A Phase I/II Study of M3814 and Avelumab in Combination with Hypofractionated Radiation in Patients with Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies

Brief description of study

The purpose of the study is to determine if M3814 in combination with radiation therapy and avelumab is safe and tolerable in patients with advanced or metastatic cancers? We want to answer the question: can we increase the chance that your hepatobiliary cancer or chance it responds (tumor shrinkage) by combining M3814 with radiation therapy and avelumab and what dose of M3814 should be used in the future trials with this combination? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your cancer. The study drug M3814 is investigational, which means that it has not been approved by the U.S Food and Drug Administration (FDA), the health auiputhority that gives approval for new medicines to be prescribed in the United States, but the FDA has given its permission to test this agent in the current trial.


Clinical Study Identifier: s20-01391
ClinicalTrials.gov Identifier: NCT04068194
Principal Investigator: Nina Beri.
Other Investigators: Theresa Ryan, Jennifer Wu, Daniel J Becker, Cristian C Papazoglu Statescu, Jennifer Chuy, Kristen Spencer, Colin Hill, Keriann M Scavone, Benjamin Cooper, Paul E. Oberstein, Shun Yu, Mary Lynn R Nierodzik, Fauzia Shaikh.


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