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).
Viktor Grünwald, Jürgen Alt, Mareike Tometten et al.
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In 30 seconds
OPTIM was a randomized phase II trial in adults with platinum-refractory recurrent or metastatic squamous cell carcinoma of the head and neck. Patients received nivolumab and, at progression, were assigned to nivolumab plus ipilimumab or docetaxel. Among 14 and 17 patients, respectively, objective response rates were 0% versus 17.6%; median progression-free survival was 1.97 versus 3.66 months (P = 0.036). Nivolumab-ipilimumab did not improve efficacy over docetaxel and was associated with numerically shorter overall survival, while docetaxel had more grade ≥3 adverse events.
Key findings
- Objective response was 0% with nivolumab-ipilimumab and 17.6% with docetaxel.
- Median progression-free survival was 1.97 versus 3.66 months (P = 0.036), respectively.
- Median overall survival was 3.97 versus 11.9 months (P = 0.356); 12-month overall survival rates were 28.6% and 44.6%.
- Grade ≥3 treatment-emergent adverse events occurred in 38.5% with nivolumab-ipilimumab and 68.8% with docetaxel.
Why it matters
The trial addresses a difficult treatment setting in which options after PD-1 inhibition are limited. Its results do not support improved efficacy from adding ipilimumab to continued nivolumab after progression, while docetaxel showed better response and progression-free survival but more severe adverse events. These findings highlight the need to weigh potential disease control against toxicity in this setting.
What to keep in mind
The randomized phase II comparison included only 14 and 17 patients in the respective treatment arms, limiting the precision and generalisability of the estimates.