Please note that this summary only contains information from the full scientific abstract: View ESMO Scientific Abstract

Finding the best dose of M9241 (NHS-IL12) combined with avelumab for people with solid tumors

Date of summary: September 2019

Study number: NCT02994953

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Study start date: January 2017

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Estimated study end date: January 2020

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The full title of this abstract is: Phase 1b, open-label, dose-escalation study of M9241 (NHS-IL12) plus avelumab in patients (pts) with advanced solid tumors

The combination of M9241 (NHS-IL12) and avelumab is not approved to treat the conditions under study that are discussed in this summary.

 

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.

 

This summary reports the results of only one study. The results of this study might be different from the results of other studies that the researchers look at.

This summary reports the interim results from the study – results may not be the same when the study is complete.

 

More information can be found in the scientific abstract of this study, which you can access here:
View ESMO Scientific Abstract

What did this study look at?

  • Solid tumors are cancers that do not contain any liquid areas.
    • In some people, the cancer spreads to nearby tissues (known as locally advanced). The cancer can also spread to other parts of the body (known as metastatic).

 

  • M9241 (NHS-IL12) is an investigational immunotherapy that targets cells at the center of a tumor.
    • Investigational means that a medicine is approved for testing in people with a certain condition in clinical trials. It is not approved for sale.
    • Immunotherapy is a type of treatment that boosts the body’s immune system to help fight cancer.
    • M9241 may help the immune system to become more active in stopping tumors from growing.

 

  • Avelumab is an immunotherapy that binds to a protein called PD-L1. This protein tells immune cells not to attack cancer cells.
    • When avelumab binds to PD-L1, it may prevent PD-L1 from working correctly, which releases the ‘brakes’ on the immune system. This may allow immune cells to attack and destroy the cancer cells.
  •  Researchers are interested in using M9241 and avelumab in combination to find a treatment that offers the best of both drugs.

 

  •  In this ongoing study, researchers increased the dose of the study drug to a point where people started to develop serious medical problems.

 

  •  Researchers wanted to know:
    • what was the maximum dose of M9241 combined with avelumab that did not cause serious medical problems, and
    • which were the medical problems, if any, that people developed.

 

  •  This summary describes the results so far from this ongoing study.

Who took part in this study?

What were the results of the study?

More results from this study can be found here:
View ESMO Scientific Abstract

What was the main conclusion reported by the researchers?

  • In this study, researchers identified a suitable combined dose of M9241 and avelumab for people with solid tumors.
    • Researchers will use this dose in future studies to find out more about the safety of this combined study treatment and how it affects the body.

Who sponsored this study?

Merck KGaA
Frankfurter Strasse 250
Darmstadt, 64293, Germany
Phone (Germany): +49 6151 720

Pfizer Inc.
235 East 42nd Street NY, NY 10017
Phone (United States): +1 212-733-2323

The sponsors would like to thank all of the people who took part in this study.

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