Clinical trial assessments
Tumors, DLBCL, tumor, Cancer
ADVERSE EVENT, TUMOR, SOLID TUMORS, TUMORS, CANCER
Safety was assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. In the monotherapy portion of the trial, tumor evaluation (by CT and/or MRI scans) occurred at screening and at every 8-week cycle. In the combination portion of the trial, tumor evaluation occurred at screening and every three cycles for the first 12 cycles and then every four cycles beginning at cycle 13 (a cycle is defined as 21 d). Response assessment was done using conventional RECIST version 1.1 and immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) for patients with solid tumors and the Revised International Working Group criteria (that is, the Lugano classification) for patients with DLBCL.