Assessments
tumor, bleeding, Tumor, thrombocytopenia, hyponatremia, colitis
TUMOR, BLEEDING, TUMOR, ADVERSE EVENTS, THROMBOCYTOPENIA, HYPONATREMIA, DISEASE, METASTATIC DISEASE, NONINFECTIOUS PNEUMONITIS, COLITIS
The primary endpoint was safety, assessed by incidence of adverse events (AEs) from the time of informed consent until 90 days after the last dose of study treatment. Causality of AEs were assessed by the investigator. AEs of special interest (AESIs) for durvalumab and tremelimumab were monitored and included immune‐mediated AEs, defined as AEs with a potential inflammatory or immune‐mediated mechanism. DLT in Part A was defined as a clinically significant laboratory abnormality (liver transaminase elevation >8 × the upper limit of normal [ULN] or total bilirubin >5 × ULN, Grade 3 or 4 thrombocytopenia with clinically significant bleeding, any Grade 4 thrombocytopenia lasting >48 h, Grade 4 hyponatremia lasting ≥24 h, or alanine aminotransferase or aspartate aminotransferase >5 to 20 × ULN and total bilirubin >1.5 to 3 × ULN), any Grade 4 immune‐related AE not attributable to local tumor response (e.g., inflammatory reaction attributed to local tumor response or inflammatory reaction at sites of metastatic disease or lymph nodes), any Grade ≥3 colitis, any Grade 3 or 4 noninfectious pneumonitis, or any Grade ≥3 AE that did not downgrade to Grade ≤1 or baseline status within 14 days, which were definitively related to the study medication.Exploratory antitumor activity assessments included objective response rate (ORR; rate of complete response and partial response), duration of response (DoR), disease control rate (DCR; rate of complete response, partial response, and stable disease) at 3 and 12 months, progression‐free survival (PFS) and overall survival (OS). Tumor response was evaluated according to RECIST 1.1 and confirmed by the investigator.