Abstract

BackgroundIn 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 (240mg 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 3mg/kg Q2W + ipilimumab 1mg/kg Q6W) and chemotherapy (docetaxel 75mg/m2 Q3W). 157 patients are planned to be randomized. Patients who do not progress during the first 24 weeks of nivolumab monotherapy continue treatment according to standard of care. After randomization, study treatment continues until disease progress or for up to 12 months. The primary endpoint is overall response rate after randomization, hypothesizing that dual checkpoint blockade improves ORR to 25% compared to 10% with docetaxel. Secondary endpoints are overall survival, progression-free survival, safety, and quality of life. Recruitment started in July 2018 and is ongoing. Clinical trial identification2017-003349-14. Legal entity responsible for the studyAIO-Studien-gGmbH, Berlin. FundingBristol-Myers Squibb. DisclosureV. Grünwald: Full / Part-time employment: University Hospital Essen; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Shareholder / Stockholder / Stock options: AstraZeneca; Advisory / Consultancy, Speaker Bureau / Expert testimony: Astellas; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Shareholder / Stockholder / Stock options: BMS; Advisory / Consultancy, Speaker Bureau / Expert testimony: Cerulean; Advisory / Consultancy, Speaker Bureau / Expert testimony: COCS; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Roche; Advisory / Consultancy, Speaker Bureau / Expert testimony: EUSAPharm; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): EISAI; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Ipsen; Advisory / Consultancy, Speaker Bureau / Expert testimony: MedUpdate; Advisory / Consultancy, Speaker Bureau / Expert testimony: Merck Serono; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Shareholder / Stockholder / Stock options: MSD; Advisory / Consultancy, Speaker Bureau / Expert testimony: MedKomAkademie; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Novartis; Advisory / Consultancy, Speaker Bureau / Expert testimony: NewConceptOncology; Advisory / Consultancy, Speaker Bureau / Expert testimony: Lilly; Advisory / Consultancy, Speaker Bureau / Expert testimony: Johnson & Johnson; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Pfizer; Advisory / Consultancy, Speaker Bureau / Expert testimony: PharmaMar; Advisory / Consultancy, Speaker Bureau / Expert testimony: PeerVoice; Advisory / Consultancy, Speaker Bureau / Expert testimony: StreamedUp!; Advisory / Consultancy, Speaker Bureau / Expert testimony: ThinkWired!. All other authors have declared no conflicts of interest.

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