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)
Start Date
5/16/2023
Completion Date
4/10/2029
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 Criteria
Age Range: 18 years to No maximum
Interventions
Paclitaxel
Irinotecan
Pembrolizumab
MK-4830
Lenvatinib
Sacituzumab tirumotecan
Antihistamine
H2 Receptor Antagonist
Acetaminophen (or equivalent)
Dexamethasone (or equivalent)
Steroid Mouthwash (dexamethasone or equivalent)
Supportive care measures
Conditions
Locations
University of Arizona Cancer Center-University of Arizona Cancer Center ( Site 4927)
Tucson, Arizona 85719
United States
UCLA Hematology/Oncology - Santa Monica ( Site 4905)
Los Angeles, California 90404
United States
Hematology-Oncology Associates of Central NY, P.C. ( Site 4925)
East Syracuse, New York 13057
United States
Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 4907)
New York, New York 10032
United States
UPMC Hillman Cancer Center-UPMC ( Site 4904)
Pittsburgh, Pennsylvania 15232
United States
Liga Norte Riograndense Contra o Câncer ( Site 4303)
Natal, Rio Grande do Norte 59062-000
Brazil
Hospital Nossa Senhora da Conceição ( Site 4301)
Porto Alegre, Rio Grande do Sul 91350-200
Brazil
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 4300)
São Paulo, 01246-000
Brazil
FALP-UIDO ( Site 4400)
Santiago, Region M. de Santiago 7500921
Chile
Centro de Oncología de Precisión-Oncology ( Site 4404)
Santiago, Region M. de Santiago 7560908
Chile
Clínica las Condes ( Site 4403)
Santiago, Region M. de Santiago 7591047
Chile
Clínica UC San Carlos de Apoquindo ( Site 4405)
Santiago, Region M. de Santiago 7620002
Chile
Anhui Provincial Hospital ( Site 3501)
Hefei, Anhui 230001
China
Beijing Cancer hospital-Digestive Oncology ( Site 3500)
Beijing, Beijing Municipality 100142
China
The First Affiliated Hospital of Xiamen University ( Site 3516)
Xiamen, Fujian 361003
China
The First Affiliated Hospital of Xinxiang Medical University-Oncology ( Site 3510)
Xinxiang, Henan 453100
China
Henan Cancer Hospital ( Site 3518)
Zhengzhou, Henan 450008
China
First Huai'an Hospital Affiliated to Nanjing Medical University ( Site 3506)
Huai'an, Jiangsu 223300
China
Shanghai Chest Hospital-Esophageal surgery department ( Site 3513)
Shanghai, Shanghai Municipality 200030
China
Zhejiang Cancer Hospital-Thoracic oncology ( Site 3511)
Hangzhou, Zhejiang 310022
China
Institut für Klinisch Onkologische Forschung-Klink für Onkologie und Hämatologie ( Site 4801)
Frankfurt am Main, Hesse 60488
Germany
Universitaetsklinikum Duesseldorf ( Site 4802)
Düsseldorf, North Rhine-Westphalia 40225
Germany
Universitaetsklinikum Carl Gustav Carus Dresden-Medical Dept I - Medical Oncology ( Site 4806)
Dresden, Saxony 01307
Germany
Charité Campus Virchow-Klinikum-Klinik Hämatologie Onkologie Tumorimmunologie ( Site 4804)
Berlin, 13353
Germany
Facharztzentrum Eppendorf ( Site 4807)
Hamburg, 20249
Germany
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 3207)
Meldola, Emilia-Romagna 47014
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 3200)
Milan, Lombardy 20133
Italy
Azienda Ospedaliero Universitaria Pisana ( Site 3206)
Pisa, Tuscany 56126
Italy
Istituto Oncologico Veneto IRCCS-Oncologia Medica 1 ( Site 3203)
Padova, Veneto 35128
Italy
Ospedale San Raffaele-Oncologia Medica ( Site 3202)
Milan, 20132
Italy
Istituto Europeo di Oncologia IRCCS-Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative ( Site 3201)
Milan, 20141
Italy
Aichi Cancer Center ( Site 3702)
Nagoya, Aichi-ken 464-8681
Japan
National Cancer Center Hospital East ( Site 3701)
Kashiwa, Chiba 277-8577
Japan
Saitama Prefectural Cancer Center ( Site 3703)
Kitaadachi-gun, Saitama 3620806
Japan
Shizuoka Cancer Center ( Site 3704)
Nagaizumi-cho,Sunto-gun, Shizuoka 411-8777
Japan
National Cancer Center Hospital ( Site 3700)
Chuo-ku, Tokyo 104-0045
Japan
Oslo universitetssykehus, Radiumhospitalet ( Site 4501)
Oslo, 0379
Norway
National University Hospital ( Site 3800)
Singapore, South West 119074
Singapore
Asan Medical Center-Department of Oncology ( Site 3901)
Seoul, 05505
South Korea
Samsung Medical Center-Division of Hematology/Oncology ( Site 3900)
Seoul, 06351
South Korea
Hôpitaux Universitaires de Genève (HUG) ( Site 4702)
Geneva, Canton of Geneva 1211
Switzerland
Kantonsspital Graubünden-Medizin ( Site 4700)
Chur, Kanton Graubünden 7000
Switzerland
Chang Gung Memorial Hospital at Kaohsiung ( Site 4003)
Kaohsiung Niao Sung Dist, Kaohsiung 83301
Taiwan
China Medical University Hospital ( Site 4007)
Taichung, 404332
Taiwan
Taichung Veterans General Hospital-Radiation Oncology ( Site 4008)
Taichung, 407
Taiwan
National Cheng Kung University Hospital ( Site 4001)
Tainan, 704
Taiwan
National Taiwan University Hospital ( Site 4000)
Taipei, 10002
Taiwan
Taipei Veterans General Hospital ( Site 4005)
Taipei, 112
Taiwan
Chang Gung Medical Foundation-Linkou Branch ( Site 4006)
Taoyuan, 33305
Taiwan
Faculty of Medicine Siriraj Hospital ( Site 4102)
Bangkoknoi, Bangkok 10700
Thailand
Chulalongkorn University ( Site 4104)
Pathumwan, Bangkok 10330
Thailand
Songklanagarind hospital ( Site 4105)
Hat Yai, Changwat Songkhla 90110
Thailand
Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 3417)
Adana, 01140
Turkey (Türkiye)
Hacettepe Universite Hastaneleri-oncology hospital ( Site 3402)
Ankara, 06230
Turkey (Türkiye)
Memorial Ankara Hastanesi-Medical Oncology ( Site 3408)
Ankara, 06520
Turkey (Türkiye)
Ankara Bilkent City Hospital-Medical Oncology ( Site 3405)
Ankara, 06800
Turkey (Türkiye)
Atatürk Üniversitesi-onkoloji ( Site 3416)
Erzurum, 25070
Turkey (Türkiye)
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 3403)
Istanbul, 34722
Turkey (Türkiye)
I.E.U. Medical Point Hastanesi-Oncology ( Site 3406)
Izmir, 35575
Turkey (Türkiye)