Bladder CancerPhase 3KEYNOTE-866NCT03924856
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)
A Phase 3 study testing Pembrolizumab, Gemcitabine and Cisplatin in people with Bladder Cancer, run by Merck Sharp & Dohme LLC at 175 sites in 22 countries.
Trial summary
A global study to evaluate peri-operative pembrolizumab with chemotherapy versus placebo to pembrolizumab plus chemotherapy in cisplatin eligible patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Pembrolizumab, Gemcitabine and Cisplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 907 participants
- Where
- 175 sitesin 22 countries
- Study dates
- 13 Jun 2019to 18 May 2026
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
175 sites in 22 countries.
175 sites in 22 countries
United States24 sites
UNM Comprehensive Cancer Center-Clinical Research Office ( Site 0045)
Albuquerque, New Mexico, 87106
Charleston Area Medical Center ( Site 0023)
Charles Town, West Virginia, 25304
University Hospitals Cleveland Medical Center ( Site 0038)
Cleveland, Ohio, 44106
Henry Ford Hospital ( Site 0039)
Detroit, Michigan, 48202
Inova Schar Cancer Institute ( Site 0007)
Fairfax, Virginia, 22031
Parkview Cancer Institute ( Site 0077)
Fort Wayne, Indiana, 46845
MD Anderson Cancer Center ( Site 0063)
Houston, Texas, 77030
Indiana University Melvin and Bren Simon Cancer Center ( Site 0004)
Indianapolis, Indiana, 46202
Scripps MD Anderson ( Site 0010)
La Jolla, California, 92037
Morristown Medical Center ( Site 0015)
Morristown, New Jersey, 07960
Ochsner Medical Center ( Site 0049)
New Orleans, Louisiana, 70121
New York University Perlmutter Cancer Center ( Site 0008)
New York, New York, 10016
AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 0005)
Orlando, Florida, 32804
Allegheny General Hospital ( Site 0048)
Pittsburgh, Pennsylvania, 15212
Portland VA Medical Center ( Site 0084)
Portland, Oregon, 97239
Northwest Medical Specialties, PLLC ( Site 0061)
Puyallup, Washington, 98373
Providence Saint John's Health Center ( Site 0075)
Santa Monica, California, 90404
New England Cancer Specialists ( Site 0070)
Scarborough, Maine, 04074
Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 0033)
Seattle, Washington, 98109
Mercy Hospital Saint Louis ( Site 0064)
St Louis, Missouri, 63141
Central Texas Veterans Healthcare System ( Site 0057)
Temple, Texas, 76504
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0021)
Tulsa, Oklahoma, 74146
Georgetown University Medical Center ( Site 0022)
Washington D.C., District of Columbia, 20007
UMass Memorial Medical Center ( Site 0051)
Worcester, Massachusetts, 01655
Japan15 sites
Chiba Cancer Center ( Site 1506)
Chiba, 260-8717
Harasanshin Hospital ( Site 1515)
Fukuoka, 812-0033
Saitama Medical University International Medical Center ( Site 1505)
Hidaka, Saitama, 350-1298
Hirosaki University Hospital ( Site 1502)
Hirosaki, Aomori, 036-8563
Hiroshima City Hiroshima Citizens Hospital ( Site 1513)
Hiroshima, 730-8518
Nara Medical University Hospital ( Site 1510)
Kashihara, Nara, 634-8522
National Cancer Center Hospital East ( Site 1504)
Kashiwa, Chiba, 2778577
Nagano Municipal Hospital ( Site 1516)
Nagano, 381-8551
Osaka Metropolitan University Hospital ( Site 1512)
Osaka, 545-8586
Sapporo Medical University Hospital ( Site 1501)
Sapporo, Hokkaido, 060-8543
Tokushima University Hospital ( Site 1514)
Tokushima, 770-8503
Tokyo Medical and Dental University Hospital ( Site 1517)
Tokyo
Ehime University Hospital ( Site 1508)
Tōon, Ehime, 791-0295
University of Tsukuba Hospital ( Site 1503)
Tsukuba, Ibaraki, 305-8576
Yokosuka Kyosai Hospital ( Site 1509)
Yokosuka, Kanagawa, 238-8558
France12 sites
Institut de Cancerologie de l Ouest Site Paul Papin ( Site 0453)
Angers, Maine-et-Loire, 49000
Institut Sainte Catherine ( Site 0454)
Avignon, Vaucluse, 84918
CHU de Bordeaux- Hopital Saint Andre ( Site 0456)
Bordeaux, Aquitaine, 33075
Centre Francois Baclesse ( Site 0459)
Caen, Calvados, 14075
Centre Jean Perrin ( Site 0460)
Clermont-Ferrand, Puy-de-Dome, 63011
Clinique Victor Hugo ( Site 0463)
Le Mans, Sarthe, 72000
Centre Leon Berard ( Site 0465)
Lyon, Auvergne, 69373
Hopital Robert Schuman ( Site 0452)
Metz, Moselle, 57070
CHU de Montpellier - Hopital Saint-Eloi ( Site 0469)
Montpellier, Languedoc-Roussillon, 34295
Centre Armoricain de Radiotherapie Imagerie medicale et Oncologie ( Site 0457)
Plérin, Cotes-d Armor, 22190
CHU de Rouen ( Site 0493)
Rouen, Seine-Maritime, 76031
Hopital Foch ( Site 0483)
Suresnes, Hauts-de-Seine, 92150
Russia12 sites
Ivanovo Regional Oncology Dispensary ( Site 0852)
Ivanovo, Ivanovo Oblast, 153040
Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0861)
Krasnoyarsk, Krasnoyarsk Krai, 660133
Kursk Regional Clinical Oncology Dispensary ( Site 0854)
Kursk, Kursk Oblast, 305524
FSBI ""United Hospital with Polyclinic"" of the Administrative Department of the President of the Ru
Moscow, Moscow, 119285
Central Clinical Hospital with outpatient Clinic ( Site 0856)
Moscow, Moscow, 121359
Bayandin Murmansk Regional Clinical Hospital ( Site 0859)
Murmansk, Murmansk Oblast, 183057
Volga District Medical Center Federal Medical and Biological Agency ( Site 0857)
Nizhny Novgorod, Nizhny Novgorod Oblast, 603074
Omsk Clinical Oncology Dispensary ( Site 0865)
Omsk, Omsk Oblast, 644013
Leningrad Regional Oncology Center ( Site 0868)
Saint Petersburg, Sankt-Peterburg, 188663
Clinical Hospital Saint Luka ( Site 0867)
Saint Petersburg, Sankt-Peterburg, 194044
Saratov State Medical University n.a. V.I.Razumovskiy ( Site 0866)
Saratov, Saratov Oblast, 410012
Clinic of Bashkortostan State Medical University ( Site 0869)
Ufa, Baskortostan, Respublika, 450081
Israel10 sites
Ha Emek Medical Center ( Site 0808)
Afula, 1834111
Soroka Medical Center ( Site 0806)
Beersheba, 8410101
Rambam Health Care Campus-Oncology Division ( Site 0802)
Haifa, 3109601
Shaare Zedek Medical Center ( Site 0809)
Jerusalem, 9103102
Hadassah Ein Kerem Medical Center ( Site 0810)
Jerusalem, 9112001
Meir Medical Center ( Site 0803)
Kfar Saba, 4428164
Rabin Medical Center ( Site 0804)
Petah Tikva, 4941492
Sheba Medical Center ( Site 0801)
Ramat Gan, 5265601
Sourasky Medical Center ( Site 0807)
Tel Aviv, 6423906
Yitzhak Shamir Medical Center ( Site 0805)
Ẕerifin, 7030001
Ukraine10 sites
Cherkasy Regional Oncology Dispensary ( Site 0959)
Cherkasy, Cherkasy Oblast, 18009
Regional Oncological Hospital ( Site 0956)
Dnipro, Dnipropetrovsk Oblast, 49055
Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC ( Site 0951)
Dnipro, Dnipropetrovsk Oblast, 49102
MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov ( Site 0963)
Dnipropetrovsk, Dnipropetrovsk Oblast, 49005
Reg. Clinical Center of Urology and Nephrology n.a. V. I. Shapoval ( Site 0969)
Kharkiv, Kharkiv Oblast, 61037
CNPE "Regional Center of Oncology" ( Site 0958)
Kharkiv, Kharkiv Oblast, 61070
National Cancer Institute of the MoH of Ukraine ( Site 0962)
Kyiv, Kyivska Oblast, 03022
Kyiv City Clinical Oncology Center ( Site 0960)
Kyiv, 03115
Lviv Regional Clinical Hospital ( Site 0955)
Lviv, Lviv Oblast, 79000
Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 0967)
Lviv, Lviv Oblast, 79000
Spain9 sites
Hospital del Mar ( Site 0653)
Barcelona, 08003
Hospital San Pedro de Alcantara ( Site 0654)
Cáceres, Extremadura, 10003
H. de Gerona Dr. Josep Trueta ( Site 0651)
Girona, Gerona, 17007
Hospital Universitario Ramon y Cajal ( Site 0660)
Madrid, Madrid, Comunidad de, 28034
Hospital Universitario San Carlos ( Site 0663)
Madrid, 28040
Hospital Universitario La Paz ( Site 0661)
Madrid, 28046
Hospital Universitario Quiron Madrid ( Site 0657)
Pozuelo de Alarcón, Madrid, Comunidad de, 28223
Hospital Nuestra Sra. de Valme ( Site 0658)
Seville, 41014
Instituto Valenciano de Oncologia - IVO ( Site 0662)
Valencia, Valenciana, Comunitat, 46009
Canada8 sites
Tom Baker Cancer Centre ( Site 0100)
Calgary, Alberta, T2N 4N2
Nova Scotia Health Authority ( Site 0109)
Halifax, Nova Scotia, B3H 1V7
Kingston Health Sciences Centre ( Site 0103)
Kingston, Ontario, K7L 2V7
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0105)
Montreal, Quebec, H1T 2M4
Lakeridge Health ( Site 0104)
Oshawa, Ontario, L1G 2B9
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0
Québec, Quebec, G1J 1Z4
Sunnybrook Research Institute ( Site 0110)
Toronto, Ontario, M4N 3M5
Princess Margaret Cancer Centre ( Site 0107)
Toronto, Ontario, M5G 2M9
Italy8 sites
A.O.U. Policlinico Vittorio Emanuele - Presidio Gaspare Rodolico ( Site 0559)
Catania, 95123
Istituto Nazionale Studio e Cura dei Tumori ( Site 0551)
Milan, 20133
Policlinico di Modena ( Site 0553)
Modena, Emilia-Romagna, 41124
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori ( Site 0552)
Naples, 80131
Fondazione Salvatore Maugeri IRCCS. ( Site 0554)
Pavia, 27100
Policlinico Gemelli di Roma ( Site 0558)
Roma, Abruzzo, 00168
Azienda Ospedaliera San Camillo Forlanini ( Site 0560)
Roma, 00152
Azienda Ospedaliera Santa Maria Terni ( Site 0557)
Terni, 05100
United Kingdom8 sites
Aberdeen Royal Infirmary ( Site 0708)
Aberdeen, Aberdeen City, AB25 2ZN
Kent and Canterbury Hospital ( Site 0709)
Canterbury, England, CT1 3NG
The Royal Marsden Foundation Trust ( Site 0702)
London, London, City of, SW3 6JJ
Imperial College Healthcare NHS Trust ( Site 0721)
London, London, City of, W6 8RF
Norfolk & Norwich University Hospital NHS Foundation Trust ( Site 0725)
Norwich, Norfolk, NR4 7UY
Lister Hospital ( Site 0715)
Stevenage, Hertfordshire, SG1 4AB
Torbay Hospital ( Site 0704)
Torquay, Devon, TQ2 7AA
Royal Cornwall Hospital ( Site 0703)
Truro, TR1 3LJ
Germany7 sites
Charite Universitaetsmedizin Berlin ( Site 0515)
Berlin, 10117
Vivantes Klinikum am Urban ( Site 0522)
Berlin, 10967
Universitaetsklinikum Carl Gustav Carus ( Site 0519)
Dresden, Saxony, 01307
Universitaetsklinikum Erlangen ( Site 0505)
Erlangen, Bavaria, 91058
Universitaetsklinikum Schleswig-Holstein-Campus Lubeck ( Site 0512)
Lübeck, Schleswig-Holstein, 23538
Universitaetsklinikum Magdeburg A.o.R. ( Site 0516)
Magdeburg, Saxony-Anhalt, 39120
Klinikum der Eberhard-Karls-Universitaet Tuebingen ( Site 0502)
Tübingen, Baden-Wurttemberg, 72076
Hungary7 sites
Bajcsy Zsilinszki Korhaz es Rendelointezet ( Site 1001)
Budapest, 1106
Debreceni Egyetem Klinikai Kozpont ( Site 1006)
Debrecen, 4032
Petz Aladar Megyei Oktato Korhaz ( Site 1012)
Győr, 9023
Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 1007)
Kaposvár, 7400
Pecsi Tudomanyegyetem AOK ( Site 1009)
Pécs, Baranya, 7624
SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 1010)
Szeged, Csongrád megye, 6720
Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1002)
Szolnok, Jász-Nagykun-Szolnok, 5004
Turkey (Türkiye)7 sites
Hacettepe Universitesi Tıp Fakultesi ( Site 0911)
Ankara, 06100
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0910)
Istanbul, 34096
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0906)
Istanbul, 34722
Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 0901)
Istanbul, 34899
Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 0909)
Konya, 42080
Sakarya Universitesi Tip Fakultesi ( Site 0913)
Sakarya, 54290
Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi ( Site 0904)
Trabzon, 61080
South Korea6 sites
National Cancer Center ( Site 1354)
Goyang-si, Kyonggi-do, 10408
Seoul National University Bundang Hospital ( Site 1356)
Seongnam-si, Kyonggi-do, 13620
Korea University Anam Hospital ( Site 1351)
Seoul, 02841
Seoul National University Hospital ( Site 1352)
Seoul, 03080
Asan Medical Center ( Site 1355)
Seoul, 05505
Samsung Medical Center ( Site 1353)
Seoul, 06351
Australia5 sites
Eastern Health ( Site 1255)
Box Hill, Victoria, 3128
Cairns Base Hospital ( Site 1257)
Cairns, Queensland, 4870
Peninsula Health Frankston Hospital ( Site 1258)
Frankston, Victoria, 3199
Mid North Coast Cancer Institute ( Site 1256)
Port Macquarie, New South Wales, 2444
Southside Cancer Care Centre ( Site 1252)
Sydney, New South Wales, 2228
Belgium5 sites
O.L.V. Ziekenhuis Aalst ( Site 0356)
Aalst, Oost-Vlaanderen, 9300
UZ Brussel ( Site 0358)
Brussels, Bruxelles-Capitale, Region de, 1090
AZ Maria Middelares Gent ( Site 0353)
Ghent, Oost-Vlaanderen, 9000
Jessa Ziekenhuis ( Site 0360)
Hasselt, Limburg, 3500
CHU UCL Namur Site de Godinne ( Site 0354)
Yvoir, Namur, 5530
Poland5 sites
Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1060)
Bielsko-Biala, Silesian Voivodeship, 43-300
Centrum Onkologii im.prof. F. Lukaszczyka w Bydgoszczy ( Site 1068)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796
Europejskie Centrum Zdrowia Otwock ( Site 1057)
Otwock, Masovian Voivodeship, 05-400
Luxmed Onkologia sp. z o. o. ( Site 1051)
Warsaw, Masovian Voivodeship, 01-748
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 1062)
Wroclaw, Lower Silesian Voivodeship, 50-556
Mexico4 sites
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V. ( Site 0300)
Aguascalientes, 20010
Centro Estatal de Cancerologia de Chihuahua ( Site 0253)
Chihuahua City, 31000
Centro de Urologia Avanzada del Noreste S.A. de C.V. ( Site 0254)
Monterrey, Nuevo León, 66269
Instituto Nacional de Cancerologia ( Site 0256)
Tlalpan, 14080
Thailand4 sites
Ramathibodi Hospital. ( Site 1451)
Bangkok, Bangkok, 10400
Faculty of Medicine Siriraj Hospital ( Site 1452)
Bangkok, Bangkok, 10700
Maharaj Nakorn Chiangmai Hospital ( Site 1453)
Chiang Mai, 50200
Srinagarind Hospital ( Site 1454)
Khon Kaen, 40002
Denmark3 sites
Rigshospitalet University Hospital ( Site 0401)
Copenhagen, Capital Region, 2100
Herlev og Gentofte Hospital. ( Site 0402)
Herlev, Capital Region, 2730
Odense Universitetshospital ( Site 0403)
Odense, Region Syddanmark, 5000
Ireland3 sites
Cork University Hospital ( Site 0722)
Cork, T12 DC4A
Tallaght University Hospital ( Site 0710)
Dublin, D24 DH74
University Hospital Waterford ( Site 0723)
Waterford, X91ER8E
Sweden3 sites
Laenssjukhuset Ryhov ( Site 1205)
Jönköping, Jönköping County, 551 85
Cancercentrum ( Site 1204)
Umeå, Västerbotten County, 901 85
Akademiska Sjukhuset ( Site 1201)
Uppsala, Uppsala County, 751 85
About this study
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)
A global study to evaluate peri-operative pembrolizumab with chemotherapy versus placebo to pembrolizumab plus chemotherapy in cisplatin eligible patients.
- Conditions
- Bladder Cancer
- Being tested
- Pembrolizumab, Gemcitabine, Cisplatin, Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND]), Placebo
- Keywords
- Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1), Pembrolizumab (MK-3475), Chemotherapy
- Medical subject headings
- Urinary Bladder Neoplasms, Parkinson Disease 4, Autosomal Dominant Lewy Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called MK-3475
Pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle
GemcitabineDrug
Gemcitabine 1000 mg/m^2, IV infusion on Days 1 and 8 of each 21-day cycle
CisplatinDrug
Cisplatin 70 mg/m^2, IV infusion on Day 1 of each 21-day cycle
Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND])Procedure or surgery
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.
PlaceboDrug
Placebo to pembrolizumab by IV infusion, given on Day 1 of each 21-day cycle
| Study group | Role | What they receive |
|---|---|---|
| Pembrolizumab + Gemcitabine + Cisplatin + Surgery | Experimental | Participants received 4 preoperative cycles of pembrolizumab PLUS gemcitabine PLUS cisplatin, followed by surgery, followed by up to 13 cycles of postoperative pembrolizumab. Receives: Drug: Pembrolizumab; Drug: Gemcitabine; Drug: Cisplatin; Procedure: Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND]) |
| Placebo + Gemcitabine + Cisplatin + Surgery | Placebo comparator | 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. Receives: Drug: Gemcitabine; Drug: Cisplatin; Procedure: Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND]); Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-Free Survival (EFS)
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; failure to undergo RC surgery in participants with residual disease and any radiographical disease present; gross residual disease left behind at the time of surgery; local or distant recurrence based on investigator assessments and/or biopsy, or death due to any cause.
Measured: Up to approximately 60 months
Secondary outcomes (13)
Pathologic Complete Response (pCR) Rate
pCR rate is defined as the percentage of participants having pCR. pCR is defined as absence of viable tumor (pT0N0) in examined tissue from RC and PLND, as assessed by blinded independent central review (BICR).
Measured: Up to approximately 72 months
Overall Survival (OS)
Overall survival is defined as the time from randomization to death due to any cause.
Measured: Up to approximately 72 months
Disease-Free Survival (DFS)
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.
Measured: From approximately 20 weeks up to approximately 72 months
Pathologic Downstaging (pDS) Rate
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.
Measured: Up to approximately 72 months
Number of Participants Who Experienced an Adverse Event (AE)
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.
Measured: Up to approximately 72 months
Number of Participants Who Discontinued Study Treatment Due to an AE
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.
Measured: Up to approximately 12 months
Number of Participants Who Experienced Perioperative Complications
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.
Measured: Up to approximately 12 months
Change in Patient-Reported Outcomes from Baseline in Total Score of Functional Assessment of Cancer Therapy - General (FACT-G)
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.
Measured: Baseline, Up to approximately 72 months
Change in Patient-Reported Outcomes from Baseline in Total Score of FACT-Bladder- (FACT-BI-Cys)
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.
Measured: Baseline, Up to approximately 72 months
Change in Patient-Reported Outcomes from Baseline in FACT-BI-Cys-Trial Outcome Index (TOI)
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.
Measured: Baseline, Up to approximately 72 months
Change in Patient-Reported Outcomes from Baseline in EuroQol Five-Dimensional Questionnaire (EQ-5D-5L) Visual Analog Score (VAS)
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.
Measured: Baseline, Up to approximately 72 months
Time to Deterioration (TTD) in the Total Score of FACT-G
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.
Measured: Up to approximately 72 months
TTD in EQ-5D-5L VAS
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.
Measured: Up to approximately 72 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study start13 Jun 2019
- Primary completion26 Jan 2026
- Study completion18 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 907 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03924856
- Sponsor's protocol ID
- 3475-866
- Other IDs
- MK-3475-866, KEYNOTE-866, 2080224790, 2022-501970-20-00, 194870, U1111-1282-6279, 2018-003808-39, 2018
- Acronym
- KEYNOTE-866
- Status last verified
- Oct 2026
- First submitted
- 22 Apr 2019
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Publications
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.
PubMed 34008425