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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)

  • Clinicaltrials.gov identifier

    NCT03924856

  • Recruitment Status

    Recruiting

  • First Posted

    April 23, 2019

  • Last update posted

    May 24, 2021

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

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 870 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • 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 2019
  • Estimated Primary Completion Date: June 2025
  • Estimated Study Completion Date: June 2025

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

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

Outcome Measures

  • Primary Outcome Measures: 1. Pathologic Complete Response (pCR) Rate [ Time Frame: Up to approximately 15 Weeks (Time of surgery) ]
    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).
  • 2. Event-Free Survival (EFS) [ Time Frame: Up to approximately 71 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 BICR assessments, or death due to any cause.
  • Secondary Outcome Measures: 1. Overall Survival (OS) [ Time Frame: Up to approximately 71 months ]
    Overall survival is defined as the time from randomization to death due to any cause.
  • 2. Disease-Free Survival (DFS) [ Time Frame: From approximately 20 weeks up to approximately 71 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 CT or MRI (BICR) and/or computerized tomography (CT) or magnetic resonance imaging (MRI) by BICR and or biopsy or death from any cause.
  • 3. Pathologic Downstaging (pDS) Rate [ Time Frame: Up to approximately 15 Weeks (Time of surgery) ]
    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.
  • 4. Number of Participants Who Experienced an Adverse Event (AE) [ Time Frame: Up to approximately 71 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.
  • 5. 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.
  • 6. 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.
  • 7. 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 71 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.
  • 8. Change in Patient-Reported Outcomes from Baseline in Total Score of FACT-Bladder- (FACT-BI-Cys) [ Time Frame: Baseline, Up to approximately 71 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.
  • 9. Change in Patient-Reported Outcomes from Baseline in FACT-BI-Cys-Trial Outcome Index (TOI) [ Time Frame: Baseline, Up to approximately 71 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.
  • 10. 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 71 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.
  • 11. Time to Deterioration (TTD) in the Total Score of FACT-G [ Time Frame: Up to approximately 71 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.
  • 12. TTD in EQ-5D-5L VAS [ Time Frame: Up to approximately 71 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

  • 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

Contacts

Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com

Locations

United States, California
Scripps MD Anderson ( Site 0010)
La Jolla

United States, California
Providence Saint John's Health Center ( Site 0075)
Santa Monica

United States, District of Columbia
Georgetown University Medical Center ( Site 0022)
Washington

United States, Florida
Advent Health ( Site 0005)
Orlando

United States, Indiana
Parkview Cancer Institute ( Site 0077)
Fort Wayne

United States, Indiana
Indiana University Melvin and Bren Simon Cancer Center ( Site 0004)
Indianapolis

United States, Louisiana
Ochsner Medical Center ( Site 0049)
New Orleans

United States, Maine
New England Cancer Specialists ( Site 0070)
Scarborough

United States, Massachusetts
UMass Memorial Medical Center ( Site 0051)
Worcester

United States, Michigan
Henry Ford Hospital ( Site 0039)
Detroit

United States, Missouri
Mercy Hospital Saint Louis ( Site 0064)
Saint Louis

United States, New Jersey
Morristown Medical Center ( Site 0015)
Morristown

United States, New Mexico
University of New Mexico Cancer Center ( Site 0045)
Albuquerque

United States, New York
New York University Perlmutter Cancer Center ( Site 0008)
New York

United States, Ohio
University Hospitals Cleveland Medical Center ( Site 0038)
Cleveland

United States, Oklahoma
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0021)
Tulsa

United States, Oregon
Portland VA Medical Center ( Site 0084)
Portland

United States, Pennsylvania
Allegheny General Hospital ( Site 0048)
Pittsburgh

United States, Texas
MD Anderson Cancer Center ( Site 0063)
Houston

United States, Texas
Central Texas Veterans Healthcare System ( Site 0057)
Temple

United States, Virginia
Inova Schar Cancer Institute ( Site 0007)
Fairfax

United States, Washington
Northwest Medical Specialties, PLLC ( Site 0061)
Puyallup

United States, Washington
Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 0033)
Seattle

United States, West Virginia
Charleston Area Medical Center ( Site 0023)
Charles Town

Australia, New South Wales
Mid North Coast Cancer Institute ( Site 1256)
Port Macquarie

Australia, New South Wales
Southside Cancer Care Centre ( Site 1252)
Sydney

Australia, Queensland
Cairns Base Hospital ( Site 1257)
Cairns

Australia, Victoria
Eastern Health ( Site 1255)
Box Hill

Australia, Victoria
Peninsula Health Frankston Hospital ( Site 1258)
Frankston

Belgium, Bruxelles-Capitale, Region De
UZ Brussel ( Site 0358)
Brussels

Belgium, Limburg
Jessa Ziekenhuis ( Site 0360)
Hasselt

Belgium, Namur
CHU UCL Namur Site de Godinne ( Site 0354)
Yvoir

Belgium, Oost-Vlaanderen
O.L.V. Ziekenhuis Aalst ( Site 0356)
Aalst

Belgium, Oost-Vlaanderen
AZ Maria Middelares Gent ( Site 0353)
Gent

Canada, Alberta
Tom Baker Cancer Centre ( Site 0100)
Calgary

Canada, Nova Scotia
Nova Scotia Health Authority ( Site 0109)
Halifax

Canada, Ontario
Kingston Health Sciences Centre ( Site 0103)
Kingston

Canada, Ontario
Lakeridge Health ( Site 0104)
Oshawa

Canada, Ontario
Sunnybrook Research Institute ( Site 0110)
Toronto

Canada, Ontario
Princess Margaret Cancer Centre ( Site 0107)
Toronto

Canada, Quebec
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0105)
Montreal

Canada
CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 0111)
Quebec

Denmark, Hovedstaden
Herlev og Gentofte Hospital. ( Site 0402)
Herlev

Denmark, Hovedstaden
Rigshospitalet University Hospital ( Site 0401)
Kobenhavn

Denmark, Syddanmark
Odense Universitetshospital ( Site 0403)
Odense

France, Aquitaine
CHU de Bordeaux- Hopital Saint Andre ( Site 0456)
Bordeaux

France, Auvergne
Centre Leon Berard ( Site 0465)
Lyon

France, Calvados
Centre Francois Baclesse ( Site 0459)
Caen

France, Cotes-d Armor
Centre Armoricain de Radiotherapie Imagerie medicale et Oncologie ( Site 0457)
Plerin

France, Hauts-de-Seine
Hopital Foch ( Site 0483)
Suresnes

France, Herault
CHU de Montpellier - Hopital Saint-Eloi ( Site 0469)
Montpellier

France, Maine-et-Loire
Institut de Cancerologie de l Ouest Site Paul Papin ( Site 0453)
Angers

France, Moselle
Hopital Robert Schuman ( Site 0452)
Vantoux

France, Puy-de-Dome
Centre Jean Perrin ( Site 0460)
Clermont-Ferrand

France, Sarthe
Clinique Victor Hugo ( Site 0463)
Le Mans

France, Seine-Maritime
CHU de Rouen ( Site 0493)
Rouen

France, Vaucluse
Institut Sainte Catherine ( Site 0454)
Avignon

Germany, Baden-Wurttemberg
Klinikum der Eberhard-Karls-Universitaet Tuebingen ( Site 0502)
Tuebingen

Germany, Bayern
Universitaetsklinikum Erlangen ( Site 0505)
Erlangen

Germany, Sachsen-Anhalt
Universitaetsklinikum Magdeburg A.o.R. ( Site 0516)
Magdeburg

Germany, Sachsen
Universitaetsklinikum Carl Gustav Carus ( Site 0519)
Dresden

Germany, Schleswig-Holstein
Universitaetsklinikum Schleswig-Holstein-Campus Lubeck ( Site 0512)
Luebeck

Germany
Charite Universitaetsmedizin Berlin ( Site 0515)
Berlin

Germany
Vivantes Klinikum am Urban ( Site 0522)
Berlin

Hungary, Baranya
Pecsi Tudomanyegyetem AOK ( Site 1009)
Pecs

Hungary, Csongrad
SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 1010)
Szeged

Hungary, Jasz-Nagykun-Szolnok
Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1002)
Szolnok

Hungary
Bajcsy Zsilinszki Korhaz es Rendelointezet ( Site 1001)
Budapest

Hungary
Debreceni Egyetem Klinikai Kozpont ( Site 1006)
Debrecen

Hungary
Petz Aladar Megyei Oktato Korhaz ( Site 1012)
Gyor

Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 1007)
Kaposvar

Ireland
Cork University Hospital ( Site 0722)
Cork

Ireland
Tallaght University Hospital ( Site 0710)
Dublin

Ireland
University Hospital Waterford ( Site 0723)
Waterford

Israel, Tell Abib
Sheba Medical Center ( Site 0801)
Ramat Gan

Israel
Ha Emek Medical Center ( Site 0808)
Afula

Israel
Soroka Medical Center ( Site 0806)
Beer Sheva

Israel
Rambam Medical Center ( Site 0802)
Haifa

Israel
Shaare Zedek Medical Center ( Site 0809)
Jerusalem

Israel
Hadassah Ein Kerem Medical Center ( Site 0810)
Jerusalem

Israel
Meir Medical Center ( Site 0803)
Kfar Saba

Israel
Rabin Medical Center ( Site 0804)
Petach Tikva

Israel
Sourasky Medical Center ( Site 0807)
Tel Aviv

Israel
Assaf Harofeh Medical Center ( Site 0805)
Zerifin

Italy
A.O.U. Policlinico Vittorio Emanuele - Presidio Gaspare Rodolico ( Site 0559)
Catania

Italy
Istituto Nazionale Studio e Cura dei Tumori ( Site 0551)
Milano

Italy
Policlinico di Modena ( Site 0553)
Modena

Italy
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori ( Site 0552)
Napoli

Italy
Fondazione Salvatore Maugeri IRCCS. ( Site 0554)
Pavia

Italy
Azienda Ospedaliera San Camillo Forlanini ( Site 0560)
Roma

Italy
Policlinico Gemelli di Roma ( Site 0558)
Roma

Italy
Azienda Ospedaliera Santa Maria Terni ( Site 0557)
Terni

Japan, Aomori
Hirosaki University Hospital ( Site 1502)
Hirosaki

Japan, Chiba
National Cancer Center Hospital East ( Site 1504)
Kashiwa

Japan, Ehime
Ehime University Hospital ( Site 1508)
Toon

Japan, Hokkaido
Sapporo Medical University Hospital ( Site 1501)
Sapporo

Japan, Ibaraki
University of Tsukuba Hospital ( Site 1503)
Tsukuba

Japan, Kanagawa
Yokosuka Kyosai Hospital ( Site 1509)
Yokosuka

Japan, Nara
Nara Medical University Hospital ( Site 1510)
Kashihara

Japan, Saitama
Saitama Medical University International Medical Center ( Site 1505)
Hidaka

Japan
Chiba Cancer Center ( Site 1506)
Chiba

Japan
Harasanshin Hospital ( Site 1515)
Fukuoka

Japan
Hiroshima City Hiroshima Citizens Hospital ( Site 1513)
Hiroshima

Japan
Nagano Municipal Hospital ( Site 1516)
Nagano

Japan
Osaka City University Hospital ( Site 1512)
Osaka

Japan
Tokushima University Hospital ( Site 1514)
Tokushima

Japan
Medical Hospital, Tokyo Medical And Dental University ( Site 1517)
Tokyo

Korea, Republic of, Kyonggi-do
National Cancer Center ( Site 1354)
Goyang-si

Korea, Republic of, Kyonggi-do
Seoul National University Bundang Hospital ( Site 1356)
Seongnam-si

Korea, Republic of
Korea University Anam Hospital ( Site 1351)
Seoul

Korea, Republic of
Seoul National University Hospital ( Site 1352)
Seoul

Korea, Republic of
Asan Medical Center ( Site 1355)
Seoul

Korea, Republic of
Samsung Medical Center ( Site 1353)
Seoul

Mexico, Nuevo Leon
Centro de Urologia Avanzada del Noreste S.A. de C.V. ( Site 0254)
Monterrey

Mexico
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V. ( Site 0300)
Aguascalientes

Mexico
Centro Estatal de Cancerologia de Chihuahua ( Site 0253)
Chihuahua

Mexico
Instituto Nacional de Cancerologia ( Site 0256)
Tlalpan

Poland, Dolnoslaskie
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 1062)
Wroclaw

Poland, Kujawsko-pomorskie
Centrum Onkologii im.prof. F. Lukaszczyka w Bydgoszczy ( Site 1068)
Bydgoszcz

Poland, Mazowieckie
Europejskie Centrum Zdrowia Otwock ( Site 1057)
Otwock

Poland, Mazowieckie
Luxmed Onkologia sp. z o. o. ( Site 1051)
Warszawa

Poland, Slaskie
Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1060)
Bielsko-Biala

Russian Federation, Baskortostan, Respublika
Clinic of Bashkortostan State Medical University ( Site 0869)
Ufa

Russian Federation, Ivanovskaya Oblast
Ivanovo Regional Oncology Dispensary ( Site 0852)
Ivanovo

Russian Federation, Krasnoyarskiy Kray
Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0861)
Krasnoyarsk

Russian Federation, Kurskaya Oblast
Kursk Regional Clinical Oncology Dispensary ( Site 0854)
Kursk

Russian Federation, Leningradskaya Oblast
Leningrad Regional Oncology Center ( Site 0868)
Saint Petersburg

Russian Federation, Moskva
FSBI ""United Hospital with Polyclinic"" of the Administrative Department of the President of the Ru
Moscow

Russian Federation, Moskva
Central Clinical Hospital with outpatient Clinic ( Site 0856)
Moscow

Russian Federation, Murmanskaya Oblast
Bayandin Murmansk Regional Clinical Hospital ( Site 0859)
Murmansk

Russian Federation, Nizhegorodskaya Oblast
Volga District Medical Center Federal Medical and Biological Agency ( Site 0857)
Nizhny Novgorod

Russian Federation, Omskaya Oblast
Omsk Clinical Oncology Dispensary ( Site 0865)
Omsk

Russian Federation, Sankt-Peterburg
Clinical Hospital Saint Luka ( Site 0867)
St. Petersburg

Russian Federation, Saratovskaya Oblast
Saratov State Medical University n.a. V.I.Razumovskiy ( Site 0866)
Saratov

Spain, Extremadura
Hospital San Pedro de Alcantara ( Site 0654)
Caceres

Spain, Gerona
H. de Gerona Dr. Josep Trueta ( Site 0651)
Girona

Spain, Madrid, Comunidad De
Hospital Universitario Quiron Madrid ( Site 0657)
Pozuelo de Alarcon

Spain, Valenciana, Comunitat
Instituto Valenciano de Oncologia - IVO ( Site 0662)
Valencia

Spain
Hospital del Mar ( Site 0653)
Barcelona

Spain
Hospital Universitario Ramon y Cajal ( Site 0660)
Madrid

Spain
Hospital Universitario San Carlos ( Site 0663)
Madrid

Spain
Hospital Universitario La Paz ( Site 0661)
Madrid

Spain
Hospital Nuestra Sra. de Valme ( Site 0658)
Sevilla

Sweden, Jonkopings Lan
Laenssjukhuset Ryhov ( Site 1205)
Jonkoping

Sweden, Uppsala Lan
Akademiska Sjukhuset ( Site 1201)
Uppsala

Sweden, Vasterbottens Lan
Cancercentrum ( Site 1204)
Umea

Thailand, Krung Thep Maha Nakhon
Ramathibodi Hospital. ( Site 1451)
Bangkok

Thailand, Krung Thep Maha Nakhon
Faculty of Medicine Siriraj Hospital ( Site 1452)
Bangkok

Thailand
Maharaj Nakorn Chiangmai Hospital ( Site 1453)
Chiang Mai

Thailand
Srinagarind Hospital ( Site 1454)
Khon Kaen

Turkey
Hacettepe Universitesi Tıp Fakultesi ( Site 0911)
Ankara

Turkey
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0910)
Istanbul

Turkey
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0906)
Istanbul

Turkey
Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 0901)
Istanbul

Turkey
Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 0909)
Konya

Turkey
Sakarya Universitesi Tip Fakultesi ( Site 0913)
Sakarya

Turkey
Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi ( Site 0904)
Trabzon

Ukraine, Cherkaska Oblast
Cherkasy Regional Oncology Dispensary ( Site 0959)
Cherkasy

Ukraine, Dnipropetrovska Oblast
MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov ( Site 0963)
Dnipropetrovsk

Ukraine, Dnipropetrovska Oblast
Regional Oncological Hospital ( Site 0956)
Dnipro

Ukraine, Dnipropetrovska Oblast
Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC ( Site 0951)
Dnipro

Ukraine, Kharkivska Oblast
Reg. Clinical Center of Urology and Nephrology n.a. V. I. Shapoval ( Site 0969)
Kharkiv

Ukraine, Kharkivska Oblast
CNPE "Regional Center of Oncology" ( Site 0958)
Kharkiv

Ukraine, Kyivska Oblast
National Cancer Institute of the MoH of Ukraine ( Site 0962)
Kyiv

Ukraine, Lvivska Oblast
Lviv Regional Clinical Hospital ( Site 0955)
Lviv

Ukraine, Lvivska Oblast
Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 0967)
Lviv

Ukraine
Kyiv City Clinical Oncology Center ( Site 0960)
Kyiv

United Kingdom, Aberdeen City
Aberdeen Royal Infirmary ( Site 0708)
Aberdeen

United Kingdom, Devon
Torbay Hospital ( Site 0704)
Torquay

United Kingdom, England
Kent and Canterbury Hospital ( Site 0709)
Canterbury

United Kingdom, Hertfordshire
Lister Hospital ( Site 0715)
Stevenage

United Kingdom, London, City Of
The Royal Marsden Foundation Trust ( Site 0702)
London

United Kingdom, London, City Of
Imperial College Healthcare NHS Trust ( Site 0721)
London

United Kingdom, Norfolk
Norfolk & Norwich University Hospital NHS Foundation Trust ( Site 0725)
Norwich

United Kingdom
Royal Cornwall Hospital ( Site 0703)
Truro

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators

Study Director: Medical Director Merck Sharp & Dohme Corp.

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