Metastatic Esophageal Squamous Cell Carcinoma Clinical Trial
Official title:
A Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) + Lenvatinib (E7080/MK-7902) + Chemotherapy Compared With Standard of Care as First-line Intervention in Participants With Metastatic Esophageal Carcinoma
The purpose of this study is to assess the efficacy and safety of pembrolizumab plus lenvatinib plus chemotherapy compared with pembrolizumab plus chemotherapy as first-line intervention in participants with metastatic esophageal carcinoma The primary hypotheses are that pembrolizumab plus lenvatinib plus chemotherapy is superior to pembrolizumab plus chemotherapy with respect to overall survival (OS) and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).
| Status | Recruiting |
| Enrollment | 862 |
| Est. completion date | December 29, 2025 |
| Est. primary completion date | December 29, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Has a histologically or cytologically confirmed diagnosis of metastatic squamous cell carcinoma of the esophagus - Male participants are abstinent from heterosexual intercourse or agree to use contraception during the intervention period and for at least 7 days after the last dose of lenvatinib or 90 days after the last dose of chemotherapy, whichever comes last; 7 days after lenvatinib is stopped, if the participant is on pembrolizumab only and is greater than 90 days post chemotherapy, no male contraception is needed - Female participant is not pregnant or breastfeeding and is not a woman of childbearing potential (WOCBP) or is a WOCBP using a contraceptive method that is highly effective or is abstinent from heterosexual intercourse as their preferred and usual lifestyle during the intervention period and for at least 120 days after the last dose of pembrolizumab, 30 days after the last dose of lenvatinib, or 180 days after the last dose of chemotherapy, whichever occurs last, and agrees not to donate eggs during this period - Has adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP=150/90 millimeters of mercury (mm Hg) with no change in antihypertensive medications within 1 week prior to randomization - Has adequate organ function Exclusion Criteria: - Has had previous therapy for locally advanced unresectable or metastatic esophageal cancer - Has locally advanced esophageal carcinoma - Has metastatic adenocarcinoma of the esophagus - Has direct invasion into adjacent organs such as the aorta or trachea - Has radiographic evidence of encasement of a major blood vessel, or of intratumoral cavitation - Has perforation risks or significant gastrointestinal (GI) bleeding - Has had clinically significant hemoptysis within 3 weeks prior to the first dose of study drug or tumor bleeding within 2 weeks prior to the first dose of study intervention - Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention - Has GI obstruction, poor oral intake, difficulty in taking oral medication, or existing esophageal stent - Has had major surgery, open biopsy, or significant traumatic injury within 3 weeks prior to first dose of study interventions - Has received prior radiotherapy within 2 weeks of start of study intervention or have had a history of radiation pneumonitis - Has received a live or live attenuated vaccine within 30 days prior to the first dose of study intervention; administration of killed vaccines is allowed - Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any form of immunosuppressive therapy within 7 days prior to the first dose of study intervention, or has a history of organ transplant, including allogeneic stem cell transplant - Has a known additional malignancy that is progressing or has required active treatment within the past 3 years - Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis - Has an active autoimmune disease that has required systemic treatment in past 2 years; replacement therapy is not considered a form of systemic treatment and is allowed - Has a history of non-infectious pneumonitis/interstitial lung disease that required steroids or current pneumonitis/interstitial lung disease - Has poorly controlled diarrhea - Has clinically significant cardiovascular disease within 12 months from first dose of study intervention - Has peripheral neuropathy =Grade 2 - Has a known history of human immunodeficiency virus (HIV) infection - Has a known history of Hepatitis B or know active Hepatitis C virus infection - Has a weight loss of >20% within the last 3 months |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0203) | Berazategui | Buenos Aires |
| Argentina | Fundacion Favaloro ( Site 0201) | Buenos Aires | |
| Argentina | Fundación Respirar ( Site 0216) | Buenos Aires | |
| Argentina | IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 0202) | Caba | Buenos Aires |
| Argentina | Hospital Italiano de Córdoba ( Site 0218) | Cordoba | |
| Argentina | Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0221) | La Rioja | |
| Argentina | Instituto de Investigaciones Clinicas Mar del Plata ( Site 0205) | Mar del Plata | Buenos Aires |
| Argentina | Fundacion Estudios Clinicos-Oncology ( Site 0215) | Rosario | Santa Fe |
| Argentina | Hospital Provincial del Centenario ( Site 0217) | Rosario | Santa Fe |
| Argentina | Sanatorio Parque ( Site 0206) | Rosario | Santa Fe |
| Argentina | Instituto San Marcos ( Site 0213) | San Juan | |
| Canada | Hotel-Dieu de Levis ( Site 0013) | Levis | Quebec |
| Canada | Princess Margaret Cancer Centre ( Site 0004) | Toronto | Ontario |
| Canada | CancerCare Manitoba ( Site 0001) | Winnipeg | Manitoba |
| Chile | Bradford Hill Centro de Investigaciones Clinicas ( Site 0404) | Santiago | Region M. De Santiago |
| Chile | Clínica San Carlos de Apoquindo Red Salud UC Christus ( Site 0407) | Santiago | Region M. De Santiago |
| Chile | Fundacion Arturo Lopez Perez FALP ( Site 0403) | Santiago | Region M. De Santiago |
| Chile | Oncovida ( Site 0413) | Santiago | Region M. De Santiago |
| Chile | Centro de Investigacion y desarrollo Oncologico SpA - CIDO SpA ( Site 0401) | Temuco | Araucania |
| Chile | James Lind Centro de Investigación del Cáncer ( Site 0412) | Temuco | Araucania |
| China | Anyang Cancer Hospital ( Site 8006) | Anyang | Henan |
| China | Beijing Cancer Hospital ( Site 8001) | Beijing | Beijing |
| China | Jilin Cancer Hospital ( Site 8016) | Changchun | Jilin |
| China | The Third Xiangya Hospital of Central South University ( Site 8046) | Changsha | Hainan |
| China | Affiliated Hospital of Chengde Medical Univeristy ( Site 8053) | Chengde | Hebei |
| China | West China Hospital of Sichuan University ( Site 8048) | Chengdu | Sichuan |
| China | Fujian Provincial Cancer Hospital ( Site 8029) | Fuzhou | Fujian |
| China | Southern Medical University Nanfang Hospital ( Site 8031) | Guangzhou | Guangdong |
| China | The First Affiliated Hospital.Sun Yat-sen University ( Site 8047) | Guangzhou | Guangdong |
| China | The First Affiliated Hospital of Hainan Medical University ( Site 8042) | Haikou | Hainan |
| China | Sir Run Run Shaw Hospital ( Site 8021) | Hangzhou | Zhejiang |
| China | Harbin Medical University Cancer Hospital ( Site 8009) | Harbin | Heilongjiang |
| China | Anhui Cancer Hospital ( Site 8058) | Hefei | Anhui |
| China | The Second Affiliated Hospital of Anhui Medical University ( Site 8026) | Hefei | Anhui |
| China | Jinan Central Hospital ( Site 8052) | Jinan | Shandong |
| China | Shandong Cancer Hospital ( Site 8060) | Jinan | Shandong |
| China | Affiliated Hospital of Jining Medical University ( Site 8017) | Jining | Shandong |
| China | Linyi Cancer Hospital- Medical Oncology Department ( Site 8051) | Linyi | Shandong |
| China | The First Affiliated Hospital of Henan University of Science &Technology-Tumor ( Site 8036) | Luoyang | Henan |
| China | Shanxi Provincial Cancer Hospital ( Site 8019) | Taiyuan | Shanxi |
| China | Tianjin Medical University Cancer Institute & Hospital ( Site 8035) | Tianjin | Tianjin |
| China | Cancer Hospital Affiliated to Xinjiang Medical University ( Site 8041) | Urumqi | Xinjiang |
| China | Hubei Cancer Hospital ( Site 8014) | Wuhan | Hubei |
| China | Tongji Medical College Huazhong Uinversity Of Science and Technology ( Site 8025) | Wuhan | Hubei |
| China | Affiliated hospital of Jiangnan university ( Site 8049) | Wuxi | Jiangsu |
| China | The First Affiliated Hospital of Xiamen University ( Site 8003) | Xiamen | Fujian |
| China | Zhongshan Hospital Affiliated to Xiamen University ( Site 8055) | Xiamen | Fujian |
| China | The First Affiliated Hospital of Xinxiang Medical University ( Site 8018) | Xinxiang | Henan |
| China | The Affiliated Hospital of Xuzhou Medical University ( Site 8015) | Xuzhou | Jiangsu |
| Costa Rica | CIMCA Centro de Investigacion y Manejo del Cancer ( Site 0902) | San Jose | |
| Costa Rica | Onco Tech S A ( Site 0901) | San Jose | |
| Costa Rica | ICIMED-Oncology Research Unit ( Site 0903) | San José | San Jose |
| Costa Rica | PROCLINICAL Pharma ( Site 0904) | San José | San Jose |
| Denmark | Rigshospitalet ( Site 2102) | Copenhagen | Hovedstaden |
| Denmark | Odense University Hospital ( Site 2101) | Odense | Syddanmark |
| France | CHU Besançon ( Site 1015) | Besançon | Franche-Comte |
| France | C.H. regional Unv. de Brest - Hopital La Cavale Blanche - Institut de Cancerologie et d Imagerie ( S | Brest | Bretagne |
| France | Centre François Baclesse ( Site 1009) | Caen | Calvados |
| France | Hopital Henri Mondor ( Site 1007) | Creteil | Val-de-Marne |
| France | Centre Georges Francois Leclerc ( Site 1008) | Dijon | Cote-d Or |
| France | Hôpital Claude Huriez ( Site 1030) | Lille | Nord |
| France | Institut du Cancer de Montpellier ( Site 1002) | Montpellier | Herault |
| France | Hopital Saint Louis ( Site 1029) | Paris | |
| France | CHU Bordeaux Haut-Leveque ( Site 1012) | Pessac | Gironde |
| France | Institut De Cancerologie De L Ouest ( Site 1003) | Saint Herblain | Loire-Atlantique |
| France | Institut de cancérologie Strasbourg Europe (ICANS) ( Site 1014) | Strasbourg | Alsace |
| France | CHRU de Tours - Hopital Bretonneau ( Site 1018) | Tours | Indre-et-Loire |
| France | Institut De Cancerologie De Lorraine ( Site 1010) | Vandoeuvre les Nancy | Ain |
| Guatemala | Centro Regional de Sub Especialidades Medicas SA ( Site 0604) | Guatemala | Quetzaltenango |
| Guatemala | Medi-K Cayala ( Site 0601) | Guatemala | |
| Guatemala | Oncomedica ( Site 0602) | Guatemala | |
| Guatemala | Soluciones Gastrointestinales S.A. ( Site 0607) | Guatemala | |
| Hong Kong | Queen Mary Hospital ( Site 4001) | Hong Kong | |
| Hong Kong | Queen Elizabeth Hospital. ( Site 4004) | Kowloon | |
| Hungary | Orszagos Onkologiai Intezet ( Site 1207) | Budapest | |
| Hungary | Petz Aladar Egyetemi Oktato Korhaz ( Site 1210) | Gyor | Gyor-Moson-Sopron |
| Hungary | Pecsi Tudomanyegyetem AOK ( Site 1204) | Pecs | Baranya |
| Hungary | Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 1203) | Szolnok | Jasz-Nagykun-Szolnok |
| Italy | Azienda Ospedaliera Mater Domini-Translational Oncology Unit ( Site 1314) | Catanzaro | |
| Italy | Azienda Ospedaliero Universitaria Careggi ( Site 1301) | Firenze | |
| Italy | Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-Oncologia Medica ( Site 1313) | Meldola | Emilia-Romagna |
| Italy | Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1306) | Milano | |
| Italy | IRCCS Ospedale San Raffaele di Milano ( Site 1304) | Milano | Lombardia |
| Italy | A.O. Universitaria di Modena ( Site 1307) | Modena | |
| Italy | A.O.U. Universita degli Studi della Campania-Luigi Vanvitelli ( Site 1305) | Napoli | |
| Italy | Istituto Oncologico Veneto IRCCS-Oncologia Medica 1 ( Site 1311) | Padova | Veneto |
| Italy | Azienda Ospedaliera Universitaria Pisana ( Site 1312) | Pisa | Toscana |
| Italy | Universita Cattolica del Sacro Cuore - Policlinico Gemelli ( Site 1310) | Roma | |
| Italy | Humanitas Research Hospital ( Site 1309) | Rozzano | Lombardia |
| Italy | A.O.U. Santa Maria della Misericordia di Udine ( Site 1302) | Udine | Friuli-Venezia Giulia |
| Japan | Hyogo Cancer Center ( Site 9014) | Akashi | Hyogo |
| Japan | Tokyo Metropolitan Komagome Hospital ( Site 9028) | Bunkyo ku | Tokyo |
| Japan | Chiba cancer center ( Site 9023) | Chiba-shi | Chiba |
| Japan | National Hospital Organization Kyushu Cancer Center ( Site 9010) | Fukuoka | |
| Japan | Ibaraki Prefectural Central Hospital ( Site 9007) | Kasama | Ibaraki |
| Japan | National Cancer Center Hospital East ( Site 9002) | Kashiwa | Chiba |
| Japan | Kagawa University Hospital ( Site 9015) | Kita | Kagawa |
| Japan | Saitama Prefectural Cancer Center ( Site 9003) | Kitaadachi-gun | Saitama |
| Japan | Kyoto University Hospital ( Site 9011) | Kyoto | |
| Japan | University Hospital,Kyoto Prefectural University of Medicine ( Site 9027) | Kyoto | |
| Japan | National Hospital Organization Shikoku Cancer Center ( Site 9019) | Matsuyama | Ehime |
| Japan | Toranomon Hospital ( Site 9026) | Minato-ku | Tokyo |
| Japan | Shizuoka Cancer Center ( Site 9016) | Nagaizumi | Shizuoka |
| Japan | Aichi Cancer Center Hospital ( Site 9006) | Nagoya | Aichi |
| Japan | Niigata Cancer Center Hospital ( Site 9022) | Niigata-shi | Niigata |
| Japan | Okayama University Hospital ( Site 9024) | Okayama | |
| Japan | Osaka General Medical Center ( Site 9018) | Osaka | |
| Japan | Osaka International Cancer Institute ( Site 9009) | Osaka | |
| Japan | Kindai University Hospital- Osakasayama Campus ( Site 9017) | Osaka-sayama | Osaka |
| Japan | Tohoku University Hospital ( Site 9013) | Sendai-shi | Miyagi |
| Japan | Showa University Hospital ( Site 9025) | Shinagawa | Tokyo |
| Japan | Osaka University Hospital ( Site 9021) | Suita | Osaka |
| Japan | Osaka Medical and Pharmaceutical University Hospital ( Site 9008) | Takatsuki | Osaka |
| Japan | Keio university hospital ( Site 9020) | Tokyo | |
| Japan | National Cancer Center Hospital ( Site 9001) | Tokyo | |
| Japan | The Cancer Institute Hospital of JFCR ( Site 9005) | Tokyo | |
| Japan | Kanagawa Cancer Center ( Site 9004) | Yokohama | Kanagawa |
| Korea, Republic of | Seoul National University Bundang Hospital ( Site 5006) | Seongnam-si | Kyonggi-do |
| Korea, Republic of | Korea University Guro Hospital ( Site 5001) | Seoul | |
| Korea, Republic of | Samsung Medical Center ( Site 5005) | Seoul | |
| Korea, Republic of | Severance Hospital ( Site 5003) | Seoul | |
| Korea, Republic of | Asan Medical Center ( Site 5002) | Songpagu | Seoul |
| Malaysia | Hospital Kuala Lumpur ( Site 9104) | Kuala Lumpur | |
| Malaysia | Sarawak General Hospital-Radiotherapy Unit ( Site 9100) | Kuching | Sarawak |
| Malaysia | University Malaya Medical Centre ( Site 9101) | Lembah Pantai | Kuala Lumpur |
| Romania | S.C.Focus Lab Plus S.R.L ( Site 2201) | Bucuresti | |
| Romania | Cardiomed SRL Cluj-Napoca-Medical Oncology ( Site 2207) | Cluj-Napoca | Cluj |
| Romania | SC Radiotherapy Center Cluj SRL ( Site 2202) | Comuna Floresti | Cluj |
| Romania | S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2204) | Craiova | Dolj |
| Romania | Ovidius Clinical Hospital OCH-Oncology and Hematology ( Site 2203) | Ovidiu | Constanta |
| Romania | Policlinica Oncomed SRL ( Site 2206) | Timisoara | Timis |
| Russian Federation | Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1509) | Kazan | Tatarstan, Respublika |
| Russian Federation | FSBI National Medical Oncology Research Center n.a. N.N. Blokhina ( Site 1510) | Moscow | Moskva |
| Russian Federation | Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1503) | Saint Petersburg | Sankt-Peterburg |
| Russian Federation | Academician I.P. Pavlov First St. Petersburg State Medical University ( Site 1519) | Saint-Petersburg | Sankt-Peterburg |
| Russian Federation | GBUZ LOKB ( Site 1502) | Saint-Petersburg | Leningradskaya Oblast |
| Russian Federation | SAIH of Tyumen reg "Multifield clinical medical center "Medical city" ( Site 1520) | Tyumen | Tyumenskaya Oblast |
| Russian Federation | Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1507) | Ufa | Baskortostan, Respublika |
| Singapore | National Cancer Centre Singapore ( Site 9201) | Singapore | Central Singapore |
| South Africa | The Oncology Centre ( Site 9505) | Durban | Kwazulu-Natal |
| Spain | Hospital General Universitari Vall d Hebron ( Site 1607) | Barcelona | |
| Spain | Hospital General Universitario Gregorio Maranon ( Site 1604) | Madrid | |
| Spain | Complexo Hospitalario Universitario de Ourense-MEDICAL ONCOLOGY ( Site 1609) | Ourense | Orense |
| Spain | Hospital Universitario General de Asturias ( Site 1601) | Oviedo | Asturias |
| Spain | Hospital Universitario Marques de Valdecilla ( Site 1602) | Santander | Cantabria |
| Spain | Hospital Virgen del Rocio ( Site 1606) | Sevilla | |
| Taiwan | Chang Gung Med Foundation. Kaohsiung Branch ( Site 6005) | Kaohsiung | |
| Taiwan | China Medical University Hospital ( Site 6003) | Taichung | |
| Taiwan | National Cheng Kung University Hospital ( Site 6004) | Tainan | |
| Taiwan | Chi Mei Hospital - Liouying Branch-Clinical Trial Center ( Site 6007) | Tainan City | Tainan |
| Taiwan | National Taiwan University Hospital ( Site 6001) | Taipei | |
| Taiwan | Taipei Veterans General Hospital ( Site 6006) | Taipei | |
| Thailand | Faculty of Medicine Siriraj Hospital ( Site 7002) | Bangkok | Krung Thep Maha Nakhon |
| Thailand | Songklanagarind hospital ( Site 7001) | Hatyai | Songkhla |
| Turkey | Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 1714) | Adana | |
| Turkey | Ankara Bilkent Sehir Hastanesi-Medical Oncology ( Site 1715) | Ankara | |
| Turkey | Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1701) | Ankara | |
| Turkey | Memorial Ankara Hastanesi ( Site 1702) | Ankara | |
| Turkey | Atatürk Üniversitesi-onkoloji ( Site 1712) | Erzurum | |
| Turkey | Acibadem Universitesi Atakent Hastanesi-Medical Oncology ( Site 1716) | Istanbul | |
| Turkey | Istanbul Okmeydani Egitim ve Arastirma Hastanesi ( Site 1711) | Istanbul | |
| Turkey | Medeniyet Universitesi Tip Fakultesi ( Site 1703) | Istanbul | |
| Ukraine | Communal nonprofit enterprise "Kherson Regional Oncology Dispensary" of Kherson Regional Council ( | Antonivka Village | Khersonska Oblast |
| Ukraine | Chernihiv Medical Center of Modern Oncology ( Site 1811) | Chernihiv | Chernihivska Oblast |
| Ukraine | Institute of General and Emergency Surgery n.a Zaitsev NAMS of Ukraine ( Site 1813) | Kharkiv | Kharkivska Oblast |
| Ukraine | Kharkiv Regional Clinical Oncology Center ( Site 1812) | Kharkiv | Kharkivska Oblast |
| Ukraine | MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council ( Site 1804) | Kryviy Rih | Dnipropetrovska Oblast |
| Ukraine | SNPE National Cancer Institute ( Site 1806) | Kyiv | Kyivska Oblast |
| Ukraine | Volyn Regional Oncological Dispensary ( Site 1816) | Lutsk | Volynska Oblast |
| Ukraine | Podillya Regional Center of Oncology ( Site 1809) | Vinnytsia | Vinnytska Oblast |
| United Kingdom | Cambridge University Hospitals NHSFT ( Site 1908) | Cambridge | Cambridgeshire |
| United Kingdom | Ninewells Hospital and Medical School ( Site 1907) | Dundee | Dundee City |
| United Kingdom | Western General Hospital ( Site 1912) | Edinburgh | Midlothian |
| United Kingdom | Royal Marsden NHS Foundation Trust ( Site 1905) | London | London, City Of |
| United Kingdom | St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1915) | London | London, City Of |
| United Kingdom | University College London Hospitals NHS Foundation Trust ( Site 1901) | London | London, City Of |
| United Kingdom | The Christie NHS Foundation Trust ( Site 1909) | Manchester | |
| United Kingdom | Nottingham University Hospital NHS Trust ( Site 1910) | Nottingham | England |
| United Kingdom | Royal Marsden NHS Trust. ( Site 1906) | Sutton | London, City Of |
| United States | Johns Hopkins Bayview Medical Center ( Site 0152) | Baltimore | Maryland |
| United States | St. Luke's University Health Network ( Site 0185) | Bethlehem | Pennsylvania |
| United States | Medical University of South Carolina-Hollings Cancer Center ( Site 0177) | Charleston | South Carolina |
| United States | City of Hope ( Site 0102) | Duarte | California |
| United States | Hematology-Oncology Associates of CNY ( Site 0173) | East Syracuse | New York |
| United States | James Graham Brown Cancer Center ( Site 0117) | Louisville | Kentucky |
| United States | Norton Cancer Institute ( Site 0116) | Louisville | Kentucky |
| United States | Memorial Sloan Kettering Cancer Center ( Site 0132) | New York | New York |
| United States | Weill Cornell Medical College ( Site 0133) | New York | New York |
| United States | Capital Health Medical Center - Hopewell ( Site 0189) | Pennington | New Jersey |
| United States | AHN Allegheny General Hospital ( Site 0164) | Pittsburgh | Pennsylvania |
| United States | VCU Health Adult Outpatient Pavillion ( Site 0160) | Richmond | Virginia |
| United States | Seattle Cancer Care Alliance ( Site 0145) | Seattle | Washington |
| United States | MedStar Washington Hospital Center ( Site 0186) | Washington | District of Columbia |
| United States | UMASS Memorial Medical Center ( Site 0120) | Worcester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Merck Sharp & Dohme LLC | Eisai Inc. |
United States, Argentina, Canada, Chile, China, Costa Rica, Denmark, France, Guatemala, Hong Kong, Hungary, Italy, Japan, Korea, Republic of, Malaysia, Romania, Russian Federation, Singapore, South Africa, Spain, Taiwan, Thailand, Turkey, Ukraine, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Part 1 (FP and TP Safety Run-in): Number of Participants With Dose Limiting Toxicities (DLTs) | Hematologic DLTs are defined as Grade 4 neutropenia lasting for =7 days, Grade 3 or Grade 4 febrile neutropenia, Grade 3 thrombocytopenia with bleeding, Grade 4 thrombocytopenia, or Grade 4 anemia. Other nonhematologic toxicities considered a DLT include any other Grade 4 or Grade 5 toxicity, Grade 3 toxicities lasting >3 days (excluding nausea, vomiting, and diarrhea controlled by medical intervention within 72 hours, and Grade 3 rash in the absence of desquamation with no mucosal involvement), Grade 3 hypertension not able to be controlled by medication, =Grade 3 gastrointestinal perforation, =Grade 3 wound dehiscence requiring medical or surgical intervention, any grade thromboembolic event or any Grade 3 nonhematologic laboratory value requiring medical intervention or hospitalization. The number of participants in Part 1 with DLTs will be presented. | Up to ~21 days | |
| Primary | Part 1 (FP and TP Safety Run-in): Number of Participants With Adverse Events (AEs) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants in Part 1 with AEs will be presented. | Up to ~51 months | |
| Primary | Part 1 (FP and TP Safety Run-in): Number of Participants who Discontinued Study Treatment Due to an AE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants in Part 1 who discontinue study treatment due to an AE will be presented. | Up to ~51 months | |
| Primary | Part 2 (Main Study): Overall Survival (OS) in all Participants | OS is defined as the time from randomization to death due to any cause. OS in Part 2 for all randomized participants will be presented. | Up to ~49 months | |
| Primary | Part 2 (Main Study): Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in all Participants | PFS is defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as =20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of =5 mm. The appearance of one or more new lesions is also considered PD. RECIST 1.1 has been adjusted to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. PFS in Part 2 for all randomized participants will be presented. | Up to ~41 months | |
| Secondary | Part 2 (Main Study): Objective Response Rate (ORR) per RECIST 1.1 as Assessed by BICR in all Participants | ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions), per RECIST 1.1 adjusted to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, as assessed by BICR. ORR in Part 2 for all randomized participants will be presented. | Up to ~34 months | |
| Secondary | Part 2 (Main Study): Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR in all Participants | For participants who demonstrate 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 by BICR, DOR is defined as the time from first documented evidence of CR or PR until PD or death. Per RECIST 1.1, PD is 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 must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. RECIST 1.1 has been adjusted to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. DOR in Part 2 for all randomized participants will be presented. | Up to ~34 months | |
| Secondary | Part 2 (Main Study): OS in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) =10 | OS is defined as the time from randomization to death due to any cause. OS in Part 2 for randomized participants with PD-L1 CPS =10 will be presented. | Up to ~49 months | |
| Secondary | Part 2 (Main Study): PFS per RECIST 1.1 as Assessed by BICR in Participants With PD-L1 CPS =10 | PFS is defined as the time from randomization to the first documented PD per RECIST 1.1 by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as =20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of =5 mm. The appearance of one or more new lesions is also considered PD. RECIST 1.1 has been adjusted to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. PFS in Part 2 for randomized participants with PD-L1 CPS =10 will be presented. | Up to ~41 months | |
| Secondary | Part 2 (Main Study): ORR per RECIST 1.1 as Assessed by BICR in Participants With PD-L1 CPS =10 | ORR is defined as the percentage of participants with 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 adjusted to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, as assessed by BICR. ORR in Part 2 for randomized participants with PD-L1 CPS =10 will be presented. | Up to ~34 months | |
| Secondary | Part 2 (Main Study): DOR per RECIST 1.1 as Assessed by BICR in Participants With PD-L1 CPS =10 | For participants who demonstrate 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 by BICR, DOR is defined as the time from first documented evidence of CR or PR until PD or death. Per RECIST 1.1, PD is 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 must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. RECIST 1.1 has been adjusted to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. DOR in Part 2 for randomized participants with PD-L1 CPS =10 will be presented. | Up to ~34 months | |
| Secondary | Part 2 (Main Study): Number of Participants With AEs | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants in Part 2 with AEs will be presented. | Up to ~49 months | |
| Secondary | Part 2 (Main Study): Number of Participants who Discontinued Study Treatment Due to an AE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants in Part 2 who discontinue study treatment due to an AE will be presented. | Up to ~49 months | |
| Secondary | Part 2 (Main Study): Change From Baseline in Health-related Quality of life (HRQoL) Score Using European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) | The EORTC QLQ-C30 is a questionnaire to assess the overall HRQoL. Participant responses to the question " How would you rate your overall quality of life (QoL) during the past week?" are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall QoL. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in HRQoL EORTC QLQ-C30 score in participants in Part 2 will be presented. | Baseline and ~24 months | |
| Secondary | Part 2 (Main Study): Change From Baseline in HRQoL Score Using EORTC Quality of Life Questionnaire-Oesophageal Module (QLQ-OES18) | The EORTC QLQ-OES18 is a disease-specific questionnaire to assess measurements specific to esophageal cancer. It contains 18 items and is based on four subscales-dysphagia, eating, reflux and pain. All items are scored using a four-point scale that offers these response choices: 1=not at all, 2=a little, 3=quite a bit, 4=very much. A higher score indicates worse level of symptoms. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in HRQoL QLQ-OES18 score in participants in Part 2 will be presented. | Baseline and ~24 months | |
| Secondary | Part 2 (Main Study): Time to Deterioration (TTD) in HRQoL Score Using EORTC QLQ-C30 | TTD is defined as the time from baseline to the first onset of a =10-point change from baseline in the HRQoL EORTC QLQ-C30 score. The EORTC QLQ-C30 is a questionnaire to assess the overall HRQoL. Participant responses to the question " How would you rate your overall QoL during the past week?" are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall QoL. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A longer TTD indicates a better outcome. The TTD in HRQoL EORTC QLQ-C30 score in participants in Part 2 will be presented. | Up to ~ 24 months | |
| Secondary | Part 2 (Main Study): TTD in HRQoL Score Using EORTC QLQ-OES18 | TTD is defined as the time from baseline to the first onset of a =10-point change from baseline in the HRQoL EORTC QLQ-OES18 score. The EORTC QLQ-OES18 is a disease-specific questionnaire to assess measurements specific to esophageal cancer. It contains 18 items and is based on four subscales-dysphagia, eating, reflux and pain. All items are scored using a four-point scale that offers these response choices: 1=not at all, 2=a little, 3=quite a bit, 4=very much. A higher score indicates worse level of symptoms. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A longer TTD indicates a better outcome. The TTD in HRQoL QLQ-OES18 score in participants in Part 2 will be presented. | Up to ~ 24 months |
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