Table 2.
Ongoing clinical trials evaluating novel immunotherapies in patients with recurrent/metastatic HNSCC.
| Novel Immunotherapies in Combination with PD-1/PD-L1 Inhibitors, and Other Novel Checkpoint Inhibitor/Immunotherapies | |||||
|---|---|---|---|---|---|
| Drug(s) | Study Phase | Clinical Trials | Study Name | Intervention | HPV Status |
| Lenvatinib | III | NCT04199104 | LEAP-10 | Pembrolizumab vs. pembrolizumab + lenvatinib | HPV-positive |
| Bempegaldesleukin | II/III | NCT04969861 | PROPEL-36 | Bempegaldesleukin + pembrolizumab | |
| Nivolumab + ipilimumab | III | NCT03700905 | IMSTAR-HN | Nivolumab + ipilimumab vs. surgery + RT | HPV-negative |
| Nivolumab | III | NCT03576417 | NIVOSTOP | Nivolumab + RT + cisplatin vs. RT + cisplatin | unknown |
| Nivolumab + ipilimumab | III | NCT02741570 | CheckMate 651 | Nivolumab + ipilimumab vs. SOC (EXTREME regimen) | HPV-positive |
| Abemaciclib | I/II | NCT03655444 | Abemaciclib + nivolumab | ||
| Ramucirumab | I/II | NCT03650764 | Ramucirumab + pembrolizumab | unknown | |
| Duvelisib | I/II | NCT04193293 | Duvelisib + pembrolizumab | unknown | |
| Intratumoral MK-1454 | II | NCT04220866 | Intratumoral MK-1454 + pembrolizumab vs. pembrolizumab | unknown | |
| Eftilagimod alpha | II | NCT04811027 | TACTI-003 | Eftilagimod alpha + pembrolizumab vs. pembrolizumab | HPV-positive |
| BNT113 | II | NCT04534205 | AHEAD-MERIT | BNT113 + pembrolizumab vs. pembrolizumab | HPV-positive |
| PDS0101 (HPV E6/E7 vaccine) | II | NCT04260126 | VERSATILE002 | Pembrolizumab + PDS0101 (HPV E6/E7 vaccine) | HPV-positive |
| Pepinemab | I/II | NCT04815720 | KEYNOTE B84 | Pepinemab + pembrolizumab | |
| Atezolizumab | II | NCT03818061 | ATHENA | Atezolizumab + bevacizumab | HPV-positive |
| Avelumab | I | NCT03498378 | Avelumab + Palbociclib + cetuximab | unknown | |
| Alisertib | I | NCT04555837 | Alisertib + pembrolizumab | HPV-positive | |
| Cemiplimab | II | NCT04831450 | Maintenance cemiplimab (anti-PD1) | ||
| Other Novel Checkpoint Inhibitors/Immunotherapy | |||||
| Tiragolumab | II | NCT04665843 | SKYSCRAPER-09 | Tiragolumab + atezolizumab vs. atezolizumab | HPV-positive |
| Relatlimab | II | NCT04326257 | Nivolumab + relatlimab vs. nivolumab + ipilimumab | unknown | |
| Monalizumab | III | NCT04590963 | INTERLINK-1 | Monalizumab + cetuximab vs. cetuximab | |
| Epacadostat | I/II | NCT02327078 | ECHO-204 | Epacadostat + nivolumab | unknown |
| Enoblituzumab | I | NCT02475213 | MGA271 | Enoblituzumab + pembrolizumab | unknown |
| IMA201 | I | NCT03247309 | IMA201 (TCR-engineered in solid tumors, ACTengine) | ||
| KITE-439 | I | NCT03912831 | KITE-439 (E7 T-cell receptor + cyclophosphamide + fludarabine) | HPV-positive | |
| Autologous TILs | II | NCT03083873 | Autologous TILs | HPV-positive | |
HPV, human papillomavirus; RT, radiotherapy; SOC, standard of care; TCR, T-cell receptor; TIL, tumor-infiltrating lymphocyte.