Safety and efficacy of oral cancer vaccine B440 in patients with PD-1/PD-L1 inhibitor-resistant advanced urothelial cancer: a study protocol for a phase 1 multicenter, open-label, single-arm clinical trial - Furukawa, Junya; Kakei, Yasumasa; Murakami, Sae; Kita, Hiroshi; Ueki, Hideto; Hara, Takuto; Teishima, Jun; Hinata, Nobuyuki; Miyake, Hideaki; Fujisawa, Masato; Shirakawa, Toshiro (BMC cancer, 2025)
Keywords: Administration, Oral; Adult; advanced urothelial cancer; Aged; Angina pectoris; Antibodies; Antigens; B440; B7-H1 Antigen - antagonists & inhibitors; Biomedical and Life Sciences; Biomedicine; Bladder cancer; Breastfeeding & lactation; Cancer Research; Cancer therapies; Cancer vaccines; Cancer Vaccines - administration & dosage; Cancer Vaccines - adverse effects; Cancer Vaccines - therapeutic use; Clinical trial; Clinical trials; Clinical Trials, Phase I as Topic; Creatinine; Drug Resistance, Neoplasm; Drugs; Female; Health Promotion and Disease Prevention; Humans; ICI; Immune Checkpoint Inhibitors - pharmacology; Immune Checkpoint Inhibitors - therapeutic use; Immune system; Immunity (Disease); Immunotherapy; Japan; Male; Medicine/Public Health; Metastasis; Middle Aged; Multicenter Studies as Topic; Oncology; Oral cancer; Patients; PD-1 protein; PD-L1 protein; Phase 1; Programmed Cell Death 1 Receptor - antagonists & inhibitors; Protein expression; Proteins; Registration; Response rates; Study Protocol; Surgical Oncology; Toxicity; Treatment Outcome; Urologic Neoplasms - drug therapy; Urologic Neoplasms - immunology; Urologic Neoplasms - pathology; Urothelial cancer; Vaccines; WT-1 protein; Japan; B440; Clinical trial; WT-1 protein; Phase 1; advanced urothelial cancer; ICI