A Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First Line (1L) Intervention in a Programmed Cell Death-ligand 1 (PD-L1) Selected Population With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (LEAP-010) (MK-7902-010)

  • End date
    Apr 13, 2024
  • participants needed
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 27 October 2021
Toll Free Number
Primary Contact
Instituto Nacional de Enfermedades Neoplasicas ( Site 0701) (2.5 mi away) Contact
+152 other location
measurable disease
squamous cell carcinoma
primary tumor
metastatic head and neck squamous cell carcinoma


This is a study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) as a first line intervention in a PD-L1 selected population with participants with recurrent or metastatic head and neck squamous cell carcinoma.

Hypotheses include:

  • Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).
  • Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR.
  • Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to overall survival (OS).

Condition Squamous Cell Carcinoma of the Head and Neck, Head and Neck Squamous Cell Carcinoma, Squamous Cell Carcinoma of Head and Neck
Treatment Placebo, Pembrolizumab, Lenvatinib
Clinical Study IdentifierNCT04199104
SponsorMerck Sharp & Dohme Corp.
Last Modified on27 October 2021


Yes No Not Sure

Inclusion Criteria

Has histologically confirmed diagnosis of R/M HNSCC that is considered incurable by local therapies
Note: Participants with newly-diagnosed HNSCC must be M1/Stage IV
Has a primary tumor location of oropharynx, oral cavity, hypopharynx, or larynx
Note: Primary tumor site of nasopharynx (any histology) or unknown primary
tumor (including p16+ unknown primary) are not eligible
Contraceptive use by men should be consistent with local regulations regarding
Female participants are not pregnant or breastfeeding, and are not a woman of childbearing potential (WOCBP), OR are a WOCBP that agrees to use contraception during the treatment period (or 14 days prior to the initiation of study treatment for oral contraception) and for at least 120 days post pembrolizumab, or 30 days post lenvatinib/placebo, whichever occurs last
the methods of contraception for those participating in clinical studies. If
the contraception requirements in the local label for any of the study
interventions is more stringent than the requirements above, the local label
Participants with oropharyngeal cancer must have results from testing of human papillomavirus HPV status
requirements are to be followed
Has an Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1
Male participants agree to use approved contraception during the treatment period for at least 7 days after the last dose of lenvatinib/placebo, or refrain from heterosexual intercourse during this period
Has adequately controlled blood pressure with or without antihypertensive medications
Has adequate organ function
Has measurable disease per RECIST 1.1 as assessed by BICR. Note: Lesions situated in a previously irradiated area are considered measurable if progression has been showed in such lesions

Exclusion Criteria

Has a history of any contraindication or has a severe hypersensitivity to any components of pembrolizumab (Grade 3) or lenvatinib
Has pre-existing Grade 3 gastrointestinal or non-gastrointestinal fistula
Has a history of a gastrointestinal condition or procedure that, in the opinion of the investigator, may affect oral study drug absorption
Has disease that is suitable for local therapy administered with curative intent
Had PD within 6 months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC
Has clinically significant cardiovascular impairment within 12 months of the first dose of study intervention, such as history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or cerebrovascular accident/transient ischemic attack (TIA)/stroke, cardiac revascularization, or cardiac arrhythmia associated with hemodynamic instability
Has received prior therapy with lenvatinib or pembrolizumab
Has received 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)
Has had major surgery within 3 weeks before to first dose of study interventions
Has received prior radiotherapy within 2 weeks of start of study intervention
Has difficulty swallowing capsules or ingesting a suspension orally or by a feeding tube
Received last dose of systemic therapy for locoregionally advanced disease less than 6 months before signing consent
Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization
Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
Note: Participants with basal cell carcinoma of the skin, squamous cell
carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical
Has received a live vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed
cancer in situ) that have undergone potentially curative therapy are not
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
Has a known history of human immunodeficiency virus (HIV) infection
Has a known history of hepatitis B (defined as HBsAg reactive) or known active hepatitis C virus (defined as HCV ribonucleic acid (RNA) [qualitative] is detected) infection
Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study intervention
Has an active infection requiring systemic therapy. (e.g., tuberculosis, known viral or bacterial infections, etc.)
Has had an allogenic tissue/solid organ transplant
Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
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