cancer. A number of immunotherapy drugs have been approved for use in certain cancers. Despite being effective in some patients, many of these promising drugs do not demonstrate efficacy in other patients. M7824 (MSB0011359C), a bifunction...

Immunotherapy agents utilize the immune system to help fight cancer. A number of immunotherapy drugs have been approved for use in certain cancers. Despite being effective in some patients, many of these promising drugs do not demonstrate efficacy in other patients. M7824 (MSB0011359C), a bifunctional fusion protein that blocks both PD-L1 and transforming growth factor beta (TGF-beta) signaling, is a promising novel drug that has proven efficacious in a subset of cancer patients. However, we have observed side effects in patients receiving M7824 that include both immune related adverse events and skin neoplasms. It is imperative that these M7824 side effects be identified and characterized so that they can be prevented or diminished during future cancer treatments. By thoroughly analyzing the side effect profile of this drug, management of adverse effects and overall patient outcomes can be better understood and optimized. The primary goal of this protocol is to perform a retrospective chart review for the investigation of the adverse events arising in cancer patients being treated with systemic therapies including M7824 at the National Cancer Institute (NCI). This study will not involve the use of specimens or participant contact. All data that are needed have already been collected on the individual treatment protocols and are available in CRIS records or protocol specific databases. Data will only be collected from treatment protocols where the PI has given permission for use of the data on the trial the subjects were enrolled on and the subjects did not opt out of future use of data. This protocol will be amended to incorporate new research objectives and new protocols as necessary.

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