Esophageal Cancer Clinical Trial
Study of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Who Are Receiving Chemotherapy and Radiation Therapy (MK-3475-975/KEYNOTE-975)
Summary
The purpose of this study is to assess the efficacy and safety of treatment with definitive chemoradiotherapy (dCRT) + pembrolizumab (MK-3475) compared to treatment with dCRT + placebo with respect to Overall Survival (OS) and Event-free Survival (EFS) in:
participants with esophageal squamous cell carcinoma (ESCC),
participants whose tumors express Programmed Death-Ligand 1 (immunotherapy-drugs-are-boosting-survival/" >PD-L1) Combined Positive Score (CPS) ≥10, and
all participants.
The primary study hypotheses are that dCRT+ pembrolizumab is better than dCRT + placebo with respect to:
OS in participants with ESCC,
OS in participants whose tumors express PD-L1 CPS ≥10,
OS in all participants,
EFS in participants with ESCC,
EFS in participants whose tumors express PD-L1 CPS ≥10, and
EFS in all participants.
Full Description
Participants receive pembrolizumab or placebo PLUS one of two chemotherapy regimens PLUS radiation therapy for up to approximately one year. The chemotherapy regimens are either:
FP (5-fluorouracil [5-FU] + cisplatin) or
FOLFOX (5-FU + oxaliplatin + leucovorin or levoleucovorin).
Eligibility Criteria
Inclusion Criteria:
Has histologically or cytologically confirmed diagnosis of CTX N+ M0 or cT2-T4a NX M0 ESCC, GEJC, EAC, or histologically or cytologically confirmed diagnosis of cTX N+ M1 cervical or upper thoracic esophageal carcinoma with supraclavicular lymph node metastases only
Is deemed suitable for dCRT
Is ineligible for curative surgery based on the documented opinion of a qualified medical/surgical/radiation oncologist.
Is not expected to require tumor resection during the course of the study
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 3 days of the first dose of study treatment.
Has adequate organ function.
Male participants must use adequate contraception (a male condom plus partner use of an additional contraceptive method) unless confirmed to be azoospermic (vasectomized or secondary to medical cause) and refrain from donating sperm during the study treatment period and through 90 days after the last dose of chemotherapy.
Female participants who are a Woman of Childbearing Potential (WOCBP) must use contraception that is highly effective (with a failure rate of <1% per year), with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle, during the study treatment period through 180 days after the last dose of chemotherapy or 120 days after the last dose of pembrolizumab, whichever is greater, and agree not to donate eggs to others or freeze/store for her own use for the purpose of reproduction during this period
Female participants must not be pregnant or breastfeeding
Exclusion Criteria:
Has direct invasion of tumor into adjacent organs such as the aorta or trachea or has radiographic evidence of >90 degree encasement or invasion of a major blood vessel, or of intratumoral cavitation.
Has had major surgery other than for insertion of a feeding tube, open biopsy, or significant traumatic injury within 28 days prior to randomization, or anticipates the need for major surgery during study treatment; participants with gastric or esophageal fistulae are excluded
Has had weight loss of >20% in the previous 3 months
Has had prior chemotherapy or radiotherapy for esophageal cancer
Has had a myocardial infarction within the past 6 months
Has symptomatic congestive heart failure
Has received prior therapy with an anti-programmed cell death-1 (anti PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti-programmed cell death-ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX-40, CD137)
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 received any prior systemic anticancer therapy for esophageal cancer including investigational agents
Has not recovered from all adverse events (AEs) due to previous non-anticancer therapies to ≤Grade 1 or Baseline
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment
Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded from the study. Participants with localized prostate cancer that has undergone potentially curative treatment can be enrolled in the study.
Has severe hypersensitivity (≥Grade 3) to pembrolizumab, any of the study chemotherapy agents, or their excipients
Has an active autoimmune disease that has required systemic treatment in past 2 years
Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
Has an active infection requiring systemic therapy
Has a known history of human immunodeficiency virus (HIV) infection
Has a known history of Hepatitis B or known active Hepatitis C virus infection
Has a known history of active tuberculosis (TB; Bacillus tuberculosis)
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 treatment (180 days for participants receiving cisplatin who are breastfeeding)
Has had an allogenic tissue/solid organ transplant
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There are 162 Locations for this study
Long Beach California, 90806, United States
Columbus Georgia, 31904, United States
Westwood Kansas, 66205, United States
Wichita Kansas, 67214, United States
New Orleans Louisiana, 70112, United States
Baltimore Maryland, 21204, United States
Boston Massachusetts, 02215, United States
Detroit Michigan, 48202, United States
Columbia Missouri, 65212, United States
Reno Nevada, 89502, United States
New Brunswick New Jersey, 08903, United States
New York New York, 10065, United States
Oklahoma City Oklahoma, 73104, United States
Portland Oregon, 97239, United States
Pittsburgh Pennsylvania, 15212, United States
Knoxville Tennessee, 37916, United States
Salt Lake City Utah, 84106, United States
Spokane Valley Washington, 99216, United States
Madison Wisconsin, 53792, United States
Buenos Aires Caba, C1426, Argentina
Ciudad de Buenos Aires Caba, C1093, Argentina
Buenos Aires , C1264, Argentina
Buenos Aires , C1431, Argentina
Brussels Bruxelles-Capitale, Region De, 1200, Belgium
Gent Oost-Vlaanderen, 9000, Belgium
Leuven Vlaams-Brabant, 3000, Belgium
Roeselare West-Vlaanderen, 8800, Belgium
Ijui Rio Grande Do Sul, 98700, Brazil
Porto Alegre Rio Grande Do Sul, 91350, Brazil
Blumenau Santa Catarina, 89010, Brazil
Sao Paulo , 01246, Brazil
Edmonton Alberta, T6G 1, Canada
Winnipeg Manitoba, R3E 0, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H2X 0, Canada
Temuco Araucania, 48008, Chile
Temuco Araucania, 48102, Chile
Concepcion Biobio, 40700, Chile
Santiago Region M. De Santiago, 83300, Chile
Hefei Anhui, 23007, China
Fuzhou Fujian, 35002, China
Xiamen Fujian, 36100, China
Wuhan Hubei, 43007, China
Changsha Hunan, 41000, China
Huai An Jiangsu, 22300, China
Nanjing Jiangsu, 21000, China
Xuzhou Jiangsu, 22100, China
Zhenjiang Jiangsu, 21200, China
Nanchang Jiangxi, 33002, China
Shangai Shanghai, 20003, China
Shanghai Shanghai, 20003, China
Shanghai Shanghai, 20003, China
Chengdu Sichuan, 61004, China
Tianjin Tianjin, 30006, China
Hangzhou Zhejiang, 31000, China
Hangzhou Zhejiang, 31001, China
Hangzhou Zhejiang, 31002, China
Brno Brno-mesto, 656 5, Czechia
Ostrava Moravskoslezsky Kraj, 708 5, Czechia
Olomouc Olomoucky Kraj, 779 0, Czechia
Praha Praha 5, 150 0, Czechia
Copenhagen Hovedstaden, 2100, Denmark
Odense Syddanmark, 5000, Denmark
Tallinn Harjumaa, 13419, Estonia
Tartu Tartumaa, 50406, Estonia
Vandoeuvre les Nancy Ain, 54519, France
Caen Calvados, 14075, France
Dijon Cote-d Or, 21079, France
Limoges Haute-Vienne, 87042, France
Saint-Cloud Hauts-de-Seine, 92210, France
Reims Marne, 51726, France
Nantes Pays-de-la-Loire, 44093, France
Avignon Provence-Alpes-Cote-d Azur, 84918, France
Amiens Somme, 80054, France
La Roche sur Yon Vendee, 85925, France
Stuttgart Baden-Wurttemberg, 70199, Germany
Koeln Nordrhein-Westfalen, 50937, Germany
Muenster Nordrhein-Westfalen, 48149, Germany
Mainz Rheinland-Pfalz, 55131, Germany
Berlin , 13353, Germany
Hamburg , 20249, Germany
Guatemala , 01010, Guatemala
Guatemala , 01010, Guatemala
Guatemala , 01010, Guatemala
Guatemala , 01015, Guatemala
Guatemala , 01016, Guatemala
Quetzaltenango , 09002, Guatemala
Hong Kong , , Hong Kong
Hong Kong , , Hong Kong
Pokfulam , , Hong Kong
Pecs Baranya, 7624, Hungary
Gyula Bekes, 5700, Hungary
Budapest , 1122, Hungary
Debrecen , 4032, Hungary
Pavia Lombardia, 27100, Italy
San Donato Milanese Milano, 20097, Italy
Pisa Toscana, 56126, Italy
Bergamo , 24127, Italy
Cremona , 26100, Italy
Milano , 20133, Italy
Napoli , 80131, Italy
Padova , 35128, Italy
Roma , 00168, Italy
Nagoya Aichi, 464-8, Japan
Kashiwa Chiba, 27785, Japan
Yokohama Kanagawa, 241-8, Japan
Kitaadachi-gun Saitama, 362-0, Japan
Sunto-gun Shizuoka, 411-8, Japan
Tokyo , 104-0, Japan
Hwasun Gun Jeonranamdo, 58128, Korea, Republic of
Goyang-si Kyonggi-do, 10408, Korea, Republic of
Songpagu Seoul, 05505, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 08308, Korea, Republic of
Cuauhtémoc, Ciudad De México Distrito Federal, 06100, Mexico
Toluca de Lerdo , 50120, Mexico
Lima Muni Metro De Lima, Lima , Peru
Surquillo Muni Metro De Lima, 15038, Peru
Lima , 15082, Peru
Lima , 15087, Peru
Baguio City Benguet, 2600, Philippines
Cebu City Cebu, 6000, Philippines
Iloilo City Iloilo, 5000, Philippines
Quezon National Capital Region, 1102, Philippines
Loures Lisboa, 2674-, Portugal
Lisboa , 1099-, Portugal
Lisboa , 1500 , Portugal
Lisboa , 1649-, Portugal
Porto , 4200-, Portugal
București Bucuresti, 02234, Romania
Cluj-Napoca Cluj, 40001, Romania
Cluj-Napoca Cluj, 40728, Romania
Ovidiu Constanta, 90590, Romania
Craiova Dolj, 20054, Romania
Targu-Mures Mures, 54015, Romania
Bucuresti , 02254, Romania
Ufa Baskortostan, Respublika, 45005, Russian Federation
Kaluga Kaluzskaja Oblast, 24800, Russian Federation
Moscow Moskva, 10522, Russian Federation
Moscow Moskva, 12536, Russian Federation
Samara Samarskaya Oblast, 44303, Russian Federation
St. Petersburg Sankt-Peterburg, 19702, Russian Federation
St. Petersburg Sankt-Peterburg, 19775, Russian Federation
Ekaterinburg Sverdlovskaya Oblast, 62003, Russian Federation
Kazan Tatarstan, Respublika, 42002, Russian Federation
Kaohsiung , 833, Taiwan
Taichung , 40447, Taiwan
Taichung , 407, Taiwan
Tainan , 70457, Taiwan
Taipei , 10002, Taiwan
Taipei , 11259, Taiwan
Taoyuan , 33305, Taiwan
Istambul Istanbul, 34098, Turkey
Ankara , 06520, Turkey
Istanbul , 34722, Turkey
Izmir , 35040, Turkey
Izmir , 35360, Turkey
Aberdeen Aberdeen City, AB25 , United Kingdom
Cambridge Cambridgeshire, CB2 0, United Kingdom
London England, NW32Q, United Kingdom
London London, City Of, SW3 6, United Kingdom
London London, City Of, W12 O, United Kingdom
Nottingham Nottinghamshire, NG5 1, United Kingdom
Sutton Surrey, SM2 5, United Kingdom
London Worcestershire, NW1 2, United Kingdom
Manchester , M20 4, United Kingdom
Northwood , HA6 2, United Kingdom
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