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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
112
Lenvatinib, 20 mg (two 10-mg oral capsules) administered QD
Pembrolizumab (MK-3475), 200 mg, every 3 weeks (Q3W) by intravenous (IV) infusion for up to 35 3-week cycles
Lenvatinib-matching placebo, oral capsules, administered once daily (QD)
Anhui Cancer Hospital-Radiology Department ( Site 3333)
Hefei, Anhui, China
Beijing Tongren Hospital affiliated to Capital Medical University ( Site 3343)
Beijing, Beijing Municipality, China
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
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.
Time frame: 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.
Time frame: Up to approximately 33 months
Overall Survival (OS)
OS was the time from randomization to death due to any cause.
Time frame: Up to approximately 33 months
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.
Time frame: Up to approximately 33 months
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.
Time frame: Up to approximately 52 months
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.
Time frame: Up to approximately 52 months
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Fujian Provincial Cancer Hospital ( Site 3326)
Fuzhou, Fujian, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 3336)
Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 3338)
Guangzhou, Guangdong, China
The First Affiliated Hospital, Sun Yat-sen University ( Site 3344)
Guangzhou, Guangdong, China
Guangxi Medical University Affiliated Tumor Hospital ( Site 3322)
Nanning, Guangxi, China
...and 18 more locations