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
Status: Recruiting
Location: See all (56) locations...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Histologically or cytologically confirmed diagnosis of metastatic or locally advanced unresectable esophageal squamous cell carcinoma (ESCC)
• Has experienced investigator documented radiographic or clinical disease progression on one prior line of standard therapy, that includes a platinum agent and previous exposure to an anti-programmed cell death 1 (PD1)/programmed cell death ligand 1 (PD-L1) based immune oncology (IO) therapy
• Has provided an archival or most recent tumor tissue sample obtained as part of clinical practice
• Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible
Locations
United States
Arizona
University of Arizona Cancer Center-University of Arizona Cancer Center ( Site 4927)
RECRUITING
Tucson
California
UCLA Hematology/Oncology - Santa Monica ( Site 4905)
RECRUITING
Los Angeles
New York
Hematology-Oncology Associates of Central NY, P.C. ( Site 4925)
RECRUITING
East Syracuse
Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 4907)
COMPLETED
New York
Pennsylvania
UPMC Hillman Cancer Center-UPMC ( Site 4904)
RECRUITING
Pittsburgh
Other Locations
Brazil
Liga Norte Riograndense Contra o Câncer ( Site 4303)
RECRUITING
Natal
Hospital Nossa Senhora da Conceição ( Site 4301)
RECRUITING
Porto Alegre
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 4300)
RECRUITING
São Paulo
Chile
Centro de Oncología de Precisión-Oncology ( Site 4404)
RECRUITING
Santiago
Clínica las Condes ( Site 4403)
COMPLETED
Santiago
Clínica UC San Carlos de Apoquindo ( Site 4405)
RECRUITING
Santiago
FALP-UIDO ( Site 4400)
RECRUITING
Santiago
China
Beijing Cancer hospital-Digestive Oncology ( Site 3500)
RECRUITING
Beijing
Zhejiang Cancer Hospital-Thoracic oncology ( Site 3511)
RECRUITING
Hangzhou
Anhui Provincial Hospital South District ( Site 3501)
RECRUITING
Hefei
First Huai'an Hospital Affiliated to Nanjing Medical University ( Site 3506)
RECRUITING
Huai'an
Shanghai Chest Hospital-Esophageal surgery department ( Site 3513)
RECRUITING
Shanghai
The First Affiliated Hospital of Xinxiang Medical University-Oncology ( Site 3510)
RECRUITING
Xinxiang
Germany
Charité Campus Virchow-Klinikum-Klinik Hämatologie Onkologie Tumorimmunologie ( Site 4804)
COMPLETED
Berlin
Universitaetsklinikum Carl Gustav Carus Dresden-Medical Dept I - Medical Oncology ( Site 4806)
RECRUITING
Dresden
Universitaetsklinikum Duesseldorf ( Site 4802)
COMPLETED
Düsseldorf
Institut für Klinisch Onkologische Forschung-Klink für Onkologie und Hämatologie ( Site 4801)
RECRUITING
Frankfurt Am Main
Italy
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori-Oncologia Medica ( Site 3207)
RECRUITING
Meldola
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 3200)
RECRUITING
Milan
Istituto Europeo di Oncologia IRCCS-Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative ( Site 3201)
COMPLETED
Milan
Ospedale San Raffaele-Oncologia Medica ( Site 3202)
RECRUITING
Milan
Istituto Oncologico Veneto IRCCS-Oncologia Medica 1 ( Site 3203)
RECRUITING
Padua
Azienda Ospedaliero Universitaria Pisana ( Site 3206)
RECRUITING
Pisa
Japan
National Cancer Center Hospital ( Site 3700)
RECRUITING
Chuo-ku
National Cancer Center Hospital East ( Site 3701)
RECRUITING
Kashiwa
Saitama Prefectural Cancer Center ( Site 3703)
RECRUITING
Kitaadachi-gun
Shizuoka Cancer Center ( Site 3704)
RECRUITING
Nagaizumi-cho,sunto-gun
Aichi Cancer Center ( Site 3702)
RECRUITING
Nagoya
Norway
Oslo universitetssykehus, Radiumhospitalet ( Site 4501)
RECRUITING
Oslo
Republic of Korea
Asan Medical Center-Department of Oncology ( Site 3901)
RECRUITING
Seoul
Samsung Medical Center-Division of Hematology/Oncology ( Site 3900)
RECRUITING
Seoul
Singapore
National University Hospital ( Site 3800)
RECRUITING
Singapore
Switzerland
Kantonsspital Graubünden-Medizin ( Site 4700)
RECRUITING
Chur
Hôpitaux Universitaires de Genève (HUG) ( Site 4702)
RECRUITING
Geneva
Taiwan
Chang Gung Memorial Hospital at Kaohsiung ( Site 4003)
RECRUITING
Kaohsiung Niao Sung Dist
China Medical University Hospital ( Site 4007)
RECRUITING
Taichung
Taichung Veterans General Hospital-Radiation Oncology ( Site 4008)
RECRUITING
Taichung
National Cheng Kung University Hospital ( Site 4001)
RECRUITING
Tainan City
National Taiwan University Hospital ( Site 4000)
RECRUITING
Taipei
Taipei Veterans General Hospital ( Site 4005)
RECRUITING
Taipei
Chang Gung Medical Foundation-Linkou Branch ( Site 4006)
RECRUITING
Taoyuan District
Thailand
Chulalongkorn University ( Site 4104)
RECRUITING
Bangkok
Faculty of Medicine Siriraj Hospital ( Site 4102)
RECRUITING
Bangkok
Songklanagarind hospital ( Site 4105)
RECRUITING
Hat Yai
Turkey
Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 3417)
RECRUITING
Adana
Ankara Bilkent City Hospital-Medical Oncology ( Site 3405)
RECRUITING
Ankara
Hacettepe Universite Hastaneleri-oncology hospital ( Site 3402)
COMPLETED
Ankara
Memorial Ankara Hastanesi-Medical Oncology ( Site 3408)
COMPLETED
Ankara
Atatürk Üniversitesi-onkoloji ( Site 3416)
RECRUITING
Erzurum
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 3403)
RECRUITING
Istanbul
I.E.U. Medical Point Hastanesi-Oncology ( Site 3406)
COMPLETED
Izmir
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2023-05-16
Estimated Completion Date: 2029-04-10
Participants
Target number of participants: 230
Treatments
Active_comparator: Paclitaxel or irinotecan
Participants receive paclitaxel 80-100 mg/m\^2 intravenously (IV) on Days 1, 8, and 15 every 28-day cycle until progressive disease (PD) or discontinuation, or irinotecan 180 mg/m\^2 IV on day 1 of every 14-day cycle until PD or discontinuation.
Experimental: Pembrolizumab + MK-4830 + paclitaxel or irinotecan
Participants receive pembrolizumab 200 mg IV once every 3 weeks (Q3W) for up to 35 cycles (cycle=21 days) or until PD or discontinuation + MK-4830 800 mg IV Q3W up to 35 infusions + paclitaxel 80-100 mg/m\^2 IV on Days 1, 8, and 15 every 28-day cycle until PD or discontinuation or irinotecan 180 mg/m\^2 180 mg/m\^2 on day 1 every 14-day cycle until PD or discontinuation.
Experimental: Pembrolizumab + MK-4830 + lenvatinib
Participants receive pembrolizumab 200 mg IV Q3W up to 35 cycles (cycle=21 days) until PD or discontinuation + MK-4830 800 mg IV Q3W up to 35 infusions + lenvatinib 20 mg oral administration every day until PD or discontinuation.
Experimental: Sacituzumab tirumotecan 4 mg/kg
Participants will receive 4 mg/kg of sacituzumab tirumotecan via IV infusion on Days 1, 15, and 29 of each 42-day cycle until discontinuation.
Experimental: Sacituzumab tirumotecan 5 mg/kg
Participants will receive 5 mg/kg of sacituzumab tirumotecan via IV infusion on Days 1, 15, and 29 of each 42-day cycle until discontinuation.
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC