Retrospective Study of M7824 Related Adverse Effects in Adults With Cancer

Official Summary

Background: Immunotherapy drugs use a person s own immune system to help fight cancer. These drugs work better for some people than others. The drug M7824 has helped some people with cancer. But it can cause side effects. Researchers want to learn all the side effects that M7824 can cause. Once they do, they can prevent or reduce these side effects in future cancer treatments. This will lead to better overall outcomes for people with cancer. Objective: To make a thorough list of adverse events in people with cancer being treated with systemic therapies including M7824 at the National Cancer Institute (NCI). Eligibility: Participants previously enrolled in NCI protocols #15-C-0179 and #18-C-0056 Design: All needed data have already been collected. These data are stored in existing records and databases. Researchers will review the medical records of adults with cancer who were enrolled in the above protocols. The data collected will be relevant to the specific objectives being addressed. Data will be collected only if 2 conditions are met. One, the principal investigator gave permission for use of the data gathered in the trial. Two, the participants of the trial did not opt out of future use of the data. Other protocols may be added. This will be done with an amendment. ...

Study Design

• Study Type: OBSERVATIONAL
• Enrollment: 232 participants

Primary Outcomes

• M7824 related adverse events (ongoing)

Eligibility Criteria

* INCLUSION CRITERIA:

Adults with cancer enrolled on immunotherapy treatment protocols including M8724 in the NCI.

EXCLUSION CRITERIA:

Patients who opted out of future use of data on their prior studies will be excluded from this study.

Trial Locations

• National Cancer Institute (NCI), Bethesda, Maryland, United States

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