Table 3.
Results of published head and neck-specific clinical trials using preoperative immunotherapy.
| Author | Trial Number | Phase | Patient population | OCSCC | Preoperative therapy | Pathologic and safety outcomes | ||
|---|---|---|---|---|---|---|---|---|
| Uppaluri et al. (61) | NCT02296684 | II | Stage III-IVb (AJCC, 7th ed) HPV- HNSCC (n = 36) | 61% (22/36) | Pembrolizumab (200mg) 13-22 days preoperatively | pTR 10%–49% = 22% | ||
| pTR ≥ 50% = 22% | ||||||||
| MPR > 90% = 6% | ||||||||
| Grade 3-4 AE = 0% | ||||||||
| Schoenfeld et al. (66) | NCT02919683 | II | ≥T2-4b or N+, M0 (AJCC, 7th ed) OCSCC (n = 29) | 100% (29/29) | Nivolumab (3mg/kg) wk 1 and 3 ± ipilimumab (1mg/kg) wk 1; Surgery wk 4 | Nivo (n=14) | Nivo + ipi (n=15) | |
| pTR 10%–49% = 38% | pTR 10%–49% = 40% | |||||||
| pTR ≥ 50% = 15% | pTR ≥ 50% = 33% | |||||||
| MPR > 90% = 8% | MPR > 90% = 20% | |||||||
| Grade 3-4 AE = 14% | Grade 3-4 AE = 33% | |||||||
| Zinner et al. (73) | NCT03342911 | II | Stage III/IVA (AJCC, 8th ed) HPV- HNSCC (n=26) Stage II/III (AJCC, 88h ed) HPV+ OPSCC (n=6) |
81% (21/26) | Nivolumab (240mg) q 2 wks x 3 | HPV- HNSCC: | ||
| Carboplatin q wk x 6 | MPR > 90% = 65% | |||||||
| Paclitaxel (100mg/m2) q wk x 3 | pCR = 42% | |||||||
| Grade 3-4 AE = 35% | ||||||||
| Horton et al. (67) | NCT03021993 | II | Stage II-IVA OCSCC (n=9) | 100% (9/9) | Nivolumab (3 mg/kg) q 2 weeks x 3/4 | pTR > 30% = 44% | ||
| pCR = 0% | ||||||||
| Grade 3-4 AE = 0% | ||||||||
| Wise-Draper et al. (69) | NCT02641093 | II | T3-4 and/or >2 + LNs HPV- HNSCC (n=34) | Unknown | Pembrolizumab (200mg) x1 1-3 wks preoperatively | pTR ≥ 10% = 52% | ||
| pCR = 4% | ||||||||
| Grade 3-4 AE = 3% | ||||||||
| Ferris et al. (84) (CHECKMATE-358) | NCT02488759 | I, II | ≥T1 and ≥N1 | Unknown | Nivolumab (240mg) q2 weeks x2 | No pathologic data | ||
| HPV+ (n=12) | Tumor reduction on CT scan = 48% | |||||||
| HPV- (n=17) | Tumor reduction 40 -75% = 13% | |||||||
| HNSCC | Grade 3-4 AE: HPV+ = 17%; HPV- = 12% | |||||||
| Bell et al. (MEDI6469) (85) | NCT02274155 | Ib | Stage III-IVA | Unknown | Anti OX40 antibody (MEDI6469) (0.4mg/kg) q2/3 days x3 | No pathologic data | ||
| HPV+ (n=7) | Increased activation and proliferation of T cells | |||||||
| HPV- (n=11) | Grade 3-4 AE = 0% | |||||||
| HNSCC | ||||||||
| Zuur et al. (IMCISION) (71) | NCT03003637 | Ib/II | T3-4, N0-3, M0 HPV- HNSCC (n = 12) | Unknown | Nivolumab (240mg) wk 1 and 3 ± ipilimumab (1mg/kg) wk 1 | Nivo (n=6) | Niv + Ipi (n=6) | |
| MPR >90% = 16.7% | MPR >90% = 33.3% | |||||||
| Surgery wk 5 | pTR >50% = 0 | pTR >50% = 16.7% | ||||||
| Grade 3-4 AE = 16.7% | Grade 3-4 AE = 33.3% | |||||||
AE, adverse events; AJCC, American Joint Committee on Cancer; HNSCC, head and neck squamous cell carcinoma; HPV, human papilloma virus; MPR; major pathologic response; OCSCC, oral cavity squamous cell carcinoma; pCR, pathologic complete response; pTR, pathologic tumor response.