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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)

Primary Purpose

Bladder Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pembrolizumab
Gemcitabine
Cisplatin
Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND])
Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1), Pembrolizumab (MK-3475), Chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Scripps MD Anderson ( Site 0010)
  • Providence Saint John's Health Center ( Site 0075)
  • Georgetown University Medical Center ( Site 0022)
  • AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 0005)
  • Parkview Cancer Institute ( Site 0077)
  • Indiana University Melvin and Bren Simon Cancer Center ( Site 0004)
  • Ochsner Medical Center ( Site 0049)
  • New England Cancer Specialists ( Site 0070)
  • UMass Memorial Medical Center ( Site 0051)
  • Henry Ford Hospital ( Site 0039)
  • Mercy Hospital Saint Louis ( Site 0064)
  • Morristown Medical Center ( Site 0015)
  • UNM Comprehensive Cancer Center-Clinical Research Office ( Site 0045)
  • New York University Perlmutter Cancer Center ( Site 0008)
  • University Hospitals Cleveland Medical Center ( Site 0038)
  • Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0021)
  • Portland VA Medical Center ( Site 0084)
  • Allegheny General Hospital ( Site 0048)
  • MD Anderson Cancer Center ( Site 0063)
  • Central Texas Veterans Healthcare System ( Site 0057)
  • Inova Schar Cancer Institute ( Site 0007)
  • Northwest Medical Specialties, PLLC ( Site 0061)
  • Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 0033)
  • Charleston Area Medical Center ( Site 0023)
  • Mid North Coast Cancer Institute ( Site 1256)
  • Southside Cancer Care Centre ( Site 1252)
  • Cairns Base Hospital ( Site 1257)
  • Eastern Health ( Site 1255)
  • Peninsula Health Frankston Hospital ( Site 1258)
  • UZ Brussel ( Site 0358)
  • Jessa Ziekenhuis ( Site 0360)
  • CHU UCL Namur Site de Godinne ( Site 0354)
  • O.L.V. Ziekenhuis Aalst ( Site 0356)
  • AZ Maria Middelares Gent ( Site 0353)
  • Tom Baker Cancer Centre ( Site 0100)
  • Nova Scotia Health Authority ( Site 0109)
  • Kingston Health Sciences Centre ( Site 0103)
  • Lakeridge Health ( Site 0104)
  • Sunnybrook Research Institute ( Site 0110)
  • Princess Margaret Cancer Centre ( Site 0107)
  • CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0105)
  • Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0
  • Herlev og Gentofte Hospital. ( Site 0402)
  • Rigshospitalet University Hospital ( Site 0401)
  • Odense Universitetshospital ( Site 0403)
  • CHU de Bordeaux- Hopital Saint Andre ( Site 0456)
  • Centre Leon Berard ( Site 0465)
  • Centre Francois Baclesse ( Site 0459)
  • Centre Armoricain de Radiotherapie Imagerie medicale et Oncologie ( Site 0457)
  • Hopital Foch ( Site 0483)
  • CHU de Montpellier - Hopital Saint-Eloi ( Site 0469)
  • Institut de Cancerologie de l Ouest Site Paul Papin ( Site 0453)
  • Hopital Robert Schuman ( Site 0452)
  • Centre Jean Perrin ( Site 0460)
  • Clinique Victor Hugo ( Site 0463)
  • CHU de Rouen ( Site 0493)
  • Institut Sainte Catherine ( Site 0454)
  • Klinikum der Eberhard-Karls-Universitaet Tuebingen ( Site 0502)
  • Universitaetsklinikum Erlangen ( Site 0505)
  • Universitaetsklinikum Magdeburg A.o.R. ( Site 0516)
  • Universitaetsklinikum Carl Gustav Carus ( Site 0519)
  • Universitaetsklinikum Schleswig-Holstein-Campus Lubeck ( Site 0512)
  • Charite Universitaetsmedizin Berlin ( Site 0515)
  • Vivantes Klinikum am Urban ( Site 0522)
  • Pecsi Tudomanyegyetem AOK ( Site 1009)
  • SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 1010)
  • Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1002)
  • Bajcsy Zsilinszki Korhaz es Rendelointezet ( Site 1001)
  • Debreceni Egyetem Klinikai Kozpont ( Site 1006)
  • Petz Aladar Megyei Oktato Korhaz ( Site 1012)
  • Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 1007)
  • Cork University Hospital ( Site 0722)
  • Tallaght University Hospital ( Site 0710)
  • University Hospital Waterford ( Site 0723)
  • Ha Emek Medical Center ( Site 0808)
  • Soroka Medical Center ( Site 0806)
  • Rambam Health Care Campus-Oncology Division ( Site 0802)
  • Shaare Zedek Medical Center ( Site 0809)
  • Hadassah Ein Kerem Medical Center ( Site 0810)
  • Meir Medical Center ( Site 0803)
  • Rabin Medical Center ( Site 0804)
  • Sheba Medical Center ( Site 0801)
  • Sourasky Medical Center ( Site 0807)
  • Yitzhak Shamir Medical Center ( Site 0805)
  • Policlinico Gemelli di Roma ( Site 0558)
  • Policlinico di Modena ( Site 0553)
  • A.O.U. Policlinico Vittorio Emanuele - Presidio Gaspare Rodolico ( Site 0559)
  • Istituto Nazionale Studio e Cura dei Tumori ( Site 0551)
  • Istituto Nazionale Per Lo Studio E La Cura Dei Tumori ( Site 0552)
  • Fondazione Salvatore Maugeri IRCCS. ( Site 0554)
  • Azienda Ospedaliera San Camillo Forlanini ( Site 0560)
  • Azienda Ospedaliera Santa Maria Terni ( Site 0557)
  • Hirosaki University Hospital ( Site 1502)
  • National Cancer Center Hospital East ( Site 1504)
  • Ehime University Hospital ( Site 1508)
  • Sapporo Medical University Hospital ( Site 1501)
  • University of Tsukuba Hospital ( Site 1503)
  • Yokosuka Kyosai Hospital ( Site 1509)
  • Nara Medical University Hospital ( Site 1510)
  • Saitama Medical University International Medical Center ( Site 1505)
  • Chiba Cancer Center ( Site 1506)
  • Harasanshin Hospital ( Site 1515)
  • Hiroshima City Hiroshima Citizens Hospital ( Site 1513)
  • Nagano Municipal Hospital ( Site 1516)
  • Osaka Metropolitan University Hospital ( Site 1512)
  • Tokushima University Hospital ( Site 1514)
  • Tokyo Medical and Dental University Hospital ( Site 1517)
  • National Cancer Center ( Site 1354)
  • Seoul National University Bundang Hospital ( Site 1356)
  • Korea University Anam Hospital ( Site 1351)
  • Seoul National University Hospital ( Site 1352)
  • Asan Medical Center ( Site 1355)
  • Samsung Medical Center ( Site 1353)
  • Centro de Urologia Avanzada del Noreste S.A. de C.V. ( Site 0254)
  • Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V. ( Site 0300)
  • Centro Estatal de Cancerologia de Chihuahua ( Site 0253)
  • Instituto Nacional de Cancerologia ( Site 0256)
  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 1062)
  • Centrum Onkologii im.prof. F. Lukaszczyka w Bydgoszczy ( Site 1068)
  • Europejskie Centrum Zdrowia Otwock ( Site 1057)
  • Luxmed Onkologia sp. z o. o. ( Site 1051)
  • Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1060)
  • Clinic of Bashkortostan State Medical University ( Site 0869)
  • Ivanovo Regional Oncology Dispensary ( Site 0852)
  • Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0861)
  • Kursk Regional Clinical Oncology Dispensary ( Site 0854)
  • FSBI ""United Hospital with Polyclinic"" of the Administrative Department of the President of the Ru
  • Central Clinical Hospital with outpatient Clinic ( Site 0856)
  • Bayandin Murmansk Regional Clinical Hospital ( Site 0859)
  • Volga District Medical Center Federal Medical and Biological Agency ( Site 0857)
  • Omsk Clinical Oncology Dispensary ( Site 0865)
  • Leningrad Regional Oncology Center ( Site 0868)
  • Clinical Hospital Saint Luka ( Site 0867)
  • Saratov State Medical University n.a. V.I.Razumovskiy ( Site 0866)
  • Hospital San Pedro de Alcantara ( Site 0654)
  • H. de Gerona Dr. Josep Trueta ( Site 0651)
  • Hospital Universitario Ramon y Cajal ( Site 0660)
  • Hospital Universitario Quiron Madrid ( Site 0657)
  • Instituto Valenciano de Oncologia - IVO ( Site 0662)
  • Hospital del Mar ( Site 0653)
  • Hospital Universitario San Carlos ( Site 0663)
  • Hospital Universitario La Paz ( Site 0661)
  • Hospital Nuestra Sra. de Valme ( Site 0658)
  • Laenssjukhuset Ryhov ( Site 1205)
  • Akademiska Sjukhuset ( Site 1201)
  • Cancercentrum ( Site 1204)
  • Ramathibodi Hospital. ( Site 1451)
  • Faculty of Medicine Siriraj Hospital ( Site 1452)
  • Maharaj Nakorn Chiangmai Hospital ( Site 1453)
  • Srinagarind Hospital ( Site 1454)
  • Hacettepe Universitesi Tıp Fakultesi ( Site 0911)
  • Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0910)
  • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0906)
  • Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 0901)
  • Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 0909)
  • Sakarya Universitesi Tip Fakultesi ( Site 0913)
  • Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi ( Site 0904)
  • Cherkasy Regional Oncology Dispensary ( Site 0959)
  • MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov ( Site 0963)
  • Regional Oncological Hospital ( Site 0956)
  • Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC ( Site 0951)
  • Reg. Clinical Center of Urology and Nephrology n.a. V. I. Shapoval ( Site 0969)
  • CNPE "Regional Center of Oncology" ( Site 0958)
  • National Cancer Institute of the MoH of Ukraine ( Site 0962)
  • Lviv Regional Clinical Hospital ( Site 0955)
  • Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 0967)
  • Kyiv City Clinical Oncology Center ( Site 0960)
  • Aberdeen Royal Infirmary ( Site 0708)
  • Torbay Hospital ( Site 0704)
  • Kent and Canterbury Hospital ( Site 0709)
  • Lister Hospital ( Site 0715)
  • The Royal Marsden Foundation Trust ( Site 0702)
  • Imperial College Healthcare NHS Trust ( Site 0721)
  • Norfolk & Norwich University Hospital NHS Foundation Trust ( Site 0725)
  • Royal Cornwall Hospital ( Site 0703)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pembrolizumab + Gemcitabine + Cisplatin + Surgery

Placebo + Gemcitabine + Cisplatin + Surgery

Arm Description

Participants received 4 preoperative cycles of pembrolizumab PLUS gemcitabine PLUS cisplatin, followed by surgery, followed by up to 13 cycles of postoperative pembrolizumab.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
Overall Survival (OS)
Overall survival is defined as the time from randomization to death due to any cause.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
April 22, 2019
Last Updated
August 28, 2023
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03924856
Brief Title
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)
Acronym
KEYNOTE-866
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 13, 2019 (Actual)
Primary Completion Date
June 15, 2025 (Anticipated)
Study Completion Date
June 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1), Pembrolizumab (MK-3475), Chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blind
Allocation
Randomized
Enrollment
907 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pembrolizumab + Gemcitabine + Cisplatin + Surgery
Arm Type
Experimental
Arm Description
Participants received 4 preoperative cycles of pembrolizumab PLUS gemcitabine PLUS cisplatin, followed by surgery, followed by up to 13 cycles of postoperative pembrolizumab.
Arm Title
Placebo + Gemcitabine + Cisplatin + Surgery
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
MK-3475
Intervention Description
Pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Gemcitabine 1000 mg/m^2, IV infusion on Days 1 and 8 of each 21-day cycle
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Cisplatin 70 mg/m^2, IV infusion on Day 1 of each 21-day cycle
Intervention Type
Procedure
Intervention Name(s)
Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND])
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo to pembrolizumab by IV infusion, given on Day 1 of each 21-day cycle
Primary Outcome Measure Information:
Title
Event-Free Survival (EFS)
Description
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.
Time Frame
Up to approximately 60 months
Secondary Outcome Measure Information:
Title
Pathologic Complete Response (pCR) Rate
Description
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).
Time Frame
Up to approximately 72 months
Title
Overall Survival (OS)
Description
Overall survival is defined as the time from randomization to death due to any cause.
Time Frame
Up to approximately 72 months
Title
Disease-Free Survival (DFS)
Description
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.
Time Frame
From approximately 20 weeks up to approximately 72 months
Title
Pathologic Downstaging (pDS) Rate
Description
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.
Time Frame
Up to approximately 72 months
Title
Number of Participants Who Experienced an Adverse Event (AE)
Description
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.
Time Frame
Up to approximately 72 months
Title
Number of Participants Who Discontinued Study Treatment Due to an AE
Description
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.
Time Frame
Up to approximately 12 months
Title
Number of Participants Who Experienced Perioperative Complications
Description
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.
Time Frame
Up to approximately 12 months
Title
Change in Patient-Reported Outcomes from Baseline in Total Score of Functional Assessment of Cancer Therapy - General (FACT-G)
Description
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.
Time Frame
Baseline, Up to approximately 72 months
Title
Change in Patient-Reported Outcomes from Baseline in Total Score of FACT-Bladder- (FACT-BI-Cys)
Description
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.
Time Frame
Baseline, Up to approximately 72 months
Title
Change in Patient-Reported Outcomes from Baseline in FACT-BI-Cys-Trial Outcome Index (TOI)
Description
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.
Time Frame
Baseline, Up to approximately 72 months
Title
Change in Patient-Reported Outcomes from Baseline in EuroQol Five-Dimensional Questionnaire (EQ-5D-5L) Visual Analog Score (VAS)
Description
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 Frame
Baseline, Up to approximately 72 months
Title
Time to Deterioration (TTD) in the Total Score of FACT-G
Description
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.
Time Frame
Up to approximately 72 months
Title
TTD in EQ-5D-5L VAS
Description
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.
Time Frame
Up to approximately 72 months

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
34008425
Citation
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.
Results Reference
derived
Links:
URL
https://merckclinicaltrials.com/
Description
Merck Clinical Trials Information

Learn more about this trial

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)

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