Table 2.
Ongoing randomised trials with selected immunotherapeuticsa in locoregionally advanced head and neck cancer (also including nasopharyngeal carcinoma) as of April 2017 (≥ 100 patients)
| Trial, ClinicalTrials.gov identifier | Phase, setting | Estimated enrolment | Immunotherapeutic approach | Regimen (treatment arms A, B, C) | Primary completion date |
|---|---|---|---|---|---|
| NCT02421640b | IIR, adjuvant | 116 | Adoptive T-cell transfer | A: Autologous TILse, f
B: No adjuvant therapy |
3/2017 |
|
NCT02707588 (PembroRad) |
IIR, definitive | 114 | Anti-PD-1 | A: Pembrolizumabe + RT B: Cetuximab + RT |
8/2017 |
|
NCT02841748 (PATHWay) |
IIR, adjuvant | 100 | Anti-PD-1 | A: Pembrolizumabe
B: Placebo |
8/2018 |
|
NCT02609386c
(INSPIRE) |
IIR, neo-adjuvant and adjuvant | 200 | Cytokines | A: IRX-2e + CIZO B: CIZO |
2/2019 |
|
NCT02764593 (RTOG 3504) |
I/III, definitive and adjuvant | 120 | Anti-PD-1 | A: Nivolumabe + low-dose cisplatin + RT B: Nivolumabe + high-dose cisplatin + RT C: Nivolumabe + cetuximab + RT D: Nivolumabe + RT |
3/2019 |
|
NCT02999087 (REACH) |
III, definitived | 688 | Anti-PD-L1 | A: Cisplatin + RT B, C: Cetuximab + avelumabe + RT D: Cetuximab + RT |
10/2019 |
|
NCT03040999 (KEYNOTE-412) |
III, definitived | 780 | Anti-PD-1 | A: Pembrolizumabe + cisplatin + RT B: Placebo + cisplatin + RT |
3/2021 |
|
NCT02952586 (JAVELIN Head and Neck 100) |
III, definitived | 640 | Anti-PD-L1 | A: Avelumabe + cisplatin + RT B: Placebo + cisplatin + RT |
4/2021 |
IIR phase II randomised, TILs tumour-infiltrating lymphocytes, PD-1 programmed cell death protein-1, PD-L1 programmed cell death ligand-1, RT radiotherapy, CIZO cyclophosphamide, indomethacin, zinc-containing multivitamin, omeprazole
aimmune-modulating agents, vaccines, and adoptive T-cell transfer
bonly nasopharyngeal cancer
conly oral cavity cancer
dincluding maintenance therapy
eimmunotherapeutic approach under investigation
fafter definitive chemoradiotherapy with cisplatin