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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