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) (MK-7902-010) (KEYNOTE-010)

Completed · Phase 3 · Has a placebo group

Conditions studied: Head and Neck Squamous Cell Carcinoma

In brief

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).

Key facts

Study ID: NCT04199104
Run by: Merck Sharp & Dohme LLC
People needed: 511
Starts: 2020-02-05
Expected to finish: 2025-03-31
Last updated by the study team: 2026-05-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 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 requirements are to be followed.
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
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
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 shown in such lesions.
Participants with oropharyngeal cancer must have results from testing of human papillomavirus HPV status.
Has an Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1.
Have adequately controlled blood pressure with or without antihypertensive medications.
Has adequate organ function.

You may not qualify if…

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 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 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 had major surgery within 3 weeks before to first dose of study interventions.
Has difficulty swallowing capsules or ingesting a suspension orally or by a feeding tube.
Has received prior therapy with lenvatinib or pembrolizumab.
Received last dose of systemic therapy for locoregionally advanced disease less than 6 months before signing consent.
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 received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
Has received prior radiotherapy within 2 weeks of start of study intervention.
Has received a live vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
Received an investigational agent or has used an investigational device within 4 weeks prior to study intervention-administration.
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 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 cancer in situ) that have undergone potentially curative therapy are not excluded.
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. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid) is allowed.
Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
Has an active infection requiring systemic therapy. (e.g., tuberculosis, known viral or bacterial infections, etc.).
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.

Where it is running

California Cancer Associates for Research & Excellence ( Site 0059) — San Marcos, California, United States
University of Colorado Cancer Center ( Site 0023) — Aurora, Colorado, United States
University of Connecticut Health Center ( Site 0020) — Farmington, Connecticut, United States
Memorial Regional Hospital-Memorial Cancer Institute ( Site 0069) — Hollywood, Florida, United States
Georgia Cancer Center at Augusta University ( Site 0013) — Augusta, Georgia, United States
Northwest Georgia Oncology Centers PC ( Site 0028) — Marietta, Georgia, United States
University of Kansas Cancer Center ( Site 0033) — Westwood, Kansas, United States
University of Louisville, James Graham Brown Cancer Center ( Site 0045) — Louisville, Kentucky, United States
Dana Farber Cancer Institute ( Site 0019) — Boston, Massachusetts, United States
University of Michigan ( Site 0064) — Ann Arbor, Michigan, United States
Karmanos Cancer Institute ( Site 0054) — Detroit, Michigan, United States
Henry Ford Health System ( Site 0001) — Detroit, Michigan, United States
Washington University School of Medicine ( Site 0060) — St Louis, Missouri, United States
St. Vincent Frontier Cancer Center ( Site 0008) — Billings, Montana, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0053) — Omaha, Nebraska, United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0002) — Hackensack, New Jersey, United States
Weill Cornell Medicine New York Presbyterian Hospital ( Site 0040) — New York, New York, United States
SUNY Upstate Medical University ( Site 0051) — Syracuse, New York, United States
University of North Carolina- Chapel Hill ( Site 0056) — Chapel Hill, North Carolina, United States
Duke Cancer Center ( Site 0044) — Durham, North Carolina, United States
Providence Portland Medical Center ( Site 0048) — Portland, Oregon, United States
Blue Ridge Cancer Care ( Site 0015) — Blacksburg, Virginia, United States
Inova Schar Cancer Institute ( Site 0009) — Fairfax, Virginia, United States
Cancer Care Northwest ( Site 0017) — Spokane Valley, Washington, United States
California Cancer Associates for Research & Excellence ( Site 0025) — Fresno, California, United States

Full record on ClinicalTrials.gov

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