Table 2.
Ongoing immunotherapy trials in Recurrent/Metastatic HNSCC*.
| NCT | Trial name | Phase | Experimental Arm | Control Arm | Primary Endpoint |
|---|---|---|---|---|---|
| Adjuvant immunotherapy after surgical resection of recurrent HNSCC | |||||
| 04671667 | ECOG 3191 | II | 1. Adjuvant Reirradiation plus Pembrolizumab 2. Adjuvant Pembrolizumab monotherapy |
Reirradiation plus platinum | Overall Survival |
| 03355560 | II | Neoadjuvant and adjuvant Nivolumab plus Lirilumab | Disease-Free Survival | ||
| 03406247 | II | 1. Adjuvant Nivolumab 2. Adjuvant Nivolumab plus Ipilimumab |
Disease-Free Survival | ||
| 03355560 | II | Adjuvant Nivolumab | Toxicity | ||
| 02769520 | II | Adjuvant Pembrolizumab | Disease-Free Survival | ||
| Reirradiation plus immunotherapy | |||||
| 03546582 | KEYSTROKE | II | SBRT reirradiation plus Pembrolizumab | SBRT alone | Progression-Free Survival |
| 02289209 | II | Hyperfractionated reirradiation plus Pembrolizumab | Progression-Free Survival | ||
| 03521570 | II | Re-irradiation plus Nivolumab (definitive or adjuvant) | Progression-Free Survival | ||
| 03803774 | I | BAY1895344 plus SBRT and Pembrolizumab | Toxicity | ||
| Frontline Systemic Therapy Trials (PD-L1 positive) | |||||
| Combination immunotherapy | |||||
| 04634825 | II | Enoblituzumab plus Retifanlimab | Response Rate | ||
| 04633278 | II | CMP-001 plus pembrolizumab | Response Rate | ||
| 04260126 | VERSATILE002 | II | PDS0101 plus pembrolizumab | Response Rate | |
| 04398524 | II | Cemiplimab plus ISA101b | Cempilimab + Placebo | Response Rate | |
| 04034225 | I/II | SNS-301 Intra-tumor injection + Pembrolizumab | Toxicity | ||
| 04453046 | I | Hemopurifier plus pembrolizumab | Safety | ||
| 04408898 | SPEARHEAD 2 | II | ADP-A2M4 plus pembrolizumab | Response Rate | |
| Molecularly targeted therapy plus immunotherapy | |||||
| 04199104 | LEAP-010 | III | Pembrolizumab plus Lenvatinib | Pembrolizumab plus Placebo | Overall Survival, Response Rate, Progression-Free Survival |
| 04114136 | II | 1. Metformin plus Pembrolizumab 2. Rosiglitazone plus Pembrolizumab |
Pembrolizumab | Response Rate | |
| Frontline Systemic Therapy Trials (regardless of PD-L1 status) | |||||
| Combination immunotherapy | |||||
| 02741570 | Checkmate 651 | III | Ipilimumab plus Nivolumab | EXTREME | Overall Survival |
| 04634825 | II | Enoblituzumab plus tebotelimab (PD-L1 negative) | Response rate | ||
| Molecularly targeted therapy plus immunotherapy | |||||
| 03468218 | II | Pembrolizumab plus Cabozantinib | Response Rate | ||
| 03498378 | I | Avelumab plus Cetuximab plus Palbociclib | Toxicity | ||
| Cytotoxic chemotherapy plus immunotherapy | |||||
| 04489888 | KEYNOTE B10 | IV | Pembrolizumab plus Platinum plus Paclitaxel | ORR | |
| 04282109 | NIVOTAX | II | Paclitaxel plus Nivolumab | Paclitaxel plus cetuximab | Overall Survival |
| Immunotherapy failure trials | |||||
| Immunotherapy Combination | |||||
| 04590963 | INTERLINK-1 | III | Monalizumab + Cetuximab | Placebo + Cetuximab | Overall survival |
| 04326257 | II | 1. Nivolumab plus Relatlimab 2. Nivolumab plus Ipilimumab |
Response Rate | ||
| 04150900 | II | Pembrolizumab plus Bavituximab | Response Rate | ||
| 04408898 | II | ADP-A2M4 T cells plus pembrolizumab | Response Rate | ||
| 03769467 | I/II | Tabelecleucel plus pembrolizumab | Toxicity/Response Rate | ||
| 04196283 | I | 1.ABBV-368 plus Tilsotolimod plus Nab-paclitaxel plus ABBV-181 2. ABBV-368 plus Tilsotolimod plus Nab-paclitaxel 3. ABBV-368 plus Tilsotolimod |
Toxicity | ||
| Molecular targeted therapy plus Immunotherapy | |||||
| 04428151 | LEAP-009 | II | Pembrolizumab plus Lenvatinib | 1. Chemotherapy (Taxane, cetuximab, or capecitabine) 2. Lenvatinib |
Response Rate |
| 03019003 | I/II | Decitabine plus Durvalumab | Toxicity/Response Rate | ||
| 04624113 | – | I/II | Tazemetostat plus Pembrolizumab | Toxicity/Response Rate | |
*Trials included are those that are focused entirely in HNSCC.