Clinical Trials List
Protocol NumberMK-7902-010 (E7080-G000-319)
NCT Number(ClinicalTrials.gov Identfier)NCT04199104
2020-01-06 - 2026-01-31
Phase III
Recruiting5
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).
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Trial Applicant
Merck Sharp & Dohme (I.A.) LLC
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Sponsor
Merck Sharp & Dohme Corp.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Ling-Wei Wang Division of Hematology & Oncology
- Mu-Hsin Chang Division of Hematology & Oncology
- Sheng-Yu Chen Division of Hematology & Oncology
- 陳盛裕 Division of Hematology & Oncology
- Tien-Hua Chen Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 蘇迺文 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 顏志傑 Division of Hematology & Oncology
- 劉奕廷 Division of Hematology & Oncology
- Shang-Yin Wu Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 黃泰霖 Division of Hematology & Oncology
- 吳佳哲 Division of Hematology & Oncology
- 黃詩喻 Division of Hematology & Oncology
- Tai-Jan Chiu Division of Hematology & Oncology
- 陳彥豪 Division of Hematology & Oncology
- 李易濰 Division of Radiology
- Yu-Li Su Division of Hematology & Oncology
- 賴香蘭 Division of Hematology & Oncology
- 郭明濬 Division of Hematology & Oncology
- 劉建廷 Division of Hematology & Oncology
- 林偉哲 Division of Radiology
- 賴香蘭 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- HUAI-CHENG HUANG Division of Hematology & Oncology
- 黃彥霖 Division of Hematology & Oncology
- YA-FANG CHEN Division of Hematology & Oncology
- Hsiang-Fong Kao Division of Hematology & Oncology
- 廖斌志 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)
Objectives
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).
Test Drug
Keytruda、Lenvima
Active Ingredient
Lenvatinib
Pembrolizumab
Pembrolizumab
Dosage Form
IVT
capsule
capsule
capsule
capsule
Dosage
100 mg
4mg
10mg
4mg
10mg
Endpoints
Primary Outcome Measures :
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 24 months ]
ORR is 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 experience a CR or PR based on modified RECIST 1.1 will be presented.
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). [ Time Frame: Up to approximately 30 months ]
PFS is 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 is 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. Note: The appearance of one or more new lesions is also considered PD.
Overall Survival (OS) [ Time Frame: Up to approximately 44 months ]
OS is the time from randomization to death due to any cause.
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 24 months ]
ORR is 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 experience a CR or PR based on modified RECIST 1.1 will be presented.
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). [ Time Frame: Up to approximately 30 months ]
PFS is 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 is 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. Note: The appearance of one or more new lesions is also considered PD.
Overall Survival (OS) [ Time Frame: Up to approximately 44 months ]
OS is the time from randomization to death due to any cause.
Inclution Criteria
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 are not eligible.
Male participants agree to use approved contraception during the treatment period for at least 30 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 demonstrated 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.
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 are not eligible.
Male participants agree to use approved contraception during the treatment period for at least 30 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 demonstrated 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.
Exclusion Criteria
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 drug, 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 prior to first dose of study interventions.
Has difficulty swallowing capsules or ingesting a suspension either orally or by a nasogastric (NG) tube.
Has received prior therapy with lenvatinib or pembrolizumab.
Received last dose of systemic therapy for locoregionally advanced disease less than 6 months prior to 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 prior to randomization.
Has received prior radiotherapy within 2 weeks of start of study intervention.
Has received a live vaccine within 30 days prior to the first dose of study drug.
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to 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 drug.
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 (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 an active infection requiring systemic therapy.
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.
Has a known history of active tuberculosis (TB; Bacillus tuberculosis).
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.
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 drug, 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 prior to first dose of study interventions.
Has difficulty swallowing capsules or ingesting a suspension either orally or by a nasogastric (NG) tube.
Has received prior therapy with lenvatinib or pembrolizumab.
Received last dose of systemic therapy for locoregionally advanced disease less than 6 months prior to 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 prior to randomization.
Has received prior radiotherapy within 2 weeks of start of study intervention.
Has received a live vaccine within 30 days prior to the first dose of study drug.
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to 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 drug.
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 (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 an active infection requiring systemic therapy.
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.
Has a known history of active tuberculosis (TB; Bacillus tuberculosis).
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.
The Estimated Number of Participants
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Taiwan
30 participants
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Global
500 participants
