Toxicity and safety measures
diarrhea, fatigue, toxicity, constipation, intercurrent illness, pancreatitis, hepatic injuries, weight loss, anorexia, nausea, vomiting
ADVERSE EVENT, DISEASE PROGRESSION, ADVERSE EVENT, PANCREATITIS, MALNUTRITION, DISEASE, ANOREXIA
All patients who received at least 1 dose of either galunisertib or nivolumab were evaluated for safety and toxicity. Any other significant toxicity deemed to be dose limiting or resulted in the patient getting < 75% of the total doses or lead to holding galunisertib for > 2 weeks. For nivolumab, any toxicity that occurred during Cycles 1 or 2 managed by discontinuation. Any Grade ≥ 2 nonskin, drug-related AE; any Grade 3 skin, drug related AE; any Grade 3 drug-related laboratory abnormality; any adverse event (AE), laboratory abnormality, or intercurrent illness which, in the judgment of the investigator, warranted delaying the dose of study medication. Exceptions not considered a DLT included: Grade 3 amylase or lipase abnormalities not associated with symptoms or clinical manifestations of pancreatitis that did not require a dose delay; nausea, vomiting, diarrhea, and constipation controlled with treatment; fatigue relieved by rest; Grade 3 elevations of alanine aminotransferase and/or aspartate aminotransferase, without evidence of other hepatic injuries; anorexia not associated with significant weight loss (weight loss of > 10% baseline) or malnutrition. The AEs were assessed, according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, continuously during the study and for 100 days after the last dose of combination treatment. Disease assessment with computed tomography and/or magnetic resonance imaging, as appropriate, were performed at baseline and approximately between Days 22 and 28 of every other cycle and completed before the first dose in the next cycle, until disease progression or patient withdrawal from the study.