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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: AlloVaxâ„¢ 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