Trial Title:
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
NCT ID:
NCT05523323
Condition:
Head and Neck Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Pembrolizumab
Lenvatinib
Conditions: Keywords:
head and neck squamous cell carcinoma
pembrolizumab
lenvatinib
PD-L1
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Masking description:
Study was unblinded on August 16, 2023
Intervention:
Intervention type:
Drug
Intervention name:
Lenvatinib
Description:
Lenvatinib, 20 mg (two 10-mg oral capsules) administered QD
Arm group label:
Pembrolizumab + Lenvatinib
Other name:
E7080
Other name:
MK-7902
Other name:
LENVIMA®
Intervention type:
Biological
Intervention name:
Pembrolizumab
Description:
Pembrolizumab (MK-3475), 200 mg, every 3 weeks (Q3W) by intravenous (IV) infusion for up
to 35 3-week cycles
Arm group label:
Pembrolizumab + Lenvatinib
Arm group label:
Pembrolizumab + Placebo
Other name:
MK-3475
Other name:
Keytruda®
Intervention type:
Drug
Intervention name:
Placebo
Description:
Lenvatinib-matching placebo, oral capsules, administered once daily (QD)
Arm group label:
Pembrolizumab + Placebo
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).
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Anhui Cancer Hospital-Radiology Department ( Site 3333)
Address:
City:
Hefei
Zip:
230031
Country:
China
Facility:
Name:
Beijing Tongren Hospital affiliated to Capital Medical University ( Site 3343)
Address:
City:
Beijing
Zip:
100730
Country:
China
Facility:
Name:
Beijing Cancer Hospital ( Site 3314)
Address:
City:
Beining
Zip:
100036
Country:
China
Facility:
Name:
Peking Union Medical College Hospital ( Site 3304)
Address:
City:
Bejiing
Zip:
100032
Country:
China
Facility:
Name:
Chongqing Cancer Hospital ( Site 3327)
Address:
City:
Chongqing
Zip:
400030
Country:
China
Facility:
Name:
Fujian Provincial Cancer Hospital ( Site 3326)
Address:
City:
Fuzhou
Zip:
350014
Country:
China
Facility:
Name:
Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 3336)
Address:
City:
Guangzhou
Zip:
510000
Country:
China
Facility:
Name:
Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 3338)
Address:
City:
Guangzhou
Zip:
510000
Country:
China
Facility:
Name:
The First Affiliated Hospital, Sun Yat-sen University ( Site 3344)
Address:
City:
Guangzhou
Zip:
510080
Country:
China
Facility:
Name:
Guangxi Medical University Affiliated Tumor Hospital ( Site 3322)
Address:
City:
Nanning
Zip:
530000
Country:
China
Facility:
Name:
Guizhou Cancer Hospital ( Site 3330)
Address:
City:
Guiyang
Zip:
550003
Country:
China
Facility:
Name:
The Third Affiliated Hospital of Harbin Medical University ( Site 3302)
Address:
City:
Harbin
Zip:
150081
Country:
China
Facility:
Name:
Henan Cancer Hospital ( Site 3309)
Address:
City:
Zhengzhou
Zip:
450008
Country:
China
Facility:
Name:
Wuhan Union hospital Cancer Center ( Site 3307)
Address:
City:
Wuhan
Zip:
430000
Country:
China
Facility:
Name:
Tongji Hospital Tongji Medical,Science & Technology ( Site 3316)
Address:
City:
Wuhan
Zip:
430030
Country:
China
Facility:
Name:
Hunan Cancer Hospital ( Site 3311)
Address:
City:
Changsha
Zip:
410000
Country:
China
Facility:
Name:
Xiangya Hospital of Central South University ( Site 3305)
Address:
City:
Changsha
Zip:
410008
Country:
China
Facility:
Name:
Hunan Cancer Hospital ( Site 3334)
Address:
City:
Changsha
Zip:
410013
Country:
China
Facility:
Name:
Changzhou Tumor Hospital - Changzhou Fourth People's Hospital ( Site 3339)
Address:
City:
Changzhou
Zip:
213000
Country:
China
Facility:
Name:
Jiangxi Cancer Hospital ( Site 3313)
Address:
City:
Nanchang
Zip:
330029
Country:
China
Facility:
Name:
Jilin Cancer Hospital ( Site 3310)
Address:
City:
Changchun
Zip:
130000
Country:
China
Facility:
Name:
The First Affiliated Hospital of Xi an Jiaotong University ( Site 3328)
Address:
City:
XI An
Zip:
710000
Country:
China
Facility:
Name:
Shanghai 9th People hospital ( Site 3332)
Address:
City:
Shanghai
Zip:
200011
Country:
China
Facility:
Name:
Fudan University Shanghai Cancer Center ( Site 3324)
Address:
City:
Shanghai
Zip:
200032
Country:
China
Facility:
Name:
Shanghai East Hospital ( Site 3300)
Address:
City:
Shanghai
Zip:
200120
Country:
China
Facility:
Name:
West China Hospital of Sichuan University ( Site 3308)
Address:
City:
Chengdu
Zip:
610047
Country:
China
Facility:
Name:
Tianjin Medical University Cancer Hospital ( Site 3312)
Address:
City:
Tianjin
Zip:
300060
Country:
China
Facility:
Name:
Zhejiang Cancer Hospital ( Site 3303)
Address:
City:
Hangzhou
Zip:
310022
Country:
China
Start date:
October 30, 2020
Completion date:
March 1, 2025
Lead sponsor:
Agency:
Merck Sharp & Dohme LLC
Agency class:
Industry
Collaborator:
Agency:
Eisai Inc.
Agency class:
Industry
Source:
Merck Sharp & Dohme LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05523323
https://www.merckclinicaltrials.com/
