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Brief Title: Study of Avelumab-M3814 Combinations
Official Title: A Multicenter, Open-Label, Dose Escalation Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of the DNA-PK Inhibitor M3814 in Combination With Avelumab With and Without Palliative Radiotherapy in Participants With Selected Advanced Solid Tumors
Study ID: NCT03724890
Brief Summary: The main purpose of the study is to evaluate a safe, tolerable recommended Phase II dose (RP2D) and/or the maximum tolerated dose (MTD) of M3814 when given in combination with avelumab with and without radiotherapy in participants with selected advanced solid tumors.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
H. Lee Moffitt Cancer Center and Research Institute, Inc, Tampa, Florida, United States
The University of Chicago Medical Center, Chicago, Illinois, United States
Mount Sinai - PRIME (10707), Lake Success, New York, United States
UC Health Clinical Trials Office (10702), Cincinnati, Ohio, United States
University of Oklahoma Health Sciences Center - Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
University of Pittsburgh Medical Center Health System, Pittsburgh, Pennsylvania, United States
Greenville Hospital System University Medical Center (ITOR), Greenville, South Carolina, United States
Vanderbilt-Ingram Cancer Center (8867), Nashville, Tennessee, United States
Name: Medical Responsible
Affiliation: Merck KGaA, Darmstadt, Germany
Role: STUDY_DIRECTOR