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Head and Neck Squamous Cell CarcinomaPhase 3NCT05523323

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/LEAP-010)-China Extension

A Phase 3 study testing Lenvatinib and Pembrolizumab in people with Head and Neck Squamous Cell Carcinoma, run by Merck Sharp & Dohme LLC at 28 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Squamous Cell Carcinoma
What is being tested?
Lenvatinib and Pembrolizumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
112 participants
Where
28 sitesChina
Study dates
30 Oct 2020to 28 Mar 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has histologically confirmed diagnosis of recurrent/metastatic head and neck squamous cell carcinoma (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 Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR) Note: Lesions situated in a previously irradiated area are considered measurable if progression has been showed in such lesions
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  • 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
  • Has adequately controlled blood pressure with or without antihypertensive medications
  • Has adequate organ function

Who cannot join

  • Has any evidence of symptoms or signs of active tumor bleeding within 6 months before randomization
  • Has radiographic evidence of major blood vessel invasion/infiltration or tumor demonstrates >90 degree abutment or encasement of a major blood vessel Note: The degree of proximity to major blood vessels should be considered because of the potential risk of severe hemorrhage associated with tumor shrinkage/necrosis after lenvatinib therapy
  • 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 ulceration and/or fungation of disease onto the skin surface
  • 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
Show all 30Show fewer
  • 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-programmed cell death 1 protein (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-programmed cell death ligand 2 (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
  • Has 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 hepatitis B surface antigen [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

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

China28 sites

  • Beijing Tongren Hospital affiliated to Capital Medical University ( Site 3343)

    Beijing, Beijing Municipality, 100730

  • Beijing Cancer Hospital ( Site 3314)

    Beining, Beijing Municipality, 100036

  • Peking Union Medical College Hospital ( Site 3304)

    Bejiing, Beijing Municipality, 100032

  • Jilin Cancer Hospital ( Site 3310)

    Changchun, Jilin, 130000

  • Hunan Cancer Hospital ( Site 3311)

    Changsha, Hunan, 410000

  • Xiangya Hospital of Central South University ( Site 3305)

    Changsha, Hunan, 410008

  • Hunan Cancer Hospital ( Site 3334)

    Changsha, Hunan, 410013

  • Changzhou Tumor Hospital - Changzhou Fourth People's Hospital ( Site 3339)

    Changzhou, Jiangsu, 213000

  • West China Hospital of Sichuan University ( Site 3308)

    Chengdu, Sichuan, 610047

  • Chongqing Cancer Hospital ( Site 3327)

    Chongqing, Chongqing Municipality, 400030

  • Fujian Provincial Cancer Hospital ( Site 3326)

    Fuzhou, Fujian, 350014

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 3336)

    Guangzhou, Guangdong, 510000

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 3338)

    Guangzhou, Guangdong, 510000

  • The First Affiliated Hospital, Sun Yat-sen University ( Site 3344)

    Guangzhou, Guangdong, 510080

  • Guizhou Cancer Hospital ( Site 3330)

    Guiyang, Guizhou, 550003

  • Zhejiang Cancer Hospital ( Site 3303)

    Hangzhou, Zhejiang, 310022

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

    Harbin, Heilongjiang, 150081

  • Anhui Cancer Hospital-Radiology Department ( Site 3333)

    Hefei, Anhui, 230031

  • Jiangxi Cancer Hospital ( Site 3313)

    Nanchang, Jiangxi, 330029

  • Guangxi Medical University Affiliated Tumor Hospital ( Site 3322)

    Nanning, Guangxi, 530000

  • Shanghai 9th People hospital ( Site 3332)

    Shanghai, Shanghai Municipality, 200011

  • Fudan University Shanghai Cancer Center ( Site 3324)

    Shanghai, Shanghai Municipality, 200032

  • Shanghai East Hospital ( Site 3300)

    Shanghai, Shanghai Municipality, 200120

  • Tianjin Medical University Cancer Hospital ( Site 3312)

    Tianjin, Tianjin Municipality, 300060

  • Wuhan Union hospital Cancer Center ( Site 3307)

    Wuhan, Hubei, 430000

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

    Wuhan, Hubei, 430030

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

    Xi'an, Shaanxi, 710000

  • Henan Cancer Hospital ( Site 3309)

    Zhengzhou, Henan, 450008

Other trials in China

About this study

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).

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).
Read the detailed description

The MK-7902-010-China Extension Study will include participants previously enrolled in China in the global study for MK-7902-010 (NCT04199104) plus those enrolled during the China extension enrollment period.

Being tested
Lenvatinib, Pembrolizumab, Placebo
Keywords
head and neck squamous cell carcinoma, pembrolizumab, lenvatinib, PD-L1
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LenvatinibDrug

    Also called E7080, MK-7902, LENVIMA®

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

  • PembrolizumabBiological

    Also called MK-3475, Keytruda®

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

  • PlaceboDrug

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

Study groups in NCT05523323
Study groupRoleWhat they receive
Pembrolizumab + LenvatinibExperimentalParticipants receive lenvatinib 20 mg orally once a day (QD) plus pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W). Pembrolizumab will be administered for up to 35 cycles (approximately 24 months). Lenvatinib will be administered until progressive disease or unacceptable toxicity.
Receives: Drug: Lenvatinib; Biological: Pembrolizumab
Pembrolizumab + PlaceboActive comparatorParticipants receive lenvatinib-matching placebo orally once a day (QD) plus pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W). Pembrolizumab will be administered for up to 35 cycles (approximately 24 months). Lenvatinib-matching placebo will be administered until progressive disease or unacceptable toxicity.
Receives: Biological: Pembrolizumab; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

    ORR was defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The percentage of participants who experienced a CR or PR based on modified RECIST 1.1 were reported.

    Measured: Up to approximately 33 months

  2. Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

    PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.

    Measured: Up to approximately 33 months

  3. Overall Survival (OS)

    OS was the time from randomization to death due to any cause.

    Measured: Up to approximately 33 months

Secondary outcomes (3)

  1. Duration of Response (DOR)

    For participants who demonstrate a confirmed complete response (CR: Disappearance of all target lesions) or confirmed Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until disease progression or death.

    Measured: Up to approximately 33 months

  2. Number of Participants Who Experienced an Adverse Event (AE)

    An adverse event (AE) was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Number of participants who experienced an AE will be reported.

    Measured: Up to approximately 52 months

  3. Number of Participants Who Discontinued Study Drug Due to an AE

    An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

    Measured: Up to approximately 34 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2022
  2. Study start30 Oct 2020
  3. Primary completion25 Aug 2023
  4. Study completion28 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05523323
Sponsor's protocol ID
7902-010 China Extension
Other IDs
MK-7902-010 China Extension, 205240, LEAP-10
Status last verified
Feb 2026
First submitted
29 Aug 2022
Last updated
13 Mar 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lenvatinib and Pembrolizumab in people with Head and Neck Squamous Cell Carcinoma, run by Merck Sharp & Dohme LLC at 28 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) (time frame: Up to approximately 33 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05523323.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.

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