1173TiPA randomized phase II study on the OPTimization of Immunotherapy in squamous carcinoma of the head and neck (SCCHN) - OPTIM (AIO-KHT-0117)

AbstractBackgroundIn most SCCHN patients receiving palliative treatment with platinum-based chemotherapy, the tumor eventually progresses and requires further treatment options. PD-1 inhibitor nivolumab was authorized in this setting in 2017 after proving superior to single agent chemotherapy in objective response and overall survival. But there are still patients who progress rapidly with nivolumab monotherapy. In this population, prompt escalation of immunotherapy by adding the CTLA-4 antagonist ipilimumab to nivolumab may be beneficial, as this combined checkpoint blockade has proven superior to nivolumab alone in several tumors. It is not clear, though, if combined immunotherapy is superior to chemotherapy in this setting of SCCHN patients responding poorly to nivolumab alone. The OPTIM trial investigates this question.Trial design280 patients with recurrent or metastatic SCCHN progressing after platinum-based chemotherapy or within 6 months after RCT will be recruited at 24 German sites. All patients initially receive nivolumab monotherapy according to current prescribing information (240  mg Q2W). They are closely followed for tumor progression by radiologic assessment every 4-6 weeks, i.e. at increased frequency compared to standard of care. Patients who progress during the first 24 weeks of nivolumab monotherapy are randomized 1:1 between intensified immunotherapy (nivolumab 3  mg/kg Q2W + ipilimumab 1 mg/kg Q6W) and chemotherapy (docetaxel 75 mg/m2 Q3W). 157 ...
Source: Annals of Oncology - Category: Cancer & Oncology Source Type: research