Clinical trial patients
pulmonary or gastrointestinal disease, toxicities, tumor, autoimmune disease
TUMOR, MALIGNANT NEOPLASM, DISEASE, CNS METASTASES, AUTOIMMUNE DISEASE
Eligible patients were adult individuals with histologically proven, unresectable, locally advanced or metastatic malignant neoplasms for whom no approved therapy with demonstrated clinical benefit was available or who were intolerant of or had declined standard therapy. Patients had to have good performance status (ECOG PS of 0 or 1), life expectancy ≥12 weeks, radiographic evidence of measurable disease, acceptable laboratory parameters and adequate end organ function. Patients had to have an FFPE tumor specimen. In CPI-experienced patients, toxicities related to prior CPIs had to be resolved to grade ≤1 or baseline. Key exclusion criteria were symptomatic CNS metastases; history of known or suspected autoimmune disease with specific exceptions; treatment with systemic chemotherapy within 3 weeks, treatment with biologics or investigational therapy within 4 weeks; radiation therapy or corticosteroid treatment within 2 weeks; clinically important cardiovascular, pulmonary or gastrointestinal disease; and serious concurrent illnesses that would increase the risk to the patient or confound the study data.The full inclusion and exclusion criteria are provided below.