NeoplasmsNCT04267861
M7824 Related Adverse Effects in Adults With Cancer
An observational study of Neoplasms and Skin Neoplasms, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Skin Neoplasms
- How many people
- 232 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2020to 1 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects enrolled on CC protocols 15-C-0179 and 18-C-0056
Who may be able to join
- Adults with cancer enrolled on immunotherapy treatment protocols including M8724 in the NCI.
Who cannot join
- Patients who opted out of future use of data on their prior studies will be excluded from this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
About this study
Official title: Retrospective Study of 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.
Read more
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.
Read the detailed 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 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.
- Conditions
- Neoplasms, Skin Neoplasms
- Keywords
- Skin Neoplasms, Immunotherapy, Anti-PD-1, Natural History
- Medical subject headings
- Neoplasms, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Medical records of subjects enrolled on NCI protocols 15-C-0179 and 18-C-0056 |
What is being measured
The primary outcome is the main question the study is designed to answer.
M7824 related adverse events
adverse event frequency and characterization
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start28 Jan 2020
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Isaac F Brownell, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04267861
- Sponsor's protocol ID
- 999920055
- Other IDs
- 20-C-N055
- Status last verified
- 18 May 2026
- First submitted
- 12 Feb 2020
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study of M7824 Related Adverse Effects in Adults With Cancer
- ClinicalTrials.gov ID
- NCT04267861
- Acronym / sponsor ID
- 999920055
- Conditions
- Neoplasms, Skin Neoplasms
- Keywords
- Skin Neoplasms, Immunotherapy, Anti-PD-1, Natural History
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 232 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 28 Jan 2020 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 13 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Medical records of subjects enrolled on NCI protocols 15-C-0179 and 18-C-0056 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects enrolled on CC protocols 15-C-0179 and 18-C-0056
Key inclusion criteria (1 listed)
- Adults with cancer enrolled on immunotherapy treatment protocols including M8724 in the NCI.
Key exclusion criteria (1 listed)
- Patients who opted out of future use of data on their prior studies will be excluded from this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
M7824 related adverse events
Time frame: ongoing
adverse event frequency and characterization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isaac F Brownell, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms and Skin Neoplasms, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
M7824 related adverse events (time frame: ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.