Table 2.
Illustrative listing of clinical trials examining combination immunotherapy in the Neoadjuvant setting for LA-HNSCC.
| Trial | Ref | Phase | Study Design | Study Eligibility | Primary Outcome | Status | Estimated Completion |
|---|---|---|---|---|---|---|---|
| NCT02274155 | I | Anti-OX40 x3 (0.4mg/kg 1-3 weeks pre-op) → S → RAA | LA-HNSCC | Safety/Feasibility | Active, Not Reruiting | Oct-22 | |
| NCT02488759 (CheckMate 358) | Ferris 2017 ESMO | I/II | Nivo x2 (240mg D1 & D15) → S D30 → RAA | Multiple Cohort (including HPV+ HNSCC) | Objective Response Rate | Active, Not Reruiting | Aug-22 |
| NCT03003637 | I/II | Nivo x2 +/- Ipi x1 (240mg and 1mg/kg Wk 1 & 3 pre-op) → S → RAA | LA-HNSCC | Pathologic Treatment Response, Delay to Surgery | Completed | Feb-21 | |
| NCT03247712 | I/II | Nivo x3 + Xrt x3 (240mg and 8Gy GTV+3mm x3) → S → RAA | LA-HNSCC | Delay to Surgery | Recruiting | Dec-26 | |
| NCT02296684 | Uppaluri CCR 2020 | II | Pembrolizumab x1 (200mg 2-3 weeks pre-op) → S → RAA +/- Pembro x6 | HPV- LA-HNSCC; any site | Major Pathologic Treatment Response | Active, Not Reruiting | Dec-21 |
| NCT02919683 | Schoenfeld JamaOnc 2020 | II | Nivo x2 (3mg/kg Wk1 & Wk 3) or Nivo + Ipi (3mg/kg & 1mg/kg Wk1) → S → RAA | LA-HNSCC; oral cavity | Volumetric Treatment Response | Active, Not Reruiting | Apr-24 |
| NCT03021993 | II | Nivo x3 or 4 (3mg/kg D1, 15, 29 +/- 43 for response or stable disease) → S → RAA | LA-HNSCC; oral cavity | Objective Response Rate | Active, Not Reruiting | Dec-21 | |
| NCT03721757 | II | Nivo x1 (240mg 1-2 weeks pre-op) → S → RAA +/- Nivo x6 (480mg q4wk) | LA-HNSCC; oral cavity | Disease Free Survival | Active, Not Reruiting | Nov-23 | |
| NCT02827838 | II | Durval x2 (D1 & D14 pre-op) → S → RAA | HNSCC (any stage, surgical candidates) | Immune Biomarkers | Recruiting | May-21 | |
| NCT03708224 | II | Atezo (840mg total from D1-D15 pre-op) +/- Tiragolumab or Tocilizumab → S → RAA +/- Atezo x12 (1200mg q3 weeks) | LA-HNSCC | CD3 T Cell Tumor Infiltration, R0 Resection Rate | Recruiting | Nov-25 | |
| NCT04080804 | II | Nivo x1 +/- anti-LAG3 x1 (480mg and 160mg) or Nivo x2 +/- Ipi x1 (240mg and 1mg/kg) | LA-HNSCC | Adverse Events | Recruiting | May-25 | |
| NCT03247712 | Leidner JITC 2021 | Ib | Nivo x3 (240mg q2 wk pre-op) +/- SBRT (GTV; 40Gy x5 fxs or 24Gy x3 fxs or 8Gy x3) → S → RAA +/- Nivo x3 | LA-HNSCC | pCR, mPR & clinical to pathologic downstaging | Active, Not Reruiting | Dec-26 |
| NCT03765918 (MK-3475-689) | III | Pembro x2 (200mg D1 & D21) → S → RAA +/- Pembro x6 | Multiple Cohort (including LA-HNSCC) | Major Pathologic Treatment Response | Recruiting | Jul-26 | |
| NCT03700905 (IMSTAR-HN) | III | Nivo x1 (3mg/kg within 2 weeks pre-op) → S → RAA +/- Nivo x3 +/- Ipi x1 (3mg/kg and 1mg/kg q2 weeks) | LA-HNSCC | Disease Free Survival | Active, Not Reruiting | May-24 |