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. 2023 Jul 13;14:1196970. doi: 10.3389/fimmu.2023.1196970

Table 1.

Clinical trials of M7824.

NCT number Cancer type Phase Primary Measure Outcomes Status
NCT03833661 Biliary tract cancer, Cholangiocarcinoma, Gallbladder cancer 2 ORR Completed
NCT03524170 Breast cancer 1 Safety Completed
NCT03840915 NSCLC 1/2 Safety Completed
NCT02699515 Solid tumors 1 Safety Completed
NCT04066491 Biliary tract cancer, Cholangiocarcinoma, Gallbladder cancer 2/3 Safety and OS Completed
NCT02517398 Solid tumors 1 Safety Completed
NCT04489940 TNBC 2 ORR Completed
NCT04246489 Uterine cervical neoplasms 2 ORR Completed
NCT04220775 HNSCC 1/2 Safety and PFS Completed
NCT04551950 Cervical cancer 1 Safety Completed
NCT04501094 Urothelial cancer 2 ORR Terminated
NCT03840902 NSCLC 2 PFS Terminated
NCT03451773 Pancreatic cancer 1/2 Safety and ORR Terminated
NCT04327986 Pancreatic cancer 1/2 PR2D, Safety, and ORR Terminated
NCT04560686 NSCLC 2 ORR Terminated
NCT04428047 HNSCC 2 ORR Terminated
NCT04727541 Cholangiocarcinoma 2 ORR Terminated
NCT04971187 NSCLC 2 ORR and PFS Terminated
NCT04417660 Thymic cancer 2 ORR Recruiting
NCT05005429 Mesothelioma and lung cancer 2 PFS Recruiting
NCT04303117 Kaposi sarcoma 1/2 Safety Recruiting
NCT04432597 HPV+ cancer 1/2 Safety, PR2D, and CD3+ TIL Recruiting
NCT03554473 SCLC 1/2 ORR Recruiting
NCT03493945 Prostate cancer 1/2 Clinical benefit Recruiting
NCT05012098 Olfactory neuroblastoma 2 ORR Recruiting
NCT03315871 Prostate cancer 2 PSA Recruiting
NCT04708470 Solid tumors 1/2 ORR and PR2D Recruiting
NCT03427411 Solid tumors 2 ORR Active, not recruiting
NCT03631706 NSCLC 3 PFS and OS Active, not recruiting
NCT03436563 Colorectal cancer, MSI-H solid tumors 1/2 ORR, ctDNA Active, not recruiting
NCT05061823 Lung cancer 3 Safety Active, not recruiting
NCT04247282 Head and neck cancer 1/2 ORR Active, not recruiting
NCT04574583 Solid tumors 1/2 ORR Active, not recruiting
NCT04491955 Small bowel cancer, colorectal cancer 2 ORR Active, not recruiting
NCT04287868 Solid tumors 1/2 ORR Active, not recruiting
NCT04789668 Solid tumors 1/2 ORR, PR2D, Safety, and OS Active, not recruiting
NCT04396535 NSCLC 2 PFS Active, not recruiting

ORR, objective response rate; NSCLC, non-small cell lung cancer; SCLC, small cell lung cancer; TNBC, triple negative breast cancer; OS, overall survival; HNSCC, head and neck squamous cell carcinoma; PFS, progression-free survival; PR2D, recommended phase II dose; TIL, tumor-infiltrating lymphocyte; MSI-H, microsatellite instability-high; ctDNA, circulating tumor DNA.