A Phase 3, Randomized, Double-blind Study to Evaluate Perioperative Pembrolizumab (MK-3475) + Neoadjuvant Chemotherapy Versus Perioperative Placebo + Neoadjuvant Chemotherapy in Cisplatin-eligible Participants With Muscle-invasive Bladder Cancer (KEYNOTE-866)

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)

Sponsors

Lead sponsor: Merck Sharp & Dohme Corp.

Source Merck Sharp & Dohme Corp.
Brief Summary

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

Overall Status Recruiting
Start Date June 13, 2019
Completion Date January 15, 2025
Primary Completion Date January 15, 2025
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Pathologic Complete Response (pCR) Rate in All Participants Up to approximately 4 months (Time of surgery)
Pathologic Complete Response Rate in Participants Whose Tumors Express PD-L1 Combined Positive Score (CPS) ≥10 Up to approximately 4 months (Time of surgery)
Event-Free Survival (EFS) in All Participants Up to approximately 5.5 years
Event-Free Survival in Participants Whose Tumors Express PD-L1, CPS ≥10 Up to approximately 5.5 years
Secondary Outcome
Measure Time Frame
Overall Survival (OS) in All Participants Up to approximately 5.5 years
Overall Survival in Participants Whose Tumors Express PD-L1, CPS ≥10 Up to approximately 5.5 years
Disease-Free Survival (DFS) in All Participants From approximately 5 months up to approximately 5.5 years
Disease-Free Survival in Participants Whose Tumors Express PD-L1, CPS ≥10 From approximately 5 months up to approximately 5.5 years
Pathologic Downstaging (pDS) Rate in All Participants Up to approximately 4 months (Time of surgery)
Pathologic Downstaging (pDS) Rate in Participants Whose Tumors Express PD-L1, CPS ≥10 Up to approximately 4 months (Time of surgery)
Number of Participants Experiencing Adverse Events (AEs) Up to approximately 5.5 years
Number of Participants Discontinuing Study Drug Due to an AE Up to approximately 1 year
Number of Participants Experiencing Perioperative Complications Up to approximately 1 year
Change in Patient-Reported Outcomes from Baseline in Total Score of Functional Assessment of Cancer Therapy - General (FACT-G) Baseline and time of last patient-reported outcome assessment (up to approximately 5.5 years)
Change in Patient-Reported Outcomes from Baseline in Total Score of Functional Assessment of Cancer Therapy-Bladder Cancer-Specific Subscale/Symptom Index for Participants Undergoing Cystectomy (Total Score FACT BI-Cys) Baseline and time of last patient-reported outcome assessment (up to approximately 5.5 years)
Change in Patient-Reported Outcomes from Baseline in FACT-Bl-Cys-Trial Outcome Index (TOI) Baseline and time of last patient-reported outcome assessment (up to approximately 5.5 years)
Change in Patient-Reported Outcomes from Baseline in EuroQol Five-Dimensional Questionnaire (EQ-5D-5L) Visual Analog Score (VAS) Baseline and time of last patient-reported outcome assessment (up to approximately 5.5 years)
Change in Patient-Reported Outcomes from Baseline in EQ-5D-5L Utility Score Baseline and time of last patient-reported outcome assessment (up to approximately 5.5 years)
Time to Deterioration (TTD) in the Total Score of FACT-G Up to approximately 5.5 years
Time to Deterioration in EQ-5D-5L VAS Up to approximately 5.5 years
Enrollment 790
Condition
Intervention

Intervention type: Drug

Intervention name: Pembrolizumab

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

Arm group label: Pembrolizumab + Gemcitabine + Cisplatin + Surgery

Other name: MK-3475

Intervention type: Drug

Intervention name: Gemcitabine

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

Intervention type: Drug

Intervention name: Cisplatin

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

Intervention type: Procedure

Intervention name: Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND])

Description: 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.

Intervention type: Drug

Intervention name: Placebo

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

Arm group label: Placebo + Gemcitabine + Cisplatin + Surgery

Eligibility

Criteria:

Inclusion Criteria:

- Have a histologically confirmed diagnosis of muscle invasive bladder cancer (T2-T4aN0M0) with predominant (≥50%) urothelial histology (histology and presence of muscle invasion to be confirmed by BICR): Participants with mixed histology are eligible provided the urothelial component is ≥50%.

Participants whose tumors contain any neuroendocrine component are not eligible.

Urothelial carcinomas not originating from the bladder (e.g., upper tract [ureters, renal pelvis], urethra) are not eligible.

- Have clinically non-metastatic bladder cancer (N0M0) determined by imaging (computed tomography (CT) chest or magnetic resonance imaging (MRI) of the abdomen/pelvis.

- Be deemed eligible for RC + PLND by his/her urologist and/or oncologist and agree to undergo curative intent standard RC + PLND (including prostatectomy if applicable).

- Have a transurethral resection (TUR) of a bladder tumor that is submitted and adequate to determine histology, muscle invasion, and PD-L1 status by central pathology vendor.

- Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

- Have demonstrated adequate organ function.

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 anti-neoplastic treatment for MIBC.

- Is cisplatin-ineligible, as defined by meeting any one of the study criteria.

- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137).

- Has received therapy with hematopoietic growth factor such as granulocyte-colony stimulating factor (G-CSF) or granulocyte-monocyte-colony stimulating factor(GM-CSF) in 14 days prior to randomization.

- Has received prior systemic anti-cancer therapy including investigational agents within 3 years of randomization.

- Has received any prior radiotherapy to the bladder.

- Has received a live vaccine within 30 days prior to the first dose of study drug.

- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.

- 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 drug.

- Has hypersensitivity to monoclonal antibodies (mAbs, including pembrolizumab) and/or any of their excipients.

- Has severe hypersensitivity (≥Grade 3) to cisplatin and/or gemcitabine and any of 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Medical Director Study Director Merck Sharp & Dohme Corp.
Overall Contact

Last name: Toll Free Number

Phone: 1-888-577-8839

Email: [email protected]

Location
facility status contact
Scripps MD Anderson ( Site 0010) | La Jolla, California, 92037, United States Recruiting Study Coordinator 858-554-8367
Providence Saint John's Health Center ( Site 0075) | Santa Monica, California, 90404, United States Recruiting Study Coordinator 310-582-7456
Georgetown University Medical Center ( Site 0022) | Washington, District of Columbia, 20007, United States Recruiting Study Coordinator 202-444-2198
Advent Health ( Site 0005) | Orlando, Florida, 32804, United States Recruiting Study Coordinator 407-303-2038
Parkview Cancer Institute ( Site 0077) | Fort Wayne, Indiana, 46845, United States Recruiting Study Coordinator 260-266-9167
Indiana University Melvin and Bren Simon Cancer Center ( Site 0004) | Indianapolis, Indiana, 46202, United States Recruiting Study Coordinator 317-274-7477
Ochsner Medical Center ( Site 0049) | New Orleans, Louisiana, 70121, United States Recruiting Study Coordinator 504-842-9917
New England Cancer Specialists ( Site 0070) | Scarborough, Maine, 04074, United States Recruiting Study Coordinator 207-303-3423
UMass Memorial Medical Center ( Site 0051) | Worcester, Massachusetts, 01655, United States Recruiting Study Coordinator 508-334-5539
Henry Ford Hospital ( Site 0039) | Detroit, Michigan, 48202, United States Recruiting Study Coordinator 313-916-8862
Mercy Hospital Saint Louis ( Site 0064) | Saint Louis, Missouri, 63141, United States Recruiting Study Coordinator 314-251-7061
Morristown Medical Center ( Site 0015) | Morristown, New Jersey, 07962, United States Recruiting Study Coordinator 973-971-5373
University of New Mexico Cancer Center ( Site 0045) | Albuquerque, New Mexico, 87131, United States Recruiting Study Coordinator 505-925-0421
New York University Perlmutter Cancer Center ( Site 0008) | New York, New York, 10016, United States Recruiting Study Coordinator 212-731-5820
University Hospitals Cleveland Medical Center ( Site 0038) | Cleveland, Ohio, 44106, United States Recruiting Study Coordinator 216-844-6031
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0021) | Tulsa, Oklahoma, 74146, United States Recruiting Study Coordinator 918-505-3200
Portland VA Medical Center ( Site 0084) | Portland, Oregon, 97239, United States Recruiting Study Coordinator 503220826256128
Allegheny General Hospital ( Site 0048) | Pittsburgh, Pennsylvania, 15212, United States Recruiting Study Coordinator 412-359-8373
MD Anderson Cancer Center ( Site 0063) | Houston, Texas, 77030, United States Recruiting Study Coordinator 713-563-1602
Central Texas Veterans Healthcare System ( Site 0057) | Temple, Texas, 76504, United States Recruiting Study Coordinator 254-743-1226
Inova Schar Cancer Institute ( Site 0007) | Fairfax, Virginia, 22031, United States Recruiting Study Coordinator 571-472-0623
Northwest Medical Specialties, PLLC ( Site 0061) | Puyallup, Washington, 98372, United States Recruiting Study Coordinator 253-428-8753
Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 0033) | Seattle, Washington, 98109, United States Recruiting Study Coordinator 206-606-7486
Charleston Area Medical Center ( Site 0023) | Charles Town, West Virginia, 25304, United States Recruiting Study Coordinator 304-388-9945
Mid North Coast Cancer Institute ( Site 1256) | Port Macquarie, New South Wales, 2444, Australia Recruiting Study Coordinator +61265814053
Southside Cancer Care Centre ( Site 1252) | Sydney, New South Wales, 2228, Australia Recruiting Study Coordinator +61285569300
Cairns Base Hospital ( Site 1257) | Cairns, Queensland, 4870, Australia Recruiting Study Coordinator +61742268085
Eastern Health ( Site 1255) | Box Hill, Victoria, 3128, Australia Recruiting Study Coordinator +61398953585
Peninsula Health Frankston Hospital ( Site 1258) | Frankston, Victoria, 3199, Australia Recruiting Study Coordinator +61397848520
UZ Brussel ( Site 0358) | Brussels, Bruxelles-Capitale, Region De, 1090, Belgium Recruiting Study Coordinator +3224776415
CHU UCL Namur Site de Godinne ( Site 0354) | Yvoir, Namur, 5530, Belgium Recruiting Study Coordinator +3281422111
O.L.V. Ziekenhuis Aalst ( Site 0356) | Aalst, Oost-Vlaanderen, 9300, Belgium Recruiting Study Coordinator +3253724378
AZ Maria Middelares Gent ( Site 0353) | Gent, Oost-Vlaanderen, 9000, Belgium Recruiting Study Coordinator +3292469522
Tom Baker Cancer Centre ( Site 0100) | Calgary, Alberta, T2N 4N2, Canada Recruiting Study Coordinator 4034762543
Nova Scotia Health Authority ( Site 0109) | Halifax, Nova Scotia, B3H 1V7, Canada Recruiting Study Coordinator 9024735122
Kingston Health Sciences Centre ( Site 0103) | Kingston, Ontario, K7L 2V7, Canada Recruiting Study Coordinator 61354966663743
Lakeridge Health ( Site 0104) | Oshawa, Ontario, L1G 2B9, Canada Recruiting Study Coordinator 9055768711
Sunnybrook Research Institute ( Site 0110) | Toronto, Ontario, M4N 3M5, Canada Recruiting Study Coordinator 416480500082139
Princess Margaret Cancer Centre ( Site 0107) | Toronto, Ontario, M5G 2M9, Canada Recruiting Study Coordinator 4169462246
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0105) | Montreal, Quebec, H1T 2M4, Canada Recruiting Study Coordinator 51425234005853
CHU de Quebec-Universite Laval-Hotel Dieu de Quebec ( Site 0111) | Quebec, G1R 2J6, Canada Recruiting Study Coordinator 418525444420414
Herlev og Gentofte Hospital. ( Site 0402) | Herlev, Hovedstaden, 2730, Denmark Recruiting Study Coordinator +4538686518
Rigshospitalet University Hospital ( Site 0401) | Kobenhavn, Hovedstaden, 2100, Denmark Recruiting Study Coordinator +4534458403
Odense Universitetshospital ( Site 0403) | Odense, Syddanmark, 5000, Denmark Recruiting Study Coordinator +4524998173
Centre Leon Berard ( Site 0465) | Lyon, Auvergne, 69373, France Recruiting Study Coordinator +33478782828
Centre Francois Baclesse ( Site 0459) | Caen, Calvados, 14076, France Recruiting Study Coordinator +33231455002
Centre Armoricain de Radiotherapie Imagerie medicale et Oncologie ( Site 0457) | Plerin, Cotes-d'Armor, 22190, France Recruiting Study Coordinator +33296752216
CHU de Bordeaux- Hopital Saint Andre ( Site 0456) | Bordeaux, Gironde, 33075, France Recruiting Study Coordinator +33556795808
Hopital Foch ( Site 0483) | Suresnes, Hauts-de-Seine, 92150, France Recruiting Study Coordinator +0033146251979
CHU de Montpellier - Hopital Saint-Eloi ( Site 0469) | Montpellier, Herault, 34295, France Recruiting Study Coordinator +33467336733
Institut de Cancerologie de l Ouest Site Paul Papin ( Site 0453) | Angers, Maine-et-Loire, 49055, France Recruiting Study Coordinator +33241352734
Hopital Belle Isle ( Site 0452) | Metz, Moselle, 57045, France Recruiting Study Coordinator +33357841590
Institut Sainte Catherine ( Site 0454) | Avignon, Provence-Alpes-Cote-d'Azur, 84000, France Recruiting Study Coordinator +33490276090
Centre Jean Perrin ( Site 0460) | Clermont-Ferrand, Puy-de-Dome, 63011, France Recruiting Study Coordinator +33473278117
Clinique Victor Hugo ( Site 0463) | Le Mans, Sarthe, 72000, France Recruiting Study Coordinator +33243479493
Klinikum der Eberhard-Karls-Universitaet Tuebingen ( Site 0502) | Tuebingen, Baden-Wurttemberg, 72076, Germany Recruiting Study Coordinator +4970712987235
Universitaetsklinikum Erlangen ( Site 0505) | Erlangen, Bayern, 91054, Germany Recruiting Study Coordinator +4991318333122
Universitaetsklinikum Magdeburg A.o.R. ( Site 0516) | Magdeburg, Sachsen-Anhalt, 39120, Germany Recruiting Study Coordinator +493916715036
Universitaetsklinikum Carl Gustav Carus ( Site 0519) | Dresden, Sachsen, 01307, Germany Recruiting Study Coordinator +493514582157
Universitaetsklinikum Schleswig-Holstein-Campus Lubeck ( Site 0512) | Luebeck, Schleswig-Holstein, 23538, Germany Recruiting Study Coordinator +4945150043616
Charite Universitaetsmedizin Berlin ( Site 0515) | Berlin, 10117, Germany Recruiting Study Coordinator +4930450515288
Vivantes Klinikum am Urban ( Site 0522) | Berlin, 10967, Germany Recruiting Study Coordinator +4930130226303
Pecsi Tudomanyegyetem AOK ( Site 1009) | Pecs, Baranya, 7624, Hungary Recruiting Study Coordinator +36302457110
SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 1010) | Szeged, Csongrad, 6720, Hungary Recruiting Study Coordinator +366262545259
Petz Aladar Megyei Oktato Korhaz ( Site 1012) | Gyor, Gyor-Moson-Sopron, 9023, Hungary Recruiting Study Coordinator +36209323256
Bajcsy Zsilinszki Korhaz es Rendelointezet ( Site 1001) | Budapest, 1106, Hungary Recruiting Study Coordinator +36703815172
Debreceni Egyetem Klinikai Kozpont ( Site 1006) | Debrecen, 4032, Hungary Recruiting Study Coordinator +3652255585
Tallaght University Hospital ( Site 0710) | Dublin, D24 DH74, Ireland Recruiting Study Coordinator +35314144259
University Hospital Waterford ( Site 0723) | Waterford, X91 ER8E, Ireland Recruiting Study Coordinator +35351848934
Soroka Medical Center ( Site 0806) | Beer Sheva, HaDarom, 8410101, Israel Recruiting Study Coordinator +972523514527
Meir Medical Center ( Site 0803) | Kfar Saba, HaMerkaz, 4428164, Israel Recruiting Study Coordinator +97297471606
Rabin Medical Center ( Site 0804) | Petach Tikva, HaMerkaz, 4941492, Israel Recruiting Study Coordinator +97239378074
Assaf Harofeh Medical Center ( Site 0805) | Zerifin, HaMerkaz, 7030001, Israel Recruiting Study Coordinator +97289779715
Ha Emek Medical Center ( Site 0808) | Afula, HaTsafon, 1834111, Israel Recruiting Study Coordinator +97246495723
Rambam Medical Center ( Site 0802) | Haifa, Heifa, 3109601, Israel Recruiting Study Coordinator +97247776750
Sheba Medical Center ( Site 0801) | Ramat Gan, Tell Abib, 5265601, Israel Recruiting Study Coordinator +97235302191
Sourasky Medical Center ( Site 0807) | Tel Aviv, Tell Abib, 6423906, Israel Recruiting Study Coordinator +97236973413
Shaare Zedek Medical Center ( Site 0809) | Jerusalem, Yerushalayim, 9103102, Israel Recruiting Study Coordinator +97226666331
A.O.U. Policlinico Vittorio Emanuele - Presidio Gaspare Rodolico ( Site 0559) | Catania, 95123, Italy Recruiting Study Coordinator +390953781518
Istituto Nazionale Studio e Cura dei Tumori ( Site 0551) | Milano, 20133, Italy Recruiting Study Coordinator +390223902402
Policlinico di Modena ( Site 0553) | Modena, 41100, Italy Recruiting Study Coordinator +390594222648
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori ( Site 0552) | Napoli, 80131, Italy Recruiting Study Coordinator +39815903637
Fondazione Salvatore Maugeri IRCCS. ( Site 0554) | Pavia, 27100, Italy Recruiting Study Coordinator +390382592265
Azienda Ospedaliera San Camillo Forlanini ( Site 0560) | Roma, 00152, Italy Recruiting Study Coordinator +390658704356
Policlinico Gemelli di Roma ( Site 0558) | Roma, 00168, Italy Recruiting Study Coordinator +390630154953
Azienda Ospedaliera Santa Maria Terni ( Site 0557) | Terni, 05100, Italy Recruiting Study Coordinator +393294092709
Hirosaki University Hospital ( Site 1502) | Hirosaki, Aomori, 036-8563, Japan Recruiting Study Coordinator +81172335111
National Cancer Center Hospital East ( Site 1504) | Kashiwa, Chiba, 277-8577, Japan Recruiting Study Coordinator +81471331111
Ehime University Hospital ( Site 1508) | Toon, Ehime, 791-0295, Japan Recruiting Study Coordinator +81899645111
Sapporo Medical University Hospital ( Site 1501) | Sapporo, Hokkaido, 060-8543, Japan Recruiting Study Coordinator +81116112111
University of Tsukuba Hospital ( Site 1503) | Tsukuba, Ibaraki, 305-8576, Japan Recruiting Study Coordinator +81298533900
Yokosuka Kyosai Hospital ( Site 1509) | Yokosuka, Kanagawa, 238-8558, Japan Recruiting Study Coordinator +81468222710
Nara Medical University Hospital ( Site 1510) | Kashihara, Nara, 634-8522, Japan Recruiting Study Coordinator +81744223051
Saitama Medical University International Medical Center ( Site 1505) | Hidaka, Saitama, 350-1298, Japan Recruiting Study Coordinator +81429844111
Chiba Cancer Center ( Site 1506) | Chiba, 260-8717, Japan Recruiting Study Coordinator +81432645431
Harasanshin Hospital ( Site 1515) | Fukuoka, 812-0033, Japan Recruiting Study Coordinator +81922913434
Hiroshima City Hiroshima Citizens Hospital ( Site 1513) | Hiroshima, 730-8518, Japan Recruiting Study Coordinator +81822212291
Nagano Municipal Hospital ( Site 1516) | Nagano, 381-8551, Japan Recruiting Study Coordinator +81262951199
Osaka City University Hospital ( Site 1512) | Osaka, 545-8586, Japan Recruiting Study Coordinator +81666452121
Tokushima University Hospital ( Site 1514) | Tokushima, 770-8503, Japan Recruiting Study Coordinator +81886313111
Medical Hospital, Tokyo Medical And Dental University ( Site 1517) | Tokyo, 113-8519, Japan Recruiting Study Coordinator +81338136111
National Cancer Center ( Site 1354) | Goyang-si, Kyonggi-do, 10408, Korea, Republic of Recruiting Study Coordinator +82319201678
Seoul National University Bundang Hospital ( Site 1356) | Seongnam-si, Kyonggi-do, 13620, Korea, Republic of Recruiting Study Coordinator +82317877351
Korea University Anam Hospital ( Site 1351) | Seoul, Seoul-teukbyeolsi [Seoul], 02841, Korea, Republic of Recruiting Study Coordinator +821099288097
Seoul National University Hospital ( Site 1352) | Seoul, Seoul-teukbyeolsi [Seoul], 03080, Korea, Republic of Recruiting Study Coordinator +82220720361
Asan Medical Center ( Site 1355) | Seoul, Seoul-teukbyeolsi [Seoul], 05505, Korea, Republic of Recruiting Study Coordinator +82230103980
Samsung Medical Center ( Site 1353) | Seoul, Seoul-teukbyeolsi [Seoul], 06351, Korea, Republic of Recruiting Study Coordinator +82234103557
Centro de Urologia Avanzada del Noreste S.A. de C.V. ( Site 0254) | Monterrey, Nuevo Leon, 66269, Mexico Recruiting Study Coordinator +528180267452
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V. ( Site 0300) | Aguascalientes, 20010, Mexico Recruiting Study Coordinator +524494735100
Centro Estatal de Cancerologia de Chihuahua ( Site 0253) | Chihuahua, 31000, Mexico Recruiting Study Coordinator +526141420241
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 1062) | Wroclaw, Dolnoslaskie, 50-556, Poland Recruiting Study Coordinator 48601143281
Centrum Onkologii im.prof. F. Lukaszczyka w Bydgoszczy ( Site 1068) | Bydgoszcz, Kujawsko-pomorskie, 85-796, Poland Recruiting Study Coordinator +48501446778
Europejskie Centrum Zdrowia Otwock ( Site 1057) | Otwock, Mazowieckie, 05-400, Poland Recruiting Study Coordinator +48601200599
Magodent Szpital Elblaska ( Site 1051) | Warszawa, Mazowieckie, 01-748, Poland Recruiting Study Coordinator +48691666578
Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1060) | Bielsko-Biala, Slaskie, 43-300, Poland Recruiting Study Coordinator 48606399091
Ivanovo Regional Oncology Dispensary ( Site 0852) | Ivanovo, Ivanovskaya Oblast', 153040, Russian Federation Recruiting Study Coordinator +79106672833
Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0861) | Krasnoyarsk, Krasnoyarskiy Kray, 660133, Russian Federation Recruiting Study Coordinator +79135349316
Kursk Regional Clinical Oncology Dispensary ( Site 0854) | Kursk, Kurskaya Oblast', 305524, Russian Federation Recruiting Study Coordinator +79103113475
Central Clinical Hospital with outpatient Clinic ( Site 0856) | Moscow, Moskva, 121359, Russian Federation Recruiting Study Coordinator +79031691379
Bayandin Murmansk Regional Clinical Hospital ( Site 0859) | Murmansk, Murmanskaya Oblast', 183057, Russian Federation Recruiting Study Coordinator +79217252994
Volga District Medical Center Federal Medical and Biological Agency ( Site 0857) | Nizhny Novgorod, Nizhegorodskaya Oblast', 603074, Russian Federation Recruiting Study Coordinator +78314216977
Omsk Clinical Oncology Dispensary ( Site 0865) | Omsk, Omskaya Oblast', 644013, Russian Federation Recruiting Study Coordinator +79139885114
Leningrad Regional Oncology Center ( Site 0868) | Saint Petersburg, Sankt-Peterburg, 188663, Russian Federation Recruiting Study Coordinator +79219410363
Clinical Hospital Saint Luka ( Site 0867) | St. Petersburg, Sankt-Peterburg, 194044, Russian Federation Recruiting Study Coordinator +79817217460
Saratov State Medical University n.a. V.I.Razumovskiy ( Site 0866) | Saratov, Saratovskaya Oblast', 410012, Russian Federation Recruiting Study Coordinator +79271233801
Hospital del Mar ( Site 0653) | Barcelona, Barcelona [Barcelona], 08003, Spain Recruiting Study Coordinator +34932483139
H. de Gerona Dr. Josep Trueta ( Site 0651) | Girona, Girona [Gerona], 17007, Spain Recruiting Study Coordinator +349722258284028
Hospital Universitario Quiron Madrid ( Site 0657) | Pozuelo de Alarcon, Madrid, 28223, Spain Recruiting Study Coordinator +34914521987
Instituto Valenciano de Oncologia - IVO ( Site 0662) | Valencia, Valenciana, Comunitat, 46009, Spain Recruiting Study Coordinator +34961114605
Hospital San Pedro de Alcantara ( Site 0654) | Caceres, 10003, Spain Recruiting Study Coordinator +34927256200
Hospital Universitario Ramon y Cajal ( Site 0660) | Madrid, 28034, Spain Recruiting Study Coordinator +34913368263
Hospital Universitario San Carlos ( Site 0663) | Madrid, 28040, Spain Recruiting Study Coordinator +349133030007554
Hospital Universitario La Paz ( Site 0661) | Madrid, 28046, Spain Recruiting Study Coordinator +34912071138
Hospital Nuestra Sra. de Valme ( Site 0658) | Sevilla, 41014, Spain Recruiting Study Coordinator +34955015000
Laenssjukhuset Ryhov ( Site 1205) | Jonkoping, Jonkopings Lan [se-06], 551 85, Sweden Recruiting Study Coordinator +46102428577
Akademiska Sjukhuset ( Site 1201) | Uppsala, Uppsala Lan [se-03], 751 85, Sweden Recruiting Study Coordinator +46186110000
Cancercentrum ( Site 1204) | Umea, Vasterbottens Lan [se-24], 901 89, Sweden Recruiting Study Coordinator +46907853296
Faculty of Medicine Siriraj Hospital ( Site 1452) | Bangkok, Krung Thep Maha Nakhon, 10700, Thailand Recruiting Study Coordinator +6624194488
Maharaj Nakorn Chiangmai Hospital ( Site 1453) | Chiang Mai, 50200, Thailand Recruiting Study Coordinator +66539455324
Hacettepe Universitesi Tıp Fakultesi ( Site 0911) | Ankara, 06100, Turkey Recruiting Study Coordinator +905327233093
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0910) | Istanbul, 34096, Turkey Recruiting Study Coordinator +905324167355
Medeniyet Uni. Goztepe Egitim ve Arast. Hast. ( Site 0906) | Istanbul, 34732, Turkey Recruiting Study Coordinator +905324543079
Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 0901) | Istanbul, 34899, Turkey Recruiting Study Coordinator +905333832234
Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 0909) | Konya, 42080, Turkey Recruiting Study Coordinator +905322679838
Sakarya Universitesi Tip Fakultesi ( Site 0913) | Sakarya, 54290, Turkey Recruiting Study Coordinator +905054785576
Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi ( Site 0904) | Trabzon, 61080, Turkey Recruiting Study Coordinator +905052292035
Cherkasy Regional Oncology Dispensary ( Site 0959) | Cherkasy, Cherkaska Oblast, 18009, Ukraine Recruiting Study Coordinator +380501606360
MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov ( Site 0963) | Dnipropetrovsk, Dnipropetrovska Oblast, 49005, Ukraine Recruiting Study Coordinator +380567134785
Regional Oncological Hospital ( Site 0956) | Dnipro, Dnipropetrovska Oblast, 49055, Ukraine Recruiting Study Coordinator +380687400930
Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC ( Site 0951) | Dnipro, Dnipropetrovska Oblast, 49102, Ukraine Recruiting Study Coordinator +380675625054
Reg. Clinical Center of Urology and Nephrology n.a. V. I. Shapoval ( Site 0969) | Kharkiv, Kharkivska Oblast, 61037, Ukraine Recruiting Study Coordinator +380577387134
Regional Oncology Center of Kharkiv ( Site 0958) | Kharkiv, Kharkivska Oblast, 61070, Ukraine Recruiting Study Coordinator +380508266088
National Cancer Institute of the MoH of Ukraine ( Site 0962) | Kyiv, Kyivska Oblast, 03022, Ukraine Recruiting Study Coordinator +380672365175
Kyiv City Clinical Oncology Center ( Site 0960) | Kyiv, Kyivska Oblast, 03115, Ukraine Recruiting Study Coordinator +380667027558
Lviv Regional Clinical Hospital ( Site 0955) | Lviv, Lvivska Oblast, 79000, Ukraine Recruiting Study Coordinator +380677280861
Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 0967) | Lviv, Lvivska Oblast, 79031, Ukraine Recruiting Study Coordinator +380973317578
Kent and Canterbury Hospital ( Site 0709) | Canterbury, Kent, CT1 3NG, United Kingdom Recruiting Study Coordinator +441227766877
Imperial College Healthcare NHS Trust ( Site 0721) | London, London, City Of, W6 8RF, United Kingdom Recruiting Study Coordinator +442033117627
Norfolk & Norwich University Hospital NHS Foundation Trust ( Site 0725) | Norwich, Norfolk, NR4 7UY, United Kingdom Recruiting Study Coordinator +441603287226
Royal Cornwall Hospital ( Site 0703) | Truro, TR1 3LJ, United Kingdom Recruiting Study Coordinator 441872250000
Location Countries

Australia

Belgium

Canada

Denmark

France

Germany

Hungary

Ireland

Israel

Italy

Japan

Korea, Republic of

Mexico

Poland

Russian Federation

Spain

Sweden

Thailand

Turkey

Ukraine

United Kingdom

United States

Verification Date

May 2020

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Pembrolizumab + Gemcitabine + Cisplatin + Surgery

Arm group type: Experimental

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

Arm group label: Placebo + Gemcitabine + Cisplatin + Surgery

Arm group type: Placebo Comparator

Description: 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.

Acronym KEYNOTE-866
Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking description: Double-blind

Source: ClinicalTrials.gov