Esophageal Cancer Clinical Trial
Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Plus Chemotherapy in Participants With Metastatic Esophageal Carcinoma (MK-7902-014/E7080-G000-320/LEAP-014)
Summary
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).
Full Description
There will be 2 parts to the study: the cisplatin and 5-fluorouracil (5-FU) (FP) and paclitaxel and cisplatin (TP) Safety Run-in (Part 1) and the Main Study (Part 2). In Part 1 (FP and TP Safety Run-in), participants will be treated with pembrolizumab plus lenvatinib plus FP or TP. Dose-limiting toxicities, safety, and tolerability will be assessed.
In Part 2 (Main Study), participants (not including those participating in Part 1) will be treated with pembrolizumab plus lenvatinib plus chemotherapy or pembrolizumab plus chemotherapy. Efficacy, safety, and tolerability will be assessed.
Eligibility Criteria
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
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There are 173 Locations for this study
Duarte California, 91010, United States
Washington District of Columbia, 20010, United States More Info
Baltimore Maryland, 21224, United States More Info
East Syracuse New York, 13057, United States More Info
New York New York, 10065, United States More Info
Richmond Virginia, 23219, United States More Info
Berazategui Buenos Aires, B1884, Argentina More Info
Caba Buenos Aires, C1012, Argentina More Info
Mar del Plata Buenos Aires, B7600, Argentina More Info
La Rioja , F5300, Argentina More Info
Temuco Araucania, 48102, Chile More Info
Santiago Region M. De Santiago, 75008, Chile More Info
Santiago Region M. De Santiago, 75500, Chile More Info
Santiago Region M. De Santiago, 84203, Chile More Info
Hefei Anhui, 23003, China More Info
Xiamen Fujian, 36100, China More Info
Xiamen Fujian, 36100, China More Info
Guangzhou Guangdong, 51008, China More Info
Guangzhou Guangdong, 51051, China More Info
Changsha Hainan, 41001, China More Info
Haikou Hainan, 57010, China More Info
Chengde Hebei, 06705, China More Info
Luoyang Henan, 47100, China More Info
Xinxiang Henan, 45310, China More Info
Wuhan Hubei, 43003, China More Info
Xuzhou Jiangsu, 22100, China More Info
Jining Shandong, 27200, China More Info
Linyi Shandong, 27600, China More Info
Tianjin Tianjin, 30006, China More Info
Urumqi Xinjiang, 83000, China More Info
San Jose , 10103, Costa Rica More Info
Strasbourg Alsace, 67033, France More Info
Brest Bretagne, 29200, France More Info
Pessac Gironde, 33604, France
Saint Herblain Loire-Atlantique, 44805, France More Info
Guatemala Quetzaltenango, 09001, Guatemala More Info
Guatemala , 01010, Guatemala
Szolnok Jasz-Nagykun-Szolnok, 5000, Hungary More Info
Meldola Emilia-Romagna, 47014, Italy More Info
Udine Friuli-Venezia Giulia, 33100, Italy More Info
Catanzaro , 88100, Italy More Info
Milano , 20133, Italy More Info
Napoli , 80131, Italy More Info
Roma , 00168, Italy More Info
Matsuyama Ehime, 791-0, Japan More Info
Osaka-sayama Osaka, 589-8, Japan More Info
Takatsuki Osaka, 569-8, Japan More Info
Kyoto , 602-8, Japan More Info
Seongnam-si Kyonggi-do, 13605, Korea, Republic of More Info
Ovidiu Constanta, 90590, Romania More Info
Ufa Baskortostan, Respublika, 45005, Russian Federation
Saint-Petersburg Leningradskaya Oblast, 19429, Russian Federation
Moscow Moskva, 11547, Russian Federation
Saint Petersburg Sankt-Peterburg, 19775, Russian Federation
Saint-Petersburg Sankt-Peterburg, 19702, Russian Federation
Kazan Tatarstan, Respublika, 42002, Russian Federation
Tyumen Tyumenskaya Oblast, 62504, Russian Federation
Singapore Central Singapore, 16858, Singapore More Info
Santander Cantabria, 39008, Spain More Info
Ourense Orense, 32005, Spain More Info
Tainan City Tainan, 73657, Taiwan More Info
Ankara , 06230, Turkey
Istanbul , 34303, Turkey More Info
Istanbul , 34384, Turkey
Chernihiv Chernihivska Oblast, 14029, Ukraine
Kryviy Rih Dnipropetrovska Oblast, 50048, Ukraine
Kharkiv Kharkivska Oblast, 61000, Ukraine
Kharkiv Kharkivska Oblast, 61103, Ukraine
Antonivka Village Khersonska Oblast, 73000, Ukraine
Kyiv Kyivska Oblast, 03022, Ukraine
Vinnytsia Vinnytska Oblast, 21029, Ukraine
Lutsk Volynska Oblast, 43018, Ukraine
Cambridge Cambridgeshire, CB2 0, United Kingdom More Info
Dundee Dundee City, DD1 9, United Kingdom More Info
Nottingham England, NG5 1, United Kingdom
London London, City Of, EC1A , United Kingdom More Info
London London, City Of, NW1 2, United Kingdom More Info
London London, City Of, SW3 6, United Kingdom More Info
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