Patient Inclusion and Exclusion Criteria
NSCLC, SCLC, tumor, colorectal cancer, pneumonitis, melanoma, hepatitis B, toxicities, HNSCC, renal cell carcinoma, UC, infection, tumors
CARCINOMATOUS MENINGITIS, TUMOR, MELANOMA, TRIPLE-NEGATIVE BREAST CANCER, CENTRAL NERVOUS SYSTEM METASTASES, SURGICAL COMPLICATIONS, JC VIRUS INFECTION, ONCOLOGY, AUTOIMMUNE DISEASE, PANCREATIC DUCTAL ADENOCARCINOMA, COLORECTAL CANCER, SCLC, INTERSTITIAL LUNG DISEASE, GASTRIC CANCER, HEPATITIS B, ADVERSE EVENTS, METASTATIC ENDOMETRIAL CANCER, INFECTION, DISEASE PROGRESSION, PNEUMONITIS, DISEASE, SOLID TUMORS, HUMAN IMMUNODEFICIENCY VIRUS INFECTION, NSCLC, TRANSITIONAL CELL CARCINOMA, TUMORS
The study enrolled men and women ≥18 years of age with an Eastern Cooperative Oncology Group performance status (ECOG PS) ≤1, who were willing to provide a baseline and on-treatment tumor biopsy specimen, and had measurable disease based on RECIST v1.1. In Part 1a, enrolled patients had histologically or cytologically confirmed advanced or metastatic solid tumors that progressed after previous standard therapy. In Part 1b, patients enrolled were PD-(L)1 treatment-naïve or had disease progression on prior PD-(L)1–targeted therapy, and had histologically or cytologically confirmed advanced or metastatic endometrial cancer, gastric cancer, melanoma, microsatellite unstable colorectal cancer or other mismatch repair–deficient tumors, NSCLC, HNSCC, renal cell carcinoma, triple-negative breast cancer, genitourinary tract transitional cell carcinoma, or pancreatic ductal adenocarcinoma. In Part 2, patients who were PD-(L)1 treatment-naïve with histologically or cytologically confirmed advanced or metastatic SCLC, NSCLC, or UC were enrolled.Key exclusion criteria were serum creatinine >1.5 × institutional upper limit of normal (ULN), alkaline phosphatase, aspartate and/or alanine aminotransferase ≥2.5 × ULN, or total bilirubin ≥1.5 × ULN, persistent grade >1 toxic effects from prior therapy, or received live vaccine within 30 days. Additional exclusion criteria included having active infection (requiring systemic therapy), autoimmune disease, or central nervous system metastases and/or carcinomatous meningitis; current or history of pneumonitis; abnormal electrocardiogram; history of interstitial lung disease; history of human immunodeficiency virus infection; or evidence of hepatitis B or C virus infection or risk of reactivation. Patients who presented with unresolved (grade ≥2) toxicities from previous therapy and/or surgical complications were excluded from the study. All suspected immune-related adverse events (AE) during the study were treated with appropriate supportive care measures as determined by the treating investigator.