Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
232 participants
OBSERVATIONAL
2020-01-28
2027-11-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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1
Medical records of subjects enrolled on NCI protocols 15-C-0179 and 18-C-0056
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Isaac F Brownell, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute (NCI)
Locations
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National Cancer Institute (NCI)
Bethesda, Maryland, United States
Countries
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Other Identifiers
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20-C-N055
Identifier Type: -
Identifier Source: secondary_id
999920055
Identifier Type: -
Identifier Source: org_study_id
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