Table 5.
Ongoing clinical trials with immunotherapy in ATC.
| Target | Drug | Combination | Population | Phase | N | Primary Endpoint | Results |
|---|---|---|---|---|---|---|---|
| PD-1 | Pembrolizumab NCT02688608 |
N/A | ATC | II | 20 | RR | Not available |
| Pembrolizumab NCT03072160 |
N/A | MTC | II | 17 | CL #, PR/CR | Not available | |
| Pembrolizumab NCT03012620 |
N/A | Rare cancers | II | 350 | ORR | Not available | |
| Pembrolizumab NCT02628067 |
N/A | Advanced solid tumors | II | 1350 | ORR | Not available | |
| Pembrolizumab NCT02054806 |
N/A | Advanced solid tumors | Ib | 477 | Best OR | ORR 9% [114] | |
| Pembrolizumab NCT03360890 |
Docetaxel | TC and salivary gland tumors | I | 46 | ORR | Not available | |
| Pembrolizumab NCT03211117 |
Docetaxel Doxorubicin | ATC | II | 3 | OSR | Terminated [135] | |
| Pembrolizumab NCT02973997 |
Lenvatinib | RAI-R DTC | II | 60 | CRR > 15% | Primary endpoint not reached [116] | |
| Pembrolizumab NCT04171622 |
Lenvatinib | ATC | II | 25 | OS | Not available | |
| Pembrolizumab NCT04234113 |
SO-C101 | Solid Tumors | I/Ib | 96 | DLTs, AEs | Not available | |
| Nivolumab NCT04061980 |
Encorafenib Binimetinib | RAIR BRAF-mutated DTC | II | 40 | ORR | Not available | |
| Spartalizumab NCT02404441 |
N/A | Advanced solid tumors | I/II | 319 | RP2D, DLTs, ORR | 19% * [133] | |
| Cemiplimab NCT04238624 |
DabrafenibTrametinib | BRAF V600E ATC | II | 15 | ORR | Not available | |
| PD-1 and CTLA-4 | Nivolumab Ipilimumab NCT03246958 |
N/A | RAI-R DTC, ATC, MTC | II | 54 | RR (CR + PR) | 9.4% (DTC) 30% (ATC) 0% (MTC) [115] |
| Nivolumab Ipilimumab NCT03914300 |
Cabozantinib | DTC | II | 24 | ORR | Not available | |
| Nivolumab Ipilimumab NCT02834013 |
N/A | Rare tumors | II | 818 | ORR | Not available | |
| PD-L1 | Atezolizumab NCT03181100 |
1: Vemurafenib/Cobimetinib 2: Cobimetinib 3: Bevacizumab 4: Paclitaxel |
PDTC, ATC Cohort selection depending driver mutation |
II | 50 | OS | 1: not reached 2: 18.23 mo 3: 6.21 mo 4: 4.44 mo [134] |
| Atezolizumab NCT03170960 |
Cabozantinib | Locally advanced or metastatic solid tumors | Ib | 1732 | MTD, ORR | Not available | |
| Atezolizumab NCT04400474 |
Cabozantinib | Advanced and progressive tumors from endocrine system | II | 144 | ORR | Not available | |
| Durvalumab NCT03215095 |
N/A | TC | I | 11 | DLTs | Not available | |
| Avelumab NCT03475953 |
Regorafenib | RAI-R DTC | I/II | 362 | RP2D, OR | Not available | |
| PD-L1 and CTLA-4 | Durvalumab Tremelimumab NCT03122496 |
SBRT | ATC | I | 13 | OS | Not available |
| Durvalumab Tremelimumab NCT03753919 |
N/A | DTC, MTC, ATC | II | 46 | PFS, OS | Not available |
TC: thyroid cancer, RAI-R DTC: radioiodine-refractory differentiated thyroid cancer, MTC: medullary thyroid cancer, PDTC: poorly differentiated thyroid cancer, ATC: anaplastic thyroid cancer, RR: response rate, CL: calcitonine levels, DLTs: dose-limiting toxicities, ORR: objective response rate, CRR: complete response rate, OS: overall survival, AEs: adverse events, MTD: maximum tolerated dose, RP2D: recommended phase 2 dose, PFS: progression free survival, CR: complete response, PR: partial response, mo: months. * ORR in the ATC cohort. # 50% or greater decline in calcitonin levels, N/A: not/applicable.