Spots Global Cancer Trial Database for Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) for Advanced Melanoma in Anti-Programmed Death-1/Programmed Death-Ligand 1 (PD-1/L1)-Exposed Participants (MK-7902-004/E7080-G000-225/LEAP-004)
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Trial Identification
Brief Title: Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) for Advanced Melanoma in Anti-Programmed Death-1/Programmed Death-Ligand 1 (PD-1/L1)-Exposed Participants (MK-7902-004/E7080-G000-225/LEAP-004)
Official Title: A Multicenter, Open-label, Phase 2 Trial to Assess the Efficacy and Safety of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Melanoma Previously Exposed to an Anti-PD-1/L1 Agent (LEAP-004)
Study ID: NCT03776136
Conditions
Study Description
Brief Summary: This study will evaluate the safety and efficacy of combination therapy of lenvatinib (E7080/MK-7902) and pembrolizumab following approximately 2 years of pembrolizumab therapy and approximately 2 years or more lenvatinib therapy in adult participants with unresectable or advanced melanoma who have been exposed to anti-PD-1/L1 agents approved for unresectable or metastatic melanoma. No statistical hypothesis will be tested in this study.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Ironwood Cancer & Research Centers ( Site 0312), Chandler, Arizona, United States
John Wayne Cancer Institute ( Site 0301), Santa Monica, California, United States
Advocate Medical Group-Park Ridge ( Site 0313), Park Ridge, Illinois, United States
Southeast Nebraska Cancer Center ( Site 0316), Lincoln, Nebraska, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center ( Site 0317), Dallas, Texas, United States
Inova Schar Cancer Institute ( Site 0314), Fairfax, Virginia, United States
Melanoma Institute Australia ( Site 0152), Wollstonecraft, New South Wales, Australia
Princess Alexandra Hospital ( Site 0154), Woolloongabba, Queensland, Australia
Box Hill Hospital ( Site 0157), Box Hill, Victoria, Australia
Fiona Stanley Hospital ( Site 0156), Perth, Western Australia, Australia
Lismore Base Hospital ( Site 0153), Lismore, , Australia
Sunnybrook Research Institute ( Site 0654), Toronto, Ontario, Canada
Princess Margaret Cancer Centre ( Site 0655), Toronto, Ontario, Canada
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0652), Montreal, Quebec, Canada
McGill University Health Centre ( Site 0651), Montreal, Quebec, Canada
Hospital Clinic i Provincial Barcelona ( Site 0001), Barcelona, , Spain
Hospital General Universitario Gregorio Maranon ( Site 0003), Madrid, , Spain
Hospital Universitario Virgen de la Macarena ( Site 0004), Sevilla, , Spain
Hospital General Universitario de Valencia ( Site 0002), Valencia, , Spain
Sahlgrenska Universitetssjukhuset ( Site 0052), Goteborg, , Sweden
Skanes Universitetssjukhus ( Site 0053), Lund, , Sweden
Karolinska Universitetssjukhuset ( Site 0051), Solna, , Sweden
Norrlands Universitetssjukhus ( Site 0056), Umea, , Sweden
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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