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Study ) Phase II trial is an investigator-sponsored, randomized Phase II clinical trial that will recruit patients with recurrent or metastatic PD-L1 positive head and neck squamous cell carcinoma across 10 clinical sites in Germany. The trial will evaluate the addition of UV1 to a standard of care treatment with PD-1 checkpoint inhibitor pembrolizumab as compared to pembrolizumab monotherapy. A total of 75 patients indicated for treatment with pembrolizumab will be enrolled in the FOCUS study, randomized 2-to-1 so that 50 patients will receive UV1 and pembrolizumab and 25 patients will receive pembrolizumab alone. The primary endpoint of the study is the progression-free survival rate at 6 months, and planned readout of topline results is expected in 2023. The FOCUS Phase II trial is partially supported through an innovation grant of up to NOK 16 million from the Norwegian Research Council and will not require Ultimovacs to secure additional financing at this stage.

Mascha binderBristol myers squibbNorwegian research councilOslo university hospitalBusiness wireMedical directorImmunological tumor groupUniversity medicine halleProfessor binderChief medical officerProfessor mascha binderUniversity medicineCarlos de sousaChief executive officerபிரிஸ்டல் மைஸ் ஸ்க்விப்ப்நோர்வே ஆராய்ச்சி சபை