{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"}],"units":"Participants"}],"description":"Number of patients who experienced Dose Limiting Toxicities. DLTs are defined as occurrence of any of the following events, if judged by the Investigator to be possibly, probably or definitely related to study drug administration\n\n1. Any Grade 4 or greater adverse event per the Common Terminology Criteria for Adverse Events version 5 (CTCAE v5.0) observed within 90 days of the last dose of radiation therapy.\n2. Grade 3 nonhematologic toxicity (not laboratory) lasting \\>5 days despite optimal supportive care.\n3. Any Grade 3 nonhematologic laboratory value if: • Medical intervention is required to treat the patient, or • The abnormality leads to hospitalization, or • The abnormality persists for \\>1 week.\n4. Febrile neutropenia.\n5. Thrombocytopenia \\<25000/mm3 if associated with bleeding requiring intervention.\n6. Prolonged delay (\\>2 weeks) in initiating Cycle 2 due to treatment-related toxicity.","groups":[{"description":"Patients received pembrolizumab IV over 30 minutes on day 1 of each cycle. Starting on day 7, patients also receive 10 mg of BAY 1895344 PO BID on days 7-9 and 14-16 during cycle 1, and before and after each SBRT treatment during cycle 2 for a total of 9 doses. Beginning cycle 2, patients underwent SBRT starting between days 2 and 8 for 3 fractions with 2-3 days between fractions. Treatment repeated every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity (8 Gy x 3 SBRT). Patients also underwent CT scan and/or PET-CT scan and collection of blood samples throughout the trial.\n\nBiospecimen Collection: Undergo blood sample collection\n\nComputed Tomography: Undergo CT and/or PET-CT scan\n\nElimusertib: Given PO\n\nPembrolizumab: Given IV\n\nPositron Emission Tomography: Undergo PET-CT scan\n\nQuality-of-Life Assessment: Ancillary studies\n\nStereotactic Body Radiation Therapy: Undergo SBRT","id":"OG000","title":"Treatment (Pembrolizumab, BAY 1895344, SBRT)"}],"paramType":"NUMBER","populationDescription":"All enrolled patients were treated at the lowest dose level.","reportingStatus":"POSTED","timeFrame":"Within 90 days of treatment initiation","title":"Incidence of Dose Limiting Toxicities (DLT)","type":"PRIMARY","unitOfMeasure":"participants"}