M7824 Related Adverse Effects in Adults With Cancer

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Cancer Institute (NCI)

Bethesda, Maryland, 20892, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

M7824 related adverse events

Time frame: ongoing

adverse event frequency and characterization

Sponsors and collaborators

Lead sponsor

National Cancer Institute (NCI)

Nih

Registry information

Official study title

Retrospective Study of M7824 Related Adverse Effects in Adults With Cancer

Important dates

Study start: 2020
Primary completion: 2027
Study completion: 2027
First posted: Feb 13, 2020
Registry last updated: May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed