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NCT04199104

PHASE3

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)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

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).

Official title: 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).

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

511

Start Date

2020-02-05

Completion Date

2025-03-31

Last Updated

2026-05-05

Healthy Volunteers

Conditions

Head and Neck Squamous Cell Carcinoma

Interventions

DRUG

Lenvatinib

Lenvatinib, 20 mg (two 10-mg oral capsules) administered QD

BIOLOGICAL

Pembrolizumab

Pembrolizumab (MK-3475), 200 mg, every 3 weeks (Q3W) by intravenous (IV) infusion for up to 35 3-week cycles

DRUG

Placebo

Lenvatinib-matching placebo, oral capsules, administered once daily (QD)

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 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. 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 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. * 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.

Locations (152)

California Cancer Associates for Research & Excellence ( Site 0025)

Fresno, California, United States

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

University of Wisconsin- Madison Carbone Cancer Center ( Site 0006)

Madison, Wisconsin, United States

Chris OBrien Lifehouse ( Site 1002)

Camperdown, New South Wales, Australia

St George Hospital ( Site 1001)

Kogarah, New South Wales, Australia

Royal Adelaide Hospital ( Site 1004)

Adelaide, South Australia, Australia

Oncocentro Ceara ( Site 0412)

Fortaleza, Ceará, Brazil

Fundacao Sao Francisco Xavier ( Site 0409)

Ipatinga, Minas Gerais, Brazil

ELO Pesquisa Clinica ( Site 0405)

Maringá, Paraná, Brazil

Hospital de Passo Fundo ( Site 0401)

Passo Fundo, Rio Grande do Sul, Brazil

Clinica LACKS ( Site 0402)

Pelotas, Rio Grande do Sul, Brazil

Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0414)

Porto Alegre, Rio Grande do Sul, Brazil

A.C. Camargo Cancer Center ( Site 0407)

São Paulo, Brazil

Princess Margaret Cancer Centre ( Site 0200)

Toronto, Ontario, Canada

McGill University Health Centre ( Site 0206)

Montreal, Quebec, Canada

Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0

Québec, Quebec, Canada

Beijing Cancer Hospital ( Site 3314)

Beining, Beijing Municipality, China

Peking Union Medical College Hospital ( Site 3304)

Bejiing, Beijing Municipality, China

Chongqing Cancer Hospital ( Site 3327)

Chongqing, Chongqing Municipality, China

Fujian Provincial Cancer Hospital ( Site 3326)

Fuzhou, Fujian, China

Guangxi Medical University Affiliated Tumor Hospital ( Site 3322)

Nanning, Guangxi, China

Guizhou Cancer Hospital ( Site 3330)

Guiyang, Guizhou, China

The Third Affiliated Hospital of Harbin Medical University ( Site 3302)

Harbin, Heilongjiang, China

Henan Cancer Hospital ( Site 3309)

Zhengzhou, Henan, China

Wuhan Union hospital Cancer Center ( Site 3307)

Wuhan, Hubei, China

Tongji Hospital Tongji Medical,Science & Technology ( Site 3316)

Wuhan, Hubei, China

Hunan Cancer Hospital ( Site 3311)

Changsha, Hunan, China

Xiangya Hospital of Central South University ( Site 3305)

Changsha, Hunan, China

Jiangxi Cancer Hospital ( Site 3313)

Nanchang, Jiangxi, China

Jilin Cancer Hospital ( Site 3310)

Changchun, Jilin, China

The First Affiliated Hospital of Xi an Jiaotong University ( Site 3328)

Xi'an, Shaanxi, China

Fudan University Shanghai Cancer Center ( Site 3324)

Shanghai, Shanghai Municipality, China

Shanghai East Hospital ( Site 3300)

Shanghai, Shanghai Municipality, China

West China Hospital of Sichuan University ( Site 3308)

Chengdu, Sichuan, China

Tianjin Medical University Cancer Hospital ( Site 3312)

Tianjin, Tianjin Municipality, China

Zhejiang Cancer Hospital ( Site 3303)

Hangzhou, Zhejiang, China

Centre Leon Berard ( Site 1901)

Lyon, Auvergne, France

Hopital de la Timone ( Site 1903)

Marseille, Bouches-du-Rhone, France

Hopital Foch ( Site 1905)

Suresnes, Hauts-de-Seine, France

Centre Henri Becquerel ( Site 1904)

Rouen, Seine-Maritime, France

Gustave Roussy ( Site 1906)

Villejuif, Val-de-Marne, France

Universitaetsklinikum Tuebingen ( Site 2108)

Tübingen, Baden-Wurttemberg, Germany

Universitaetsklinikum Ulm ( Site 2102)

Ulm, Baden-Wurttemberg, Germany

Universitaetsklinikum Regensburg ( Site 2100)

Regensburg, Bavaria, Germany

Universitaetsklinikum Frankfurt ( Site 2107)

Frankfurt am Main, Hesse, Germany

KRH Klinikum Siloah ( Site 2103)

Hanover, Lower Saxony, Germany

Universitaetsklinikum Koeln ( Site 2111)

Cologne, North Rhine-Westphalia, Germany

Universitätsklinikum Leipzig-Department for ENT ( Site 2106)

Leipzig, Saxony, Germany

Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 2112)

Berlin, Germany

Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Okta-Klinikai Onkológiai és Sugárterápiás Ce

Miskolc, Borsod-Abauj Zemplen county, Hungary

Szegedi Egyetem Szent-Gyorgyi Albert Klinikai Kozpont ( Site 2207)

Szeged, Csongrád megye, Hungary

Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 2200)

Szolnok, Jász-Nagykun-Szolnok, Hungary

Uzsoki Utcai Korhaz ( Site 2201)

Budapest, Vas County, Hungary

Orszagos Onkologiai Intezet ( Site 2202)

Budapest, Hungary

Debreceni Egyetem Klinikai Kozpont ( Site 2206)

Debrecen, Hungary

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia ( Site 2402)

Brescia, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 2400)

Milan, Italy

IEO Istituto Europeo di Oncologia ( Site 2406)

Milan, Italy

ASST Santi Paolo e Carlo - Presidio Ospedaliero San Paolo ( Site 2405)

Milan, Italy

Istituto Oncologico Veneto ( Site 2404)

Padova, Italy

ASL Liguria 2 - Ospedale San Paolo ( Site 2401)

Savona, Italy

Aichi Cancer Center Hospital ( Site 1113)

Nagoya, Aichi-ken, Japan

Nagoya University Hospital ( Site 1106)

Nagoya, Aichi-ken, Japan

Chiba cancer center ( Site 1110)

Chiba, Chiba, Japan

National Cancer Center Hospital East ( Site 1100)

Kashiwa, Chiba, Japan

Hyogo Cancer Center ( Site 1112)

Akashi, Hyōgo, Japan

Kagawa University Hospital ( Site 1108)

Kita-gun, Kagawa-ken, Japan

Yokohama City University Hospital ( Site 1104)

Yokohama, Kanagawa, Japan

Kindai University Hospital ( Site 1107)

Sayama, Osaka, Japan

Shizuoka Cancer Center Hospital and Research Institute ( Site 1105)

Sunto-gun, Shizuoka, Japan

National Hospital Organization Kyushu Medical Center ( Site 1111)

Fukuoka, Japan

Hiroshima University Hospital ( Site 1109)

Hiroshima, Japan

National Cancer Center Hospital ( Site 1102)

Tokyo, Japan

The Cancer Institute Hospital of JFCR ( Site 1103)

Tokyo, Japan

Tokyo Medical and Dental University Hospital ( Site 1101)

Tokyo, Japan

Cryptex Investigación Clínica S.A. de C.V. ( Site 0608)

Cuauhtémoc, Mexico City, Mexico City, Mexico

Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 0602)

Monterrey, Nuevo León, Mexico

And 52 more locations on ClinicalTrials.gov

Clinical Research Directory

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)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (152)