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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)

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

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
  1. 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
  2. aimmune-modulating agents, vaccines, and adoptive T-cell transfer
  3. bonly nasopharyngeal cancer
  4. conly oral cavity cancer
  5. dincluding maintenance therapy
  6. eimmunotherapeutic approach under investigation
  7. fafter definitive chemoradiotherapy with cisplatin
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