Dose adjustments
toxicity, hematologic non-DLTs, toxicities, DLTs
ADVERSE EVENTS
If a patient experienced immune-related adverse events (irAEs) attributed to nivolumab, nivolumab was withheld or permanently discontinued depending on the types and severity of irAEs. Corticosteroids were administrated according to current guidelines. Dose reduction of nivolumab was not allowed in this study. The detailed dose modification regimen of GT90001 was listed as following: (1) no dose interruption or modification was made for grade 1 or 2 toxicity, regardless of non-hematologic or hematologic toxicity; (2) dose suspension or reduction is required or suggested for grade 3 non-hematologic non-DLTs (until toxicity returned to ≤ grade 1 or has returned to baseline) and grade 3 hematologic non-DLTs (until toxicity returned to ≤ grade 2 or has returned to baseline); (3) dose reduction or discontinuation is required or suggested for the following possibly-related toxicities: grade 3 non-hematologic DLTs or grade 4 non-hematologic toxicity (until the toxicity returned to ≤ grade 1 or has returned to baseline), and grade 3 hematologic DLTs or grade 4 hematologic toxicity (until the toxicity returned to ≤ grade 2 or has returned to baseline). If toxicity recovered to tolerable (grade 1 non-hematologic toxicities or grade 2 hematologic toxicities) within 4 weeks, protocol therapy could continue; if not, whether protocol therapy would be continued was judged by investigators.