Skip to main content

Table 1 Characteristics of published phase III RCTs for current US FDA-approved Immune-Checkpoint Inhibitors (ICIs)

From: The quality of reporting general safety parameters and immune-related adverse events in clinical trials of FDA-approved immune checkpoint inhibitors

Published trials N = 42 1
Type of journal
 Oncology 14 (33.3%)
 General medicine 28 (66.7%)
NCT number reported 42 (100%)
Immune-Checkpoint Inhibitors 2
 Atezolizumab (Tecentriq®) 5 (11.9%)
 Avelumab (Bavencio®) 3 (7.1%)
 Cemiplimab (Libtayo®) 0 (0%)
 Durvalumab (Imfinzi®) 2 (4.8%)
 Ipilimumab (Yervoy®) 13 (31.0%)
 Nivolumab (Opdivo®) 22 (33.3%)
 Pembrolizumab (Keytruda®) 10 (23.8%)
ICI regimen
 Monotherapy with ICI 26 (61.9%)
 Combination regimen of ICI with chemotherapy, radiotherapy, etc. 16 (38.1%)
Medical indication
 Metastatic non-small cell lung cancer (NSCLC) 16 (38.1%)
 Unresectable or metastatic melanoma 11 (26.2%)
 Renal cell carcinoma (RC) 4 (9.5%)
 Gastroesophageal / gastric cancer (GEC/GC) 3 (7.1%)
 Head and neck squamous cell carcinoma (HNSCC) 2 (4.8%)
 Urothelial carcinoma (UC) 2 (4.8%)
 Prostate cancer (PC) 2 (4.8%)
 Breast cancer (BC) 1 (2.4%)
 Small cell lung cancer (SCLC) 1 (2.4%)
Study design
 Parallel with 2 arms 36 (85.7%)
 Parallel with 3 arms 6 (14.3%)
Blinding
 Open-label 23 (54.8%)
 Double-blinded 19 (45.2%)
Primary outcomes
 Overall survival (OS) 20 (47.6%)
 Progression Free Survival (PFS) 1 (2.4%)
 Overall survival (OS) + Progression Free Survival (PFS) 14 (33.3%)
 Recurrence Free Survival 3 (7.1%)
 Safety outcomes 2 (4.8%)
 Other (e.g., objective response rate, safety or other combinations) 2 (4.8%)
RCT sites / countries
 At least one site in the USA 37 (88.1%)
 No site in the USA 5 (11.9%)
Funding source
 Pharmaceutical company 42 (100%)
 Other (European Organization for Research and Treatment of Cancer) 1 (2.4%)
  1. 1. n (%), except otherwise indicated
  2. 2. The total percentages combined are more than 100% since 5 trials included both Ipilimumab and Nivolumab in one or more of their treatment arms
\