Table 3.
Trials utilizing adjuvant immunoradiotherapy
| Trial, start year | Phase | N | Subsite and subtype | Basic scheme | Immunotherapy details | RT details | Main results |
|---|---|---|---|---|---|---|---|
| NCT02641093,142 2016 | II | 80 | LAHNSCC | neoadj. PEMBRO followed by resection, followed by PEMBRO + (C)RT | PEMBRO 1 week prior to surgery and conc. with RT for total of 7 doses | IMRT (60–66Gy/30fx) + /- LD-CDDP (if ECE + /R1) | first 23 pts (lead-in phase): 47% pathological response, no DLT, 2 pts recurred |
| NRG-HN003 (NCT02775812),143 2016 | I | 34 | resected R1/ECE + HPV- HNSCC | adj. PEMBRO + CRT | 3 different schedules aimed to determine phase II schedule | CRT with IMRT (60Gy/30fx) and LD-CDDP | No irAE unacceptably delayed RT, 50% got all 8 doses of PEMBRO |
| KEYNOTE-689 (NCT03765918),144,145 2018 | III, rand. | 600 | resected LAHNSCC | arm A: neoadj. PEMBRO followed by resection then PEMBRO + (C)RT; arm B: resection then (C)RT | arm A: 2x neoadj. PEMBRO and PEMBRO conc. with adj. (C) RT, followed by PEMBRO for up to 15 cycles | (C)RT 60–70Gy/30–35fx + /- HD-CDDP depending on risk factors | NA |
| GORTEC 2018-01 “NIVOPOSTOP” (NCT03576417),146 2018 | III, rand. | 680 | resected R1/ECE + LAHNSCC | arm A: adj. NIVO + CRT; arm B: adj. CRT | NIVO starting 3 weeks before CRT for total of 4 doses | CRT with IMRT (66Gy/33fx) and HD-CDDP | NA |
| ADHERE (NCT03673735),147 2019 | III, rand. | 650 | resected HR HPV- HNSCC | arm A: adj. DURVA + CRT; arm B: adj. CRT | 1 dose of DURVA 1 week prior to CRT and maint. DURVA for 6 doses | CRT 66Gy/33fx and HD-CDDP | NA |
| ADRISK (NCT03480672),149 2018 | II, rand. | 240 | resected LAHNSCC with >1LN/ECE + /R1 | arm A: adj. PEMBRO + CRT; arm B: adj. CRT | PEMBRO conc. with RT and for up to 12 months | CRT with CDDP | NA |
| NCT03715946,150 2018 | II | 135 | resected IR- HR HPV + oropharyngeal cancer | adj. NIVO + deescalated RT | NIVO conc. with RT and for additional 6 doses after RT | RT (45–50Gy/25fx) | NA |
| NCT03529422,151 2019 | II | 33 | resected IR HNSCC | adj. DURVA + RT | DURVA starting conc. with RT for total of 6 cycles | IMRT (60Gy/30fx) | NA |
adj. = adjuvant; CDDP = cisplatin; conc. = concurrent; CRT = chemoradiotherapy; DLT = dose-limiting toxicity; DURVA = durvalumab; ECE+ = extracapsular extension of metastasis in lymph node; fx = fractions; HD-CDDP = high dose cisplatin 100 mg/m2 every three weeks during RT; HPV+ = human papilloma virus associated cancer; HPV- = human papilloma virus negative cancer; HR = high-risk; IMRT = intensity modulated RT; IR = intermediate-risk; irAE = immune-related adverse effects; LAHNSCC = locally advanced head and neck squamous cell carcinoma; LD-CDDP = low dose cisplatin 40 mg/m2 every week during RT; N = planned enrolment; neoadj. = neoadjuvant; NIVO = nivolumab; PEMBRO = pembrolizumab; RT = radiotherapy; R1 = microscopically positive resection margin, LN = lymph node; NA - not available