SUPPORT HOTLINE (888) 901-2226
Donate Now

BRIEF TITLE: Study of Cystectomy Plus Perioperative Pembrolizumab Versus Cystectomy Alone in Cisplatin-ineligible Participants With Muscle-invasive Bladder Cancer (KEYNOTE-905)

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


  • Org Study ID: 3475-905
  • Secondary ID: MK-3475-905,2018-003809-26,KEYNOTE-905
  • NCT ID: NCT03924895
  • NCT Alias:
  • Sponsor: Merck Sharp & Dohme Corp. - Industry
  • 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).

Overal Status Start Date Phase Study Type
Recruiting July 24, 2019 Phase 3 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Pathologic Complete Response (pCR) Rate in All Participants

Primary Outcome 1 - Time Frame: Up to approximately 3 months (Time of surgery)

Primary Outcome 2 - Measure: Pathologic Complete Response Rate in Participants Whose Tumors Express PD-L1 Combined Positive Score (CPS) ≥10

Primary Outcome 2 - Time Frame: Up to approximately 3 months (Time of surgery)

Primary Outcome 3 - Measure: Event-Free Survival (EFS) in All Participants

Primary Outcome 3 - Time Frame: Up to approximately 5.5 years

Primary Outcome 4 - Measure: Event-Free Survival in Participants Whose Tumors Express PD-L1, CPS ≥10

Primary Outcome 4 - Time Frame: Up to approximately 5.5 years

Condition:

  • Urinary Bladder Cancer, Muscle-invasive

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
Show More

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Medical Director

Role: Study Director

Affiliation: Merck Sharp & Dohme Corp.

Overall Contact

Name: Toll Free Number

Phone: 1-888-577-8839

Email: Trialsites@merck.com

Locations

Facility Status Contact
Scripps MD Anderson ( Site 0010)
La Jolla, California 92037
United States
Recruiting Study Coordinator
858-554-8367
Providence St. John's Hospital ( 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
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
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
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
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
Cairns Base Hospital ( Site 1257)
Cairns, Queensland 4870
Australia
Recruiting Study Coordinator
+61742268085
AZ Maria Middelares Gent ( Site 0353)
Gent, 9000
Belgium
Recruiting Study Coordinator
+3292469522
CHU UCL Namur Site de Godinne ( Site 0354)
Yvoir, 5530
Belgium
Recruiting Study Coordinator
+3281423858
CIUSSS de l'Estrie-CHUS ( Site 0106)
Sherbrooke, Quebec J1H 5N4
Canada
Recruiting Study Coordinator
819346111012827
Herlev og Gentofte Hospital. ( Site 0412)
Herlev, 2730
Denmark
Recruiting Study Coordinator
+4538683494
Rigshospitalet University Hospital ( Site 0411)
Kobenhavn, 2100
Denmark
Recruiting Study Coordinator
+4535458403
Odense Universitetshospital ( Site 0413)
Odense, 5000
Denmark
Recruiting Study Coordinator
+4524998173
Universitaetsklinikum Carl Gustav Carus ( Site 0532)
Dresden, 01307
Germany
Recruiting Study Coordinator
+493514582447
Klinikum der Eberhard-Karls-Universitaet Tuebingen ( Site 0549)
Tuebingen, 72076
Germany
Recruiting Study Coordinator
+4970712987235
Bajcsy Zsilinszki Korhaz es Rendelointezet ( Site 1001)
Budapest, 1106
Hungary
Recruiting Study Coordinator
+36703815172
Petz Aladar Megyei Oktato Korhaz ( Site 1012)
Gyor, 9023
Hungary
Recruiting Study Coordinator
+36203310075
Soroka Medical Center ( Site 0849)
Beer Sheva, 8410101
Israel
Recruiting Study Coordinator
+972523514527
Rambam Medical Center ( Site 0845)
Haifa, 3109601
Israel
Recruiting Study Coordinator
+97247776750
Rabin Medical Center ( Site 0847)
Petach Tikva, 4941492
Israel
Recruiting Study Coordinator
+97239378074
Sheba Medical Center ( Site 0844)
Ramat Gan, 5265601
Israel
Recruiting Study Coordinator
+97235302191
Sourasky Medical Center ( Site 0850)
Tel Aviv, 6423906
Israel
Recruiting Study Coordinator
+97236973413
Assaf Harofeh Medical Center ( Site 0848)
Zerifin, 7030001
Israel
Recruiting Study Coordinator
+97289779715
A.O.U. Policlinico Vittorio Emanuele - Presidio Gaspare Rodolico ( Site 0559)
Catania, 95123
Italy
Recruiting Study Coordinator
+390953781518
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, Gyeonggi-do 10408
Korea, Republic of
Recruiting Study Coordinator
+82319201678
Seoul National University Bundang Hospital ( Site 1356)
Seongnam-si, Gyeonggi-do 13620
Korea, Republic of
Recruiting Study Coordinator
+82317877351
Korea University Anam Hospital ( Site 1351)
Seoul, 02841
Korea, Republic of
Recruiting Study Coordinator
+821099288097
Seoul National University Hospital ( Site 1352)
Seoul, 03080
Korea, Republic of
Recruiting Study Coordinator
+82220720361
Asan Medical Center ( Site 1355)
Seoul, 05505
Korea, Republic of
Recruiting Study Coordinator
+82230103980
Samsung Medical Center ( Site 1353)
Seoul, 06351
Korea, Republic of
Recruiting Study Coordinator
+82234103557
Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1061)
Bielsko-Biala, 43-300
Poland
Recruiting Study Coordinator
+48606399091
Centrum Onkologii im.prof. F. Lukaszczyka w Bydgoszczy ( Site 1068)
Bydgoszcz, 85-796
Poland
Recruiting Study Coordinator
+48501446778
Europejskie Centrum Zdrowia Otwock ( Site 1058)
Otwock, 05-400
Poland
Recruiting Study Coordinator
+48601200599
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku ( Site 1057)
Slupsk, 76-200
Poland
Recruiting Study Coordinator
+48604650631
Szpital Wojewodzki ( Site 1062)
Tarnow, 33-100
Poland
Recruiting Study Coordinator
+48602280826
Magodent Szpital Elblaska ( Site 1051)
Warszawa, 01-748
Poland
Recruiting Study Coordinator
+48691666578
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 1063)
Wroclaw, 50-556
Poland
Recruiting Study Coordinator
+48601143281
Ivanovo Regional Oncology Dispensary ( Site 0852)
Ivanovo, 153040
Russian Federation
Recruiting Study Coordinator
+79106672833
Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0861)
Krasnoyarsk, 644013
Russian Federation
Recruiting Study Coordinator
+79135349316
Kursk Regional Clinical Oncology Dispensary ( Site 0854)
Kursk, 305524
Russian Federation
Recruiting Study Coordinator
+79103113475
Central Clinical Hospital with outpatient Clinic ( Site 0856)
Moscow, 121359
Russian Federation
Recruiting Study Coordinator
+79031691379
Bayandin Murmansk Regional Clinical Hospital ( Site 0859)
Murmansk, 183057
Russian Federation
Recruiting Study Coordinator
+79217252994
Volga District Medical Center Federal Medical and Biological Agency ( Site 0857)
Nizhny Novgorod, 603074
Russian Federation
Recruiting Study Coordinator
+78314216977
Omsk Clinical Oncology Dispensary ( Site 0865)
Omsk, 644013
Russian Federation
Recruiting Study Coordinator
+79139885114
Leningrad Regional Oncology Center ( Site 0868)
Saint Petersburg, 188663
Russian Federation
Recruiting Study Coordinator
+79219410363
Clinical Hospital Saint Luka ( Site 0867)
Saint-Petersburg, 194044
Russian Federation
Recruiting Study Coordinator
+79817217460
Saratov State Medical University n.a. V.I.Razumovskiy ( Site 0866)
Saratov, 410012
Russian Federation
Recruiting Study Coordinator
+79271233801
Hospital San Pedro de Alcantara ( Site 0697)
Caceres, Extremadura 10003
Spain
Recruiting Study Coordinator
+34927256200
Hospital Universitario Quiron Madrid ( Site 0694)
Pozuelo de Alarcon, Madrid 28223
Spain
Recruiting Study Coordinator
+34914521987
Hospital del Mar ( Site 0698)
Barcelona, 08003
Spain
Recruiting Study Coordinator
+34932483139
Hospital Universitario de Girona Doctor Josep Trueta ( Site 0700)
Girona, 17007
Spain
Recruiting Study Coordinator
+349722258284028
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
Instituto Valenciano de Oncologia - IVO ( Site 0679)
Valencia, 46009
Spain
Recruiting Study Coordinator
+34961114605
Cancercentrum ( Site 1214)
Umea, 901 89
Sweden
Recruiting Study Coordinator
+46907853296
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
Barts Health NHS Trust - St Bartholomew s Hospital ( Site 0725)
London, EC1A 7BE
United Kingdom
Recruiting Study Coordinator
+442078828505
Royal Cornwall Hospital ( Site 0727)
Truro, TR1 3LJ
United Kingdom
Recruiting Study Coordinator
4418722500