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