Spots Global Cancer Trial Database for A Study to Evaluate Investigational Agents With or Without Pembrolizumab (MK-3475) in Participants With Advanced Esophageal Cancer Previously Exposed to Programmed Cell Death 1 Protein (PD-1)/ Programmed Cell Death Ligand 1 (PD-L1) Treatment (MK-3475-06B)
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Trial Identification
Brief Title: A Study to Evaluate Investigational Agents With or Without Pembrolizumab (MK-3475) in Participants With Advanced Esophageal Cancer Previously Exposed to Programmed Cell Death 1 Protein (PD-1)/ Programmed Cell Death Ligand 1 (PD-L1) Treatment (MK-3475-06B)
Official Title: A Phase 1/2 Open-Label, Umbrella Platform Design Study of Investigational Agents With or Without Pembrolizumab (MK-3475) and/or Chemotherapy in Participants With Advanced Esophageal Cancer Previously Exposed to PD-1/PD-L1 Treatment (KEYMAKER-U06): Substudy 06B
Study ID: NCT05319730
Conditions
Study Description
Brief Summary: This is a Phase 1/2, multicenter, randomized, open-label umbrella platform study to evaluate the safety and efficacy of investigational agents with or without pembrolizumab and/or chemotherapy, for the treatment of participants with second line (2L) esophageal squamous cell carcinoma (ESCC) who have previously been exposed to PD-1/PD-L1 based treatment.
Detailed Description: The master protocol is MK-3475-U06. As of Protocol Amendment 5, the Pembrolizumab Plus MK-4830 Plus Paclitaxel/Irinotecan arm and the Pembrolizumab Plus MK-4830 Plus Lenvatinib arm are no longer actively enrolling participants.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Liga Norte Riograndense Contra o Câncer ( Site 4303), Natal, Rio Grande Do Norte, Brazil
Hospital Nossa Senhora da Conceição ( Site 4301), Porto Alegre, Rio Grande Do Sul, Brazil
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 4300), São Paulo, Sao Paulo, Brazil
FALP-UIDO ( Site 4400), Santiago, Region M. De Santiago, Chile
Clínica las Condes ( Site 4403), Santiago, Region M. De Santiago, Chile
Anhui Provincil Hospital South District ( Site 3501), Hefei, Anhui, China
Beijing Cancer hospital-Digestive Oncology ( Site 3500), Beijing, Beijing, China
The First Affiliated Hospital of Xinxiang Medical University-Oncology ( Site 3510), Xinxiang, Henan, China
First Huai'an Hospital Affiliated to Nanjing Medical University ( Site 3506), Huai'an, Jiangsu, China
Shanghai Chest Hospital-Esophageal surgery department ( Site 3513), Shanghai, Shanghai, China
Zhejiang Cancer Hospital-Thoracic oncology ( Site 3511), Hangzhou, Zhejiang, China
Institut für Klinisch Onkologische Forschung-Klink für Onkologie und Hämatologie ( Site 4801), Frankfurt, Hessen, Germany
Charité Campus Virchow-Klinikum-Klinik Hämatologie Onkologie Tumorimmunologie ( Site 4804), Berlin, , Germany
Ospedale San Raffaele-Oncologia Medica ( Site 3202), Milano, Lombardia, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 3200), Milan, Lombardia, Italy
Istituto Europeo di Oncologia IRCCS-Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative (, Milano, , Italy
Aichi Cancer Center Hospital ( Site 3702), Nagoya, Aichi, Japan
National Cancer Center Hospital East ( Site 3701), Kashiwa, Chiba, Japan
Saitama Prefectural Cancer Center ( Site 3703), Ina-machi, Saitama, Japan
Shizuoka Cancer Center ( Site 3704), Nagaizumi-cho,Sunto-gun, Shizuoka, Japan
National Cancer Center Hospital ( Site 3700), Chuo-ku, Tokyo, Japan
Asan Medical Center-Department of Oncology ( Site 3901), Seoul, , Korea, Republic of
Samsung Medical Center-Division of Hematology/Oncology ( Site 3900), Seoul, , Korea, Republic of
Oslo universitetssykehus, Radiumhospitalet ( Site 4501), Oslo, , Norway
National University Hospital ( Site 3800), Singapore, South West, Singapore
Hôpitaux Universitaires de Genève (HUG) ( Site 4702), Genève, Geneve, Switzerland
Kantonsspital Graubünden-Medizin ( Site 4700), Chur, Grisons, Switzerland
Chang Gung Memorial Hospital at Kaohsiung ( Site 4003), Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
China Medical University Hospital ( Site 4007), Taichung, , Taiwan
Taichung Veterans General Hospital-Radiation Oncology ( Site 4008), Taichung, , Taiwan
National Cheng Kung University Hospital ( Site 4001), Tainan, , Taiwan
National Taiwan University Hospital ( Site 4000), Taipei, , Taiwan
Taipei Veterans General Hospital ( Site 4005), Taipei, , Taiwan
Chang Gung Medical Foundation-Linkou Branch ( Site 4006), Taoyuan, , Taiwan
Faculty of Medicine Siriraj Hospital ( Site 4102), Bangkok, Krung Thep Maha Nakhon, Thailand
Hacettepe Universite Hastaneleri-oncology hospital ( Site 3402), Ankara, , Turkey
Ankara Bilkent City Hospital-Medical Oncology ( Site 3405), Ankara, , Turkey
Atatürk Üniversitesi-onkoloji ( Site 3416), Erzurum, , Turkey
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 3403), Istanbul, , Turkey
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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