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 populat

The purpose of this study is to see how well the study drugs, pembrolizumab and lenvatinib, work together compared to pembrolizumab and placebo (a look-alike capsule with no active ingredients). The study will also assess how well the body handles the drugs, if the drugs are effective on cancer, and drug safety.

Pembrolizumab (MK-3475), also known as KEYTRUDA®, and lenvatinib (MK-7902/E7080), also known as Lenvima®, have been approved by certain health authorities, such as the U.S. Food and Drug Administration (FDA), for the treatment of various cancers.

Getting pembrolizumab and lenvatinib together is considered experimental, meaning this combination as used in this study is not approved by the U.S. FDA for head and neck squamous cell carcinoma.

Inova Schar Cancer Institute
8081 Innovation Park Drive
Fairfax, VA 22031
A department of Inova Fairfax Hospital

• Histologically confirmed head and neck squamous cell carcinoma that is considered incurable by local therapies
• A primary tumor location of oropharynx, oral cavity, hypopharynx, or larynx
• A PD-L1 positive (CPS ≥1) tumor as determined by the central laboratory
• Has adequately controlled BP with or without antihypertensive medications, defined as BP ≤150/90 mm Hg with no change in antihypertensive medications within 1 week prior to randomization
• Patients must be at least 18 years old
• Additional eligibility in protocol

• Evidence of symptoms or signs of active tumor bleeding within 6 months prior to randomization
• Radiographic evidence of major blood vessel invasion/infiltration or tumor demonstrates >90 degree abutment or encasement of a major blood vessel
• Ulceration and/or fungation of disease onto the skin surface
• Pre-existing ≥Grade 3 gastrointestinal or non-gastrointestinal fistula
• Prior therapy with lenvatinib or pembrolizumab
• Prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137)
• Additional ineligibility in protocol