Table 3.
Ongoing randomised first-line trials with selected immunotherapeuticsa in recurrent and/or metastatic head and neck cancer (also including nasopharyngeal carcinoma) as of April 2017 (≥ 100 patients)
| Trial, ClinicalTrials.gov identifier | Phase | Estimated enrolment | Immunotherapeutic approach | Regimen (treatment arms A, B, C) | Primary completion date |
|---|---|---|---|---|---|
|
NCT01836029 (ACTIVE8) |
IIR | 175 | TLR8 agonist | A: Motolimodc + PFE B: Placebo + PFE |
9/2016 |
|
NCT02823574 (CheckMate-714) |
IIR | 315 | Anti-PD-1 Anti-CTLA-4 |
A: Nivolumabc + ipilimumabc
B: Nivolumabc + placebo |
2/2018 |
|
NCT02551159 (KESTREL) |
III | 760 | Anti-PD-L1 Anti-CTLA-4 |
A: Durvalumabc
B: Durvalumabc + tremelimumabc C: PFE |
3/2018 |
|
NCT02358031 (KEYNOTE-048) |
III | 825 | Anti-PD-1 | A: Pembrolizumabc
B: Pembrolizumabc + PF C: PFE |
3/2018 |
| NCT02578641b | III | 330 | Autologous EBV-specific CTLs | A: CTLsc + gemcitabine + carboplatin B: Gemcitabine + carboplatin |
12/2018 |
| NCT02624999 | IIR | 100 | Vaccine | A: AlloVax™ c, d
B: Cisplatin |
12/2018 |
|
NCT02741570 (CheckMate-651) |
III | 490 | Anti-PD-1 Anti-CTLA-4 |
A: Nivolumabc + ipilimumabc
B: PFE |
1/2019 |
IIR phase II randomised, TLR8 toll-like receptor 8, PD-L1 programmed cell death ligand-1, CTLA-4 cytotoxic T-lymphocyte antigen-4, PD-1 programmed cell death protein-1, EBV Epstein–Barr virus, CTLs cytotoxic T-lymphocytes, PFE platinum/5-fluorouracil/cetuximab regimen according to the EXTREME trial, PF platinum/5-fluorouracil chemotherapy
aimmune-modulating agents, vaccines, and adoptive T-cell transfer
bonly EBV-positive nasopharyngeal cancer
cimmunotherapeutic approach under investigation
dbioengineered cell allograft combined with chaperone-rich cell lysate