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Researchers must look at the results of many types of studies to understand whether a study drug works, how it works, and whether it is safe to prescribe to patients.
More information can be found in the scientific abstract of this study, which you can access here: https://meetinglibrary.asco.org/record/176187/abstract
The combination of M3814 and avelumab is not approved to treat the conditions under study that are discussed in this summary.
This summary describes one ongoing study. The results of this study are not yet known, but might be di�erent from the results of other studies that the researchers look at.
Who will take part in this study?
More results from this study can be found here: https://meetinglibrary.asco.org/record/176187/abstract
M3814 is an experimental drug that prevents cancer cells from repairing damage to their DNA.• DNA contains genetic information that regulates
activity inside a cell.
Avelumab is an immunotherapy drug, which means it helps the body’s own immune system to find and destroy cancer cells.• It is being studied as an investigational treatment
for some types of cancer.
Laboratory studies suggest that M3814 could make cancer cells more sensitive to treatment with immunotherapy and radiotherapy.• Radiotherapy is a treatment that uses radiation to
destroy cancer cells, by damaging their DNA.• Immunotherapy is a type of treatment that boosts
the body’s immune system to help fight cancer, infection and other diseases.
In this ongoing study, researchers are looking at M3814 and avelumab with or without radiotherapy in people with advanced solid tumors. • A solid tumor is a cancer that does not contain any
liquid areas.• Advanced cancer is cancer that has spread from
where it first started to nearby tissues or to other parts of the body.
• This is the first time that people will receive this combination of study treatments.
This summary describes how researchers will combine these study treatments to:• find the right doses, and • look at whether they are safe and potentially e�ective
in people with: – advanced solid tumors (Part A), or – advanced cancer that can have started in the
lung or have spread to the lung from elsewhere in the body (Part B).
What did this study look at?
What information will be reported from this study?
Please note that this summary only contains information from the full scientific abstract:https://meetinglibrary.asco.org/record/176187/abstract
Design for a study of M3814 plus avelumab and radiotherapy in people with advanced solid tumors
Date of summary: May 2019Study number: NCT03724890 | Study start date: November 2018 | Estimated study end date: July 2021
The full title of this abstract is: Phase 1, open-label, dose-escalation study of M3814 + avelumab ± radiotherapy (RT) in patients (pts) with advanced solid tumors
Who sponsored this study?Merck KGaAFrankfurter Strasse 250Darmstadt, 64293, GermanyPhone (Germany): +49 6151 720
The sponsors would like to thank all of the people who took part in this study.
Further information
For more information on this study, please visit:
https://meetinglibrary.asco.org/record/176187/abstracthttps://clinicaltrials.gov/ct2/show/NCT03724890
For more information on clinical studies in general, please visit:
https://www.clinicaltrials.gov/ct2/about-studies/learnhttp://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/what-clinical-trials-are
Abstract Plain Language Summary writing support was provided by Alexandra Bound PhD, CMPP, Envision Pharma Group, Inc. and was funded by Pfizer.
What is the main aim of the researchers? In this 2-part study, researchers are combining M3814 with avelumab and radiotherapy as an investigational study treatment. They will look at whether this treatment is safe and potentially e�ective in people with advanced solid tumors (Part A), or advanced cancer that can have started in the lung or have spread to the lung from elsewhere in the body (Part B).
Avelumab <a-VEL-yoo-mab>
Part A
6 to 24
Between 6 and 24 people will take part
They can have dierent types of advanced solid tumors
Everyone will receive M3814 and avelumab
Part B
6 to 18
Between 6 and 18 people will take part
They will have advanced cancer. This can have started in the lung, or spread to the lung from elsewhere in the body
Everyone will receive M3814 and avelumab + radiotherapy
Researchers will report:
* Medical problems could be caused by reasons not related to the study (for example, an underlying disease or by chance). Or, medical problems could have been caused by a study treatment, or by another medicine the participant was taking.
Medical problems* that people report during the study
How long people live after they start the study
How long people live without their cancer getting worse
Whether people’s cancers shrink, stay the same or grow
Whether people’s immune systems react to the study treatments
How long the study treatments stay in the body
The recommended doses of the study treatments for future clinical studies
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