At a glance
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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)
In Brief
A Phase 2 clinical trial evaluating Lenvatinib, Pembrolizumab, and 4 other interventions for Squamous Cell Carcinoma of Head and Neck. Completed, enrolled 408 participants across 120 sites in 15 countries.
Detailed Summary
Researchers are looking for new ways to treat people with head and neck cancer whose cancer has come back after treatment (recurrent) or whose cancer has spread to other parts of the body (metastatic). Some people with recurrent or metastatic head and neck cancer are treated with chemotherapy and immunotherapy, but the cancer gets worse. The goal of this study is to learn if more people who receive lenvatinib and pembrolizumab have a better overall survival rate than people who receive standard chemotherapy treatment.
Study Details
Timeline
Interventions
20 mg once daily, taken as oral capsules
200 mg 30-minute IV infusion on day 1 of each 21-day cycle
75 mg/m\^2 administered as an IV infusion on day 1 of each 21-day cycle
1250 mg/m\^2 twice daily on days 1-14 of each 21-day cycle, taken as oral tablets
80 mg/m\^2 administered as an IV infusion on days 1, 8, and 15 of each 21-day cycle
400 mg/m\^2 loading dose, followed by 250 mg/m\^2 administered as an IV infusion on days 1, 8, and 15 of each 21-day cycle
24 mg once daily, taken as oral capsules