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Spots Global Cancer Trial Database for Safety and Efficacy Study of Pembrolizumab (MK-3475) Combined With Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Advanced Melanoma (MK-7902-003/E7080-G000-312/LEAP-003)-China Extension Study

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Trial Identification

Brief Title: Safety and Efficacy Study of Pembrolizumab (MK-3475) Combined With Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Advanced Melanoma (MK-7902-003/E7080-G000-312/LEAP-003)-China Extension Study

Official Title: A Phase 3 Randomized, Placebo-controlled Trial to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) and Lenvatinib (E7080/MK-7902) Versus Pembrolizumab Alone as First-line Intervention in Participants With Advanced Melanoma (LEAP-003)

Study ID: NCT04889118

Study Description

Brief Summary: 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.

Detailed Description: 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Beijing Cancer Hospital (0601), Beijing, Beijing, China

Fujian Provincial Cancer Hospital ( Site 0612), Fuzhou, Fujian, China

Sun Yat-Sen University Cancer Center (0602), Guangzhou, Guangdong, China

Henan Cancer Hospital ( Site 0610), Zhengzhou, Henan, China

Nanjing Drum Tower Hospital (0609), Nanjing, Jiangsu, China

The First Hospital Of Jilin University (0603), Chang Chun, Jilin, China

Fudan University Shanghai Cancer Center ( Site 0607), Shanghai, Shanghai, China

Tianjin Medical University Cancer Institute & Hospital (0606), Tianjin, Tianjin, China

Yunnan Cancer Hospital (0604), Kunming, Yunnan, China

Sir Run Run Shaw Hospital (0605), Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital ( Site 0608), Hangzhou, Zhejiang, China

Contact Details

Name: Medical Director

Affiliation: Merck Sharp & Dohme LLC

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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