Table 7.
Ongoing immunotherapy clinical trials for HPV+ OPSCC
| Study | Cohort | Treatment | Outcome measures | Current status |
|---|---|---|---|---|
| IMvoke010 (NCT03452137) | 406 patients, with a CR/PR or stable disease following definitive local therapy | Atezolizumab or placebo as adjuvant therapy after definitve local therapy for patients with high-risk disease | EFS (primary outcome), OS and AEs included as secondary outcomes | Active |
| NCT03799445 | 180 patients with T1 N2a–N2 cM0, T2 N1–2c M0, T3 N0–2 cM0 (AJCC 7th edn) or stage I/II disease excluding T1 N0–1 and T2 N0 (AJCC 8th edn) | IMRT (50–66 Gy) plus nivolumab and ipilimumab | Dose-limiting toxicities, CR rate, PFS (primary outcomes); grade 3 AEs, tolerability, clinical CR, acute and chronic AEs, acute toxicities, late toxicities, swallowing, pattern of failure, OS | Recruiting |
| NCT03410615 | 180 patients with locoregionally advanced, intermediate-risk non-metastatic disease (AJCC 8th edn) | 70 Gy RT with cisplatin vs durvalumab plus adjuvant durvaluamb vs durvalumab plus adjuvant durvalumab/tremelimumab (third arm closed to accrual) | 3-year EFS (primary outcome); FACT–HN score, local regional failure, distant MFS, OS, cost-effectiveness, toxicities | Recruiting |
| NCT03669718 | 194 patients with PD-L1+, p16+ recurrent and/or metastatic disease | ISA101b plus cemiplimab vs placebo plus cemiplimab | ORR, treatment-related AEs, DOR | Recruiting |
| NCT03952585 | 711 patients with early stage, p16+ non-smoking-associated disease | Image-guided RT or IMRT plus concurrent cisplatin vs reduced-dose image-guided RT or IMRT plus concurrent cisplatin vs reduced-dose image-guided RT or IMRT plus nivolumab | PFS, QOL (primary outcomes), locoregional failure, distant failure, OS, AEs | Recruiting |
| NCT03811015 | 744 patients with a ≥10 pack-year smoking history and stage T1–2 N2–3 or T3–4 N0–3 disease or <10 pack-years with stage T4 N0–3 or T1–2 N2–3 | Cisplatin plus IMRT followed by nivolumab vs cisplatin plus IMRT followed by observation with potential crossover to nivolumab at 12 months | PFS, OS, negative FDG–PET at 12 weeks post-therapy | Recruiting |
AJCC, American Joint Committee on Cancer; AEs, adverse events; CR, complete response; DOR, duration of response; EFS, event-free survival; FDG, fluorodeoxyglucose; FACT–HN, functional assessment of cancer therapy, head & neck; IMRT, intensity-modulated radiotherapy; MFS, metastasis-free survival; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; PR, partial response; QOL, quality of life; RT, radiotherapy.