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A Phase II, 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)
This study is designed to compare pembrolizumab plus lenvatinib as a combination therapy and standard of care (SOC) chemotherapy and see if its safe and effective for patients with recurrent or metastatic head and neck squamous cell carcinoma.
18 year(s) or older
Inclusion Criteria:Be male or female and at least 18 years of age on the day of signing informed consent.
Have histologically confirmed recurrent (not amenable to curative treatment with local and/or systemic therapies) or metastatic (disseminated) HNSCC
Have experienced disease progression at any time during or after treatment with a platinum-containing (eg, carboplatin or cisplatin) regimen with or without cetuximab.
Have submitted pre-study imaging that demonstrates evidence of disease progression based on investigator review of at least 2 pre-study images per RECIST 1.1,
Have provided tissue for PD-L1 biomarker analysis from a core or excisional biopsy (fine needle aspirate is not adequate) not previously irradiated.
Exclusion Criteria:Has carcinoma of the nasopharynx, salivary gland, unknown primary origin, or nonsquamous histologies as primary tumors.
Has a history of re-irradiation to any head and neck sites of disease including the cervical, infraclavicular or supraclavicular lymph nodes for head and neck cancer.
Has a life expectancy of less than 3 months and/or has rapidly progressing disease
Has any evidence of symptoms or signs of active tumor bleeding within 6 months prior to randomization
Has a history of (noninfectious) pneumonitis that required systemic steroids, or current pneumonitis/interstitial lung disease.