Immunotherapeutic drugs in clinical development for head and neck cancer [196, 197]

Trial IDTargetInterventionStudy typePatient population
NCT04375384EGFR inhibitorCetuximabPhase II treatment, non-randomized, open-label clinical trialHNSCC patients with R/M after the failure or intolerance of the immunotherapeutic drug
NCT04326257LAG-3
CTLA4
PD-1
Nivolumab + Relatlimab
Nivolumab + Ipilimumab
Phase II, open-label, parallel arms trialR/M HNSCC patients with preceding failure of immunotherapy with anti-PD-1 or PD-L1, having a high expression of LAG-3 and CTLA4 genes
NCT04428151RTK and VEGFR1 inhibitor
PD-1
Lenvatinib (E7080/MK-7902)
Pembrolizumab (MK-3475)
Phase II, randomized, open-label, three-arm clinical trialR/M HNSCC patients with the progressed disease after platinum therapy and immunotherapy (PD-1/ PD-L1 inhibitors)
NCT03283605PD-1
CTLA4
Durvalumab (MEDI4736) + Tremelimumab + stereotactic body radiotherapy (SBRT)Phase II, open-label, single groupHNSCC metastatic patients following prior treatment failures
NCT04555837Serine/threonine-protein kinase Aurora-A inhibitor
PD-1
Alisertib
Pembrolizumab
A Phase I-II, open-label studyRetinoblastoma (Rb)-deficient, HPV+ HNSCC patients.
NCT03022409ATR inhibitor
PARP inhibitor
Ceralasertib
Olaparib
Phase I, randomized, open-labelTreatment naïve HNSCC patients
NCT04634825B7-H3
PD-1
LAG-3
Enoblituzumab
Enoblituzumab + Tebotelimab
Phase II, open-label, non-randomizedPatients with R/M HNSCC
NCT04193293PI3K inhibitor
PD-1
Duvelsib
Pembrolizumab
Phase Ia/IIb multicentre, non-randomized, open-label studyPatients with R/M HNSCC
NCT03565783PD-1CemiplimabPhase II, open-labelPatients with stage III-IV R/M HNSCC before surgery
NCT03854032PD-1
IDO1
Nivolumab
BMS-986205
Phase 2 Randomized, open-labelStage II-IV HNSCC patients
NCT04080804PD-1
LAG-3
CTLA4
Nivolumab + Relatlimab
Nivolumab + Ipilimumab
Phase II Neoadjuvant study, randomized, open-labelLocally advanced resectable HNSCC patients prior to surgical resection
NCT03795610PI3Kγ inhibitorIPI-549Phase II, open-labelLocally advanced HPV+ and HPV HNSCC patients
NCT04144517IL-2
PD-1
ALKS 4230
Pembrolizumab
Phase II, open-labelPatients with HNSCC prior treated with anti-PD-L1 therapy but not achieved a CR
NCT03336606OX40 agonistMEDI0562Phase1, randomized, open-labelHNSCC patients prior to surgical resection
NCT04602013PD-1SintilimabPhase II, open-label, multicentreLocally advanced OSCC patients
NCT03818061PD-L1
VEGF
Atezolizumab
Bevacizumab
Phase II, multi-center, non-randomizedAdvanced stage patients with recurrence of HNSCC
NCT04393506VEGFR2 inhibitor
PD-1
Apatinib
Camrelizumab
Phase I, open-labelPatients with locally advanced and resectable OSCC
CTRI/2020/ 11/028953PD-1NivolumabPhase I and II, randomized groupHNSCC patients under palliative systemic therapy

RTK: receptor tyrosine kinase; ATR: ataxia telangiectasia and Rad3-related; PARP: Poly (ADP-ribose) polymerase; B7-H3: CD276; DART: dual-affinity re-targeting; ALKS 4230: nemvaleukin Alfa; CR: complete response