The purpose of the China Extension study is to assess the safety and efficacy of pembrolizumab (MK-3475) combined with lenvatinib (MK-7902/E7080) compared to pembrolizumab alone (with placebo for lenvatinib) as first-line treatment in Chinese participants with no prior systemic therapy for their advanced melanoma.
As of 03-Apr-2023, active participants, investigator, and sponsor personnel or delegate(s) involved in the treatment administration or clinical evaluation of the participants will be unblinded.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
131
Beijing Cancer Hospital (0601)
Beijing, Beijing Municipality, China
Fujian Provincial Cancer Hospital ( Site 0612)
Fuzhou, Fujian, China
Sun Yat-Sen University Cancer Center (0602)
Guangzhou, Guangdong, China
Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) Per Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
PFS is defined as the time from date of randomization to the date of the first documentation of progressive disease (PD) or death from 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. For this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.
Time frame: Up to approximately 30 months
Overall Survival (OS)
OS is defined as the time from date of randomization to date of death from any cause.
Time frame: Up to approximately 30 months
Objective Response Rate (ORR) as Assessed by BICR Per RECIST 1.1
ORR is defined as the percentage of participants in the analysis population 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) per RECIST 1.1. For this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.
Time frame: Up to approximately 30 months
Duration of Response (DOR) as Assessed by BICR Per RECIST 1.1
For participants who demonstrated CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions), DOR is defined as the date of the first documented evidence of CR or PR until PD or death from 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. For this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Henan Cancer Hospital ( Site 0610)
Zhengzhou, Henan, China
Nanjing Drum Tower Hospital (0609)
Nanjing, Jiangsu, China
The First Hospital Of Jilin University (0603)
Changchun, Jilin, China
Fudan University Shanghai Cancer Center ( Site 0607)
Shanghai, Shanghai Municipality, China
Tianjin Medical University Cancer Institute & Hospital (0606)
Tianjin, Tianjin Municipality, China
Yunnan Cancer Hospital (0604)
Kunming, Yunnan, China
Sir Run Run Shaw Hospital (0605)
Hangzhou, Zhejiang, China
...and 1 more locations
Time frame: Up to approximately 30 months
Number of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Time frame: Up to approximately 50 months
Number of Participants Who Discontinue Study Treatment Due to Adverse Events (AEs)
The number of participants who discontinue study treatment due to an AE will be presented.
Time frame: Up to approximately 39 months