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) (KEYNOTE-866)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT03924856

Recruitment Status : Active, not recruiting

First Posted : April 23, 2019

Last Update Posted : January 23, 2023

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Merck Sharp & Dohme LLC

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Urinary Bladder Cancer, Muscle-invasive	Drug: Pembrolizumab Drug: Gemcitabine Drug: Cisplatin Procedure: Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND]) Drug: Placebo	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	907 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:	Double-blind
Primary Purpose:	Treatment
Official 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)
Actual Study Start Date :	June 13, 2019
Estimated Primary Completion Date :	June 15, 2025
Estimated Study Completion Date :	June 15, 2025

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Bladder cancer

MedlinePlus related topics: Bladder Cancer

Drug Information available for: Cisplatin Gemcitabine Pembrolizumab

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Pembrolizumab + Gemcitabine + Cisplatin + Surgery 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 Pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle Other Name: MK-3475 Drug: Gemcitabine Gemcitabine 1000 mg/m^2, IV infusion on Days 1 and 8 of each 21-day cycle Drug: Cisplatin Cisplatin 70 mg/m^2, IV infusion on Day 1 of each 21-day cycle Procedure: Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND]) 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.
Placebo Comparator: Placebo + Gemcitabine + Cisplatin + Surgery 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 Gemcitabine 1000 mg/m^2, IV infusion on Days 1 and 8 of each 21-day cycle Drug: Cisplatin Cisplatin 70 mg/m^2, IV infusion on Day 1 of each 21-day cycle Procedure: Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND]) 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. Drug: Placebo Placebo to pembrolizumab by IV infusion, given on Day 1 of each 21-day cycle

Arm

Intervention/treatment

Experimental: Pembrolizumab + Gemcitabine + Cisplatin + Surgery

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

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

Other Name: MK-3475

Drug: Gemcitabine

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

Drug: Cisplatin

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

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

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.

Placebo Comparator: Placebo + Gemcitabine + Cisplatin + Surgery

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

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

Drug: Cisplatin

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

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

Drug: Placebo

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

Outcome Measures

Primary Outcome Measures :

Event-Free Survival (EFS) [ Time Frame: Up to approximately 60 months ]
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 or failure to undergo RC surgery in participants with residual disease, gross residual disease left behind at the time of surgery, local or distant recurrence based on investigator assessments, or death due to any cause.

Secondary Outcome Measures :

Pathologic Complete Response (pCR) Rate [ Time Frame: Up to approximately 72 months ]
pCR rate is defined as the percentage of participants having pCR. pCR is defined as absence of viable tumor (pT0pT0N0) in examined tissue from RC and PLND, as assessed by blinded independent central review (BICR).
Overall Survival (OS) [ Time Frame: Up to approximately 72 months ]
Overall survival is defined as the time from randomization to death due to any cause.
Disease-Free Survival (DFS) [ Time Frame: From approximately 20 weeks up to approximately 72 months ]
DFS is defined as the time from post-surgery baseline scan until the first occurrence of either local or distant recurrence as assessed by investigator by CT or MRI and/or computerized tomography (CT) or magnetic resonance imaging (MRI) and or biopsy or death from any cause.
Pathologic Downstaging (pDS) Rate [ Time Frame: Up to approximately 72 months ]
pDS rate is defined as the percentage of participants having pDS. pDS is defined as participants with a tumor classification of <pT2 (includes pT0, pTis, pTa, pT1) and N0 in examined tissue from RC plus PLND as assessed by BICR.
Number of Participants Who Experienced an Adverse Event (AE) [ Time Frame: Up to approximately 72 months ]
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Number of Participants Who Discontinued Study Treatment Due to an AE [ Time Frame: Up to approximately 12 months ]
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Number of Participants Who Experienced Perioperative Complications [ Time Frame: Up to approximately 12 months ]
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Change in Patient-Reported Outcomes from Baseline in Total Score of Functional Assessment of Cancer Therapy - General (FACT-G) [ Time Frame: Baseline, Up to approximately 72 months ]
The FACT-G is a health-related quality of life (HRQoL) 27-item questionnaire in patients being treated for cancer. The FACT-G subscales include Physical Well-Being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB), and Functional Well-Being (FWB). All items are scored on a 5-point Likert scale of 0 to 4, with higher scores indicating higher HRQoL. The total score can range from 0 to 108.
Change in Patient-Reported Outcomes from Baseline in Total Score of FACT-Bladder- (FACT-BI-Cys) [ Time Frame: Baseline, Up to approximately 72 months ]
Total Score of FACT BI-Cys is the sum of FACT-G total score and FACT-Bl-Cys score. FACT-Bl-Cys contains 17 items on the bowel, bladder, and sexual symptoms following cystectomy. The FACT-G is a health-related quality of life (HRQoL) 27-item questionnaire in patients being treated for cancer. The FACT-G subscales include Physical Well-Being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB), and Functional Well-Being (FWB). All items are scored on a 5-point Likert scale of 0 to 4, with higher scores indicating higher HRQoL. The total score of FACT-Bl-Cys can range from 0 to 168.
Change in Patient-Reported Outcomes from Baseline in FACT-BI-Cys-Trial Outcome Index (TOI) [ Time Frame: Baseline, Up to approximately 72 months ]
FACT-Bl-Cys Trial Outcome Index (TOI) is the sum of FACT-G PWB score, FWB score, and FACT-Bl-Cys score. FACT-Bl-Cys contains 17 items on the bowel, bladder, and sexual symptoms following cystectomy. The FACT-G is a health-related quality of life (HRQoL) 27-item questionnaire in patients being treated for cancer. The FACT-G subscales include Physical Well-Being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB), and Functional Well-Being (FWB). All items are scored on a 5-point Likert scale of 0 to 4, with higher scores indicating higher HRQoL. The total score of FACT-Bl-Cys TOI can range from 0 to 116.
Change in Patient-Reported Outcomes from Baseline in EuroQol Five-Dimensional Questionnaire (EQ-5D-5L) Visual Analog Score (VAS) [ Time Frame: Baseline, Up to approximately 72 months ]
The EQ-5D-5L is a standardized instrument for use as a measure of health outcome. In the EQ-5D-5L VAS, the participant rates his or her general state of health at the time of the assessment on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.
Time to Deterioration (TTD) in the Total Score of FACT-G [ Time Frame: Up to approximately 72 months ]
The FACT-G is a health-related quality of life (HRQoL) 27-item questionnaire in patients being treated for cancer. The FACT-G subscales include Physical Well-Being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB), and Functional Well-Being (FWB). All items are scored on a 5-point Likert scale of 0-4, with higher scores indicating higher HRQoL. TTD is defined as the time from baseline to the first onset of patient-reported outcomes (PRO) deterioration. For the FACT-G questionnaire, deteriorations are defined as a decrease of 7 points or more (out of 108) from baseline in total score.
TTD in EQ-5D-5L VAS [ Time Frame: Up to approximately 72 months ]
The EQ-5D-5L is a standardized instrument for use as a measure of health outcome and includes 5 health state dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. In the EQ-5D-5L VAS, the participant rates his or her general state of health at the time of the assessment on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. TTD is defined as the time from baseline to the first onset of PRO deterioration. For the EQ 5D-5L, deterioration is defined as a decrease of 7 points or more from baseline in the VAS.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

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 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.

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03924856

Locations

Show 175 study locations

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United States, California
Scripps MD Anderson ( Site 0010)
La Jolla, California, United States, 92037
Providence Saint John's Health Center ( Site 0075)
Santa Monica, California, United States, 90404
United States, District of Columbia
Georgetown University Medical Center ( Site 0022)
Washington, District of Columbia, United States, 20007
United States, Florida
AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 0005)
Orlando, Florida, United States, 32804
United States, Indiana
Parkview Cancer Institute ( Site 0077)
Fort Wayne, Indiana, United States, 46845
Indiana University Melvin and Bren Simon Cancer Center ( Site 0004)
Indianapolis, Indiana, United States, 46202
United States, Louisiana
Ochsner Medical Center ( Site 0049)
New Orleans, Louisiana, United States, 70121
United States, Maine
New England Cancer Specialists ( Site 0070)
Scarborough, Maine, United States, 04074
United States, Massachusetts
UMass Memorial Medical Center ( Site 0051)
Worcester, Massachusetts, United States, 01655
United States, Michigan
Henry Ford Hospital ( Site 0039)
Detroit, Michigan, United States, 48202
United States, Missouri
Mercy Hospital Saint Louis ( Site 0064)
Saint Louis, Missouri, United States, 63141
United States, New Jersey
Morristown Medical Center ( Site 0015)
Morristown, New Jersey, United States, 07960
United States, New Mexico
UNM Comprehensive Cancer Center-Clinical Research Office ( Site 0045)
Albuquerque, New Mexico, United States, 87106
United States, New York
New York University Perlmutter Cancer Center ( Site 0008)
New York, New York, United States, 10016
United States, Ohio
University Hospitals Cleveland Medical Center ( Site 0038)
Cleveland, Ohio, United States, 44106
United States, Oklahoma
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0021)
Tulsa, Oklahoma, United States, 74146
United States, Oregon
Portland VA Medical Center ( Site 0084)
Portland, Oregon, United States, 97239
United States, Pennsylvania
Allegheny General Hospital ( Site 0048)
Pittsburgh, Pennsylvania, United States, 15212
United States, Texas
MD Anderson Cancer Center ( Site 0063)
Houston, Texas, United States, 77030
Central Texas Veterans Healthcare System ( Site 0057)
Temple, Texas, United States, 76504
United States, Virginia
Inova Schar Cancer Institute ( Site 0007)
Fairfax, Virginia, United States, 22031
United States, Washington
Northwest Medical Specialties, PLLC ( Site 0061)
Puyallup, Washington, United States, 98373
Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 0033)
Seattle, Washington, United States, 98109
United States, West Virginia
Charleston Area Medical Center ( Site 0023)
Charles Town, West Virginia, United States, 25304
Australia, New South Wales
Mid North Coast Cancer Institute ( Site 1256)
Port Macquarie, New South Wales, Australia, 2444
Southside Cancer Care Centre ( Site 1252)
Sydney, New South Wales, Australia, 2228
Australia, Queensland
Cairns Base Hospital ( Site 1257)
Cairns, Queensland, Australia, 4870
Australia, Victoria
Eastern Health ( Site 1255)
Box Hill, Victoria, Australia, 3128
Peninsula Health Frankston Hospital ( Site 1258)
Frankston, Victoria, Australia, 3199
Belgium
UZ Brussel ( Site 0358)
Brussels, Bruxelles-Capitale, Region De, Belgium, 1090
Jessa Ziekenhuis ( Site 0360)
Hasselt, Limburg, Belgium, 3500
CHU UCL Namur Site de Godinne ( Site 0354)
Yvoir, Namur, Belgium, 5530
O.L.V. Ziekenhuis Aalst ( Site 0356)
Aalst, Oost-Vlaanderen, Belgium, 9300
AZ Maria Middelares Gent ( Site 0353)
Gent, Oost-Vlaanderen, Belgium, 9000
Canada, Alberta
Tom Baker Cancer Centre ( Site 0100)
Calgary, Alberta, Canada, T2N 4N2
Canada, Nova Scotia
Nova Scotia Health Authority ( Site 0109)
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Kingston Health Sciences Centre ( Site 0103)
Kingston, Ontario, Canada, K7L 2V7
Lakeridge Health ( Site 0104)
Oshawa, Ontario, Canada, L1G 2B9
Sunnybrook Research Institute ( Site 0110)
Toronto, Ontario, Canada, M4N 3M5
Princess Margaret Cancer Centre ( Site 0107)
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0105)
Montreal, Quebec, Canada, H1T 2M4
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0
Quebec City, Quebec, Canada, G1J 1Z4
Denmark
Herlev og Gentofte Hospital. ( Site 0402)
Herlev, Hovedstaden, Denmark, 2730
Rigshospitalet University Hospital ( Site 0401)
Kobenhavn, Hovedstaden, Denmark, 2100
Odense Universitetshospital ( Site 0403)
Odense, Syddanmark, Denmark, 5000
France
CHU de Bordeaux- Hopital Saint Andre ( Site 0456)
Bordeaux, Aquitaine, France, 33075
Centre Leon Berard ( Site 0465)
Lyon, Auvergne, France, 69373
Centre Francois Baclesse ( Site 0459)
Caen, Calvados, France, 14075
Centre Armoricain de Radiotherapie Imagerie medicale et Oncologie ( Site 0457)
Plerin, Cotes-d Armor, France, 22190
Hopital Foch ( Site 0483)
Suresnes, Hauts-de-Seine, France, 92150
CHU de Montpellier - Hopital Saint-Eloi ( Site 0469)
Montpellier, Languedoc-Roussillon, France, 34295
Institut de Cancerologie de l Ouest Site Paul Papin ( Site 0453)
Angers, Maine-et-Loire, France, 49000
Hopital Robert Schuman ( Site 0452)
Metz, Moselle, France, 57070
Centre Jean Perrin ( Site 0460)
Clermont-Ferrand, Puy-de-Dome, France, 63011
Clinique Victor Hugo ( Site 0463)
Le Mans, Sarthe, France, 72000
CHU de Rouen ( Site 0493)
Rouen, Seine-Maritime, France, 76031
Institut Sainte Catherine ( Site 0454)
Avignon, Vaucluse, France, 84918
Germany
Klinikum der Eberhard-Karls-Universitaet Tuebingen ( Site 0502)
Tuebingen, Baden-Wurttemberg, Germany, 72076
Universitaetsklinikum Erlangen ( Site 0505)
Erlangen, Bayern, Germany, 91058
Universitaetsklinikum Magdeburg A.o.R. ( Site 0516)
Magdeburg, Sachsen-Anhalt, Germany, 39120
Universitaetsklinikum Carl Gustav Carus ( Site 0519)
Dresden, Sachsen, Germany, 01307
Universitaetsklinikum Schleswig-Holstein-Campus Lubeck ( Site 0512)
Luebeck, Schleswig-Holstein, Germany, 23538
Charite Universitaetsmedizin Berlin ( Site 0515)
Berlin, Germany, 10117
Vivantes Klinikum am Urban ( Site 0522)
Berlin, Germany, 10967
Hungary
Pecsi Tudomanyegyetem AOK ( Site 1009)
Pecs, Baranya, Hungary, 7624
SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 1010)
Szeged, Csongrad, Hungary, 6720
Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1002)
Szolnok, Jasz-Nagykun-Szolnok, Hungary, 5004
Bajcsy Zsilinszki Korhaz es Rendelointezet ( Site 1001)
Budapest, Hungary, 1106
Debreceni Egyetem Klinikai Kozpont ( Site 1006)
Debrecen, Hungary, 4032
Petz Aladar Megyei Oktato Korhaz ( Site 1012)
Gyor, Hungary, 9023
Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 1007)
Kaposvar, Hungary, 7400
Ireland
Cork University Hospital ( Site 0722)
Cork, Ireland, T12 DC4A
Tallaght University Hospital ( Site 0710)
Dublin, Ireland, D24 DH74
University Hospital Waterford ( Site 0723)
Waterford, Ireland, X91ER8E
Israel
Ha Emek Medical Center ( Site 0808)
Afula, Israel, 1834111
Soroka Medical Center ( Site 0806)
Beer Sheva, Israel, 8410101
Rambam Health Care Campus-Oncology Division ( Site 0802)
Haifa, Israel, 3109601
Shaare Zedek Medical Center ( Site 0809)
Jerusalem, Israel, 9103102
Hadassah Ein Kerem Medical Center ( Site 0810)
Jerusalem, Israel, 9112001
Meir Medical Center ( Site 0803)
Kfar Saba, Israel, 4428164
Rabin Medical Center ( Site 0804)
Petach Tikva, Israel, 4941492
Sheba Medical Center ( Site 0801)
Ramat Gan, Israel, 5265601
Sourasky Medical Center ( Site 0807)
Tel Aviv, Israel, 6423906
Yitzhak Shamir Medical Center ( Site 0805)
Zerifin, Israel, 7030001
Italy
Policlinico Gemelli di Roma ( Site 0558)
Roma, Abruzzo, Italy, 00168
Policlinico di Modena ( Site 0553)
Modena, Emilia-Romagna, Italy, 41124
A.O.U. Policlinico Vittorio Emanuele - Presidio Gaspare Rodolico ( Site 0559)
Catania, Italy, 95123
Istituto Nazionale Studio e Cura dei Tumori ( Site 0551)
Milano, Italy, 20133
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori ( Site 0552)
Napoli, Italy, 80131
Fondazione Salvatore Maugeri IRCCS. ( Site 0554)
Pavia, Italy, 27100
Azienda Ospedaliera San Camillo Forlanini ( Site 0560)
Roma, Italy, 00152
Azienda Ospedaliera Santa Maria Terni ( Site 0557)
Terni, Italy, 05100
Japan
Hirosaki University Hospital ( Site 1502)
Hirosaki, Aomori, Japan, 036-8563
National Cancer Center Hospital East ( Site 1504)
Kashiwa, Chiba, Japan, 2778577
Ehime University Hospital ( Site 1508)
Toon, Ehime, Japan, 791-0295
Sapporo Medical University Hospital ( Site 1501)
Sapporo, Hokkaido, Japan, 060-8543
University of Tsukuba Hospital ( Site 1503)
Tsukuba, Ibaraki, Japan, 305-8576
Yokosuka Kyosai Hospital ( Site 1509)
Yokosuka, Kanagawa, Japan, 238-8558
Nara Medical University Hospital ( Site 1510)
Kashihara, Nara, Japan, 634-8522
Saitama Medical University International Medical Center ( Site 1505)
Hidaka, Saitama, Japan, 350-1298
Chiba Cancer Center ( Site 1506)
Chiba, Japan, 260-8717
Harasanshin Hospital ( Site 1515)
Fukuoka, Japan, 812-0033
Hiroshima City Hiroshima Citizens Hospital ( Site 1513)
Hiroshima, Japan, 730-8518
Nagano Municipal Hospital ( Site 1516)
Nagano, Japan, 381-8551
Osaka Metropolitan University Hospital ( Site 1512)
Osaka, Japan, 545-8586
Tokushima University Hospital ( Site 1514)
Tokushima, Japan, 770-8503
Tokyo Medical and Dental University Hospital ( Site 1517)
Tokyo, Japan
Korea, Republic of
National Cancer Center ( Site 1354)
Goyang-si, Kyonggi-do, Korea, Republic of, 10408
Seoul National University Bundang Hospital ( Site 1356)
Seongnam-si, Kyonggi-do, Korea, Republic of, 13620
Korea University Anam Hospital ( Site 1351)
Seoul, Korea, Republic of, 02841
Seoul National University Hospital ( Site 1352)
Seoul, Korea, Republic of, 03080
Asan Medical Center ( Site 1355)
Seoul, Korea, Republic of, 05505
Samsung Medical Center ( Site 1353)
Seoul, Korea, Republic of, 06351
Mexico
Centro de Urologia Avanzada del Noreste S.A. de C.V. ( Site 0254)
Monterrey, Nuevo Leon, Mexico, 66269
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V. ( Site 0300)
Aguascalientes, Mexico, 20010
Centro Estatal de Cancerologia de Chihuahua ( Site 0253)
Chihuahua, Mexico, 31000
Instituto Nacional de Cancerologia ( Site 0256)
Tlalpan, Mexico, 14080
Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 1062)
Wroclaw, Dolnoslaskie, Poland, 50-556
Centrum Onkologii im.prof. F. Lukaszczyka w Bydgoszczy ( Site 1068)
Bydgoszcz, Kujawsko-pomorskie, Poland, 85-796
Europejskie Centrum Zdrowia Otwock ( Site 1057)
Otwock, Mazowieckie, Poland, 05-400
Luxmed Onkologia sp. z o. o. ( Site 1051)
Warszawa, Mazowieckie, Poland, 01-748
Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1060)
Bielsko-Biala, Slaskie, Poland, 43-300
Russian Federation
Clinic of Bashkortostan State Medical University ( Site 0869)
Ufa, Baskortostan, Respublika, Russian Federation, 450081
Ivanovo Regional Oncology Dispensary ( Site 0852)
Ivanovo, Ivanovskaya Oblast, Russian Federation, 153040
Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0861)
Krasnoyarsk, Krasnoyarskiy Kray, Russian Federation, 660133
Kursk Regional Clinical Oncology Dispensary ( Site 0854)
Kursk, Kurskaya Oblast, Russian Federation, 305524
FSBI ""United Hospital with Polyclinic"" of the Administrative Department of the President of the Ru
Moscow, Moskva, Russian Federation, 119285
Central Clinical Hospital with outpatient Clinic ( Site 0856)
Moscow, Moskva, Russian Federation, 121359
Bayandin Murmansk Regional Clinical Hospital ( Site 0859)
Murmansk, Murmanskaya Oblast, Russian Federation, 183057
Volga District Medical Center Federal Medical and Biological Agency ( Site 0857)
Nizhny Novgorod, Nizhegorodskaya Oblast, Russian Federation, 603074
Omsk Clinical Oncology Dispensary ( Site 0865)
Omsk, Omskaya Oblast, Russian Federation, 644013
Leningrad Regional Oncology Center ( Site 0868)
Saint Petersburg, Sankt-Peterburg, Russian Federation, 188663
Clinical Hospital Saint Luka ( Site 0867)
St. Petersburg, Sankt-Peterburg, Russian Federation, 194044
Saratov State Medical University n.a. V.I.Razumovskiy ( Site 0866)
Saratov, Saratovskaya Oblast, Russian Federation, 410012
Spain
Hospital San Pedro de Alcantara ( Site 0654)
Caceres, Extremadura, Spain, 10003
H. de Gerona Dr. Josep Trueta ( Site 0651)
Girona, Gerona, Spain, 17007
Hospital Universitario Ramon y Cajal ( Site 0660)
Madrid, Madrid, Comunidad De, Spain, 28034
Hospital Universitario Quiron Madrid ( Site 0657)
Pozuelo de Alarcon, Madrid, Comunidad De, Spain, 28223
Instituto Valenciano de Oncologia - IVO ( Site 0662)
Valencia, Valenciana, Comunitat, Spain, 46009
Hospital del Mar ( Site 0653)
Barcelona, Spain, 08003
Hospital Universitario San Carlos ( Site 0663)
Madrid, Spain, 28040
Hospital Universitario La Paz ( Site 0661)
Madrid, Spain, 28046
Hospital Nuestra Sra. de Valme ( Site 0658)
Sevilla, Spain, 41014
Sweden
Laenssjukhuset Ryhov ( Site 1205)
Jonkoping, Jonkopings Lan, Sweden, 551 85
Akademiska Sjukhuset ( Site 1201)
Uppsala, Uppsala Lan, Sweden, 751 85
Cancercentrum ( Site 1204)
Umea, Vasterbottens Lan, Sweden, 901 85
Thailand
Ramathibodi Hospital. ( Site 1451)
Bangkok, Krung Thep Maha Nakhon, Thailand, 10400
Faculty of Medicine Siriraj Hospital ( Site 1452)
Bangkok, Krung Thep Maha Nakhon, Thailand, 10700
Maharaj Nakorn Chiangmai Hospital ( Site 1453)
Chiang Mai, Thailand, 50200
Srinagarind Hospital ( Site 1454)
Khon Kaen, Thailand, 40002
Turkey
Hacettepe Universitesi Tıp Fakultesi ( Site 0911)
Ankara, Turkey, 06100
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0910)
Istanbul, Turkey, 34096
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0906)
Istanbul, Turkey, 34722
Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 0901)
Istanbul, Turkey, 34899
Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 0909)
Konya, Turkey, 42080
Sakarya Universitesi Tip Fakultesi ( Site 0913)
Sakarya, Turkey, 54290
Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi ( Site 0904)
Trabzon, Turkey, 61080
Ukraine
Cherkasy Regional Oncology Dispensary ( Site 0959)
Cherkasy, Cherkaska Oblast, Ukraine, 18009
MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov ( Site 0963)
Dnipropetrovsk, Dnipropetrovska Oblast, Ukraine, 49005
Regional Oncological Hospital ( Site 0956)
Dnipro, Dnipropetrovska Oblast, Ukraine, 49055
Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC ( Site 0951)
Dnipro, Dnipropetrovska Oblast, Ukraine, 49102
Reg. Clinical Center of Urology and Nephrology n.a. V. I. Shapoval ( Site 0969)
Kharkiv, Kharkivska Oblast, Ukraine, 61037
CNPE "Regional Center of Oncology" ( Site 0958)
Kharkiv, Kharkivska Oblast, Ukraine, 61070
National Cancer Institute of the MoH of Ukraine ( Site 0962)
Kyiv, Kyivska Oblast, Ukraine, 03022
Lviv Regional Clinical Hospital ( Site 0955)
Lviv, Lvivska Oblast, Ukraine, 79000
Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 0967)
Lviv, Lvivska Oblast, Ukraine, 79000
Kyiv City Clinical Oncology Center ( Site 0960)
Kyiv, Ukraine, 03115
United Kingdom
Aberdeen Royal Infirmary ( Site 0708)
Aberdeen, Aberdeen City, United Kingdom, AB25 2ZN
Torbay Hospital ( Site 0704)
Torquay, Devon, United Kingdom, TQ2 7AA
Kent and Canterbury Hospital ( Site 0709)
Canterbury, England, United Kingdom, CT1 3NG
Lister Hospital ( Site 0715)
Stevenage, Hertfordshire, United Kingdom, SG1 4AB
The Royal Marsden Foundation Trust ( Site 0702)
London, London, City Of, United Kingdom, SW3 6JJ
Imperial College Healthcare NHS Trust ( Site 0721)
London, London, City Of, United Kingdom, W6 8RF
Norfolk & Norwich University Hospital NHS Foundation Trust ( Site 0725)
Norwich, Norfolk, United Kingdom, NR4 7UY
Royal Cornwall Hospital ( Site 0703)
Truro, United Kingdom, TR1 3LJ

Sponsors and Collaborators

Merck Sharp & Dohme LLC

Investigators

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Study Director:	Medical Director	Merck Sharp & Dohme LLC

More Information

Additional Information:

Merck Oncology Clinical Trials Information This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier:	NCT03924856
Other Study ID Numbers:	3475-866 MK-3475-866 ( Other Identifier: Merck Protocol Number ) KEYNOTE-866 ( Other Identifier: Merck ) 194870 ( Registry Identifier: JAPIC-CTI ) 2022-501970-20-00 ( Other Identifier: EU CT ) 2018-003808-39 ( EudraCT Number )
First Posted:	April 23, 2019 Key Record Dates
Last Update Posted:	January 23, 2023
Last Verified:	January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL:	http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Merck Sharp & Dohme LLC:


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

Additional relevant MeSH terms:

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Urinary Bladder Neoplasms Muscle Neoplasms 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	Soft Tissue Neoplasms Muscular Diseases Musculoskeletal Diseases Gemcitabine Pembrolizumab Antineoplastic Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Immunological Immune Checkpoint Inhibitors

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