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)

NCT03924856 | Completed Phase 3 DMC FDA Drug

• 8 other identifiers: 3475-866MK-3475-866KEYNOTE-86620802247902022-501970-20-00194870U1111-1282-62792018-003808-39
• Study Type: interventional
• Target: 907
• Locations: 22 countries
• Sites: 175

Brief Summary

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

Conditions

Bladder Cancer

Keywords

Programmed Cell Death-1 (PD1, PD-1); Programmed Death-Ligand 1 (PDL1, PD-L1); Pembrolizumab (MK-3475); Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Event-Free Survival (EFS)

  EFS is defined as the time from randomization to the first occurrence of any of the following events: progression of disease that precludes RC surgery; failure to undergo RC surgery in participants with residual disease and any radiographical disease present; gross residual disease left behind at the time of surgery; local or distant recurrence based on investigator assessments and/or biopsy, or death due to any cause.

  Up to approximately 60 months

Secondary Outcomes (13)

• Pathologic Complete Response (pCR) Rate

  Up to approximately 72 months

• Overall Survival (OS)

  Up to approximately 72 months

• Disease-Free Survival (DFS)

  From approximately 20 weeks up to approximately 72 months

• Pathologic Downstaging (pDS) Rate

  Up to approximately 72 months

• Number of Participants Who Experienced an Adverse Event (AE)

  Up to approximately 72 months

Study Arms (2)

Pembrolizumab + Gemcitabine + Cisplatin + Surgery

EXPERIMENTAL

Participants received 4 preoperative cycles of pembrolizumab PLUS gemcitabine PLUS cisplatin, followed by surgery, followed by up to 13 cycles of postoperative pembrolizumab.

Drug: Pembrolizumab; Drug: Gemcitabine; Drug: Cisplatin; Procedure: Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND])

Placebo + Gemcitabine + Cisplatin + Surgery

PLACEBO COMPARATOR

Participants received 4 preoperative cycles of placebo to pembrolizumab PLUS gemcitabine PLUS cisplatin, followed by surgery, followed by up to 13 cycles of postoperative placebo to pembrolizumab.

Drug: Gemcitabine; Drug: Cisplatin; Procedure: Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND]); Drug: Placebo

Interventions

Pembrolizumab DRUG

Pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle

Also known as: MK-3475

Pembrolizumab + Gemcitabine + Cisplatin + Surgery

Gemcitabine DRUG

Gemcitabine 1000 mg/m\^2, IV infusion on Days 1 and 8 of each 21-day cycle

Pembrolizumab + Gemcitabine + Cisplatin + Surgery; Placebo + Gemcitabine + Cisplatin + Surgery

Cisplatin DRUG

Cisplatin 70 mg/m\^2, IV infusion on Day 1 of each 21-day cycle

Pembrolizumab + Gemcitabine + Cisplatin + Surgery; Placebo + Gemcitabine + Cisplatin + Surgery

Placebo DRUG

Placebo to pembrolizumab by IV infusion, given on Day 1 of each 21-day cycle

Placebo + Gemcitabine + Cisplatin + Surgery

Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND]) PROCEDURE

Surgical RC+PLND will be done in accordance with the American Urological Association (AUA)/American Society of Clinical Oncology (ASCO)/American Society for Radiation Oncology (ASTRO)/Society of Urologic Oncology (SUO) guidelines.

Pembrolizumab + Gemcitabine + Cisplatin + Surgery; Placebo + Gemcitabine + Cisplatin + Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (175)

Scripps MD Anderson ( Site 0010)

La Jolla, California, 92037, United States

Location

Providence Saint John's Health Center ( Site 0075)

Santa Monica, California, 90404, United States

Location

Georgetown University Medical Center ( Site 0022)

Washington D.C., District of Columbia, 20007, United States

Location

AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 0005)

Orlando, Florida, 32804, United States

Location

Parkview Cancer Institute ( Site 0077)

Fort Wayne, Indiana, 46845, United States

Location

Indiana University Melvin and Bren Simon Cancer Center ( Site 0004)

Indianapolis, Indiana, 46202, United States

Location

Ochsner Medical Center ( Site 0049)

New Orleans, Louisiana, 70121, United States

Location

New England Cancer Specialists ( Site 0070)

Scarborough, Maine, 04074, United States

Location

UMass Memorial Medical Center ( Site 0051)

Worcester, Massachusetts, 01655, United States

Location

Henry Ford Hospital ( Site 0039)

Detroit, Michigan, 48202, United States

Location

Mercy Hospital Saint Louis ( Site 0064)

St Louis, Missouri, 63141, United States

Location

Morristown Medical Center ( Site 0015)

Morristown, New Jersey, 07960, United States

Location

UNM Comprehensive Cancer Center-Clinical Research Office ( Site 0045)

Albuquerque, New Mexico, 87106, United States

Location

New York University Perlmutter Cancer Center ( Site 0008)

New York, New York, 10016, United States

Location

University Hospitals Cleveland Medical Center ( Site 0038)

Cleveland, Ohio, 44106, United States

Location

Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0021)

Tulsa, Oklahoma, 74146, United States

Location

Portland VA Medical Center ( Site 0084)

Portland, Oregon, 97239, United States

Location

Allegheny General Hospital ( Site 0048)

Pittsburgh, Pennsylvania, 15212, United States

Location

MD Anderson Cancer Center ( Site 0063)

Houston, Texas, 77030, United States

Location

Central Texas Veterans Healthcare System ( Site 0057)

Temple, Texas, 76504, United States

Location

Inova Schar Cancer Institute ( Site 0007)

Fairfax, Virginia, 22031, United States

Location

Northwest Medical Specialties, PLLC ( Site 0061)

Puyallup, Washington, 98373, United States

Location

Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 0033)

Seattle, Washington, 98109, United States

Location

Charleston Area Medical Center ( Site 0023)

Charles Town, West Virginia, 25304, United States

Location

Mid North Coast Cancer Institute ( Site 1256)

Port Macquarie, New South Wales, 2444, Australia

Location

Southside Cancer Care Centre ( Site 1252)

Sydney, New South Wales, 2228, Australia

Location

Cairns Base Hospital ( Site 1257)

Cairns, Queensland, 4870, Australia

Location

Eastern Health ( Site 1255)

Box Hill, Victoria, 3128, Australia

Location

Peninsula Health Frankston Hospital ( Site 1258)

Frankston, Victoria, 3199, Australia

Location

UZ Brussel ( Site 0358)

Brussels, Bruxelles-Capitale, Region de, 1090, Belgium

Location

Jessa Ziekenhuis ( Site 0360)

Hasselt, Limburg, 3500, Belgium

Location

CHU UCL Namur Site de Godinne ( Site 0354)

Yvoir, Namur, 5530, Belgium

Location

O.L.V. Ziekenhuis Aalst ( Site 0356)

Aalst, Oost-Vlaanderen, 9300, Belgium

Location

AZ Maria Middelares Gent ( Site 0353)

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Tom Baker Cancer Centre ( Site 0100)

Calgary, Alberta, T2N 4N2, Canada

Location

Nova Scotia Health Authority ( Site 0109)

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Kingston Health Sciences Centre ( Site 0103)

Kingston, Ontario, K7L 2V7, Canada

Location

Lakeridge Health ( Site 0104)

Oshawa, Ontario, L1G 2B9, Canada

Location

Sunnybrook Research Institute ( Site 0110)

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Cancer Centre ( Site 0107)

Toronto, Ontario, M5G 2M9, Canada

Location

CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0105)

Montreal, Quebec, H1T 2M4, Canada

Location

Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0

Québec, Quebec, G1J 1Z4, Canada

Location

Rigshospitalet University Hospital ( Site 0401)

Copenhagen, Capital Region, 2100, Denmark

Location

Herlev og Gentofte Hospital. ( Site 0402)

Herlev, Capital Region, 2730, Denmark

Location

Odense Universitetshospital ( Site 0403)

Odense, Region Syddanmark, 5000, Denmark

Location

CHU de Bordeaux- Hopital Saint Andre ( Site 0456)

Bordeaux, Aquitaine, 33075, France

Location

Centre Leon Berard ( Site 0465)

Lyon, Auvergne, 69373, France

Location

Centre Francois Baclesse ( Site 0459)

Caen, Calvados, 14075, France

Location

Centre Armoricain de Radiotherapie Imagerie medicale et Oncologie ( Site 0457)

Plérin, Cotes-d Armor, 22190, France

Location

Hopital Foch ( Site 0483)

Suresnes, Hauts-de-Seine, 92150, France

Location

CHU de Montpellier - Hopital Saint-Eloi ( Site 0469)

Montpellier, Languedoc-Roussillon, 34295, France

Location

Institut de Cancerologie de l Ouest Site Paul Papin ( Site 0453)

Angers, Maine-et-Loire, 49000, France

Location

Hopital Robert Schuman ( Site 0452)

Metz, Moselle, 57070, France

Location

Centre Jean Perrin ( Site 0460)

Clermont-Ferrand, Puy-de-Dome, 63011, France

Location

Clinique Victor Hugo ( Site 0463)

Le Mans, Sarthe, 72000, France

Location

CHU de Rouen ( Site 0493)

Rouen, Seine-Maritime, 76031, France

Location

Institut Sainte Catherine ( Site 0454)

Avignon, Vaucluse, 84918, France

Location

Klinikum der Eberhard-Karls-Universitaet Tuebingen ( Site 0502)

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Universitaetsklinikum Erlangen ( Site 0505)

Erlangen, Bavaria, 91058, Germany

Location

Universitaetsklinikum Carl Gustav Carus ( Site 0519)

Dresden, Saxony, 01307, Germany

Location

Universitaetsklinikum Magdeburg A.o.R. ( Site 0516)

Magdeburg, Saxony-Anhalt, 39120, Germany

Location

Universitaetsklinikum Schleswig-Holstein-Campus Lubeck ( Site 0512)

Lübeck, Schleswig-Holstein, 23538, Germany

Location

Charite Universitaetsmedizin Berlin ( Site 0515)

Berlin, 10117, Germany

Location

Vivantes Klinikum am Urban ( Site 0522)

Berlin, 10967, Germany

Location

Pecsi Tudomanyegyetem AOK ( Site 1009)

Pécs, Baranya, 7624, Hungary

Location

SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 1010)

Szeged, Csongrád megye, 6720, Hungary

Location

Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1002)

Szolnok, Jász-Nagykun-Szolnok, 5004, Hungary

Location

Bajcsy Zsilinszki Korhaz es Rendelointezet ( Site 1001)

Budapest, 1106, Hungary

Location

Debreceni Egyetem Klinikai Kozpont ( Site 1006)

Debrecen, 4032, Hungary

Location

Petz Aladar Megyei Oktato Korhaz ( Site 1012)

Győr, 9023, Hungary

Location

Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 1007)

Kaposvár, 7400, Hungary

Location

Cork University Hospital ( Site 0722)

Cork, T12 DC4A, Ireland

Location

Tallaght University Hospital ( Site 0710)

Dublin, D24 DH74, Ireland

Location

University Hospital Waterford ( Site 0723)

Waterford, X91ER8E, Ireland

Location

Ha Emek Medical Center ( Site 0808)

Afula, 1834111, Israel

Location

Soroka Medical Center ( Site 0806)

Beersheba, 8410101, Israel

Location

Rambam Health Care Campus-Oncology Division ( Site 0802)

Haifa, 3109601, Israel

Location

Shaare Zedek Medical Center ( Site 0809)

Jerusalem, 9103102, Israel

Location

Hadassah Ein Kerem Medical Center ( Site 0810)

Jerusalem, 9112001, Israel

Location

Meir Medical Center ( Site 0803)

Kfar Saba, 4428164, Israel

Location

Rabin Medical Center ( Site 0804)

Petah Tikva, 4941492, Israel

Location

Sheba Medical Center ( Site 0801)

Ramat Gan, 5265601, Israel

Location

Sourasky Medical Center ( Site 0807)

Tel Aviv, 6423906, Israel

Location

Yitzhak Shamir Medical Center ( Site 0805)

Ẕerifin, 7030001, Israel

Location

Policlinico Gemelli di Roma ( Site 0558)

Roma, Abruzzo, 00168, Italy

Location

Policlinico di Modena ( Site 0553)

Modena, Emilia-Romagna, 41124, Italy

Location

A.O.U. Policlinico Vittorio Emanuele - Presidio Gaspare Rodolico ( Site 0559)

Catania, 95123, Italy

Location

Istituto Nazionale Studio e Cura dei Tumori ( Site 0551)

Milan, 20133, Italy

Location

Istituto Nazionale Per Lo Studio E La Cura Dei Tumori ( Site 0552)

Naples, 80131, Italy

Location

Fondazione Salvatore Maugeri IRCCS. ( Site 0554)

Pavia, 27100, Italy

Location

Azienda Ospedaliera San Camillo Forlanini ( Site 0560)

Roma, 00152, Italy

Location

Azienda Ospedaliera Santa Maria Terni ( Site 0557)

Terni, 05100, Italy

Location

Hirosaki University Hospital ( Site 1502)

Hirosaki, Aomori, 036-8563, Japan

Location

National Cancer Center Hospital East ( Site 1504)

Kashiwa, Chiba, 2778577, Japan

Location

Ehime University Hospital ( Site 1508)

Tōon, Ehime, 791-0295, Japan

Location

Sapporo Medical University Hospital ( Site 1501)

Sapporo, Hokkaido, 060-8543, Japan

Location

University of Tsukuba Hospital ( Site 1503)

Tsukuba, Ibaraki, 305-8576, Japan

Location

Yokosuka Kyosai Hospital ( Site 1509)

Yokosuka, Kanagawa, 238-8558, Japan

Location

Nara Medical University Hospital ( Site 1510)

Kashihara, Nara, 634-8522, Japan

Location

Saitama Medical University International Medical Center ( Site 1505)

Hidaka, Saitama, 350-1298, Japan

Location

Chiba Cancer Center ( Site 1506)

Chiba, 260-8717, Japan

Location

Harasanshin Hospital ( Site 1515)

Fukuoka, 812-0033, Japan

Location

Hiroshima City Hiroshima Citizens Hospital ( Site 1513)

Hiroshima, 730-8518, Japan

Location

Nagano Municipal Hospital ( Site 1516)

Nagano, 381-8551, Japan

Location

Osaka Metropolitan University Hospital ( Site 1512)

Osaka, 545-8586, Japan

Location

Tokushima University Hospital ( Site 1514)

Tokushima, 770-8503, Japan

Location

Tokyo Medical and Dental University Hospital ( Site 1517)

Tokyo, Japan

Location

Centro de Urologia Avanzada del Noreste S.A. de C.V. ( Site 0254)

Monterrey, Nuevo León, 66269, Mexico

Location

Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V. ( Site 0300)

Aguascalientes, 20010, Mexico

Location

Centro Estatal de Cancerologia de Chihuahua ( Site 0253)

Chihuahua City, 31000, Mexico

Location

Instituto Nacional de Cancerologia ( Site 0256)

Tlalpan, 14080, Mexico

Location

Centrum Onkologii im.prof. F. Lukaszczyka w Bydgoszczy ( Site 1068)

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland

Location

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 1062)

Wroclaw, Lower Silesian Voivodeship, 50-556, Poland

Location

Europejskie Centrum Zdrowia Otwock ( Site 1057)

Otwock, Masovian Voivodeship, 05-400, Poland

Location

Luxmed Onkologia sp. z o. o. ( Site 1051)

Warsaw, Masovian Voivodeship, 01-748, Poland

Location

Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1060)

Bielsko-Biala, Silesian Voivodeship, 43-300, Poland

Location

Clinic of Bashkortostan State Medical University ( Site 0869)

Ufa, Baskortostan, Respublika, 450081, Russia

Location

Ivanovo Regional Oncology Dispensary ( Site 0852)

Ivanovo, Ivanovo Oblast, 153040, Russia

Location

Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0861)

Krasnoyarsk, Krasnoyarsk Krai, 660133, Russia

Location

Kursk Regional Clinical Oncology Dispensary ( Site 0854)

Kursk, Kursk Oblast, 305524, Russia

Location

FSBI ""United Hospital with Polyclinic"" of the Administrative Department of the President of the Ru

Moscow, Moscow, 119285, Russia

Location

Central Clinical Hospital with outpatient Clinic ( Site 0856)

Moscow, Moscow, 121359, Russia

Location

Bayandin Murmansk Regional Clinical Hospital ( Site 0859)

Murmansk, Murmansk Oblast, 183057, Russia

Location

Volga District Medical Center Federal Medical and Biological Agency ( Site 0857)

Nizhny Novgorod, Nizhny Novgorod Oblast, 603074, Russia

Location

Omsk Clinical Oncology Dispensary ( Site 0865)

Omsk, Omsk Oblast, 644013, Russia

Location

Leningrad Regional Oncology Center ( Site 0868)

Saint Petersburg, Sankt-Peterburg, 188663, Russia

Location

Clinical Hospital Saint Luka ( Site 0867)

Saint Petersburg, Sankt-Peterburg, 194044, Russia

Location

Saratov State Medical University n.a. V.I.Razumovskiy ( Site 0866)

Saratov, Saratov Oblast, 410012, Russia

Location

National Cancer Center ( Site 1354)

Goyang-si, Kyonggi-do, 10408, South Korea

Location

Seoul National University Bundang Hospital ( Site 1356)

Seongnam-si, Kyonggi-do, 13620, South Korea

Location

Korea University Anam Hospital ( Site 1351)

Seoul, 02841, South Korea

Location

Seoul National University Hospital ( Site 1352)

Seoul, 03080, South Korea

Location

Asan Medical Center ( Site 1355)

Seoul, 05505, South Korea

Location

Samsung Medical Center ( Site 1353)

Seoul, 06351, South Korea

Location

Hospital San Pedro de Alcantara ( Site 0654)

Cáceres, Extremadura, 10003, Spain

Location

H. de Gerona Dr. Josep Trueta ( Site 0651)

Girona, Gerona, 17007, Spain

Location

Hospital Universitario Ramon y Cajal ( Site 0660)

Madrid, Madrid, Comunidad de, 28034, Spain

Location

Hospital Universitario Quiron Madrid ( Site 0657)

Pozuelo de Alarcón, Madrid, Comunidad de, 28223, Spain

Location

Instituto Valenciano de Oncologia - IVO ( Site 0662)

Valencia, Valenciana, Comunitat, 46009, Spain

Location

Hospital del Mar ( Site 0653)

Barcelona, 08003, Spain

Location

Hospital Universitario San Carlos ( Site 0663)

Madrid, 28040, Spain

Location

Hospital Universitario La Paz ( Site 0661)

Madrid, 28046, Spain

Location

Hospital Nuestra Sra. de Valme ( Site 0658)

Seville, 41014, Spain

Location

Laenssjukhuset Ryhov ( Site 1205)

Jönköping, Jönköping County, 551 85, Sweden

Location

Akademiska Sjukhuset ( Site 1201)

Uppsala, Uppsala County, 751 85, Sweden

Location

Cancercentrum ( Site 1204)

Umeå, Västerbotten County, 901 85, Sweden

Location

Ramathibodi Hospital. ( Site 1451)

Bangkok, Bangkok, 10400, Thailand

Location

Faculty of Medicine Siriraj Hospital ( Site 1452)

Bangkok, Bangkok, 10700, Thailand

Location

Maharaj Nakorn Chiangmai Hospital ( Site 1453)

Chiang Mai, 50200, Thailand

Location

Srinagarind Hospital ( Site 1454)

Khon Kaen, 40002, Thailand

Location

Hacettepe Universitesi Tıp Fakultesi ( Site 0911)

Ankara, 06100, Turkey (Türkiye)

Location

Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0910)

Istanbul, 34096, Turkey (Türkiye)

Location

TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0906)

Istanbul, 34722, Turkey (Türkiye)

Location

Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 0901)

Istanbul, 34899, Turkey (Türkiye)

Location

Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 0909)

Konya, 42080, Turkey (Türkiye)

Location

Sakarya Universitesi Tip Fakultesi ( Site 0913)

Sakarya, 54290, Turkey (Türkiye)

Location

Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi ( Site 0904)

Trabzon, 61080, Turkey (Türkiye)

Location

Cherkasy Regional Oncology Dispensary ( Site 0959)

Cherkasy, Cherkasy Oblast, 18009, Ukraine

Location

Regional Oncological Hospital ( Site 0956)

Dnipro, Dnipropetrovsk Oblast, 49055, Ukraine

Location

Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC ( Site 0951)

Dnipro, Dnipropetrovsk Oblast, 49102, Ukraine

Location

MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov ( Site 0963)

Dnipropetrovsk, Dnipropetrovsk Oblast, 49005, Ukraine

Location

Reg. Clinical Center of Urology and Nephrology n.a. V. I. Shapoval ( Site 0969)

Kharkiv, Kharkiv Oblast, 61037, Ukraine

Location

CNPE "Regional Center of Oncology" ( Site 0958)

Kharkiv, Kharkiv Oblast, 61070, Ukraine

Location

National Cancer Institute of the MoH of Ukraine ( Site 0962)

Kyiv, Kyivska Oblast, 03022, Ukraine

Location

Lviv Regional Clinical Hospital ( Site 0955)

Lviv, Lviv Oblast, 79000, Ukraine

Location

Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 0967)

Lviv, Lviv Oblast, 79000, Ukraine

Location

Kyiv City Clinical Oncology Center ( Site 0960)

Kyiv, 03115, Ukraine

Location

Aberdeen Royal Infirmary ( Site 0708)

Aberdeen, Aberdeen City, AB25 2ZN, United Kingdom

Location

Torbay Hospital ( Site 0704)

Torquay, Devon, TQ2 7AA, United Kingdom

Location

Kent and Canterbury Hospital ( Site 0709)

Canterbury, England, CT1 3NG, United Kingdom

Location

Lister Hospital ( Site 0715)

Stevenage, Hertfordshire, SG1 4AB, United Kingdom

Location

The Royal Marsden Foundation Trust ( Site 0702)

London, London, City of, SW3 6JJ, United Kingdom

Location

Imperial College Healthcare NHS Trust ( Site 0721)

London, London, City of, W6 8RF, United Kingdom

Location

Norfolk & Norwich University Hospital NHS Foundation Trust ( Site 0725)

Norwich, Norfolk, NR4 7UY, United Kingdom

Location

Royal Cornwall Hospital ( Site 0703)

Truro, TR1 3LJ, United Kingdom

Location

Related Publications (1)

• Galsky MD, Hoimes CJ, Necchi A, Shore N, Witjes JA, Steinberg G, Bedke J, Nishiyama H, Fang X, Kataria R, Sbar E, Jia X, Siefker-Radtke A. Perioperative pembrolizumab therapy in muscle-invasive bladder cancer: Phase III KEYNOTE-866 and KEYNOTE-905/EV-303. Future Oncol. 2021 Aug;17(24):3137-3150. doi: 10.2217/fon-2021-0273. Epub 2021 May 19.

  PMID: 34008425 DERIVED

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Parkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

pembrolizumab; Gemcitabine; Cisplatin; Surgical Procedures, Operative; Cystectomy

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2019
• First Posted: April 23, 2019
• Study Start: June 13, 2019
• Primary Completion: January 26, 2026
• Study Completion: May 18, 2026
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

CA (8); BE (5); DE (7); ME (4); UA (10); GB (8); ES (9); DK (3); PL (5); IT (8); IL (10); JP (15); RU (12); KR (6); TH (4); FR (12); US (24); AU (5); IE (3); TU (7); SE (3); HU (7)