Table 3.
Main ongoing trials for immunotherapy in BTCs.
| Study name | Phase | Drug / Target | Setting |
|---|---|---|---|
| Keynote - 158 (NCT02628067)33 | 2 | Pembrolizumab / PD-1 | Histologically/cytological confirmed incurable advanced BTC, disease progression after ≥1 prior standard therapy, ECOG-PS 0-1, no prior exposure to ICIs. |
| CA 209-538 (NCT02923934)40 | 2 | Ipilimumab / CTLA-4 + Nivolumab / PD-1 |
First or second line therapy in neuroendocrine tumors, rare gynaecological tumors and advanced upper GI tumors, including BTC. |
| Keynote-966 (NCT04003636)117 |
3 | GEMCIS + Pembrolizumab /PD-1 |
First line therapy for advanced or unresectable BTC. |
| NCT03797326121 | 2 | Lenvatinib / VEGFR + Pembrolizumab / PD-1 |
Second line therapy in selected solid tumors, including BTC. |
| NCT04720131122 | 2 | Capecitabine + Camrelizumab / PD-1 + Apatinib / VEGFR2 |
First or second line treatment for advanced BTC. |
| NCT04708067123 | 1 | RT + Bintrafusp-alfa/PD-L1:TGF-β |
Second line treatment for advanced or metastatic iCCC. |
PD-1: programmed cell death protein 1, BTC: biliary tract cancer, ICIs: immune checkpoint inhibitors, ECOG-PS: eastern cooperative oncology group- performance status, PD-L1: programmed death-ligand 1, CTLA-4: cytotoxic T-lymphocyte antigen 4, GI: gastrointestinal, GEMCIS: gemcitabine + cisplatin chemotherapy, RT: radiation therapy, iCCC: intrahepatic cholangiocarcinoma, TGF-β: Transforming growth factor beta.