Table 4.
Ongoing Immunotherapy-based Trials in CCA.
| Immunotherapy | ClinicalTrials.gov ID | Agents Used | Study Phase | Number Enrolled |
|---|---|---|---|---|
| Pembrolizumab | NCT04550624 * | Pembrolizumab + Lenvatinib | Phase 2 | 40 |
| NCT04306367 | Pembrolizumab + Olaparib | Phase 2 | 29 | |
| NCT05220722 | Pembrolizumab/Nivolumab/Ipilimumab + Pressure Enabled Delivery of SD-101 | Phase 1, 2 | 89 | |
| NCT03895970 * | Pembrolizumab + Lenvatinib | Phase 2 | 50 | |
| NCT03781934 * | Pembrolizumab/Lenvatinib + MIV-818 | Phase 1, 2 | 102 | |
| NCT02628067 | Pembrolizumab (MK-3475-158/KEYNOTE-158) | Phase 2 | 1595 | |
| NCT04430738 | (Tucatinib + trastuzumab) ± pembrolizumab ± (FOLFOX or CAPOX) in HER2+ cancers | Phase 1, 2 | 120 | |
| NCT05215574 | NGM831 ± Pembrolizumab | Phase 1 | 79 | |
| NCT04913337 | NGM707 ± Pembrolizumab | Phase 1, 2 | 179 | |
| NCT03849469 | XmAb®22841 ± Pembrolizumab | Phase 1 | 242 | |
| NCT05007106 | Pembrolizumab ± Vibostolimab ± (5-Fluorouracil + Cisplatin) ± Paclitaxel | Phase 2 | 480 | |
| NCT03329950 | CDX-1140 (CD40) ± (Pembrolizumab or CDX-301) | Phase 1 | 260 | |
| NCT03058289 | Intratumorally Dosed INT230-6 (cisplatin and vinblastine sulfate) ± (pembrolizumab or ipilimumab) |
Phase 1, 2 | 180 | |
| NCT03872947 | TRK-950 + (Gemcitabine + Cisplatin or Pembrolizumab) |
Phase 1 | 181 | |
| NCT04924062 * | Gemcitabine/Cisplatin ± Pembrolizumab (MK-3475-966/KEYNOTE-966)-China Extension Study | Phase 3 | 160 | |
| NCT04003636 | Gemcitabine/Cisplatin ± Pembrolizumab (MK-3475) (MK-3475-966/KEYNOTE-966) | Phase 3 | 1048 | |
| NCT04157985 | PD-1/PD-L1 Inhibitors (pembrolizu/nivolimu/atezolimu/ipilimu/cemiplimab) 1-year vs. more | Phase 3 | 578 | |
| Nivolumab | NCT05220722 | Pembrolizumab/Nivolumab/Ipilimumab + Pressure Enabled Delivery of SD-101 | Phase 1, 2 | 89 |
| NCT03829436 | TPST-1120 ± Nivolumab | Phase 1 | 138 | |
| NCT02834013 | Nivolumab ± Ipilimumab | Phase 2 | 818 | |
| NCT03684811 | FT 2102 ± Nivolumab ± (Gemcitabine + Cisplatin) |
Phase 1|Phase 2 | 200 | |
| NCT04648319 * | Nivolumab + SBRT | Phase 2 | 40 | |
| NCT03872947 | TRK-950 + (Gemcitabine + Cisplatin) or Nivolumab or Pembrolizumab | Phase 1 | 181 | |
| NCT04157985 | PD-1/PD-L1 Inhibitors (pembrolizu/nivolimu/atezolimu/ipilimu/cemiplimab) 1-year vs. more | Phase 3 | 578 | |
| Durvalumab | NCT04301778 | Durvalumab + CSF-1R Inhibitor (SNDX-6532) | Phase 2 | 30 |
| NCT04989218 | Durvalumab + Tremelimumab + Gem + Cis | Phase 1|Phase 2 | 20 | |
| NCT04238637 * | Y-90 SIRT + Durvalimumab ± Tremelimumab | Phase 2 | 50 | |
| NCT03991832 * | Olaparib + Durvalumab in IDH-Mutated Solid tumors |
Phase 2 | 78 | |
| NCT04298008 * | AZD6738 + Durvalumab | Phase 2 | 26 | |
| NCT04308174 * | Neoadjuvant Gem + Cis ± Durvalumab in Resectable Biliary Tract Cancer |
Phase 2 | 45 | |
| NCT03257761 | Guadecitabine + Durvalumab | Phase 1 | 55 | |
| NCT04298021 * | AZD6738 + Durvalumab or Olaparib | Phase 2 | 74 | |
| NCT03473574 * | Durvalumab + Tremelimumab + Gemcitabine ± Cisplatin | Phase 2 | 128 | |
| NCT02821754 | Durvalumab + Tremelimumab ± TACE or RFA or Cryo | Phase 2 | 53 | |
| Atezolizumab | NCT05174650 | Atezolizumab + Derazantinib | Phase 2 | 37 |
| NCT03201458 | Atezolizumab ± Cobimetinib | Phase 2 | 76 | |
| NCT05211323 | Gem + Cs ± (Bevacizumab + Atezolizumab) | Phase 2 | 88 | |
| NCT04708067 | Hypofractionated Radiation Therapy + Bintrafusp Alfa | Phase 1 | 15 | |
| NCT04941287 | Atezolizumab + CDX-1127 (Varlilumab) ± Cobimetinib |
Phase 2 | 64 | |
| NCT05000294 | Atezolizumab + Tivozanib | Phase 1|Phase 2 | 29 | |
| NCT04989218 | Durvalumab + Tremelimumabwith Platinum-based Chemotherapy in Intrahepatic Cholangiocarcinoma (ICC) |
Phase 1|Phase 2 | 20 | |
| NCT04157985 | PD-1/PD-L1 Inhibitors (pembrolizu/nivolimu/atezolimu/ipilimu/cemiplimab) 1-year vs. more | Phase 3 | 578 |
* Study conducted outside the United States.