Esophageal Cancer Clinical Trial
First-line Esophageal Carcinoma Study With Chemo vs. Chemo Plus Pembrolizumab (MK-3475-590/KEYNOTE-590)
Summary
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:
In participants with esophageal squamous cell carcinoma (ESCC), participants whose tumors are programmed cell death-ligand 1 (immunotherapy-drugs-are-boosting-survival/" >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.
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.
Eligibility Criteria
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
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There are 179 Locations for this study
West Los Angeles California, 90034, United States
Chicago Illinois, 60637, United States
Westwood Kansas, 66205, United States
Baltimore Maryland, 21201, United States
Boston Massachusetts, 02215, United States
Detroit Michigan, 48202, United States
Saint Louis Missouri, 63110, United States
Buffalo New York, 14263, United States
New York New York, 10065, United States
Cleveland Ohio, 44106, United States
Pittsburgh Pennsylvania, 15232, United States
Knoxville Tennessee, 37920, United States
Viedma Rio Negro, R8500, Argentina
Buenos Aires , C1118, Argentina
Buenos Aires , C1264, Argentina
Cordoba , X5000, Argentina
Cordoba , X5016, Argentina
Blacktown New South Wales, 2148, Australia
Liverpool New South Wales, 2170, Australia
Woolloongabba Queensland, 4102, Australia
Box Hill Victoria, 3128, Australia
Melbourne Victoria, 3000, Australia
Belo Horizonte Minas Gerais, 30110, Brazil
Recife Pernambuco, 50070, Brazil
Santa Maria Rio Grande Do Sul, 97015, Brazil
Rio de Janeiro RJ, 20231, Brazil
Passo Fundo RS, 99010, Brazil
Porto Alegre RS, 90610, Brazil
Sao Jose do Rio Preto Sao Paulo, 15090, Brazil
Sao Paulo SP, 01323, Brazil
Porto Alegre , 90035, Brazil
Sao Paulo , 01246, Brazil
Calgary Alberta, T2N 4, Canada
Edmonton Alberta, T6G 1, Canada
Winnipeg Manitoba, R3E 0, Canada
Hamilton Ontario, L8V 5, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M5G 2, Canada
Greenfield Park Quebec, J4V 2, Canada
Montreal Quebec, H3T 1, Canada
Concepcion , 40700, Chile
Santiago , 76200, Chile
Santiago , 83804, Chile
Temuco , 48102, Chile
Hefei Anhui, 23003, China
Hefei Anhui, 23008, China
Beijing Beijing, 10003, China
Xiamen Fujian, 36100, China
Guangzhou Guangdong, 51012, China
Harbin Heilongjiang, 15008, China
Wuhan Hubei, 43003, China
Changsha Hunan, 41001, China
Nanjing Jiangsu, 21000, China
Nanjing Jiangsu, 21000, China
Changchun Jilin, 13001, China
Xi'an Shannxi, 71006, China
Hangzhou Zhejiang, 31002, China
Beijing , 10014, China
Fuzhou , 35001, China
Shanghai , 20003, China
Shanghai , 20003, China
Shanghai , 20012, China
Zhengzhou , 45000, China
Medellin Antioquia, 05003, Colombia
Monteria Cordoba, 23001, Colombia
San Jose , 10103, Costa Rica
San Jose , 10103, Costa Rica
San Jose , 10108, Costa Rica
Copenhagen , 2100, Denmark
Odense , 5000, Denmark
Lyon Cedex 8, 69373, France
Brest , 29200, France
Caen , 14076, France
Lille , 59020, France
Montpellier , 34298, France
Nantes Cedex 1 , 44093, France
Paris , 75014, France
Saint Etienne , 42055, France
Dresden , 01067, Germany
Hamburg , 20249, Germany
Leipzig , 04103, Germany
Ludwigsburg , 71640, Germany
Mannheim , 68167, Germany
Moenchengladbach , 41063, Germany
Munchen , 81675, Germany
Guatemala , 01010, Guatemala
Guatemala , 01010, Guatemala
Guatemala , 01015, Guatemala
Guatemala , 01016, Guatemala
Quetzaltenango , 09001, Guatemala
Hong Kong , , Hong Kong
Hong Kong , , Hong Kong
Hong Kong , , Hong Kong
Hong Kong , , Hong Kong
Nagoya Aichi, 464-8, Japan
Kashiwa Chiba, 277-8, Japan
Matsuyama Ehime, 791-0, Japan
Sapporo Hokkaido, 060-8, Japan
Akashi Hyogo, 673-8, Japan
Kobe Hyogo, 650-0, Japan
Kasama Ibaraki, 309-1, Japan
Tsukuba Ibaraki, 305-8, Japan
Kita-gun Kagawa, 761-0, Japan
Kawasaki Kanagawa, 216-8, Japan
Yokohama Kanagawa, 241-8, Japan
Yufu Oita, 879-5, Japan
Hirakata Osaka, 573-1, Japan
Osakasayama Osaka, 589-8, Japan
Suita Osaka, 565-0, Japan
Takatsuki Osaka, 569-8, Japan
Kitaadachi-gun Saitama, 362-0, Japan
Sunto-gun Shizuoka, 411-8, Japan
Mitaka Tokyo, 181-8, Japan
Chiba , 260-8, Japan
Chiba , 260-8, Japan
Fukuoka , 811-1, Japan
Fukuoka , 812-8, Japan
Gifu , 501-1, Japan
Kumamoto , 860-8, Japan
Niigata , 951-8, Japan
Osaka , 541-8, Japan
Osaka , 558-8, Japan
Tokyo , 104-0, Japan
Tokyo , 135-8, Japan
Tokyo , 160-8, Japan
Goyang-si Gyeonggi-do, 10408, Korea, Republic of
Hwasun Gun Jeollanam Do, 58128, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Petaling Jaya Selangor, 46050, Malaysia
Kuala Lumpur , 50586, Malaysia
Kuala Lumpur , 59100, Malaysia
Arequipa , 04000, Peru
Lima , 15033, Peru
Lima , 15038, Peru
Oradea Bihor, 41046, Romania
Comuna Floresti Cluj, 40728, Romania
Craiova Dolj, 20034, Romania
Bucuresti Sector 2, 02138, Romania
Timisoara Timis, 30016, Romania
Bucuresti , 03142, Romania
Constanta , 90059, Romania
Ufa Republic Of Bashkortostan, 45005, Russian Federation
Saint-Petersburg Vsevolzhsk District, 18866, Russian Federation
Moscow , 10520, Russian Federation
Moscow , 11547, Russian Federation
Saint-Petersburg , 19775, Russian Federation
St. Petersburg , 19825, Russian Federation
Tomsk , 63402, Russian Federation
Port Elizabeth Eastern Cape, 6045, South Africa
Johannesburg Gauteng, 2196, South Africa
Parktown Gauteng, 2193, South Africa
Durban Kwa-Zulu Natal, 4091, South Africa
Cape Town Western Cape, 7570, South Africa
George Western Cape, 6530, South Africa
Alberton , 1448, South Africa
Oviedo Asturias, 33011, Spain
Badalona Barcelona, 08916, Spain
Barcelona , 08035, Spain
Cordoba , 14004, Spain
Madrid , 28034, Spain
Madrid , 28046, Spain
Malaga , 29010, Spain
Kaohsiung , 833, Taiwan
New Taipei , 235, Taiwan
Taichung , 404, Taiwan
Taichung , 43303, Taiwan
Tainan , 704, Taiwan
Tainan , 736, Taiwan
Taipei , 10002, Taiwan
Taipei , 11259, Taiwan
Taoyuan , 333, Taiwan
Bangkok , 10110, Thailand
Bangkok , 10330, Thailand
Bangkok , 10330, Thailand
Bangkok , 10400, Thailand
Songkla , 90110, Thailand
Adana , 01370, Turkey
Ankara , 06800, Turkey
Istanbul , 34093, Turkey
Istanbul , 34098, Turkey
Istanbul , 34899, Turkey
Izmir , 35575, Turkey
Malatya , 44280, Turkey
Edinburgh Mid Lothian, EH4 2, United Kingdom
Guildford , GU2 7, United Kingdom
Manchester , M20 4, United Kingdom
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