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BRIEF TITLE: 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)

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)


  • Org Study ID: 3475-866
  • Secondary ID: 2018-003808-39,MK-3475-866,KEYNOTE-866,194870
  • NCT ID: NCT03924856
  • NCT Alias:
  • Sponsor: Merck Sharp & Dohme Corp. - Industry
  • 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.

Overal Status Start Date Phase Study Type
Recruiting June 13, 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 4 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 4 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:

- 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.
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 Saint John's Health Center ( Site 0075)
Santa Monica, California 90404
United States
Recruiting Study Coordinator
310-582-7456
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
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
Mercy Hospital Saint Louis ( Site 0064)
Saint Louis, Missouri 63141
United States
Recruiting Study Coordinator
314-251-7061
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0021)
Tulsa, Oklahoma 74146
United States
Recruiting Study Coordinator
918-505-3200
Allegheny General Hospital ( Site 0048)
Pittsburgh, Pennsylvania 15212
United States
Recruiting Study Coordinator
412-359-8373
Northwest Medical Specialties, PLLC ( Site 0061)
Tacoma, Washington 98405
United States
Recruiting Study Coordinator
253-428-8753
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
Peninsula Health Frankston Hospital ( Site 1258)
Frankston, Victoria 3199
Australia
Recruiting Study Coordinator
+61397848520
O.L.V. Ziekenhuis Aalst ( Site 0356)
Aalst, 9300
Belgium
Recruiting Study Coordinator
+3253724378
AZ Maria Middelares Gent ( Site 0353)
Gent, 9000
Belgium
Recruiting Study Coordinator
+3292469522
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, 2730
Denmark
Recruiting Study Coordinator
+4538686518
Rigshospitalet University Hospital ( Site 0401)
Kobenhavn, 2100
Denmark
Recruiting Study Coordinator
+4534458403
Universitaetsklinikum Carl Gustav Carus ( Site 0519)
Dresden, 01307
Germany
Recruiting Study Coordinator
+493514582157
Soroka Medical Center ( Site 0806)
Beer Sheva, 8410101
Israel
Recruiting Study Coordinator
+972523514527
Rambam Medical Center ( Site 0802)
Haifa, 3109601
Israel
Recruiting Study Coordinator
+97247776750
Rabin Medical Center ( Site 0804)
Petach Tikva, 4941492
Israel
Recruiting Study Coordinator
+97239378074
Sheba Medical Center ( Site 0801)
Ramat Gan, 5265601
Israel
Recruiting Study Coordinator
+97235302191
Sourasky Medical Center ( Site 0807)
Tel Aviv, 6423906
Israel
Recruiting Study Coordinator
+97236973413
Assaf Harofeh Medical Center ( Site 0805)
Zerifin, 7030001
Israel
Recruiting Study Coordinator
+97289779715
Fondazione Salvatore Maugeri IRCCS. ( Site 0554)
Pavia, PV 27100
Italy
Recruiting Study Coordinator
+390382592265
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori ( Site 0552)
Napoli, 80131
Italy
Recruiting Study Coordinator
+39815903637
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
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
Yokosuka Kyosai Hospital ( Site 1509)
Yokosuka, Kanagawa 238-8558
Japan
Recruiting Study Coordinator
+81468222710
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
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 1060)
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 1057)
Otwock, 05-400
Poland
Recruiting Study Coordinator
+48601200599
Magodent Szpital Elblaska ( Site 1051)
Warszawa, 01-748
Poland
Recruiting Study Coordinator
+48691666578
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 1062)
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, 660133
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 0654)
Caceres, Extremadura 10003
Spain
Recruiting Study Coordinator
+34927256200
Hospital Universitario Quiron Madrid ( Site 0657)
Pozuelo de Alarcon, Madrid 28223
Spain
Recruiting Study Coordinator
+34914521987
Hospital del Mar ( Site 0653)
Barcelona, 08003
Spain
Recruiting Study Coordinator
+34932483139
H. de Gerona Dr. Josep Trueta ( Site 0651)
Girona, 17007
Spain
Recruiting Study Coordinator
+349722258284028
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
Instituto Valenciano de Oncologia - IVO ( Site 0662)
Valencia, 46009
Spain
Recruiting Study Coordinator
+34961114605
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
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