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Background <p>Treatment options after PD-1 inhibition for recurrent/metastatic squamous cell carcinoma of the head and neck (R/M-SCCHN) remain limited. We investigated whether staggered immune checkpoint inhibition could improve outcomes compared with docetaxel in nivolumab-refractory disease.</p> Methods <p>In this randomized phase II trial, adults with platinum-refractory R/M-SCCHN received nivolumab and were randomized at progression to nivolumab 3 mg/kg every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks (NIVO-IPI) or docetaxel 75 mg/m² every 3 weeks (DOCE) until progression or intolerance. The primary endpoint was objective response rate (ORR) per RECIST 1.1; progression-free survival (PFS), overall survival (OS), and safety were secondary endpoints. PD-L1 expression was assessed in all patients.</p> Results <p>Among 14 patients in the NIVO-IPI arm and 17 in the DOCE arm, ORR was 0% versus 17.6%, median PFS was 1.97 versus 3.66 months (<i>P</i> = 0.036), and median OS was 3.97 versus 11.9 months (<i>P</i> = 0.356), respectively. Twelve-month OS rates were 28.6% and 44.6%. Outcomes were similar irrespective of PD-L1 status. Treatment-emergent adverse events occurred in 84.6% versus 81.3% of patients, with grade ≥3 events in 38.5% and 68.8%.</p> Conclusions <p>NIVO-IPI did not improve efficacy over docetaxel and showed numerically inferior survival, whereas docetaxel was associated with greater toxicity.</p> Clinical trial registration <p> EudraCT Nr. 2017-003349-14</p> <p></p>

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OPTIM: a randomized phase II trial of nivolumab followed by nivolumab-ipilimumab or docetaxel at progression in recurrent/metastatic squamous cell carcinoma of the head and neck (OPTIM; AIO-KHT-0117)

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月18日

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  • Viktor Grünwald,
  • Jürgen Alt,
  • Mareike Tometten,
  • Mathias Hänel,
  • Philipp Ivanyi,
  • Gunter Schuch,
  • Konrad Klinghammer,
  • Kerstin Gutsche,
  • Justin Hasenkamp,
  • Gunnar Hapke,
  • Martin Mänz,
  • Carolin Mogler,
  • Dennis Hahn

摘要

Background

Treatment options after PD-1 inhibition for recurrent/metastatic squamous cell carcinoma of the head and neck (R/M-SCCHN) remain limited. We investigated whether staggered immune checkpoint inhibition could improve outcomes compared with docetaxel in nivolumab-refractory disease.

Methods

In this randomized phase II trial, adults with platinum-refractory R/M-SCCHN received nivolumab and were randomized at progression to nivolumab 3 mg/kg every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks (NIVO-IPI) or docetaxel 75 mg/m² every 3 weeks (DOCE) until progression or intolerance. The primary endpoint was objective response rate (ORR) per RECIST 1.1; progression-free survival (PFS), overall survival (OS), and safety were secondary endpoints. PD-L1 expression was assessed in all patients.

Results

Among 14 patients in the NIVO-IPI arm and 17 in the DOCE arm, ORR was 0% versus 17.6%, median PFS was 1.97 versus 3.66 months (P = 0.036), and median OS was 3.97 versus 11.9 months (P = 0.356), respectively. Twelve-month OS rates were 28.6% and 44.6%. Outcomes were similar irrespective of PD-L1 status. Treatment-emergent adverse events occurred in 84.6% versus 81.3% of patients, with grade ≥3 events in 38.5% and 68.8%.

Conclusions

NIVO-IPI did not improve efficacy over docetaxel and showed numerically inferior survival, whereas docetaxel was associated with greater toxicity.

Clinical trial registration

EudraCT Nr. 2017-003349-14