M7824 Related Adverse Effects in Adults With Cancer

NCT04267861 | Active Not Recruiting

• 2 other identifiers: 99992005520-C-N055
• Study Type: observational
• Target: 232
• Locations: 1 country
• Sites: 1

Brief 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. ...

Conditions

Neoplasms; Skin Neoplasms

Keywords

Skin Neoplasms; Immunotherapy; Anti-PD-1; Natural History

Outcome Measures

Primary Outcomes (1)

• M7824 related adverse events

  adverse event frequency and characterization

  ongoing

Study Arms (1)

1

Medical records of subjects enrolled on NCI protocols 15-C-0179 and 18-C-0056

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects enrolled on CC protocols 15-C-0179 and 18-C-0056

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Cancer Institute (NCI)

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Neoplasms; Skin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Isaac F Brownell, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: February 13, 2020
• Study Start: January 28, 2020
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2025-04-16

Locations

US (1)