Bladder Cancer Clinical Trial

Perioperative Pembrolizumab (MK-3475) Plus Neoadjuvant Chemotherapy Versus Perioperative Placebo Plus Neoadjuvant Chemotherapy for Cisplatin-eligible Muscle-invasive Bladder Cancer (MIBC) (MK-3475-866/KEYNOTE-866)

Summary

A global study to evaluate peri-operative pembrolizumab with chemotherapy versus placebo to pembrolizumab plus chemotherapy in cisplatin eligible patients.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Have a histologically confirmed diagnosis of urothelial carcinoma (UC) / muscle invasive bladder cancer (MIBC) (T2-T4aN0M0 or T1-T4aN1M0) with predominant (≥50%) urothelial histology.
Have clinically non-metastatic bladder cancer (N≤1 M0) determined by imaging (computed tomography (CT) or magnetic resonance imaging (MRI) of the chest/abdomen/pelvis
Be deemed eligible for Radical Cystectomy (RC) + Pelvic Lymph Node Dissection (PLND)
Have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Have adequate organ function.
Male and female participants are eligible to participate if they agree to the contraception use as per study protocol.

Exclusion Criteria:

Has a known additional malignancy that is progressing or has required active anti-cancer treatment ≤3 years of study randomization with certain exceptions
Has received any prior systemic treatment for MIBC or non-invasive muscle bladder cancer (NMIBC - prior treatment for NMIBC with intravesical BCG/chemotherapy is permitted) or prior therapy with an anti- programmed cell death 1 (PD-1), anti-programmed cell death ligand 1/ ligand 2 (PD-L1/L2), or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4)
Has ≥N2 disease or metastatic disease (M1) as identified by imaging
Is cisplatin-ineligible, as defined by meeting any one of the cisplatin ineligibility criteria as per protocol
Has received prior systemic anticancer therapy including investigational agents within 3 years of randomization or any radiotherapy to the bladder
Has undergone partial cystectomy of the bladder to remove any NMIBC or MIBC
Has received a live or live attenuated vaccine within 30 days before the first dose of study intervention
Has a diagnosis of immunodeficiency or has a known history of human immunodeficiency virus (HIV) infection, Hepatitis B infection or known active Hepatitis C infection
Has a known psychiatric or substance abuse disorder
Has had an allogenic tissue/solid organ transplant

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

900

Study ID:

NCT03924856

Recruitment Status:

Active, not recruiting

Sponsor:

Merck Sharp & Dohme LLC

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There are 173 Locations for this study

See Locations Near You

Scripps MD Anderson ( Site 0010)
La Jolla California, 92037, United States
Providence Saint John's Health Center ( Site 0075)
Santa Monica California, 90404, United States
Georgetown University Medical Center ( Site 0022)
Washington District of Columbia, 20007, United States
AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 0005)
Orlando Florida, 32804, United States
Parkview Cancer Institute ( Site 0077)
Fort Wayne Indiana, 46845, United States
Indiana University Melvin and Bren Simon Cancer Center ( Site 0004)
Indianapolis Indiana, 46202, United States
Ochsner Medical Center ( Site 0049)
New Orleans Louisiana, 70121, United States
New England Cancer Specialists ( Site 0070)
Scarborough Maine, 04074, United States
UMass Memorial Medical Center ( Site 0051)
Worcester Massachusetts, 01655, United States
Henry Ford Hospital ( Site 0039)
Detroit Michigan, 48202, United States
Mercy Hospital Saint Louis ( Site 0064)
Saint Louis Missouri, 63141, United States
Morristown Medical Center ( Site 0015)
Morristown New Jersey, 07960, United States
UNM Comprehensive Cancer Center-Clinical Research Office ( Site 0045)
Albuquerque New Mexico, 87106, United States
New York University Perlmutter Cancer Center ( Site 0008)
New York New York, 10016, United States
University Hospitals Cleveland Medical Center ( Site 0038)
Cleveland Ohio, 44106, United States
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0021)
Tulsa Oklahoma, 74146, United States
Portland VA Medical Center ( Site 0084)
Portland Oregon, 97239, United States
Allegheny General Hospital ( Site 0048)
Pittsburgh Pennsylvania, 15212, United States
MD Anderson Cancer Center ( Site 0063)
Houston Texas, 77030, United States
Central Texas Veterans Healthcare System ( Site 0057)
Temple Texas, 76504, United States
Inova Schar Cancer Institute ( Site 0007)
Fairfax Virginia, 22031, United States
Northwest Medical Specialties, PLLC ( Site 0061)
Puyallup Washington, 98373, United States
Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 0033)
Seattle Washington, 98109, United States
Charleston Area Medical Center ( Site 0023)
Charles Town West Virginia, 25304, United States
Mid North Coast Cancer Institute ( Site 1256)
Port Macquarie New South Wales, 2444, Australia
Southside Cancer Care Centre ( Site 1252)
Sydney New South Wales, 2228, Australia
Cairns Base Hospital ( Site 1257)
Cairns Queensland, 4870, Australia
Eastern Health ( Site 1255)
Box Hill Victoria, 3128, Australia
Peninsula Health Frankston Hospital ( Site 1258)
Frankston Victoria, 3199, Australia
UZ Brussel ( Site 0358)
Brussels Bruxelles-Capitale, Region De, 1090, Belgium
Jessa Ziekenhuis ( Site 0360)
Hasselt Limburg, 3500, Belgium
CHU UCL Namur Site de Godinne ( Site 0354)
Yvoir Namur, 5530, Belgium
O.L.V. Ziekenhuis Aalst ( Site 0356)
Aalst Oost-Vlaanderen, 9300, Belgium
AZ Maria Middelares Gent ( Site 0353)
Gent Oost-Vlaanderen, 9000, Belgium
Tom Baker Cancer Centre ( Site 0100)
Calgary Alberta, T2N 4, Canada
Nova Scotia Health Authority ( Site 0109)
Halifax Nova Scotia, B3H 1, Canada
Kingston Health Sciences Centre ( Site 0103)
Kingston Ontario, K7L 2, Canada
Lakeridge Health ( Site 0104)
Oshawa Ontario, L1G 2, Canada
Sunnybrook Research Institute ( Site 0110)
Toronto Ontario, M4N 3, Canada
Princess Margaret Cancer Centre ( Site 0107)
Toronto Ontario, M5G 2, Canada
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0105)
Montreal Quebec, H1T 2, Canada
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0
Quebec City Quebec, G1J 1, Canada
Herlev og Gentofte Hospital. ( Site 0402)
Herlev Hovedstaden, 2730, Denmark
Rigshospitalet University Hospital ( Site 0401)
Kobenhavn Hovedstaden, 2100, Denmark
Odense Universitetshospital ( Site 0403)
Odense Syddanmark, 5000, Denmark
CHU de Bordeaux- Hopital Saint Andre ( Site 0456)
Bordeaux Aquitaine, 33075, France
Centre Leon Berard ( Site 0465)
Lyon Auvergne, 69373, France
Centre Francois Baclesse ( Site 0459)
Caen Calvados, 14075, France
Centre Armoricain de Radiotherapie Imagerie medicale et Oncologie ( Site 0457)
Plerin Cotes-d Armor, 22190, France
Hopital Foch ( Site 0483)
Suresnes Hauts-de-Seine, 92150, France
CHU de Montpellier - Hopital Saint-Eloi ( Site 0469)
Montpellier Languedoc-Roussillon, 34295, France
Institut de Cancerologie de l Ouest Site Paul Papin ( Site 0453)
Angers Maine-et-Loire, 49000, France
Hopital Robert Schuman ( Site 0452)
Metz Moselle, 57070, France
Centre Jean Perrin ( Site 0460)
Clermont-Ferrand Puy-de-Dome, 63011, France
Clinique Victor Hugo ( Site 0463)
Le Mans Sarthe, 72000, France
CHU de Rouen ( Site 0493)
Rouen Seine-Maritime, 76031, France
Institut Sainte Catherine ( Site 0454)
Avignon Vaucluse, 84918, France
Klinikum der Eberhard-Karls-Universitaet Tuebingen ( Site 0502)
Tuebingen Baden-Wurttemberg, 72076, Germany
Universitaetsklinikum Erlangen ( Site 0505)
Erlangen Bayern, 91058, Germany
Universitaetsklinikum Magdeburg A.o.R. ( Site 0516)
Magdeburg Sachsen-Anhalt, 39120, Germany
Universitaetsklinikum Carl Gustav Carus ( Site 0519)
Dresden Sachsen, 01307, Germany
Universitaetsklinikum Schleswig-Holstein-Campus Lubeck ( Site 0512)
Luebeck Schleswig-Holstein, 23538, Germany
Charite Universitaetsmedizin Berlin ( Site 0515)
Berlin , 10117, Germany
Vivantes Klinikum am Urban ( Site 0522)
Berlin , 10967, Germany
Pecsi Tudomanyegyetem AOK ( Site 1009)
Pecs Baranya, 7624, Hungary
SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 1010)
Szeged Csongrad, 6720, Hungary
Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1002)
Szolnok Jasz-Nagykun-Szolnok, 5004, Hungary
Bajcsy Zsilinszki Korhaz es Rendelointezet ( Site 1001)
Budapest , 1106, Hungary
Debreceni Egyetem Klinikai Kozpont ( Site 1006)
Debrecen , 4032, Hungary
Petz Aladar Megyei Oktato Korhaz ( Site 1012)
Gyor , 9023, Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 1007)
Kaposvar , 7400, Hungary
Cork University Hospital ( Site 0722)
Cork , T12 D, Ireland
Tallaght University Hospital ( Site 0710)
Dublin , D24 D, Ireland
University Hospital Waterford ( Site 0723)
Waterford , X91ER, Ireland
Ha Emek Medical Center ( Site 0808)
Afula , 18341, Israel
Soroka Medical Center ( Site 0806)
Beer Sheva , 84101, Israel
Rambam Health Care Campus-Oncology Division ( Site 0802)
Haifa , 31096, Israel
Shaare Zedek Medical Center ( Site 0809)
Jerusalem , 91031, Israel
Hadassah Ein Kerem Medical Center ( Site 0810)
Jerusalem , 91120, Israel
Meir Medical Center ( Site 0803)
Kfar Saba , 44281, Israel
Rabin Medical Center ( Site 0804)
Petach Tikva , 49414, Israel
Sheba Medical Center ( Site 0801)
Ramat Gan , 52656, Israel
Sourasky Medical Center ( Site 0807)
Tel Aviv , 64239, Israel
Yitzhak Shamir Medical Center ( Site 0805)
Zerifin , 70300, Israel
Policlinico Gemelli di Roma ( Site 0558)
Roma Abruzzo, 00168, Italy
Policlinico di Modena ( Site 0553)
Modena Emilia-Romagna, 41124, Italy
A.O.U. Policlinico Vittorio Emanuele - Presidio Gaspare Rodolico ( Site 0559)
Catania , 95123, Italy
Istituto Nazionale Studio e Cura dei Tumori ( Site 0551)
Milano , 20133, Italy
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori ( Site 0552)
Napoli , 80131, Italy
Fondazione Salvatore Maugeri IRCCS. ( Site 0554)
Pavia , 27100, Italy
Azienda Ospedaliera San Camillo Forlanini ( Site 0560)
Roma , 00152, Italy
Azienda Ospedaliera Santa Maria Terni ( Site 0557)
Terni , 05100, Italy
Hirosaki University Hospital ( Site 1502)
Hirosaki Aomori, 036-8, Japan
National Cancer Center Hospital East ( Site 1504)
Kashiwa Chiba, 27785, Japan
Ehime University Hospital ( Site 1508)
Toon Ehime, 791-0, Japan
Sapporo Medical University Hospital ( Site 1501)
Sapporo Hokkaido, 060-8, Japan
University of Tsukuba Hospital ( Site 1503)
Tsukuba Ibaraki, 305-8, Japan
Yokosuka Kyosai Hospital ( Site 1509)
Yokosuka Kanagawa, 238-8, Japan
Nara Medical University Hospital ( Site 1510)
Kashihara Nara, 634-8, Japan
Saitama Medical University International Medical Center ( Site 1505)
Hidaka Saitama, 350-1, Japan
Chiba Cancer Center ( Site 1506)
Chiba , 260-8, Japan
Harasanshin Hospital ( Site 1515)
Fukuoka , 812-0, Japan
Hiroshima City Hiroshima Citizens Hospital ( Site 1513)
Hiroshima , 730-8, Japan
Nagano Municipal Hospital ( Site 1516)
Nagano , 381-8, Japan
Osaka Metropolitan University Hospital ( Site 1512)
Osaka , 545-8, Japan
Tokushima University Hospital ( Site 1514)
Tokushima , 770-8, Japan
Tokyo Medical and Dental University Hospital ( Site 1517)
Tokyo , , Japan
National Cancer Center ( Site 1354)
Goyang-si Kyonggi-do, 10408, Korea, Republic of
Seoul National University Bundang Hospital ( Site 1356)
Seongnam-si Kyonggi-do, 13620, Korea, Republic of
Korea University Anam Hospital ( Site 1351)
Seoul , 02841, Korea, Republic of
Seoul National University Hospital ( Site 1352)
Seoul , 03080, Korea, Republic of
Asan Medical Center ( Site 1355)
Seoul , 05505, Korea, Republic of
Samsung Medical Center ( Site 1353)
Seoul , 06351, Korea, Republic of
Centro de Urologia Avanzada del Noreste S.A. de C.V. ( Site 0254)
Monterrey Nuevo Leon, 66269, Mexico
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V. ( Site 0300)
Aguascalientes , 20010, Mexico
Centro Estatal de Cancerologia de Chihuahua ( Site 0253)
Chihuahua , 31000, Mexico
Instituto Nacional de Cancerologia ( Site 0256)
Tlalpan , 14080, Mexico
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 1062)
Wroclaw Dolnoslaskie, 50-55, Poland
Centrum Onkologii im.prof. F. Lukaszczyka w Bydgoszczy ( Site 1068)
Bydgoszcz Kujawsko-pomorskie, 85-79, Poland
Europejskie Centrum Zdrowia Otwock ( Site 1057)
Otwock Mazowieckie, 05-40, Poland
Luxmed Onkologia sp. z o. o. ( Site 1051)
Warszawa Mazowieckie, 01-74, Poland
Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1060)
Bielsko-Biala Slaskie, 43-30, Poland
Clinic of Bashkortostan State Medical University ( Site 0869)
Ufa Baskortostan, Respublika, 45008, Russian Federation
Ivanovo Regional Oncology Dispensary ( Site 0852)
Ivanovo Ivanovskaya Oblast, 15304, Russian Federation
Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0861)
Krasnoyarsk Krasnoyarskiy Kray, 66013, Russian Federation
Kursk Regional Clinical Oncology Dispensary ( Site 0854)
Kursk Kurskaya Oblast, 30552, Russian Federation
FSBI ""United Hospital with Polyclinic"" of the Administrative Department of the President of the Ru
Moscow Moskva, 11928, Russian Federation
Central Clinical Hospital with outpatient Clinic ( Site 0856)
Moscow Moskva, 12135, Russian Federation
Bayandin Murmansk Regional Clinical Hospital ( Site 0859)
Murmansk Murmanskaya Oblast, 18305, Russian Federation
Volga District Medical Center Federal Medical and Biological Agency ( Site 0857)
Nizhny Novgorod Nizhegorodskaya Oblast, 60307, Russian Federation
Omsk Clinical Oncology Dispensary ( Site 0865)
Omsk Omskaya Oblast, 64401, Russian Federation
Leningrad Regional Oncology Center ( Site 0868)
Saint Petersburg Sankt-Peterburg, 18866, Russian Federation
Clinical Hospital Saint Luka ( Site 0867)
St. Petersburg Sankt-Peterburg, 19404, Russian Federation
Saratov State Medical University n.a. V.I.Razumovskiy ( Site 0866)
Saratov Saratovskaya Oblast, 41001, Russian Federation
Hospital San Pedro de Alcantara ( Site 0654)
Caceres Extremadura, 10003, Spain
H. de Gerona Dr. Josep Trueta ( Site 0651)
Girona Gerona, 17007, Spain
Hospital Universitario Ramon y Cajal ( Site 0660)
Madrid Madrid, Comunidad De, 28034, Spain
Hospital Universitario Quiron Madrid ( Site 0657)
Pozuelo de Alarcon Madrid, Comunidad De, 28223, Spain
Instituto Valenciano de Oncologia - IVO ( Site 0662)
Valencia Valenciana, Comunitat, 46009, Spain
Hospital del Mar ( Site 0653)
Barcelona , 08003, Spain
Hospital Universitario San Carlos ( Site 0663)
Madrid , 28040, Spain
Hospital Universitario La Paz ( Site 0661)
Madrid , 28046, Spain
Hospital Nuestra Sra. de Valme ( Site 0658)
Sevilla , 41014, Spain
Laenssjukhuset Ryhov ( Site 1205)
Jonkoping Jonkopings Lan, 551 8, Sweden
Akademiska Sjukhuset ( Site 1201)
Uppsala Uppsala Lan, 751 8, Sweden
Cancercentrum ( Site 1204)
Umea Vasterbottens Lan, 901 8, Sweden
Ramathibodi Hospital. ( Site 1451)
Bangkok Krung Thep Maha Nakhon, 10400, Thailand
Faculty of Medicine Siriraj Hospital ( Site 1452)
Bangkok Krung Thep Maha Nakhon, 10700, Thailand
Maharaj Nakorn Chiangmai Hospital ( Site 1453)
Chiang Mai , 50200, Thailand
Srinagarind Hospital ( Site 1454)
Khon Kaen , 40002, Thailand
Hacettepe Universitesi Tıp Fakultesi ( Site 0911)
Ankara , 06100, Turkey
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0910)
Istanbul , 34096, Turkey
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0906)
Istanbul , 34722, Turkey
Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 0901)
Istanbul , 34899, Turkey
Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 0909)
Konya , 42080, Turkey
Sakarya Universitesi Tip Fakultesi ( Site 0913)
Sakarya , 54290, Turkey
Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi ( Site 0904)
Trabzon , 61080, Turkey
Cherkasy Regional Oncology Dispensary ( Site 0959)
Cherkasy Cherkaska Oblast, 18009, Ukraine
MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov ( Site 0963)
Dnipropetrovsk Dnipropetrovska Oblast, 49005, Ukraine
Regional Oncological Hospital ( Site 0956)
Dnipro Dnipropetrovska Oblast, 49055, Ukraine
Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC ( Site 0951)
Dnipro Dnipropetrovska Oblast, 49102, Ukraine
Reg. Clinical Center of Urology and Nephrology n.a. V. I. Shapoval ( Site 0969)
Kharkiv Kharkivska Oblast, 61037, Ukraine
CNPE "Regional Center of Oncology" ( Site 0958)
Kharkiv Kharkivska Oblast, 61070, Ukraine
National Cancer Institute of the MoH of Ukraine ( Site 0962)
Kyiv Kyivska Oblast, 03022, Ukraine
Lviv Regional Clinical Hospital ( Site 0955)
Lviv Lvivska Oblast, 79000, Ukraine
Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 0967)
Lviv Lvivska Oblast, 79000, Ukraine
Kyiv City Clinical Oncology Center ( Site 0960)
Kyiv , 03115, Ukraine
Aberdeen Royal Infirmary ( Site 0708)
Aberdeen Aberdeen City, AB25 , United Kingdom
Torbay Hospital ( Site 0704)
Torquay Devon, TQ2 7, United Kingdom
Kent and Canterbury Hospital ( Site 0709)
Canterbury England, CT1 3, United Kingdom
Lister Hospital ( Site 0715)
Stevenage Hertfordshire, SG1 4, United Kingdom
The Royal Marsden Foundation Trust ( Site 0702)
London London, City Of, SW3 6, United Kingdom
Imperial College Healthcare NHS Trust ( Site 0721)
London London, City Of, W6 8R, United Kingdom
Norfolk & Norwich University Hospital NHS Foundation Trust ( Site 0725)
Norwich Norfolk, NR4 7, United Kingdom
Royal Cornwall Hospital ( Site 0703)
Truro , TR1 3, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

900

Study ID:

NCT03924856

Recruitment Status:

Active, not recruiting

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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