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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)

From: Immunotherapy in head and neck cancer: aiming at EXTREME precision

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
  1. 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
  2. aimmune-modulating agents, vaccines, and adoptive T-cell transfer
  3. bonly EBV-positive nasopharyngeal cancer
  4. cimmunotherapeutic approach under investigation
  5. dbioengineered cell allograft combined with chaperone-rich cell lysate
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