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

NCT05523323 | Completed Phase 3 Results DMC

• 4 other identifiers: 7902-010 China ExtensionMK-7902-010 China Extension205240LEAP-10
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 28

Brief 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).

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

head and neck squamous cell carcinoma; pembrolizumab; lenvatinib; PD-L1

Outcome Measures

Primary Outcomes (3)

• 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.

  Up to approximately 33 months

• 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.

  Up to approximately 33 months

• Overall Survival (OS)

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

  Up to approximately 33 months

Secondary Outcomes (3)

• Duration of Response (DOR)

  Up to approximately 33 months

• Number of Participants Who Experienced an Adverse Event (AE)

  Up to approximately 52 months

• Number of Participants Who Discontinued Study Drug Due to an AE

  Up to approximately 34 months

Study Arms (2)

Pembrolizumab + Lenvatinib

EXPERIMENTAL

Participants 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.

Drug: Lenvatinib; Biological: Pembrolizumab

Pembrolizumab + Placebo

ACTIVE COMPARATOR

Participants 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.

Biological: Pembrolizumab; Drug: Placebo

Interventions

Lenvatinib DRUG

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

Also known as: E7080, MK-7902, LENVIMA®

Pembrolizumab + Lenvatinib

Pembrolizumab BIOLOGICAL

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

Also known as: MK-3475, Keytruda®

Pembrolizumab + Lenvatinib; Pembrolizumab + Placebo

Placebo DRUG

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

Pembrolizumab + Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• Eisai Inc.: collaborator

Study Sites (28)

Anhui Cancer Hospital-Radiology Department ( Site 3333)

Hefei, Anhui, 230031, China

Location

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

Beijing, Beijing Municipality, 100730, China

Location

Beijing Cancer Hospital ( Site 3314)

Beining, Beijing Municipality, 100036, China

Location

Peking Union Medical College Hospital ( Site 3304)

Bejiing, Beijing Municipality, 100032, China

Location

Chongqing Cancer Hospital ( Site 3327)

Chongqing, Chongqing Municipality, 400030, China

Location

Fujian Provincial Cancer Hospital ( Site 3326)

Fuzhou, Fujian, 350014, China

Location

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

Guangzhou, Guangdong, 510000, China

Location

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

Guangzhou, Guangdong, 510000, China

Location

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

Guangzhou, Guangdong, 510080, China

Location

Guangxi Medical University Affiliated Tumor Hospital ( Site 3322)

Nanning, Guangxi, 530000, China

Location

Guizhou Cancer Hospital ( Site 3330)

Guiyang, Guizhou, 550003, China

Location

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

Harbin, Heilongjiang, 150081, China

Location

Henan Cancer Hospital ( Site 3309)

Zhengzhou, Henan, 450008, China

Location

Wuhan Union hospital Cancer Center ( Site 3307)

Wuhan, Hubei, 430000, China

Location

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

Wuhan, Hubei, 430030, China

Location

Hunan Cancer Hospital ( Site 3311)

Changsha, Hunan, 410000, China

Location

Xiangya Hospital of Central South University ( Site 3305)

Changsha, Hunan, 410008, China

Location

Hunan Cancer Hospital ( Site 3334)

Changsha, Hunan, 410013, China

Location

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

Changzhou, Jiangsu, 213000, China

Location

Jiangxi Cancer Hospital ( Site 3313)

Nanchang, Jiangxi, 330029, China

Location

Jilin Cancer Hospital ( Site 3310)

Changchun, Jilin, 130000, China

Location

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

Xi'an, Shaanxi, 710000, China

Location

Shanghai 9th People hospital ( Site 3332)

Shanghai, Shanghai Municipality, 200011, China

Location

Fudan University Shanghai Cancer Center ( Site 3324)

Shanghai, Shanghai Municipality, 200032, China

Location

Shanghai East Hospital ( Site 3300)

Shanghai, Shanghai Municipality, 200120, China

Location

West China Hospital of Sichuan University ( Site 3308)

Chengdu, Sichuan, 610047, China

Location

Tianjin Medical University Cancer Hospital ( Site 3312)

Tianjin, Tianjin Municipality, 300060, China

Location

Zhejiang Cancer Hospital ( Site 3303)

Hangzhou, Zhejiang, 310022, China

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

lenvatinib; pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Study was unblinded on August 16, 2023
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: August 31, 2022
• Study Start: October 30, 2020
• Primary Completion: August 25, 2023
• Study Completion: March 28, 2025
• Last Updated: March 13, 2026
• Results First Posted: October 18, 2024

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

CN (28)