Table 1.
Summary of ongoing clinical trials in HNSCC.
| ID | Phase | N | Inclusion criteria | Interventions | Immunotherapy targets | Primary Outcome |
|---|---|---|---|---|---|---|
| NCT03406247 | II | 140 | R/M HNSCC | Nivolumab vs Nivolumab + Ipilimumab | PD-1, CTLA-4 | 2-years DFS |
| NCT04326257 | II | 40 | R/M HNSCC | Nivolumab + Relatlimab vs Nivolumab + Ipilimumab | PD-1, LAG-3, CTLA-4 | ORR |
| NCT04428151 | II | 400 | R/M HNSCC | Lenvatinib + Pembrolizumab vs Chemotherapy + Lenvatinib | PD-1 | ORR |
| NCT02296684 | II | 66 | Locoregionally Advanced, Resectable HNSCC | Neoadjuvant Pembrolizumab vs Adjuvant Pembrolizumab | PD-1 | LRR, Distant failure rate |
| NCT03283605 | I/II | 45 | Metastatic HNSCC | Durvalumab, Tremelimumab + SBRT | PD-L1, CTLA-4 | Acute toxicities, PFS |
| NCT03620123 | II | 280 | R/M HNSCC | Nivolumab and Ipilimumab vs Docetaxel | PD-1, CTLA-4 | ORR |
| NCT03313804 | II | 57 | Advanced, Metastatic HNSCC | Nivolumab OR Pembrolizumab OR Atezolizumab + RT | PD-1, PD-1, PD-L1 | PFS |
| NCT01149902 | I | 10 | Relapsed, Refractory HNSCC | cyclophosphamide, docetaxel, OK-432 | Vaccine | Safety and Feasibility |
| NCT03341936 | II | 58 | Relapsed, Resectable HNSCC | Neodjuvant Nivolumab, Lirilumab + Surgery + Adjuvant Nivolumab, Lirilumab | PD-1, KIR | DFS |
| NCT03098160 | I | 69 | Metastatic, Locally Advanced, HPV- HNSCC | Evofosfamide,,Ipilimumab | CTLA-4 | RP2D |
| NCT03317327 | I/II | 20 | Recurrent, secondary primary HNSCC | Nivolumab + RT | PD-1 | Incidence, Nature, and Severity of AE |
| NCT02999646 | II | 41 | Stage III/IV, R/M HNSCC | MVX-ONCO-1 | Autologous Tumor Cells | OS |
| NCT04183166 | I | 30 | Stage III/IVA HNSCC | TG4050 | Vaccine | Safety and Tolerability |
| NCT03708224 | II | 60 | HPV-, Stage III/IV HNSCC | Atezolizumab vs Atezolizumab + Immune-modulating Agent | PD-L1 | R0 resection rate, CD3 counts |
| NCT04247282 | I/II | 40 | Untreated intermediate/high risk, p16-negative HNSCC | M7824 vs M7824 + TriAd vaccine vs M7824 + TriAd vaccine + N-803 | PD-L1, Vaccine, | pCR |
| NCT03695510 | II | 29 | R/M HNSCC | Afatinib + Pembrolizumab | PD-1 | ORR |
| NCT03552718 | I | 16 | HNSCC | YE-NEO-001 | Vaccine | Incidence of AE, RP2D |
| NCT03088059 | II | 340 | R/M HNSCC | Afatinib, Palbociclib, Niraparib, BAY1163877, IPH2201, Durvalumab | NKG2A, PD-L1 | PFS, ORR |
| NCT03129061 | I | 24 | Unresectable, Metastatic HNSCC | baseline + Nivolumab, Pembrolizumab | PD-1 | T cell activation |
| NCT03522584 | I/II | 20 | R/M HNSCC | Tremelimumab, Durvalumab, HIGRT, SBRT | CTLA-4, PD-L1 | Incidence of AE |
| NCT04220775 | I/II | 21 | Local-regional Recurrent HNSCC | M7824, SBRT | PD-L1 | PFS |
| NCT03975270 | II | 41 | R/M HNSCC | Sintilimab + Nab-paclitaxe | PD-1, | ORR |
| NCT04139057 | I/II | 9 | EBV +,R/M HNSCC, | EBV-specific TCR-T cells | Engineered T cells | MTD |
| NCT04193293 | I/II | 30 | R/M HNSCC | Duvelisib + Pembrolizumab | PD-1 | Rate of DLT, AE, ORR |
| NCT03823131 | II | 68 | Unresectable, R/M HNSCC | Tavo-EP, Pembrolizumab, Epacadostat | PD-1, IDO1 | ORR |
| NCT02997332 | I | 36 | Locally Advanced, untreated HNSCC | Durvalumab, Docetaxel, Cisplatin, 5-FU | PD-L1, | PR2D, Number of DLT |
| NCT03546582 | II | 102 | Locoregionally Recurrent or Second Primary HNSCC | Pembrolizumab + SBRT vs SBRT | PD-1 | PFS |
| NCT03565783 | II | 44 | Advanced-Stage, Resectable HNSCC | Cemiplimab | PD-1 | Overall response rate |
| NCT03548467 | I/II | 65 | Locally advanced, Metastatic HNSCC | VB10.NEO + Bempegaldesleukin | Vaccine | Rate of AE |
| NCT03245489 | I | 20 | R/M HNSCC | Pembrolizumab + Clopidogrel + Acetylsalicylic acid vs Pembrolizumab | PD-1 | Effect on major cellular parameters |
| NCT04282109 | II | 141 | R/M HNSCC | Nivolumab + Paclitaxel vs Cetuximab + Paclitaxel | PD-1 | OS |
| NCT03426657 | II | 120 | Locally Advanced HNSCC | Durvalumab + Tremelimumab + RT | PD-L1, CTLA-4 | PFS |
| NCT03529422 | II | 33 | Intermediate Risk HNSCC | Durvalumab + IMRT | PD-L1 | DFS |
| NCT04357873 | II | 111 | R/M HNSCC | Pembrolizumab + Vorinostat | PD-1 | ORR |
| NCT03629756 | I | 44 | Advanced, Recurrent HNSCC | AB928, AB122 | PD-1 | Rate of AE and DLT |
| NCT02812524 | I | 18 | HNSCC | Intratumoral Ipilimumab | CTLA-4 | Surgery delay rate |
| NCT02764593 | I | 40 | Intermediate/High-Risk Local-Regionally Advanced HNSCC | Nivolumab + Cisplatin, Nivolumab + High-dose Cisplatin, Nivolumab + Cetuximab, Nivolumab + IMRT | PD-1 | DLT |
| NCT03226756 | II | 351 | R/M HNSCC | Nivolumab | PD-1 | Incidence for AEI |
| NCT04107103 | II | 20 | Recurrence HNSCC | Nivolumab + Pemetrexed | PD-1 | Feasibility, Safety/tolerability |
| NCT03085719 | II | 26 | R/M HNSCC | High Dose Radiation + Pembrolizumab vs High Dose + Low Dose Radiation + Pembrolizumab | PD-1 | Overall Response Rate |
| NCT03854032 | II | 48 | Stage II-IV HNSCC | BMS986205 + Nivolumab vs Nivolumab | IDO1, PD-1 | ORR |
| NCT02999087 | III | 688 | Locally Advanced HNSCC | Cisplatin + IMRT vs Cetuximab + Avelumab + IMRT vs Cetuximab + IMRT | PD-L1 | PFS |
| NCT02274155 | I | 17 | Locally Advanced HNSCC | MEDI6469 | OX40 | Safety and Feasibility |
| NCT04080804 | II | 60 | Locally Advanced, Resectable HNSCC | Nivolumab + Relatlimab vs Nivolumab + Ipilimumab vs Nivolumab | PD-1, LAG-3, CTLA-4 | Number of AE |
| NCT02955290 | I/II | 181 | Advanced HNSCC | CIMAvax,+ Nivolumab vs CIMAvax + Pembrolizumab | PD-1 | DLT, OS |
| NCT03509012 | I | 360 | Advanced HNSCC | Durvalumab + Cisplatin + RT | PD-L1 | Rate of DLT and AEs |
| NCT03336606 | I | 35 | Advanced, Resectable HNSCC | MEDI0562 + Surgery | OX40 | Activation of immune response |
| NCT04348916 | I | 71 | Refractory, Ineligible, Relapsed HNSCC | ONCR-177 vs ONCR-177 + Pembrolizumab | Vaccine, PD-1 | Rate of DLT and AE |
| NCT04129320 | II/III | 750 | R/M HNSCC | Pembrolizumab + Chemotherapy, Enoblituzumab + MGA012, Enoblituzumab + MGA012 + Chemotherapy, MGA012 + Chemotherapy | PD-1, B7-H3, PD-1 | Overall Response Rate, Incidence of AE, OS |
| NCT02575404 | I | 22 | HNSCC with progression | GR-MD-02, Pembrolizumab | PD-1 | Rate of AE |
| NCT03247712 | I/II | 28 | HNSCC planned for surgy | Nivolumab + RT | PD-1 | Rate fo Delay to Surgery |
| NCT04007744 | I | 45 | R/M HNSCC | Sonidegib + Pembrolizumab | PD-1 | MTD, Response rate |
| NCT03258554 | II/III | 523 | Locoregionally Advanced HNSCC | Durvalumab + RT vs Cetuximab + RT | PD-L1 | DLT, PFS, OS |
| NCT03083873 | II | 55 | R/M HNSCC | LN-145/LN-145-S1 | Cell transfer therapy | ORR |
| NCT03051906 | I/II | 69 | Locally Advanced HNSCC | Durvalumab + Cetuximab + Radiotherapy | PD-L1 | 2-year PFS |
| NCT02892201 | II | 9 | HNSCC with Residual Disease | Pembrolizumab | PD-1 | Overall response rate |
| NCT03993353 | II | 30 | R/M HNSCC | Tadalafil + Pembrolizumab | PDE-5, PD-1 | Rate of DLT, OS |
| NCT03665285 | I/II | 143 | Advanced, metastatic HNSCC | NC318 | experimental antibody | MTD, PAD |
| NCT03818061 | II | 110 | R/M HNSCC | Atezolizumab + Bevacizumab | PD-L1, | Overall response rate |
| NCT03228667 | II | 611 | HNSCC with progression | ALT-803 + Pembrolizumab, Nivolumab, Atezolizumab, Avelumab | PD-1, PD-L1 | ORR |
| NCT03319459 | I | 100 | Advanced HNSCC | FATE-NK100 | NK cell product | Incidence of DLT |
| NCT03633110 | I/II | 99 | HNSCC | GEN-009 Adjuvanted Vaccine + Nivolumab, Pembrolizumab | Vaccine, PD-1 | Incidence of AE, T-cell responses |
| NCT02376699 | I | 135 | Advanced HNSCC | Intravenous (IV) SEA-CD40, Pembrolizumab, Subcutaneous (SC) SEA-CD40, Gemcitabine, Nab-paclitaxel | CD40, PD-1 | Incidence of AE, ORR |
| NCT02827838 | II | 20 | OSCC, OPSCC | Durvalumab | PD-L1 | Immune effector, Immune-regulatory miR responses, |
| NCT04393506 | I | 20 | Locally Advanced and Resectable OSCC | Camrelizumab, Apatinib | PD-1 | Major pathologic response |
| NCT03673735 | III | 650 | HPV-negative HNSCC | Durvalumab + RT+ Cisplatin vs Placebo + RT + Cisplatin | PD-L1 | DFS |
| NCT03841110 | I | 76 | Advanced HNSCC | FT500 | NK cell product | Rate of DLT |
This table contains only ongoing clinical trials registered on the ClinicalTrials.gov, not including terminations or completed trials.
DFS, Disease Free Survival; R/M, Recurrence/metastasis; HNSCC, Head and neck squamous cell carcinoma; ORR, Objective Response Rate; LRR, Locoregional recurrence rates; RT, Radiation therapy; PFS, Progression-free survival; SBRT, Stereotactic Body Radiotherapy; KIR, Killer cell immunoglobulin receptor(NK cell); RP2D, Recommended phase 2 dose; OS, Overall survival; pCR, Pathologic complete response; HIGRT, Hypofractionated Image-Guided Radiation Therapy; MTD, Maximum Tolerated Dose; DLTs, dose-limiting toxicities; DLT, Dose Limiting Toxicity; AE, Adverse Events; AEI, adverse events of interest; PAD, pharmacologically active dose; OSCC, Oral Squamous Cell Carcinoma; HPV , Human papillomavirus.