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- A Phase 3, randomized, placebo-controlled, double-blind clinical study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) to evaluate the safety and efficacy of pembrolizumab and lenvatinib as 1L intervention in a PD-L1 selected population of participants with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) (LEAP-010).
Clinical Trial
A Phase 3, randomized, placebo-controlled, double-blind clinical study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) to evaluate the safety and efficacy of pembrolizumab and lenvatinib as 1L intervention in a PD-L1 selected population of participants with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) (LEAP-010).
The pupose of this study is to see how well the study drugs, pembrolizumab and lenvatinib, work together compared to pembrolizumab and placebo. It seeks to see how well the drugs work to control or stop squamous cell carcinoma of the head and neck. The study is testing the safety of the study drugs and to see if it helps patients to live longer and see how well the body handles the drugs.
Eligibility Criteria
- Patients must have a histologically confirmed diagnosis of recurrent or metastatic head and neck squamous cell carcinoma that is considered incurable by local therapies. Must have a primary tumor location of oropharynx, oral cavity, hypopharynx, or larynx. patients must not have any evidence of symptoms or signs of active tumor bleeding within 6 months prior to randomization.
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