A Phase 2 randomized open-label three-arm clinical study to evaluate the safety and efficacy of lenvatinib (E7080/MK-7902) in combination with pembrolizumab (MK-3475) versus standard of care chemotherapy and lenvatinib monotherapy in participants with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) that have progressed after platinum therapy and immunotherapy (PD-1/PD-L1 inhibitors) (LEAP-009)
Brief description of study
The purpose of the study is to evaluate the safety and efficacy of Lenvatinib with or without pembrolizumab versus standard of care chemotherapy, for previously treated participants with Recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) who progressed after platinum-containing chemotherapy. The treatments of Lenvatinib with or without pembrolizumab are investigational, which means that they have not been approved by the U.S Food and Drug Administration (FDA), the health authority that gives approval for new medicines to be prescribed in the United States, but the FDA has given its permission to test these agents in the current trial.
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