Esophageal Neoplasms Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial of Pembrolizumab (MK-3475) in Combination With Cisplatin and 5-Fluorouracil Versus Placebo in Combination With Cisplatin and 5-Fluorouracil as First-Line Treatment in Subjects With Advanced/Metastatic Esophageal Carcinoma (KEYNOTE-590)
| Verified date | April 2024 |
| Source | Merck Sharp & Dohme LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this trial is to evaluate efficacy and safety of pembrolizumab plus standard of care (SOC) chemotherapy with cisplatin and 5-fluorouracil (5-FU) versus placebo plus SOC chemotherapy with cisplatin and 5-FU as first-line treatment in participants with locally advanced or metastatic esophageal carcinoma. The overall primary efficacy hypotheses are as follows: 1. In participants with esophageal squamous cell carcinoma (ESCC), participants whose tumors are programmed cell death-ligand 1 (PD-L1)-positive (defined as combined positive score [CPS] ≥10), ESCC participants whose tumors are PD-L1 positive (CPS ≥10), and in all participants, overall survival (OS) is superior with pembrolizumab plus SOC chemotherapy compared with placebo plus SOC chemotherapy. 2. In participants with ESCC, participants whose tumors are PD-L1 positive (CPS ≥10), and in all participants, progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by investigator is superior with pembrolizumab plus SOC chemotherapy compared with placebo plus SOC chemotherapy.
| Status | Completed |
| Enrollment | 749 |
| Est. completion date | July 10, 2023 |
| Est. primary completion date | July 2, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Has histologically- or cytologically-confirmed diagnosis of locally advanced unresectable or metastatic adenocarcinoma or squamous cell carcinoma of the esophagus or advanced/metastatic Siewert type 1 adenocarcinoma of the esophagogastric junction (EGJ) - Has measurable disease per RECIST 1.1 as determined by the local site investigator/radiology assessment - Eastern Cooperative Group (ECOG) performance status of 0 to 1 - Can provide either a newly obtained or archival tissue sample for PD-L1 by immunohistochemistry analysis - Female participants of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to randomization and be willing to use an adequate method of contraception (e.g. abstinence, intrauterine device, diaphragm with spermicide, etc.) for the course of the study through 120 days after the last dose of study treatment and up to 180 days after last dose of cisplatin - Male participants of childbearing potential must agree to use an adequate method of contraception (e.g. abstinence, vasectomy, male condom, etc.) starting with the first dose of study treatment through 120 days after the last dose of study treatment and up to 180 days after last dose of cisplatin, and refrain from donating sperm during this period - Has adequate organ function Exclusion Criteria: - Has locally advanced esophageal carcinoma that is resectable or potentially curable with radiation therapy (as determined by local investigator) - Has had previous therapy for advanced/metastatic adenocarcinoma or squamous cell cancer of the esophagus or advanced/metastatic Siewert type 1 adenocarcinoma of the EGJ - Has had major surgery, open biopsy, or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of study treatment - Has a known additional malignancy that is progressing or requires active treatment. Exceptions include early-stage cancers (carcinoma in situ or Stage 1) treated with curative intent, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, in situ breast cancer that has undergone potentially curative therapy, and in situ or intramucosal pharyngeal cancer - Has known active central nervous system metastases and/or carcinomatous meningitis. - Has an active autoimmune disease that has required systemic treatment in past 2 years - Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment, or has a history of organ transplant, including allogeneic stem cell transplant - Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis, or has an active infection requiring systemic therapy - Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study medication and up to 180 days after last dose of cisplatin - Has received prior therapy with an anti-programmed cell death protein-1 (anti-PD-1), anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor or has previously participated in a pembrolizumab (MK-3475) clinical trial - Has severe hypersensitivity (= Grade 3) to any study treatment (pembrolizumab, cisplatin, or 5-FU) and/or any of its excipients - Has a known history of active tuberculosis (TB; Mycobacterium tuberculosis) or human immunodeficiency virus (HIV) infection - Has known history of or is positive for hepatitis B or hepatitis C - Has received a live vaccine within 30 days prior to the first dose of study treatment - Has had radiotherapy within 14 days of randomization. Participants who received radiotherapy >14 days prior to randomization must have completely recovered from any radiotherapy-related AEs/toxicities |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Hospital Aleman ( Site 0605) | Buenos Aires | |
| Argentina | Hospital Municipal de Gastroenterologia Dr. Bonorino Udaondo ( Site 0602) | Buenos Aires | |
| Argentina | Hospital Privado Centro Medico Cordoba ( Site 0601) | Cordoba | |
| Argentina | Sanatorio Allende - Cordoba ( Site 0604) | Cordoba | |
| Argentina | Centro de Investigaciones Clinicas - Clinica Viedma ( Site 0603) | Viedma | Rio Negro |
| Australia | Blacktown Hospital ( Site 2000) | Blacktown | New South Wales |
| Australia | Eastern Health ( Site 2002) | Box Hill | Victoria |
| Australia | Liverpool Hospital. ( Site 2001) | Liverpool | New South Wales |
| Australia | Peter MacCallum Cancer Centre ( Site 2003) | Melbourne | Victoria |
| Australia | Princess Alexandra Hospital ( Site 2005) | Woolloongabba | Queensland |
| Brazil | CETUS Hospital Dia Oncologia ( Site 0208) | Belo Horizonte | Minas Gerais |
| Brazil | Hospital Sao Vicente de Paulo ( Site 0204) | Passo Fundo | RS |
| Brazil | Hospital de Clinicas de Porto Alegre ( Site 0200) | Porto Alegre | |
| Brazil | Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0201) | Porto Alegre | RS |
| Brazil | Inst de Medicina Integral Professor Fernando Figueira- IMIP ( Site 0210) | Recife | Pernambuco |
| Brazil | Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0209) | Rio de Janeiro | RJ |
| Brazil | Clinica de Hematologia e Oncologia Viver Ltda ( Site 0211) | Santa Maria | Rio Grande Do Sul |
| Brazil | Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto. ( Site 0203) | Sao Jose do Rio Preto | Sao Paulo |
| Brazil | Hospital Alemao Oswaldo Cruz ( Site 0207) | Sao Paulo | SP |
| Brazil | Instituto do Cancer de Sao Paulo - ICESP ( Site 0206) | Sao Paulo | |
| Canada | Tom Baker Cancer Centre ( Site 0503) | Calgary | Alberta |
| Canada | Cross Cancer Institute ( Site 0502) | Edmonton | Alberta |
| Canada | CISSS de la Monteregie-Centre ( Site 0504) | Greenfield Park | Quebec |
| Canada | Juravinski Cancer Center ( Site 0508) | Hamilton | Ontario |
| Canada | Jewish General Hospital ( Site 0507) | Montreal | Quebec |
| Canada | The Ottawa Hospital - Cancer Care ( Site 0501) | Ottawa | Ontario |
| Canada | Princess Margaret Cancer Centre ( Site 0505) | Toronto | Ontario |
| Canada | CancerCare Manitoba ( Site 0500) | Winnipeg | Manitoba |
| Chile | Hospital Regional de Concepcion Dr. Guillermo Grant Benavente ( Site 1003) | Concepcion | |
| Chile | Hospital Clinico Universidad de Chile ( Site 1002) | Santiago | |
| Chile | Pontificia Universidad Catolica de Chile ( Site 1001) | Santiago | |
| Chile | Clinica Alemana de Temuco ( Site 1006) | Temuco | |
| China | Beijing Cancer Hospital ( Site 0100) | Beijing | |
| China | Peking Union Medical College Hospital ( Site 0123) | Beijing | Beijing |
| China | Jilin Cancer Hospital ( Site 0101) | Changchun | Jilin |
| China | Hunan Cancer Hospital ( Site 0105) | Changsha | Hunan |
| China | Fujian Provincial Cancer Hospital ( Site 0104) | Fuzhou | |
| China | Guangdong General Hospital ( Site 0103) | Guangzhou | Guangdong |
| China | Zhejiang Cancer Hospital ( Site 0116) | Hangzhou | Zhejiang |
| China | The Affiliated Tumour Hospital of Harbin Medical University ( Site 0102) | Harbin | Heilongjiang |
| China | Anhui Provincial Hospital ( Site 0106) | Hefei | Anhui |
| China | The First Affiliated Hospital of Anhui Medical University ( Site 0112) | Hefei | Anhui |
| China | PLA Cancer Centre of Nanjing Bayi Hospital ( Site 0110) | Nanjing | Jiangsu |
| China | Zhongda Hospital Southeast University ( Site 0125) | Nanjing | Jiangsu |
| China | Fudan University Shanghai Cancer Center ( Site 0108) | Shanghai | |
| China | Renji Hospital Shanghai Jiaotong University School of Medicine ( Site 0114) | Shanghai | |
| China | Shanghai Chest Hospital ( Site 0111) | Shanghai | |
| China | Tongji Medical College Huazhong University of Science and Technology ( Site 0109) | Wuhan | Hubei |
| China | The First Affiliated Hospital of Xi an Jiaotong University ( Site 0120) | Xi'an | Shannxi |
| China | The First Affiliated Hospital of Xiamen University ( Site 0119) | Xiamen | Fujian |
| China | Henan Cancer Hospital ( Site 0107) | Zhengzhou | |
| Colombia | Rodrigo Botero SAS ( Site 2703) | Medellin | Antioquia |
| Colombia | Oncomedica S.A. ( Site 2701) | Monteria | Cordoba |
| Costa Rica | CIMCA Centro de Investigacion y Manejo del Cancer ( Site 2600) | San Jose | |
| Costa Rica | ICIMED - Instituto de Investigacion en Ciencias Medicas ( Site 2601) | San Jose | |
| Costa Rica | Policlinico San Bosco ( Site 2602) | San Jose | |
| Denmark | Rigshospitalet ( Site 2301) | Copenhagen | |
| Denmark | Odense Universitetshospital ( Site 2300) | Odense | |
| France | CHU Brest - Institut de Cancerologie et d Hematologie ( Site 0305) | Brest | |
| France | Centre Francois Baclesse ( Site 0310) | Caen | |
| France | Centre Oscar Lambret ( Site 0304) | Lille | |
| France | Centre Leon Berard ( Site 0307) | Lyon | Cedex 8 |
| France | Institut du Cancer de Montpellier ( Site 0306) | Montpellier | |
| France | CHU de Nantes - Hotel Dieu ( Site 0303) | Nantes Cedex 1 | |
| France | Institut Mutualiste Montsouris ( Site 0300) | Paris | |
| France | CHU de Saint Etienne Hopital Nord ( Site 0309) | Saint Etienne | |
| Germany | Staedtisches Klinikum Dresden ( Site 1507) | Dresden | |
| Germany | Haematologisch-Onkologische Praxis Eppendorf Facharztzentrum Eppendorf - Hope ( Site 1502) | Hamburg | |
| Germany | Universitaetsklinikum Leipzig ( Site 1501) | Leipzig | |
| Germany | Klinikum Ludwigsburg ( Site 1509) | Ludwigsburg | |
| Germany | Universitatsklinikum Mannheim GmbH ( Site 1504) | Mannheim | |
| Germany | Klinik fuer Haematologie. Onkologie und Gastroenterologie ( Site 1508) | Moenchengladbach | |
| Germany | III. Medizinische Klinik Klinikum rechts der Isar ( Site 1506) | Munchen | |
| Guatemala | Centro de Investigacion Oncologica ( Site 1402) | Guatemala | |
| Guatemala | Grupo Medico Angeles ( Site 1401) | Guatemala | |
| Guatemala | Medi-K Cayala ( Site 1404) | Guatemala | |
| Guatemala | Oncomedica ( Site 1400) | Guatemala | |
| Guatemala | Centro Regional de Sub Especialidades Medicas SA ( Site 1403) | Quetzaltenango | |
| Hong Kong | Humanity Health Research Centre ( Site 1603) | Hong Kong | |
| Hong Kong | Pamela Youde Nethersole Eastern Hospital ( Site 1601) | Hong Kong | |
| Hong Kong | Princess Margaret Hospital. ( Site 1602) | Hong Kong | |
| Hong Kong | Queen Mary Hospital ( Site 1600) | Hong Kong | |
| Japan | Hyogo Cancer Center ( Site 0913) | Akashi | Hyogo |
| Japan | Chiba Cancer Center ( Site 0900) | Chiba | |
| Japan | Chiba University Hospital ( Site 0909) | Chiba | |
| Japan | Kyushu University Hospital ( Site 0922) | Fukuoka | |
| Japan | National Hospital Organization Kyushu Cancer Center ( Site 0906) | Fukuoka | |
| Japan | Gifu University Hospital ( Site 0920) | Gifu | |
| Japan | Kansai Medical University Hospital ( Site 0931) | Hirakata | Osaka |
| Japan | Ibaraki Prefectural Central Hospital ( Site 0918) | Kasama | Ibaraki |
| Japan | National Cancer Center Hospital East ( Site 0908) | Kashiwa | Chiba |
| Japan | St. Marianna University School of Medicine Hospital ( Site 0903) | Kawasaki | Kanagawa |
| Japan | Kagawa University Hospital ( Site 0915) | Kita-gun | Kagawa |
| Japan | Saitama Cancer Center ( Site 0926) | Kitaadachi-gun | Saitama |
| Japan | Kobe City Medical Center General Hospital ( Site 0929) | Kobe | Hyogo |
| Japan | Kumamoto University Hospital ( Site 0919) | Kumamoto | |
| Japan | National Hospital Organization Shikoku Cancer Center ( Site 0901) | Matsuyama | Ehime |
| Japan | Kyorin University Hospital ( Site 0905) | Mitaka | Tokyo |
| Japan | Aichi Cancer Center Hospital ( Site 0902) | Nagoya | Aichi |
| Japan | Niigata Cancer Center Hospital ( Site 0924) | Niigata | |
| Japan | Osaka General Medical Center ( Site 0912) | Osaka | |
| Japan | Osaka International Cancer Institute ( Site 0923) | Osaka | |
| Japan | Kindai University Hospital ( Site 0917) | Osakasayama | Osaka |
| Japan | Hokkaido University Hospital ( Site 0916) | Sapporo | Hokkaido |
| Japan | Osaka University Hospital ( Site 0911) | Suita | Osaka |
| Japan | Shizuoka Cancer Center Hospital and Research Institute ( Site 0914) | Sunto-gun | Shizuoka |
| Japan | Osaka Medical College Hospital ( Site 0925) | Takatsuki | Osaka |
| Japan | Keio University Hospital ( Site 0927) | Tokyo | |
| Japan | National Cancer Center Hospital ( Site 0907) | Tokyo | |
| Japan | The Cancer Institute Hospital of JFCR ( Site 0904) | Tokyo | |
| Japan | University of Tsukuba Hospital ( Site 0910) | Tsukuba | Ibaraki |
| Japan | Kanagawa Cancer Center ( Site 0921) | Yokohama | Kanagawa |
| Japan | Oita University Hospital ( Site 0930) | Yufu | Oita |
| Korea, Republic of | National Cancer Center ( Site 1304) | Goyang-si | Gyeonggi-do |
| Korea, Republic of | Chonnam National University Hwasun Hospital ( Site 1305) | Hwasun Gun | Jeollanam Do |
| Korea, Republic of | Asan Medical Center ( Site 1303) | Seoul | |
| Korea, Republic of | Samsung Medical Center ( Site 1300) | Seoul | |
| Korea, Republic of | Seoul National University Cancer Hospital ( Site 1301) | Seoul | |
| Korea, Republic of | Severance Hospital Yonsei University Health System ( Site 1302) | Seoul | |
| Malaysia | Hospital Kuala Lumpur ( Site 1805) | Kuala Lumpur | |
| Malaysia | University Malaya Medical Centre ( Site 1802) | Kuala Lumpur | |
| Malaysia | Beacon International Specialist Centre ( Site 1803) | Petaling Jaya | Selangor |
| Peru | Instituto Regional de Enfermedades Neoplasicas del Sur IRENSUR ( Site 1702) | Arequipa | |
| Peru | Hospital Nacional Guillermo Almenara Irigoyen ( Site 1701) | Lima | |
| Peru | Instituto Nacional de Enfermedades Neoplasicas ( Site 1705) | Lima | |
| Romania | S.C.Focus Lab Plus S.R.L ( Site 2401) | Bucuresti | Sector 2 |
| Romania | S.C.Gral Medical S.R.L ( Site 2406) | Bucuresti | |
| Romania | S.C. Radiotherapy Center Cluj S.R.L ( Site 2407) | Comuna Floresti | Cluj |
| Romania | Spitalul Clinic Judetean De Urgenta Constanta ( Site 2402) | Constanta | |
| Romania | S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2404) | Craiova | Dolj |
| Romania | S C Pelican Impex SRL ( Site 2403) | Oradea | Bihor |
| Romania | S C Oncocenter Oncologie Medicala S R L ( Site 2405) | Timisoara | Timis |
| Russian Federation | N.N. Blokhin NMRCO ( Site 0401) | Moscow | |
| Russian Federation | National Medical and Surgical Center n.a. N.I.Pirogov ( Site 0402) | Moscow | |
| Russian Federation | Leningrad Regional Oncology Center ( Site 0405) | Saint-Petersburg | Vsevolzhsk District |
| Russian Federation | Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0406) | Saint-Petersburg | |
| Russian Federation | St Petersburg City Clinical Oncology Dispensary ( Site 0409) | St. Petersburg | |
| Russian Federation | Tomsk Scientific Research Institute of Oncology ( Site 0403) | Tomsk | |
| Russian Federation | SBHCI RCOD of MHC RB ( Site 0407) | Ufa | Republic Of Bashkortostan |
| South Africa | Clinton Oncology Centre ( Site 2505) | Alberton | |
| South Africa | Cape Town Oncology Trials Pty Ltd ( Site 2508) | Cape Town | Western Cape |
| South Africa | The Oncology Centre ( Site 2502) | Durban | Kwa-Zulu Natal |
| South Africa | Outeniqua Cancercare Oncology Unit ( Site 2504) | George | Western Cape |
| South Africa | The Medical Oncology Centre of Rosebank ( Site 2506) | Johannesburg | Gauteng |
| South Africa | WITS Clinical Research CMJAH Clinical Trial Site ( Site 2500) | Parktown | Gauteng |
| South Africa | Cancer Care Langenhoven Drive Oncology Centre ( Site 2501) | Port Elizabeth | Eastern Cape |
| Spain | Hosp. Gral. Universitari Germans Trias i Pujol ( Site 0701) | Badalona | Barcelona |
| Spain | Hospital Universitari Vall d Hebron ( Site 0702) | Barcelona | |
| Spain | Hospital Universitario Reina Sofia ( Site 0706) | Cordoba | |
| Spain | Hospital Ramon y Cajal ( Site 0703) | Madrid | |
| Spain | Hospital Universitario La Paz ( Site 0700) | Madrid | |
| Spain | Complejo Hospitalario Virgen De La Victoria ( Site 0705) | Malaga | |
| Spain | Hospital Universitario Central de Asturias ( Site 0708) | Oviedo | Asturias |
| Taiwan | Chang Gung Med Foundation. Kaohsiung Branch ( Site 1906) | Kaohsiung | |
| Taiwan | Taipei Medical University Shuang Ho Hospital ( Site 1908) | New Taipei | |
| Taiwan | China Medical University Hospital ( Site 1904) | Taichung | |
| Taiwan | Kuang Tien General Hospital ( Site 1909) | Taichung | |
| Taiwan | Chi Mei Medical Center Liuying ( Site 1907) | Tainan | |
| Taiwan | National Cheng Kung University Hospital ( Site 1905) | Tainan | |
| Taiwan | Koo Foundation Sun Yat-Sen Cancer Center ( Site 1902) | Taipei | |
| Taiwan | National Taiwan University Hospital ( Site 1900) | Taipei | |
| Taiwan | Chang Gung Medical Foundation. Linkou ( Site 1903) | Taoyuan | |
| Thailand | Bumrungrad International Hospital ( Site 2203) | Bangkok | |
| Thailand | Chulalongkorn Hospital ( Site 2201) | Bangkok | |
| Thailand | Phramongkutklao Hospital ( Site 2205) | Bangkok | |
| Thailand | Ramathibodi Hospital. ( Site 2202) | Bangkok | |
| Thailand | Songklanagarind Hospital ( Site 2204) | Songkla | |
| Turkey | Adana Sehir Hastanesi ( Site 0802) | Adana | |
| Turkey | Ankara Sehir Hastanesi ( Site 0808) | Ankara | |
| Turkey | Istanbul Medeniyet Universitesi Goztepe EAH ( Site 0807) | Istanbul | |
| Turkey | Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0804) | Istanbul | |
| Turkey | Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 0801) | Istanbul | |
| Turkey | Medical Park Izmir Hastanesi ( Site 0800) | Izmir | |
| Turkey | Inonu Universitesi Turgut Ozal Tip Merkezi ( Site 0803) | Malatya | |
| United Kingdom | Lothian University Hospitals NHS Trust ( Site 1101) | Edinburgh | Mid Lothian |
| United Kingdom | St Luke's Cancer Centre ( Site 1102) | Guildford | |
| United Kingdom | The Christie NHS Foundation Trust ( Site 1100) | Manchester | |
| United States | University of Maryland Medical Center ( Site 0013) | Baltimore | Maryland |
| United States | Dana Farber Cancer Center ( Site 0009) | Boston | Massachusetts |
| United States | Roswell Park Cancer Institute ( Site 0004) | Buffalo | New York |
| United States | The University of Chicago Medical Center ( Site 0001) | Chicago | Illinois |
| United States | University Hospitals Cleveland Medical Center ( Site 0002) | Cleveland | Ohio |
| United States | Henry Ford Cancer Center ( Site 0018) | Detroit | Michigan |
| United States | University of Tennessee Medical Center Knoxville ( Site 0017) | Knoxville | Tennessee |
| United States | Weill Cornell Medical College ( Site 0024) | New York | New York |
| United States | UPMC Cancer Center/Hillman Cancer Center ( Site 0015) | Pittsburgh | Pennsylvania |
| United States | Washington University School of Medicine ( Site 0031) | Saint Louis | Missouri |
| United States | Kaiser Permanente Southern California ( Site 0003) | West Los Angeles | California |
| United States | University of Kansas ( Site 0029) | Westwood | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| Merck Sharp & Dohme LLC |
United States, Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Denmark, France, Germany, Guatemala, Hong Kong, Japan, Korea, Republic of, Malaysia, Peru, Romania, Russian Federation, South Africa, Spain, Taiwan, Thailand, Turkey, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall Survival (OS) in Participants With Esophageal Squamous Cell Carcinoma (ESCC) Whose Tumors Are Programmed Cell Death-Ligand 1 (PD-L1) Biomarker-Positive (Combined Positive Score [CPS] =10) | Overall survival was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS is reported here for all participants of the Intent-To-Treat (ITT) population (all randomized) who had ESCC and who were PD-L1 CPS =10. | Up to approximately 34 months | |
| Primary | OS in Participants With ESCC | Overall survival was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS is reported here for all participants of the ITT population (all randomized) who had ESCC. | Up to approximately 34 months | |
| Primary | OS in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS =10) | Overall survival was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS is reported here for all participants of the ITT population (all randomized) who were PD-L1 CPS =10. | Up to approximately 34 months | |
| Primary | OS in All Participants | Overall survival was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS is reported here for all participants of the ITT population (all randomized). | Up to approximately 34 months | |
| Primary | Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) As Assessed By Investigator in Participants With ESCC | PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 as assessed by the investigator, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as =20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of =5 mm. The appearance of one or more new lesions was also considered PD. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, PFS is reported here for all participants of the ITT population (all randomized) who had ESCC. | Up to approximately 34 months | |
| Primary | PFS Per RECIST 1.1 As Assessed By Investigator in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS =10) | PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 as assessed by the investigator, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as =20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of =5 mm. The appearance of one or more new lesions was also considered PD. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, PFS is reported here for all participants of the ITT population (all randomized) who were PD-L1 CPS =10. | Up to approximately 34 months | |
| Primary | PFS Per RECIST 1.1 As Assessed By Investigator in All Participants | PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 as assessed by the investigator, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as =20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of =5 mm. The appearance of one or more new lesions was also considered PD. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, PFS is reported here for all participants of the ITT population (all randomized) who were PD-L1 CPS =10. | Up to approximately 34 months | |
| Secondary | Objective Response Rate (ORR) Per RECIST 1.1 As Assessed By Investigator in All Participants | ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: =30% decrease in the sum of diameters of target lesions) per RECIST 1.1. as assessed by the investigator. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, the percentage of participants who experienced CR or PR is reported here as the ORR for all participants of the ITT population (all randomized). | Up to approximately 34 months | |
| Secondary | ORR Per RECIST 1.1 As Assessed By Investigator in Participants With ESCC Whose Tumors Are PD-L1 Biomarker-Positive (CPS =10) | ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: =30% decrease in the sum of diameters of target lesions) per RECIST 1.1. as assessed by the investigator. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, the percentage of participants who experienced CR or PR is reported here as the ORR for all participants of the ITT population (all randomized) who had ESCC and who were PD-L1 CPS =10. | Up to approximately 34 months | |
| Secondary | ORR Per RECIST 1.1 As Assessed By Investigator in Participants With ESCC | ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: =30% decrease in the sum of diameters of target lesions) per RECIST 1.1. as assessed by the investigator. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, the percentage of participants who experienced CR or PR is reported here as the ORR for all participants of the ITT population (all randomized) who had ESCC. | Up to approximately 34 months | |
| Secondary | ORR Per RECIST 1.1 As Assessed By Investigator in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS =10) | ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: =30% decrease in the sum of diameters of target lesions) per RECIST 1.1. as assessed by the investigator. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, the percentage of participants who experienced CR or PR is reported here as the ORR for all participants of the ITT population (all randomized) who were PD-L1 CPS =10. | Up to approximately 34 months | |
| Secondary | Duration of Response (DOR) Per RECIST 1.1 As Assessed By Investigator in All Participants | For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by the investigator, DOR was defined as the time from first documented evidence of confirmed CR or PR until PD or death due to any cause, whichever occurred first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of =5 mm. The appearance of one or more new lesions was also considered PD. Per protocol, DOR is reported here for all participants of the ITT population (all randomized) who had CR or PR. | Up to approximately 34 months | |
| Secondary | DOR Per RECIST 1.1 As Assessed By Investigator in Participants With ESCC Whose Tumors Are PD-L1 Biomarker-Positive (CPS =10) | For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by the investigator, DOR was defined as the time from first documented evidence of confirmed CR or PR until PD or death due to any cause, whichever occurred first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of =5 mm. The appearance of one or more new lesions was also considered PD. Per protocol, DOR is reported here for all participants of the ITT population (all randomized) who had CR or PR, and who had ESCC and were PD-L1 CPS =10. | Up to approximately 34 months | |
| Secondary | DOR Per RECIST 1.1 As Assessed By Investigator in Participants With ESCC | For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by the investigator, DOR was defined as the time from first documented evidence of confirmed CR or PR until PD or death due to any cause, whichever occurred first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of =5 mm. The appearance of one or more new lesions was also considered PD. Per protocol, DOR is reported here for all participants of the ITT population (all randomized) who had CR or PR, and who had ESCC. | Up to approximately 34 months | |
| Secondary | DOR Per RECIST 1.1 As Assessed By Investigator in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS =10) | For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by the investigator, DOR was defined as the time from first documented evidence of confirmed CR or PR until PD or death due to any cause, whichever occurred first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of =5 mm. The appearance of one or more new lesions was also considered PD. Per protocol, DOR is reported here for all participants of the ITT population (all randomized) who had CR or PR, and were PD-L1 CPS =10. | Up to approximately 34 months | |
| Secondary | Number of Participants With an Adverse Event (AE) | An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The number of participants that experienced at least one AE was reported for each treatment arm. | Up to approximately 28 months | |
| Secondary | Number of Participants Discontinuing Study Treatment Due to an AE | An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The number of participants that discontinued any study drug due to an AE was reported for each treatment arm. | Up to approximately 27 months | |
| Secondary | Change From Baseline To Week 18 in the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30) Global Health Status/Quality of Life (GHS/QoL) Combined Score in All Participants | The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the Global Health Status (GHS) question "How would you rate your overall health during the past week?" (Item 29) and the Quality of Life (QoL) question "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. Per protocol, change from baseline to Week 18 in the GHS/QoL combined score was reported by treatment arm as a pre-specified secondary analysis for all participants. | Baseline, Week 18 | |
| Secondary | Change From Baseline To Week 18 in the EORTC QLQ-C30 GHS/QoL Combined Score in Participants With ESCC Whose Tumors Are PD-L1 Biomarker-Positive (CPS =10) | The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the Global Health Status (GHS) question "How would you rate your overall health during the past week?" (Item 29) and the Quality of Life (QoL) question "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. Per protocol, change from baseline to Week 18 in the GHS/QoL combined score was reported by treatment arm as a pre-specified secondary analysis for all participants who had ESCC and who were PD-L1 CPS =10. | Baseline, Week 18 | |
| Secondary | Change From Baseline To Week 18 in the EORTC QLQ-C30 GHS/QoL Combined Score in Participants With ESCC | The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the Global Health Status (GHS) question "How would you rate your overall health during the past week?" (Item 29) and the Quality of Life (QoL) question "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. Per protocol, change from baseline to Week 18 in the GHS/QoL combined score was reported by treatment arm as a pre-specified secondary analysis for all participants who had ESCC. | Baseline, Week 18 | |
| Secondary | Change From Baseline To Week 18 in the EORTC QLQ-C30 GHS/QoL Combined Score in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS =10) | The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the Global Health Status (GHS) question "How would you rate your overall health during the past week?" (Item 29) and the Quality of Life (QoL) question "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. Per protocol, change from baseline to Week 18 in the GHS/QoL combined score was reported by treatment arm as a pre-specified secondary analysis for all participants who were PD-L1 CPS =10. | Baseline, Week 18 | |
| Secondary | Change From Baseline in the EORTC Quality Of Life Questionnaire Oesophageal Module (QLQ-OES18) Subscale Scores in All Participants | The EORTC QLQ-OES18 is a disease-specific questionnaire developed and validated to address measurements specific to esophageal cancer and contains 18 items assessing symptoms of dysphagia, pain, reflux symptoms, eating restrictions, anxiety, dry mouth, taste, body image, and hair loss. For the purposes of this study, the Dysphagia subscale (three items), Pain subscale (three items), and Reflux subscale (two items) were evaluated. All subscale items were scored using a four-point Likert scale with the following response choices: 1=not at all, 2=a little, 3=quite a bit, 4=very much. Raw scores for the subscales were standardized into a range of 0 to 100 by linear transformation, with higher symptom scores represent a higher ("worse") level of symptoms. Per protocol, change from baseline to Week 18 in the Dysphagia, Pain, and Reflux subscales was reported for all participants in each treatment arm. Negative changes from baseline indicate a decrease in symptom severity. | Baseline, Week 18 | |
| Secondary | Change From Baseline in the EORTC QLQ-OES18 Subscale Scores in Participants With ESCC Whose Tumors Are PD-L1 Biomarker-Positive (CPS =10) | The EORTC QLQ-OES18 is a disease-specific questionnaire developed and validated to address measurements specific to esophageal cancer and contains 18 items assessing symptoms of dysphagia, pain, reflux symptoms, eating restrictions, anxiety, dry mouth, taste, body image, and hair loss. For the purposes of this study, the Dysphagia subscale (three items), Pain subscale (three items), and Reflux subscale (two items) were evaluated. All subscale items were scored using a four-point Likert scale with the following response choices: 1=not at all, 2=a little, 3=quite a bit, 4=very much. Raw scores for the subscales were standardized into a range of 0 to 100 by linear transformation, with higher symptom scores representing a higher ("worse") level of symptoms. Change from baseline to Week 18 in the Dysphagia, Pain, and Reflux subscales was reported for participants with ESCC who were PD-L1 CPS=10 in each treatment arm. Negative changes from baseline indicate a decrease in symptom severity. | Baseline, Week 18 | |
| Secondary | Change From Baseline in the EORTC QLQ-OES18 Subscale Scores in Participants With ESCC | The EORTC QLQ-OES18 is a disease-specific questionnaire developed and validated to address measurements specific to esophageal cancer and contains 18 items assessing symptoms of dysphagia, pain, reflux symptoms, eating restrictions, anxiety, dry mouth, taste, body image, and hair loss. For the purposes of this study, the Dysphagia subscale (three items), Pain subscale (three items), and Reflux subscale (two items) were evaluated. All subscale items were scored using a four-point Likert scale with the following response choices: 1=not at all, 2=a little, 3=quite a bit, 4=very much. Raw scores for the subscales were standardized into a range of 0 to 100 by linear transformation, with higher symptom scores representing a higher ("worse") level of symptoms. Change from baseline to Week 18 in the Dysphagia, Pain, and Reflux subscales was reported for participants with ESCC in each treatment arm. Negative changes from baseline indicate a decrease in symptom severity. | Baseline, Week 18 | |
| Secondary | Change From Baseline in the EORTC QLQ-OES18 Subscale Scores in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS =10) | The EORTC QLQ-OES18 is a disease-specific questionnaire developed and validated to address measurements specific to esophageal cancer and contains 18 items assessing symptoms of dysphagia, pain, reflux symptoms, eating restrictions, anxiety, dry mouth, taste, body image, and hair loss. For the purposes of this study, the Dysphagia subscale (three items), Pain subscale (three items), and Reflux subscale (two items) were evaluated. All subscale items were scored using a four-point Likert scale with the following response choices: 1=not at all, 2=a little, 3=quite a bit, 4=very much. Raw scores for the subscales were standardized into a range of 0 to 100 by linear transformation, with higher symptom scores representing a higher ("worse") level of symptoms. Change from baseline to Week 18 in the Dysphagia, Pain, and Reflux subscales was reported for participants who were PD-L1 CPS=10 in each treatment arm. Negative changes from baseline indicate a decrease in symptom severity. | Baseline, Week 18 |
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