A Phase 3 Randomized Study of Cystectomy Plus Perioperative Pembrolizumab Versus Cystectomy Alone in Cisplatin-ineligible Participants With Muscle-invasive Bladder Cancer (KEYNOTE-905)

Perioperative Pembrolizumab (MK-3475) Plus Cystectomy Versus Cystectomy Alone in Cisplatin-ineligible Participants With Muscle-invasive Bladder Cancer (MK-3475-905/KEYNOTE-905)

Sponsors

Lead sponsor: Merck Sharp & Dohme Corp.

Source Merck Sharp & Dohme Corp.
Brief Summary

A global, randomized phase III study to evaluate perioperative pembrolizumab with radical cystectomy + pelvic lymph node dissection (RC+PLND) versus RC+PLND alone in cisplatin-ineligible patients with muscle-invasive bladder cancer (MIBC).

Overall Status Recruiting
Start Date July 24, 2019
Completion Date February 16, 2026
Primary Completion Date February 12, 2025
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Pathologic Complete Response (pCR) Rate in All Participants Up to approximately 3 months (Time of surgery)
Pathologic Complete Response Rate in Participants Whose Tumors Express PD-L1 Combined Positive Score (CPS) ≥10 Up to approximately 3 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 6.5 years
Overall Survival in Participants Whose Tumors Express PD-L1, CPS ≥10 Up to approximately 6.5 years
Disease-Free Survival (DFS) in All Participants Up to approximately 5.5 years
Disease-Free Survival in Participants Whose Tumors Express PD-L1, CPS ≥10 Up to approximately 5.5 years
Pathologic Downstaging (pDS) Rate in All Participants Up to approximately 3 months (Time of surgery)
Pathologic Downstaging (pDS) Rate in Participants Whose Tumors Express PD-L1, CPS ≥10 Up to approximately 3 months (Time of surgery)
Number of Participants Experiencing Adverse Events (AEs) Up to approximately 6.5 years
Number of Participants Discontinuing Study Drug Due to Adverse Events (AEs) Up to approximately 1 year
Number of Participants Experiencing Perioperative Complications Up to approximately 1 year
Enrollment 610
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 + Surgery

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.

Eligibility

Criteria:

Inclusion Criteria:

- Histologically confirmed diagnosis of muscle invasive bladder cancer (T2-T4aN0M0) with predominant (≥50%) urothelial histology. Participants with mixed histology are eligible provided the urothelial component is ≥50%. Urothelial carcinomas not originating from the bladder are not eligible. Participants whose tumors contain any neuroendocrine component are not eligible.

- Clinically non-metastatic bladder cancer determined by imaging

- Eligible for radical cystectomy (RC) + pelvic lymph node dissection (PLND ), and agreement to undergo curative intent standard RC + PLND (including prostatectomy if applicable)

- Ineligible for treatment with cisplatin, as defined by meeting at least one of the following criteria:

- Impaired renal function with measured or calculated CrCl 30 to 59 mL/min

- Eastern Cooperative Oncology Group (ECOG) Performance Status 2

- Common Terminology Criteria for Adverse Events (CTCAE) v.4 Grade ≥2 audiometric hearing loss

- CTCAE v.4 Grade ≥2 peripheral neuropathy

- New York Heart Association (NYHA) Class III heart failure

- Transurethral resection (TUR) of a bladder tumor that is submitted and adequate for evaluation of histology, muscle invasion and PD-L1 status

- ECOG performance status of 0, 1, or 2

- Adequate organ function

Exclusion Criteria:

- Known additional non-urothelial malignancy that is progressing or has required active treatment ≤3 years of study randomization, with certain exceptions

- Received any prior systemic anti-neoplastic treatment for muscle-invasive bladder cancer (MIBC)

- Received prior therapy with a anti-programmed cell death protein 1 (PD-1), anti-programmed death-ligand 1 (PD-L1), or anti-programmed cell death 1 ligand 2 (PD-L2), or with an agent directed to another stimulatory or co-inhibitory T-cell receptor

- Received prior systemic anti-cancer therapy including investigational agents within 3 years prior to randomization

- Received any prior radiotherapy to the bladder

- Received a live vaccine within 30 days prior to the first dose of study drug

- Current participation in or participation in a study of an investigational agent or use of an investigational device within 4 weeks prior to the first dose of study intervention

- Diagnosis of immunodeficiency or receipt of chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug

- Hypersensitivity to monoclonal antibodies (including pembrolizumab) and/or any of their excipients

- Active autoimmune disease that has required systemic therapy in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic therapy and is allowed.

- History of (non-infectious) pneumonitis that required steroids, or current pneumonitis.

- 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
John Wayne Cancer Institute ( 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
Emory University ( Site 0006) | Atlanta, Georgia, 30322, United States Recruiting Study Coordinator 404-778-4823
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
Wichita Urology Group ( Site 0059) | Wichita, Kansas, 67226, United States Recruiting Study Coordinator 316-636-6141
Greater Baltimore Medical Center ( Site 0014) | Baltimore, Maryland, 21204, United States Recruiting Study Coordinator 443-849-3285
Morristown Medical Center ( Site 0015) | Morristown, New Jersey, 07962, United States Recruiting Study Coordinator 973-971-5373
The University of New Mexico Comprehensive 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
Icahn School of Medicine at Mount Sinai ( Site 0031) | New York, New York, 10029, United States Recruiting Study Coordinator 212-659-5452
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0021) | Tulsa, Oklahoma, 74146, United States Recruiting Study Coordinator 918-505-3200
Abramson Cancer Center of the University of Pennsylvania ( Site 0074) | Philadelphia, Pennsylvania, 19104, United States Recruiting Study Coordinator 215-614-1842
Fox Chase Cancer Center ( Site 0055) | Philadelphia, Pennsylvania, 19111, United States Recruiting Study Coordinator 215-728-1133
Allegheny General Hospital ( Site 0048) | Pittsburgh, Pennsylvania, 15212, United States Recruiting Study Coordinator 412-359-8373
Carolina Urologic Research Center ( Site 0062) | Myrtle Beach, South Carolina, 29572, United States Recruiting Study Coordinator 8434491010257
Urology Associates [Nashville, TN] ( Site 0053) | Nashville, Tennessee, 37209, United States Recruiting Study Coordinator 615-250-9268
Vanderbilt University Medical Center ( Site 0017) | Nashville, Tennessee, 37232, United States Recruiting Study Coordinator 615-936-5173
Inova Schar Cancer Institute ( Site 0007) | Fairfax, Virginia, 22031, United States Recruiting Study Coordinator 571-472-0623
Charleston Area Medical Center ( Site 0023) | Charleston, West Virginia, 25304, United States Recruiting Study Coordinator 304-388-9944
Western Sydney Local Health District ( Site 1259) | Blacktown, New South Wales, 2148, Australia Recruiting Study Coordinator +61411462609
Macquarie University ( Site 1251) | Macquarie Park, New South Wales, 2109, Australia Recruiting Study Coordinator +61298123500
Cairns Base Hospital ( Site 1257) | Cairns, Queensland, 4870, Australia Recruiting Study Coordinator +61742268085
Mater Misericordiae Ltd ( Site 1258) | South Brisbane, Queensland, 4101, Australia Recruiting Study Coordinator +61731769289
Eastern Health ( Site 1255) | Box Hill, Victoria, 3128, Australia Recruiting Study Coordinator +61398953585
Monash Health ( Site 1260) | Clayton, Victoria, 3168, Australia Recruiting Study Coordinator +61395086161
UCL Saint-Luc - Oncologie Medicale ( Site 0357) | Bruxelles, Bruxelles-Capitale, Region De, 1200, Belgium Recruiting Study Coordinator +3227649457
CHU UCL Namur Site de Godinne ( Site 0354) | Yvoir, Namur, 5530, Belgium Recruiting Study Coordinator +3281423858
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
Silverado Resarch Inc. ( Site 0111) | Victoria, British Columbia, V8T 2C1, Canada Recruiting Study Coordinator 2505929998
Moncton Hospital - Horizon Health Network ( Site 0112) | Moncton, New Brunswick, E1C 6Z8, Canada Recruiting Study Coordinator 5068575076
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
CIUSSS de l'Estrie-CHUS ( Site 0106) | Sherbrooke, Quebec, J1H 5N4, Canada Recruiting Study Coordinator 819346111012827
Herlev og Gentofte Hospital. ( Site 0412) | Herlev, Hovedstaden, 2730, Denmark Recruiting Study Coordinator +4538683494
Rigshospitalet University Hospital ( Site 0411) | Kobenhavn, Hovedstaden, 2100, Denmark Recruiting Study Coordinator +4535458403
Odense Universitetshospital ( Site 0413) | Odense, Syddanmark, 5000, Denmark Recruiting Study Coordinator +4524998173
Centre Francois Baclesse ( Site 0459) | Caen, Calvados, 14076, France Recruiting Study Coordinator +33231455002
Centre Georges Francois Leclerc ( Site 0488) | Dijon, Cote-d'Or, 21000, France Recruiting Study Coordinator +33380293761
CHU Jean Minjoz ( Site 0455) | Besancon, Doubs, 25000, France Recruiting Study Coordinator +33370632403
Institut Claudius Regaud IUCT Oncopole ( Site 0486) | Toulouse, Haute-Garonne, 31059, France Recruiting Study Coordinator +33531155993
Hopital Belle Isle ( Site 0452) | Metz, Moselle, 57045, France Recruiting Study Coordinator +0357841650
C.H.U. Lyon Sud ( Site 0466) | Pierre Benite, Rhone, 69310, France Recruiting Study Coordinator +33478864324
Institut Gustave Roussy ( Site 0487) | Villejuif, Val-de-Marne, 94805, France Recruiting Study Coordinator +33142115348
CHU Cochin ( Site 0475) | Paris, 75014, France Recruiting Study Coordinator +33158411439
Hopital Europeen Georges Pompidou ( Site 0476) | Paris, 75015, France Recruiting Study Coordinator +33156093447
Klinikum der Eberhard-Karls-Universitaet Tuebingen ( Site 0549) | Tuebingen, Baden-Wurttemberg, 72076, Germany Recruiting Study Coordinator +4970712987235
Universitaetsklinikum Magdeburg A.o.R. ( Site 0535) | Magdeburg, Sachsen-Anhalt, 39120, Germany Recruiting Study Coordinator +493916715034
Universitaetsklinikum Carl Gustav Carus ( Site 0532) | Dresden, Sachsen, 01307, Germany Recruiting Study Coordinator +493514582447
Vivantes Klinikum am Urban ( Site 0529) | Berlin, 10967, Germany Recruiting Study Coordinator +4930130226301
SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 1010) | Szeged, Csongrad, 6720, Hungary Recruiting Study Coordinator +3662545405
Petz Aladar Megyei Oktato Korhaz ( Site 1012) | Gyor, Gyor-Moson-Sopron, 9023, Hungary Recruiting Study Coordinator +36203310075
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 0734) | Dublin, D24 NR0A, Ireland Recruiting Study Coordinator +35314144259
University Hospital Waterford ( Site 0747) | Waterford, X91 ER8E, Ireland Recruiting Study Coordinator +35351848934
Soroka Medical Center ( Site 0849) | Beer Sheva, HaDarom, 8410101, Israel Recruiting Study Coordinator +972523514527
Meir Medical Center ( Site 0846) | Kfar Saba, HaMerkaz, 4428164, Israel Recruiting Study Coordinator +97297471606
Rabin Medical Center ( Site 0847) | Petach Tikva, HaMerkaz, 4941492, Israel Recruiting Study Coordinator +97239378074
Assaf Harofeh Medical Center ( Site 0848) | Zerifin, HaMerkaz, 7030001, Israel Recruiting Study Coordinator +97289779715
Ha Emek Medical Center ( Site 0843) | Afula, HaTsafon, 1834111, Israel Recruiting Study Coordinator +97246495723
Rambam Medical Center ( Site 0845) | Afula, HaTsafon, 1834111, Israel Recruiting Study Coordinator +97247776750
Sheba Medical Center ( Site 0844) | Ramat Gan, Tell Abib, 5265601, Israel Recruiting Study Coordinator +97235302191
Sourasky Medical Center ( Site 0850) | Tel Aviv, Tell Abib, 6423906, Israel Recruiting Study Coordinator +97236973413
Shaare Zedek Medical Center ( Site 0842) | 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
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
Policlinico Gemelli di Roma ( Site 0558) | Roma, 00168, Italy Recruiting Study Coordinator +390458128116
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 0253) | 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 0254) | Chihuahua, 31000, Mexico Recruiting Study Coordinator +526141420241
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 1063) | 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 +48605680944
Szpital Wojewodzki ( Site 1062) | Tarnow, Malopolskie, 33-100, Poland Recruiting Study Coordinator +48602280826
Europejskie Centrum Zdrowia Otwock ( Site 1058) | Otwock, Mazowieckie, 05-400, Poland Recruiting Study Coordinator +48227103025
Magodent Szpital Elblaska ( Site 1051) | Warszawa, Mazowieckie, 01-748, Poland Recruiting Study Coordinator +48224308700
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku ( Site 1057) | Slupsk, Pomorskie, 76-200, Poland Recruiting Study Coordinator +48598460705
Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1061) | 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 0698) | Barcelona, Barcelona [Barcelona], 08003, Spain Recruiting Study Coordinator +34932483139
Hospital Universitario de Girona Doctor Josep Trueta ( Site 0700) | Girona, Girona [Gerona], 17007, Spain Recruiting Study Coordinator +349722258284028
Hospital Universitario Quiron Madrid ( Site 0694) | Pozuelo de Alarcon, Madrid, 28223, Spain Recruiting Study Coordinator +34914521987
Instituto Valenciano de Oncologia - IVO ( Site 0679) | Valencia, Valenciana, Comunitat, 46009, Spain Recruiting Study Coordinator +34961114605
Hospital San Pedro de Alcantara ( Site 0697) | Caceres, 10003, Spain Recruiting Study Coordinator +34927256200
Hospital Universitario Ramon y Cajal ( Site 0691) | Madrid, 28034, Spain Recruiting Study Coordinator +34913368263
Hospital Universitario San Carlos ( Site 0678) | Madrid, 28040, Spain Recruiting Study Coordinator +34913303000ext7554
Hospital Universitario la Paz ( Site 0690) | Madrid, 28046, Spain Recruiting Study Coordinator +34912071138
Hospital de Nuestra Senora de Valme ( Site 0693) | Sevilla, 41014, Spain Recruiting Study Coordinator +34955015000
Onkologiska kliniken ( Site 1212) | Solna, Stockholms Lan [se-01], 171 64, Sweden Recruiting Study Coordinator +4646768936655
Akademiska Sjukhuset ( Site 1211) | Uppsala, Uppsala Lan [se-03], 751 85, Sweden Recruiting Study Coordinator +46186110000
Cancercentrum ( Site 1214) | 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 0931) | Ankara, 06100, Turkey Recruiting Study Coordinator +905327233093
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0930) | Istanbul, 34096, Turkey Recruiting Study Coordinator +905324167355
Medeniyet Universitesi Goztepe Egitim ve Arastirma Hastanesi ( Site 0926) | Istanbul, 34722, Turkey Recruiting Study Coordinator +905323430723
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 0921) | Istanbul, 34899, Turkey Recruiting Study Coordinator +905333832234
Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 0929) | Konya, 42080, Turkey Recruiting Study Coordinator +905334150753
Sakarya Universitesi Tip Fakultesi ( Site 0933) | Sakarya, 54290, Turkey Recruiting Study Coordinator +905054785576
Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi ( Site 0924) | 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
Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC ( Site 0951) | Dnipro, Dnipropetrovska Oblast, 49102, Ukraine Recruiting Study Coordinator +380675625054
Regional Oncology Center of Kharkiv ( Site 0958) | Kharkiv, Kharkivska Oblast, 61000, Ukraine Recruiting Study Coordinator +380508266088
Reg. Clinical Center of Urology and Nephrology n.a. V. I. Shapoval ( Site 0969) | Kharkiv, Kharkivska Oblast, 61037, Ukraine Recruiting Study Coordinator +380577387134
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 Regional Oncological Center ( Site 0967) | Lviv, Lvivska Oblast, 79031, Ukraine Recruiting Study Coordinator +380973317578
Western General Hospital ( Site 0749) | Edinburgh, Edinburgh, City Of, EH4 2XU, United Kingdom Recruiting Study Coordinator +441315372211
Kent and Canterbury Hospital ( Site 0733) | Canterbury, Kent, CT1 3NG, United Kingdom Recruiting Study Coordinator +441227766877
Barts Health NHS Trust - St Bartholomew s Hospital ( Site 0725) | London, London, City Of, EC1A 7BE, United Kingdom Recruiting Study Coordinator +442078828505
Imperial College Healthcare NHS Trust ( Site 0745) | London, London, City Of, W6 8RF, United Kingdom Recruiting Study Coordinator +442033117627
Royal Cornwall Hospital ( Site 0727) | Truro, TR1 3LJ, United Kingdom Recruiting Study Coordinator 4418722500
Location Countries

Australia

Belgium

Canada

Denmark

France

Germany

Hungary

Ireland

Israel

Italy

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 + Surgery

Arm group type: Experimental

Description: Participants receive 3 preoperative cycles of pembrolizumab, followed by standard of care surgery, followed by up to 14 cycles of postoperative pembrolizumab.

Arm group label: Surgery alone

Arm group type: Active Comparator

Description: Participants receive standard of care surgery alone.

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov