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)
- Conditions
- Bladder Cancer
- Interventions
- Drug: PembrolizumabDrug: GemcitabineDrug: CisplatinProcedure: Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND])Drug: Placebo
- Registration Number
- NCT03924856
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
A global study to evaluate peri-operative pembrolizumab with chemotherapy versus placebo to pembrolizumab plus chemotherapy in cisplatin eligible patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 907
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pembrolizumab + Gemcitabine + Cisplatin + Surgery Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND]) Participants received 4 preoperative cycles of pembrolizumab PLUS gemcitabine PLUS cisplatin, followed by surgery, followed by up to 13 cycles of postoperative pembrolizumab. Placebo + Gemcitabine + Cisplatin + Surgery Placebo 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. Placebo + Gemcitabine + Cisplatin + Surgery Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND]) 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. Pembrolizumab + Gemcitabine + Cisplatin + Surgery Gemcitabine Participants received 4 preoperative cycles of pembrolizumab PLUS gemcitabine PLUS cisplatin, followed by surgery, followed by up to 13 cycles of postoperative pembrolizumab. Pembrolizumab + Gemcitabine + Cisplatin + Surgery Pembrolizumab Participants received 4 preoperative cycles of pembrolizumab PLUS gemcitabine PLUS cisplatin, followed by surgery, followed by up to 13 cycles of postoperative pembrolizumab. Pembrolizumab + Gemcitabine + Cisplatin + Surgery Cisplatin Participants received 4 preoperative cycles of pembrolizumab PLUS gemcitabine PLUS cisplatin, followed by surgery, followed by up to 13 cycles of postoperative pembrolizumab. Placebo + Gemcitabine + Cisplatin + Surgery Gemcitabine 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. Placebo + Gemcitabine + Cisplatin + Surgery Cisplatin 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.
- Primary Outcome Measures
Name Time Method Event-Free Survival (EFS) Up to approximately 60 months EFS is defined as the time from randomization to the first occurrence of any of the following events: progression of disease that precludes RC surgery; 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
Name Time Method Pathologic Complete Response (pCR) Rate Up to approximately 72 months 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) Up to approximately 72 months Overall survival is defined as the time from randomization to death due to any cause.
Disease-Free Survival (DFS) From approximately 20 weeks up to approximately 72 months DFS is defined as the time from post-surgery baseline scan until the first occurrence of either local or distant recurrence as assessed by investigator by CT or MRI and/or computerized tomography (CT) or magnetic resonance imaging (MRI) and or biopsy or death from any cause.
Pathologic Downstaging (pDS) Rate Up to approximately 72 months pDS rate is defined as the percentage of participants having pDS. pDS is defined as participants with a tumor classification of \<pT2 (includes pT0, pTis, pTa, pT1) and N0 in examined tissue from RC plus PLND as assessed by BICR.
TTD in EQ-5D-5L VAS Up to approximately 72 months The EQ-5D-5L is a standardized instrument for use as a measure of health outcome and includes 5 health state dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. In the EQ-5D-5L VAS, the participant rates his or her general state of health at the time of the assessment on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. TTD is defined as the time from baseline to the first onset of PRO deterioration. For the EQ 5D-5L, deterioration is defined as a decrease of 7 points or more from baseline in the VAS.
Number of Participants Who Discontinued Study Treatment Due to an AE Up to approximately 12 months An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Number of Participants Who Experienced Perioperative Complications Up to approximately 12 months An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Change in Patient-Reported Outcomes from Baseline in Total Score of Functional Assessment of Cancer Therapy - General (FACT-G) Baseline, Up to approximately 72 months The FACT-G is a health-related quality of life (HRQoL) 27-item questionnaire in patients being treated for cancer. The FACT-G subscales include Physical Well-Being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB), and Functional Well-Being (FWB). All items are scored on a 5-point Likert scale of 0 to 4, with higher scores indicating higher HRQoL. The total score can range from 0 to 108.
Change in Patient-Reported Outcomes from Baseline in EuroQol Five-Dimensional Questionnaire (EQ-5D-5L) Visual Analog Score (VAS) Baseline, Up to approximately 72 months The EQ-5D-5L is a standardized instrument for use as a measure of health outcome. In the EQ-5D-5L VAS, the participant rates his or her general state of health at the time of the assessment on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.
Number of Participants Who Experienced an Adverse Event (AE) Up to approximately 72 months An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Change in Patient-Reported Outcomes from Baseline in Total Score of FACT-Bladder- (FACT-BI-Cys) Baseline, Up to approximately 72 months Total Score of FACT BI-Cys is the sum of FACT-G total score and FACT-Bl-Cys score. FACT-Bl-Cys contains 17 items on the bowel, bladder, and sexual symptoms following cystectomy. The FACT-G is a health-related quality of life (HRQoL) 27-item questionnaire in patients being treated for cancer. The FACT-G subscales include Physical Well-Being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB), and Functional Well-Being (FWB). All items are scored on a 5-point Likert scale of 0 to 4, with higher scores indicating higher HRQoL. The total score of FACT-Bl-Cys can range from 0 to 168.
Time to Deterioration (TTD) in the Total Score of FACT-G Up to approximately 72 months The FACT-G is a health-related quality of life (HRQoL) 27-item questionnaire in patients being treated for cancer. The FACT-G subscales include Physical Well-Being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB), and Functional Well-Being (FWB). All items are scored on a 5-point Likert scale of 0-4, with higher scores indicating higher HRQoL. TTD is defined as the time from baseline to the first onset of patient-reported outcomes (PRO) deterioration. For the FACT-G questionnaire, deteriorations are defined as a decrease of 7 points or more (out of 108) from baseline in total score.
Change in Patient-Reported Outcomes from Baseline in FACT-BI-Cys-Trial Outcome Index (TOI) Baseline, Up to approximately 72 months FACT-Bl-Cys Trial Outcome Index (TOI) is the sum of FACT-G PWB score, FWB score, and FACT-Bl-Cys score. FACT-Bl-Cys contains 17 items on the bowel, bladder, and sexual symptoms following cystectomy. The FACT-G is a health-related quality of life (HRQoL) 27-item questionnaire in patients being treated for cancer. The FACT-G subscales include Physical Well-Being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB), and Functional Well-Being (FWB). All items are scored on a 5-point Likert scale of 0 to 4, with higher scores indicating higher HRQoL. The total score of FACT-Bl-Cys TOI can range from 0 to 116.
Trial Locations
- Locations (175)
Princess Margaret Cancer Centre ( Site 0107)
🇨🇦Toronto, Ontario, Canada
Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 0033)
🇺🇸Seattle, Washington, United States
Scripps MD Anderson ( Site 0010)
🇺🇸La Jolla, California, United States
Providence Saint John's Health Center ( Site 0075)
🇺🇸Santa Monica, California, United States
Parkview Cancer Institute ( Site 0077)
🇺🇸Fort Wayne, Indiana, United States
UMass Memorial Medical Center ( Site 0051)
🇺🇸Worcester, Massachusetts, United States
Mercy Hospital Saint Louis ( Site 0064)
🇺🇸Saint Louis, Missouri, United States
Morristown Medical Center ( Site 0015)
🇺🇸Morristown, New Jersey, United States
UNM Comprehensive Cancer Center-Clinical Research Office ( Site 0045)
🇺🇸Albuquerque, New Mexico, United States
University Hospitals Cleveland Medical Center ( Site 0038)
🇺🇸Cleveland, Ohio, United States
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0021)
🇺🇸Tulsa, Oklahoma, United States
New York University Perlmutter Cancer Center ( Site 0008)
🇺🇸New York, New York, United States
MD Anderson Cancer Center ( Site 0063)
🇺🇸Houston, Texas, United States
Allegheny General Hospital ( Site 0048)
🇺🇸Pittsburgh, Pennsylvania, United States
Central Texas Veterans Healthcare System ( Site 0057)
🇺🇸Temple, Texas, United States
Charleston Area Medical Center ( Site 0023)
🇺🇸Charles Town, West Virginia, United States
Inova Schar Cancer Institute ( Site 0007)
🇺🇸Fairfax, Virginia, United States
Northwest Medical Specialties, PLLC ( Site 0061)
🇺🇸Puyallup, Washington, United States
Mid North Coast Cancer Institute ( Site 1256)
🇦🇺Port Macquarie, New South Wales, Australia
Southside Cancer Care Centre ( Site 1252)
🇦🇺Sydney, New South Wales, Australia
Cairns Base Hospital ( Site 1257)
🇦🇺Cairns, Queensland, Australia
Peninsula Health Frankston Hospital ( Site 1258)
🇦🇺Frankston, Victoria, Australia
Jessa Ziekenhuis ( Site 0360)
🇧🇪Hasselt, Limburg, Belgium
AZ Maria Middelares Gent ( Site 0353)
🇧🇪Gent, Oost-Vlaanderen, Belgium
Kingston Health Sciences Centre ( Site 0103)
🇨🇦Kingston, Ontario, Canada
Lakeridge Health ( Site 0104)
🇨🇦Oshawa, Ontario, Canada
Sunnybrook Research Institute ( Site 0110)
🇨🇦Toronto, Ontario, Canada
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0105)
🇨🇦Montreal, Quebec, Canada
CHU de Bordeaux- Hopital Saint Andre ( Site 0456)
🇫🇷Bordeaux, Aquitaine, France
Centre Leon Berard ( Site 0465)
🇫🇷Lyon, Auvergne, France
Centre Armoricain de Radiotherapie Imagerie medicale et Oncologie ( Site 0457)
🇫🇷Plerin, Cotes-d Armor, France
CHU de Montpellier - Hopital Saint-Eloi ( Site 0469)
🇫🇷Montpellier, Languedoc-Roussillon, France
Centre Francois Baclesse ( Site 0459)
🇫🇷Caen, Calvados, France
Centre Jean Perrin ( Site 0460)
🇫🇷Clermont-Ferrand, Puy-de-Dome, France
Clinique Victor Hugo ( Site 0463)
🇫🇷Le Mans, Sarthe, France
Klinikum der Eberhard-Karls-Universitaet Tuebingen ( Site 0502)
🇩🇪Tuebingen, Baden-Wurttemberg, Germany
Universitaetsklinikum Magdeburg A.o.R. ( Site 0516)
🇩🇪Magdeburg, Sachsen-Anhalt, Germany
Universitaetsklinikum Erlangen ( Site 0505)
🇩🇪Erlangen, Bayern, Germany
Universitaetsklinikum Carl Gustav Carus ( Site 0519)
🇩🇪Dresden, Sachsen, Germany
Charite Universitaetsmedizin Berlin ( Site 0515)
🇩🇪Berlin, Germany
Vivantes Klinikum am Urban ( Site 0522)
🇩🇪Berlin, Germany
SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 1010)
🇭🇺Szeged, Csongrad, Hungary
Cork University Hospital ( Site 0722)
🇮🇪Cork, Ireland
Petz Aladar Megyei Oktato Korhaz ( Site 1012)
🇭🇺Gyor, Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 1007)
🇭🇺Kaposvar, Hungary
Tallaght University Hospital ( Site 0710)
🇮🇪Dublin, Ireland
Rambam Health Care Campus-Oncology Division ( Site 0802)
🇮🇱Haifa, Israel
Soroka Medical Center ( Site 0806)
🇮🇱Beer Sheva, 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
Sheba Medical Center ( Site 0801)
🇮🇱Ramat Gan, Israel
Sourasky Medical Center ( Site 0807)
🇮🇱Tel Aviv, Israel
Policlinico di Modena ( Site 0553)
🇮🇹Modena, Emilia-Romagna, Italy
Fondazione Salvatore Maugeri IRCCS. ( Site 0554)
🇮🇹Pavia, Italy
Istituto Nazionale Studio e Cura dei Tumori ( Site 0551)
🇮🇹Milano, Italy
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori ( Site 0552)
🇮🇹Napoli, Italy
Azienda Ospedaliera San Camillo Forlanini ( Site 0560)
🇮🇹Roma, Italy
Ehime University Hospital ( Site 1508)
🇯🇵Toon, Ehime, Japan
Sapporo Medical University Hospital ( Site 1501)
🇯🇵Sapporo, Hokkaido, Japan
University of Tsukuba Hospital ( Site 1503)
🇯🇵Tsukuba, Ibaraki, 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
Tokushima University Hospital ( Site 1514)
🇯🇵Tokushima, Japan
Osaka Metropolitan University Hospital ( Site 1512)
🇯🇵Osaka, Japan
Tokyo Medical and Dental University Hospital ( Site 1517)
🇯🇵Tokyo, Japan
National Cancer Center ( Site 1354)
🇰🇷Goyang-si, Kyonggi-do, Korea, Republic of
Seoul National University Hospital ( Site 1352)
🇰🇷Seoul, Korea, Republic of
Seoul National University Bundang Hospital ( Site 1356)
🇰🇷Seongnam-si, Kyonggi-do, Korea, Republic of
Korea University Anam Hospital ( Site 1351)
🇰🇷Seoul, Korea, Republic of
Centro de Urologia Avanzada del Noreste S.A. de C.V. ( Site 0254)
🇲🇽Monterrey, Nuevo Leon, Mexico
Samsung Medical Center ( Site 1353)
🇰🇷Seoul, Korea, Republic of
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V. ( Site 0300)
🇲🇽Aguascalientes, Mexico
Asan Medical Center ( Site 1355)
🇰🇷Seoul, Korea, Republic of
Centro Estatal de Cancerologia de Chihuahua ( Site 0253)
🇲🇽Chihuahua, Mexico
Instituto Nacional de Cancerologia ( Site 0256)
🇲🇽Tlalpan, Mexico
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 1062)
🇵🇱Wroclaw, Dolnoslaskie, Poland
Europejskie Centrum Zdrowia Otwock ( Site 1057)
🇵🇱Otwock, Mazowieckie, Poland
Luxmed Onkologia sp. z o. o. ( Site 1051)
🇵🇱Warszawa, Mazowieckie, Poland
Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1060)
🇵🇱Bielsko-Biala, Slaskie, Poland
Ivanovo Regional Oncology Dispensary ( Site 0852)
🇷🇺Ivanovo, Ivanovskaya Oblast, Russian Federation
Kursk Regional Clinical Oncology Dispensary ( Site 0854)
🇷🇺Kursk, Kurskaya Oblast, Russian Federation
FSBI ""United Hospital with Polyclinic"" of the Administrative Department of the President of the Ru
🇷🇺Moscow, Moskva, Russian Federation
Bayandin Murmansk Regional Clinical Hospital ( Site 0859)
🇷🇺Murmansk, Murmanskaya Oblast, Russian Federation
Central Clinical Hospital with outpatient Clinic ( Site 0856)
🇷🇺Moscow, Moskva, Russian Federation
Volga District Medical Center Federal Medical and Biological Agency ( Site 0857)
🇷🇺Nizhny Novgorod, Nizhegorodskaya Oblast, Russian Federation
Omsk Clinical Oncology Dispensary ( Site 0865)
🇷🇺Omsk, Omskaya Oblast, Russian Federation
Leningrad Regional Oncology Center ( Site 0868)
🇷🇺Saint Petersburg, Sankt-Peterburg, Russian Federation
Saratov State Medical University n.a. V.I.Razumovskiy ( Site 0866)
🇷🇺Saratov, Saratovskaya Oblast, Russian Federation
Hospital San Pedro de Alcantara ( Site 0654)
🇪🇸Caceres, Extremadura, Spain
Hospital Universitario Ramon y Cajal ( Site 0660)
🇪🇸Madrid, Madrid, Comunidad De, Spain
Hospital Universitario Quiron Madrid ( Site 0657)
🇪🇸Pozuelo de Alarcon, Madrid, Comunidad De, Spain
H. de Gerona Dr. Josep Trueta ( Site 0651)
🇪🇸Girona, Gerona, Spain
Hospital Universitario San Carlos ( Site 0663)
🇪🇸Madrid, Spain
Akademiska Sjukhuset ( Site 1201)
🇸🇪Uppsala, Uppsala Lan, Sweden
Hospital del Mar ( Site 0653)
🇪🇸Barcelona, Spain
Hospital Nuestra Sra. de Valme ( Site 0658)
🇪🇸Sevilla, Spain
Hospital Universitario La Paz ( Site 0661)
🇪🇸Madrid, Spain
Laenssjukhuset Ryhov ( Site 1205)
🇸🇪Jonkoping, Jonkopings Lan, Sweden
Cancercentrum ( Site 1204)
🇸🇪Umea, Vasterbottens Lan, Sweden
Ramathibodi Hospital. ( Site 1451)
🇹🇭Bangkok, Krung Thep Maha Nakhon, Thailand
Faculty of Medicine Siriraj Hospital ( Site 1452)
🇹🇭Bangkok, Krung Thep Maha Nakhon, Thailand
Maharaj Nakorn Chiangmai Hospital ( Site 1453)
🇹🇭Chiang Mai, Thailand
Srinagarind Hospital ( Site 1454)
🇹🇭Khon Kaen, Thailand
Hacettepe Universitesi Tıp Fakultesi ( Site 0911)
🇹🇷Ankara, Turkey
Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 0901)
🇹🇷Istanbul, 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
Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 0909)
🇹🇷Konya, Turkey
Sakarya Universitesi Tip Fakultesi ( Site 0913)
🇹🇷Sakarya, Turkey
Cherkasy Regional Oncology Dispensary ( Site 0959)
🇺🇦Cherkasy, Cherkaska Oblast, Ukraine
MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov ( Site 0963)
🇺🇦Dnipropetrovsk, Dnipropetrovska Oblast, Ukraine
Regional Oncological Hospital ( Site 0956)
🇺🇦Dnipro, Dnipropetrovska Oblast, Ukraine
CNPE "Regional Center of Oncology" ( Site 0958)
🇺🇦Kharkiv, Kharkivska Oblast, Ukraine
Lviv Regional Clinical Hospital ( Site 0955)
🇺🇦Lviv, Lvivska Oblast, Ukraine
National Cancer Institute of the MoH of Ukraine ( Site 0962)
🇺🇦Kyiv, Kyivska Oblast, Ukraine
Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 0967)
🇺🇦Lviv, Lvivska Oblast, Ukraine
Kyiv City Clinical Oncology Center ( Site 0960)
🇺🇦Kyiv, Ukraine
Aberdeen Royal Infirmary ( Site 0708)
🇬🇧Aberdeen, Aberdeen City, United Kingdom
Torbay Hospital ( Site 0704)
🇬🇧Torquay, Devon, United Kingdom
Lister Hospital ( Site 0715)
🇬🇧Stevenage, Hertfordshire, United Kingdom
Imperial College Healthcare NHS Trust ( Site 0721)
🇬🇧London, London, City Of, United Kingdom
Norfolk & Norwich University Hospital NHS Foundation Trust ( Site 0725)
🇬🇧Norwich, Norfolk, United Kingdom
Royal Cornwall Hospital ( Site 0703)
🇬🇧Truro, United Kingdom
Institut de Cancerologie de l Ouest Site Paul Papin ( Site 0453)
🇫🇷Angers, Maine-et-Loire, France
Universitaetsklinikum Schleswig-Holstein-Campus Lubeck ( Site 0512)
🇩🇪Luebeck, Schleswig-Holstein, Germany
CHU UCL Namur Site de Godinne ( Site 0354)
🇧🇪Yvoir, Namur, Belgium
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0
🇨🇦Quebec City, Quebec, Canada
Hopital Robert Schuman ( Site 0452)
🇫🇷Metz, Moselle, France
University Hospital Waterford ( Site 0723)
🇮🇪Waterford, Ireland
Rabin Medical Center ( Site 0804)
🇮🇱Petach Tikva, Israel
Policlinico Gemelli di Roma ( Site 0558)
🇮🇹Roma, Abruzzo, Italy
Nova Scotia Health Authority ( Site 0109)
🇨🇦Halifax, Nova Scotia, Canada
Saitama Medical University International Medical Center ( Site 1505)
🇯🇵Hidaka, Saitama, Japan
UZ Brussel ( Site 0358)
🇧🇪Brussels, Bruxelles-Capitale, Region De, Belgium
Ha Emek Medical Center ( Site 0808)
🇮🇱Afula, Israel
Institut Sainte Catherine ( Site 0454)
🇫🇷Avignon, Vaucluse, France
Ochsner Medical Center ( Site 0049)
🇺🇸New Orleans, Louisiana, United States
O.L.V. Ziekenhuis Aalst ( Site 0356)
🇧🇪Aalst, Oost-Vlaanderen, Belgium
Pecsi Tudomanyegyetem AOK ( Site 1009)
🇭🇺Pecs, Baranya, Hungary
Debreceni Egyetem Klinikai Kozpont ( Site 1006)
🇭🇺Debrecen, Hungary
Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1002)
🇭🇺Szolnok, Jasz-Nagykun-Szolnok, Hungary
Clinic of Bashkortostan State Medical University ( Site 0869)
🇷🇺Ufa, Baskortostan, Respublika, Russian Federation
Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0861)
🇷🇺Krasnoyarsk, Krasnoyarskiy Kray, Russian Federation
Georgetown University Medical Center ( Site 0022)
🇺🇸Washington, District of Columbia, United States
Kent and Canterbury Hospital ( Site 0709)
🇬🇧Canterbury, England, United Kingdom
New England Cancer Specialists ( Site 0070)
🇺🇸Scarborough, Maine, United States
Eastern Health ( Site 1255)
🇦🇺Box Hill, Victoria, Australia
Bajcsy Zsilinszki Korhaz es Rendelointezet ( Site 1001)
🇭🇺Budapest, Hungary
Yitzhak Shamir Medical Center ( Site 0805)
🇮🇱Zerifin, Israel
Hirosaki University Hospital ( Site 1502)
🇯🇵Hirosaki, Aomori, Japan
Hopital Foch ( Site 0483)
🇫🇷Suresnes, Hauts-de-Seine, France
CHU de Rouen ( Site 0493)
🇫🇷Rouen, Seine-Maritime, France
National Cancer Center Hospital East ( Site 1504)
🇯🇵Kashiwa, Chiba, Japan
Yokosuka Kyosai Hospital ( Site 1509)
🇯🇵Yokosuka, Kanagawa, Japan
Nara Medical University Hospital ( Site 1510)
🇯🇵Kashihara, Nara, Japan
Reg. Clinical Center of Urology and Nephrology n.a. V. I. Shapoval ( Site 0969)
🇺🇦Kharkiv, Kharkivska Oblast, Ukraine
Centrum Onkologii im.prof. F. Lukaszczyka w Bydgoszczy ( Site 1068)
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland
Clinical Hospital Saint Luka ( Site 0867)
🇷🇺St. Petersburg, Sankt-Peterburg, Russian Federation
Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC ( Site 0951)
🇺🇦Dnipro, Dnipropetrovska Oblast, Ukraine
Herlev og Gentofte Hospital. ( Site 0402)
🇩🇰Herlev, Hovedstaden, Denmark
Rigshospitalet University Hospital ( Site 0401)
🇩🇰Kobenhavn, Hovedstaden, Denmark
Odense Universitetshospital ( Site 0403)
🇩🇰Odense, Syddanmark, Denmark
A.O.U. Policlinico Vittorio Emanuele - Presidio Gaspare Rodolico ( Site 0559)
🇮🇹Catania, Italy
Azienda Ospedaliera Santa Maria Terni ( Site 0557)
🇮🇹Terni, Italy
Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi ( Site 0904)
🇹🇷Trabzon, Turkey
The Royal Marsden Foundation Trust ( Site 0702)
🇬🇧London, London, City Of, United Kingdom
Instituto Valenciano de Oncologia - IVO ( Site 0662)
🇪🇸Valencia, Valenciana, Comunitat, Spain
AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 0005)
🇺🇸Orlando, Florida, United States
Indiana University Melvin and Bren Simon Cancer Center ( Site 0004)
🇺🇸Indianapolis, Indiana, United States
Henry Ford Hospital ( Site 0039)
🇺🇸Detroit, Michigan, United States
Portland VA Medical Center ( Site 0084)
🇺🇸Portland, Oregon, United States
Tom Baker Cancer Centre ( Site 0100)
🇨🇦Calgary, Alberta, Canada