Pan Tumor Rollover Study
Pan-Tumor Study for Long-term Treatment of Cancer Patients Who Have Participated in BMS Sponsored Trials Investigating Nivolumab and Other Cancer Therapies
2 other identifiers
interventional
1,500
37 countries
394
Brief Summary
Main Objective of this study is to examine long-term safety of nivolumab monotherapy including combinations and other cancer therapies in various tumor types.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 cancer
Started Aug 2019
Longer than P75 for phase_2 cancer
394 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2019
CompletedFirst Posted
Study publicly available on registry
April 2, 2019
CompletedStudy Start
First participant enrolled
August 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 25, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 25, 2029
June 3, 2026
June 1, 2026
10.1 years
April 1, 2019
June 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Incidence of Adverse Events (AEs)
From Day 1 up to 135 Days after discontinuation of treatment
Incidence of drug related AEs
From Day 1 up to 135 Days after discontinuation of treatment
Incidence of AEs leading to Discontinuation
From Day 1 up to 135 Days after discontinuation of treatment
Incidence of Serious Adverse Events (SAEs)
From signature of Informed Consent up to 135 Days after discontinuation of treatment
Incidence of Select AEs
From Day 1 up to 135 Days after discontinuation of treatment
Incidence of Immune-Mediated AEs
From Day 1 up to 135 Days after discontinuation of treatment
Incidence of Death
From signature of Informed Consent up to 135 Days after discontinuation of treatment
Study Arms (32)
A1: Nivolumab Monotherapy Dose 1
EXPERIMENTALA2: Nivolumab Monotherapy Dose 2
EXPERIMENTALB1: Nivolumab + Ipilimumab
EXPERIMENTALB2: Nivolumab + Ipilimumab + Cabozantinib
EXPERIMENTALB3: Nivolumab + Ipilimumab + Trametinib
EXPERIMENTALC1: Relatlimab + Nivolumab Fixed Dose Combination Dose 1
EXPERIMENTALC3: Relatlimab + Nivolumab Fixed Dose Combination Dose 2
EXPERIMENTALC2: Relatlimab + Nivolumab Single Agent Vial (SAV) Dose 1
EXPERIMENTALC4: Relatlimab + Nivolumab SAV Dose 2
EXPERIMENTALC5: Relatlimab + Nivolumab + Ipilimumab
EXPERIMENTALC6: Relatlimab + Nivolumab + Capecitabine
EXPERIMENTALC7: Relatlimab + Nivolumab SAV Dose 3
EXPERIMENTALC10: Relatlimab + Nivolumab SAV Dose 4
EXPERIMENTALC12: Relatlimab + Nivolumab SAV Dose 5
EXPERIMENTALC8: Relatlimab + Nivolumab SAV + PDCT Dose 1
EXPERIMENTALC9: Relatlimab + Nivolumab SAV + Bevacizumab
EXPERIMENTALC11: Relatlimab + Nivolumab SAV + PDCT Dose 2
EXPERIMENTALD1: Nivolumab + Temozolomide
EXPERIMENTALD2: Nivolumab + Rucaparib
EXPERIMENTALD3: Nivolumab + Daratumumab
EXPERIMENTALD4: Nivolumab + Bevacizumab
EXPERIMENTALE1: Bevacizumab Monotherapy
EXPERIMENTALE2: Regorafinib Monotherapy
EXPERIMENTALE4: Leucovorin + Oxaliplatin + Fluorouracil
EXPERIMENTALE5: Enzalutamide Monotherapy
EXPERIMENTALE6: Sunitinib Monotherapy
EXPERIMENTALE7: Rucaparib Monotherapy
EXPERIMENTALE8: Capecitabine Monotherapy
EXPERIMENTALE9: Cabozantinib Monotherapy
EXPERIMENTALE10: Pemetrexed Monotherapy
EXPERIMENTALE11: Pembrolizumab Monotherapy
EXPERIMENTALE3: Leucovorin + Fluorouracil
EXPERIMENTALInterventions
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Eligibility Criteria
You may qualify if:
- Signed Written Informed Consent.
- Eligible to receive continued study treatment per the Parent Study, including treatment beyond progression per investigator assessment in the Parent Study.
- On treatment hold in the Parent Study following long-lasting response or are eligible for treatment rechallenge as defined in the Parent Study.
- WOCBP and male participants who are sexually active must agree to follow instructions for method(s) of contraception as described below and included in the ICF.
You may not qualify if:
- Participant is not eligible for study treatment per the Parent Study eligibility criteria.
- Participants not receiving clinical benefit as assessed by the Investigator.
- Any clinical adverse event (AE), laboratory abnormality, or intercurrent illness which, in the opinion of the Investigator, indicates that participation in the study is not in the best interest of the participant.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bristol-Myers Squibblead
- Exelixiscollaborator
- Novartiscollaborator
- Clovis Oncology, Inc.collaborator
- Janssen Pharmaceuticalscollaborator
Study Sites (399)
Local Institution - 0220
Huntsville, Alabama, 35801, United States
University of Arizona College of Medicine
Tucson, Arizona, 85724, United States
Innovative Clinical Research Institute
Lynwood, California, 90262, United States
Local Institution
San Francisco, California, 94115, United States
Local Institution - 0099
San Francisco, California, 94143, United States
Local Institution - 0233
Aurora, Colorado, 80045, United States
Local Institution - 0095
New Haven, Connecticut, 06520, United States
Local Institution - 0088
Washington D.C., District of Columbia, 20007-2113, United States
Florida Cancer Affiliates
Ocala, Florida, 34474, United States
Local Institution
Orlando, Florida, 32806, United States
Local Institution - 0024
Tampa, Florida, 33612, United States
Local Institution - 0105
Chicago, Illinois, 60637, United States
Local Institution
Maywood, Illinois, 60153, United States
Local Institution - 0279
Park Ridge, Illinois, 60068, United States
Local Institution - 0186
Westwood, Kansas, 66205, United States
Local Institution - 0165
Wichita, Kansas, 67214-3728, United States
University of Louisville-James Graham Brown Cancer Center
Louisville, Kentucky, 40202, United States
Local Institution - 0092
Baltimore, Maryland, 21287, United States
Local Institution - 0039
Boston, Massachusetts, 02114, United States
Dana_Farber Cancer Institute (DFCI)
Boston, Massachusetts, 02215, United States
Local Institution - 0081
Boston, Massachusetts, 02215, United States
Local Institution - 0143
Ann Arbor, Michigan, 48109-5008, United States
Local Institution - 0100
Minneapolis, Minnesota, 55407-3723, United States
Local Institution
St Louis, Missouri, 63110, United States
Local Institution - 0205
Omaha, Nebraska, 68130, United States
Local Institution - 0014
Lebanon, New Hampshire, 03756, United States
Local Institution
Albuquerque, New Mexico, 87131, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
NYU Langone Hematology Oncology Associates-Mineola
Mineola, New York, 11501, United States
Local Institution
New York, New York, 10016, United States
Local Institution - 0185
New York, New York, 10065, United States
Local Institution - 0202
New York, New York, 10065, United States
Local Institution
New York, New York, 10065, United States
Local Institution - 0204
Charlotte, North Carolina, 28204, United States
Local Institution - 0016
Durham, North Carolina, 27705, United States
Oncology Hematology Care
Cincinnati, Ohio, 45242, United States
Local Institution - 0408
Cincinnati, Ohio, 45267, United States
Local Institution
Cleveland, Ohio, 44106, United States
The Ohio University
Columbus, Ohio, 43210, United States
Local Institution - 0246
Tulsa, Oklahoma, 74146, United States
Local Institution - 0037
Allentown, Pennsylvania, 18103, United States
Local Institution - 0054
Easton, Pennsylvania, 18045, United States
Lancaster General Health
Lancaster, Pennsylvania, 17601, United States
Allegheny Valley Hospital
Natrona Heights, Pennsylvania, 15065, United States
Local Institution
Philadelphia, Pennsylvania, 19104, United States
Local Institution - 0162
Philadelphia, Pennsylvania, 19111, United States
Local Institution - 0110
Pittsburgh, Pennsylvania, 15213, United States
Local Institution - 0228
Charleston, South Carolina, 29414, United States
Local Institution
Greenville, South Carolina, 29615, United States
Local Institution
Chattanooga, Tennessee, 37404, United States
Tennesse Oncology
Nashville, Tennessee, 37203, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Local Institution
Dallas, Texas, 75390, United States
Local Institution - 0364
Houston, Texas, 77030-4000, United States
Local Institution - 0055
Salt Lake City, Utah, 84112-5550, United States
Local Institution
Charlottesville, Virginia, 22908, United States
Public Hospital of King County District 1 Valley Medical Center
Renton, Washington, 98055, United States
Local Institution - 0065
Madison, Wisconsin, 53792, United States
Local Institution - 0124
Madison, Wisconsin, 53792, United States
Local Institution - 0199
Berazategui, Buenos Aires, 1880, Argentina
Instituto Medico Rio Cuarto
Río Cuarto, Córdoba Province, 5800, Argentina
Centro de Investigaciones Clinicas. Clinica Viedma S.A.
Viedma, Río Negro Province, 8500, Argentina
Sanatorio Parque
Rosario, Santa Fe Province, 2000, Argentina
CAIPO Centro para la Atencion Integral del Paciente Oncologico
San Miguel de Tucumán, Tucumán Province, 4000, Argentina
Local Institution - 0191
San Miguel de Tucumán, Tucumán Province, 4000, Argentina
Local Institution - 0201
Buenos Aires, C1199 ABH, Argentina
Instituto Fleming
Buenos Aires, C1426ANZ, Argentina
Local Institution
CABA, C1426ANZ, Argentina
Fundacion Richardet Longo - IONC
Córdoba, X 5002HWE, Argentina
Local Institution - 0170
Córdoba, X5004FHP, Argentina
Local Institution - 0045
Coffs Harbour, New South Wales, 2450, Australia
Melanoma Institute Australia
North Sydney, New South Wales, 2060, Australia
Local Institution - 0009
Sydney, New South Wales, 2050, Australia
Local Institution - 0193
Waratah, New South Wales, 2298, Australia
Local Institution - 0208
Westmead, New South Wales, 2145, Australia
Gallipoli Medical Foundation
Greenslopes, Queensland, 4120, Australia
Local Institution - 0372
Greenslopes, Queensland, 4120, Australia
Local Institution
South Brisbane, Queensland, 4101, Australia
Tasman Oncology Research Ltd
Southport, Queensland, 4215, Australia
Local Institution
Adelaide, South Australia, 5000, Australia
Local Institution - 0196
Elizabeth Vale, South Australia, 05112, Australia
BRICC - Ballarat Health Services
Ballarat, Victoria, 3350, Australia
Local Institution - 0365
Fitzroy, Victoria, 3065, Australia
Cabrini Hospital Malvern
Malvern, Victoria, 3144, Australia
Local Institution - 0174
Murdoch, Western Australia, 6150, Australia
Local Institution - 0254
Graz, Styria, 8036, Austria
Ordensklinikum Linz GmbH Elisabethinen
Linz, Upper Austria, 4020, Austria
Allgemeines Krankenhaus Wien
Vienna, 1090, Austria
Local Institution - 0104
Vienna, 1090, Austria
Local Institution - 0145
Wels, 4600, Austria
Local Institution - 0329
Brussels, 1000, Belgium
Local Institution - 0232
Ghent, 9000, Belgium
Local Institution - 0139
Jette, 1090, Belgium
Local Institution - 0261
Liège, 4000, Belgium
Local Institution - 0293
Sint-Niklaas, 9100, Belgium
Local Institution - 0157
Yvoir, 5530, Belgium
Local Institution - 0260
Belo Horizonte, Minas Gerais, 30130090, Brazil
ONCOSITE - Centro de Pesquisa Clinica em Oncologia
Ijuí, Rio Grande do Sul, 98700-000, Brazil
Local Institution - 0379
Passo Fundo, Rio Grande do Sul, 99010-080, Brazil
Local Institution - 0093
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90050-170, Brazil
Hospital Sao Lucas Da Pucrs
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Local Institution - 0399
Porto Alegre, Rio Grande do Sul, 91350-250, Brazil
Local Institution - 0264
Barretos, São Paulo, 14784-400, Brazil
Local Institution - 0262
São José do Rio Preto, São Paulo, 15090-000, Brazil
ICESP - Instituto do Cancer do Estado de Soo Paulo
São Paulo, São Paulo, 01246-000, Brazil
Local Institution - 0263
São Paulo, São Paulo, 01308-050, Brazil
Hospital Alemao Oswaldo Cruz
São Paulo, São Paulo, 01327-001, Brazil
Local Institution - 0266
Rio de Janeiro, 20220-280, Brazil
Local Institution - 0258
Rio de Janeiro, 22775-001, Brazil
Local Institution - 0340
São Paulo, 01308-060, Brazil
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Local Institution
Vancouver, British Columbia, V5Z 1L3, Canada
Local Institution
Halifax, Nova Scotia, B3H1V7, Canada
Local Institution - 0168
Oshawa, Ontario, L1G 2B9, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Local Institution - 0040
Montreal, Quebec, H4A 3J1, Canada
Local Institution - 0308
Montreal, Quebec, H4J 1C5, Canada
Local Institution - 0363
Temuco, Araucania, 4780000, Chile
Orlandi Oncologia
Providencia, Santiago Metropolitan, 7500713, Chile
Bradford Hill Centro de Investigacion Clinica
Santiago, Santiago Metropolitan, 0, Chile
Fundacion Arturo Lopez Perez
Santiago, Santiago Metropolitan, 7500921, Chile
Local Institution
Santiago, Santiago Metropolitan, 7500921, Chile
Local Institution - 0079
Viña del Mar, 2540364, Chile
Local Institution - 0169
Hefei, Anhui, 230031, China
Local Institution - 0198
Beijing, Beijing Municipality, 100853, China
Local Institution
Guangzhou, Guangdong, 510080, China
Nanfang Hospital; Southern Medical University
Guangzhou, Guangdong, 510515, China
Local Institution - 0245
Harbin, Heilongjiang, 150040, China
Harbin Medical University - Cancer Hospital
Harbin, Heilongjiang, 150081, China
Local Institution - 0160
Harbin, Heilongjiang, 150081, China
Local Institution - 0172
Changsha, Hunan, 410000, China
Xiangya Hospital Central South University
Changsha, Hunan, 410008, China
Hunan Cancer Hospital
Changsha, Hunan, 410011, China
Local Institution - 0348
Nanjing, Jiangsu, 210009, China
Jilin University (JLU) - First Affiliated Hospital - Cancer Center
Changchun, Jilin, 130061, China
Jilin Cancer Hospital
Changchun, Jilin, 130103, China
Tangdu Hospital of Fourth Military Medical University
Xi'an, Shaanxi, 710038, China
Xian International Medical Center Hospital
Xi'an, Shan3XI, 710700, China
Local Institution - 0223
Shanghai, Shanghai Municipality, 200025, China
Fudan University - Shanghai Cancer Center FUSCC
Shanghai, Shanghai Municipality, 200032, China
Local Institution - 0278
Shanghai, Shanghai Municipality, 200032, China
Local Institution - 0325
Shanghai, Shanghai Municipality, 200032, China
Local Institution - 0188
Shanghai, Shanghai Municipality, 200433, China
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, 310016, China
Local Institution - 0306
Hangzhou, 310003, China
Jiangsu Cancer Hospital
Nanjing, 210009, China
Local Institution - 0371
Brno, 656 53, Czechia
FNHK Klinika onkologie a radioterapie
Hradec Králové, 500 05, Czechia
Local Institution - 0150
Olomouc, 779 00, Czechia
Local Institution - 0253
Prague, 11000, Czechia
Local Institution - 0275
Prague, 128 00, Czechia
Local Institution
Odense C, 5000, Denmark
Local Institution
Helsinki, 00029, Finland
Local Institution - 0006
Bordeaux, Gironde, 33075, France
Local Institution - 0362
Vandœuvre-lès-Nancy, Meurthe-Et-Moselle, 54500, France
Centre Jean Perrin
Clermont-Ferrand, 63011, France
Local Institution - 0107
Créteil, 94010, France
Local Institution - 0074
Dijon, 21000, France
Local Institution - 0109
Dijon, 21079, France
CHU Grenobles Alpes
La Tronche, 38700, France
Pole Biologie Pathologie Genetique - CHU de Lille
Lille, 59037, France
APHM - Hopital de la Timone
Marseille, 13385, France
Local Institution - 0153
Marseille, 13915, France
CHU Montpellier
Montpellier, 34090, France
Local Institution
Montpellier, 34295, France
Local Institution - 0300
Nantes, 44093, France
Local Institution - 0341
Nantes, 44093, France
Local Institution - 0028
Paris, 75010, France
Local Institution - 0301
Paris, 75018, France
Local Institution - 0167
Paris, 75908, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
Local Institution
Rennes, 35033, France
CHU de Saint-Etienne - Hopital Nord
Saint-Priest-en-Jarez, 42270, France
Hopital Foch
Suresnes, 92151, France
Local Institution - 0156
Toulon, 83 056, France
Local Institution
Toulouse, 31059, France
Institut Gustave Roussy
Villejuif, 94805, France
Local Institution - 0387
Paris, Île-de-France Region, 75005, France
Local Institution - 0386
Löwenstein, Baden-Wurttemberg, 74245, Germany
Local Institution - 0276
Munich, Bavaria, 80337, Germany
Local Institution - 0332
Nuremberg, Bavaria, 90419, Germany
Evangelische Kliniken Essen Mitte. Evang. Huyssens-Stiftung Essen-Huttrop
Essen, North Rhine-Westphalia, 45136, Germany
Local Institution - 0250
Essen, North Rhine-Westphalia, 45147, Germany
Local Institution - 0375
Essen, North Rhine-Westphalia, 45147, Germany
Universitaetsklinikum Aachen
Aachen, 52074, Germany
Local Institution - 0248
Berlin, 10117, Germany
Local Institution - 0249
Buxtehude, 21614, Germany
Local Institution - 0296
Cologne, 50937, Germany
Local Institution
Cologne, 50937, Germany
University of Freiburg
Freiburg im Breisgau, 79106, Germany
Local Institution
Gera, 07548, Germany
SRH Wald-Klinikum Gera GmbH
Gera, 07548, Germany
Local Institution - 0076
Göttingen, 37075, Germany
Local Institution
Göttingen, 37075, Germany
Local Institution - 0241
Hamburg, 20246, Germany
Local Institution
Heidelberg, 69120, Germany
Thoraxklinik
Heidelberg, 69126, Germany
Local Institution - 0342
Heidelberg, D-69120, Germany
SLK-Kliniken Heilbronn GmbH
Heilbronn, 74078, Germany
Universitaetsklinikum Jena - Klinik und Poliklinik fuer Urologie
Jena, 07747, Germany
Local Institution - 0288
Kassel, 34125, Germany
Local Institution - 0072
Kiel, 24105, Germany
Local Institution
Kiel, 24105, Germany
Local Institution - 0298
Löwenstein, 74245, Germany
Local Institution - 0098
Lübeck, 23538, Germany
Local Institution - 0089
Mainz, 55131, Germany
Local Institution
Mainz, 55131, Germany
Local Institution - 0017
Tübingen, 72076, Germany
Local Institution - 0277
Tübingen, 72076, Germany
Alexandra Hospital
Athens, Attica, 11528, Greece
Local Institution - 0244
Heraklion, Crete, 710 03, Greece
Local Institution - 0022
Athens, 11527, Greece
Local Institution - 0126
Athens, 11527, Greece
Local Institution - 0171
Athens, 11528, Greece
Local Institution - 0042
Athens, 18547, Greece
Local Institution - 0295
Athens, 18547, Greece
Local Institution
Pátrai, 26504, Greece
Local Institution - 0215
Thessaloniki, 57001, Greece
Queen Mary Hospital
Hong Kong, 000000, Hong Kong
Local Institution - 0290
Gyöngyössolymos, Heves County, 3233, Hungary
Local Institution - 0159
Budapest, 1121, Hungary
Local Institution - 0226
Budapest, 1121, Hungary
Local Institution - 0187
Debrecen, 4032, Hungary
Local Institution - 0227
Dublin, Dublin 7, Ireland
Local Institution
Limerick, V94 F858, Ireland
Local Institution - 0190
Haifa, 3109601, Israel
Local Institution - 0270
Jerusalem, 91120, Israel
Local Institution
Petah Tikva, 49100, Israel
Local Institution - 0052
Ramat Gan, 52621, Israel
Local Institution - 0350
Tiqwa, 49100, Israel
IRCCS - Istituto Scientifico Romagnolo per lo Studio dei Tumori - Dino Amadori - Srl
Meldola, Fc, 47014, Italy
Local Institution - 0333
Rozzano, MI, 20089, Italy
Istituto Nazionale dei Tumori Regina Elena
Roma, RM, 00144, Italy
Local Institution - 0034
Bari, 70124, Italy
Local Institution - 0002
Bergamo, 24127, Italy
Local Institution - 0326
Candiolo, 10060, Italy
"Azienda Ospedaliero - Universitaria ""Policlinico-Vittorio Emanuele"" - Ospedale Gaspare Rodolico"
Catania, 95123, Italy
Local Institution - 0251
Genova, 16132, Italy
Local Institution
Genova, 16132, Italy
Local Institution - 0108
Meldola, 47014, Italy
Local Institution - 0303
Meldola, 47014, Italy
Fondazione IRCCS istituto Neurologico Carlo Besta;
Milan, 20133, Italy
Local Institution - 0096
Milan, 20133, Italy
Local Institution - 0351
Milan, 20133, Italy
Local Institution
Milan, 20133, Italy
Local Institution - 0071
Milan, 20141, Italy
Local Institution - 0267
Milan, 20141, Italy
Local Institution
Milan, 20141, Italy
Local Institution - 0327
Modena, 41124, Italy
Local Institution - 0073
Naples, 80131, Italy
Local Institution - 0218
Naples, 80131, Italy
Local Institution - 0292
Naples, 80138, Italy
Istituto Oncologico Veneto
Padova, 35128, Italy
Local Institution - 0180
Ravenna, 48121, Italy
Local Institution - 0003
Siena, 53100, Italy
Local Institution - 0291
Terni, 05100, Italy
Azienda Ospedaliera Citta della Salute e della Scienza
Torino, 10126, Italy
Local Institution - 0242
Hirosaki-shi, Aomori, 036-8563, Japan
Chiba Cancer Center
Chiba, Chiba, 2608717, Japan
National Cancer Center Hospital East
Kashiwa-Shi, Chiba, 2778577, Japan
Ehime Prefectural Central Hospital
Matsuyama, Ehime, 7900024, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, 7910280, Japan
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582, Japan
Local Institution - 0211
Kobe, Hyōgo, 6500047, Japan
Local Institution - 0240
Tsukuba, Ibaraki, 305-8576, Japan
Local Institution - 0219
Kanazawa, Ishikawa-ken, 920-8641, Japan
Yokohama City University Medical Center
Yokohama, Kanagawa, 2320024, Japan
Local Institution - 0222
Natori-shi, Miyagi, 981-1293, Japan
Local Institution - 0230
Niigata, Niigata, 9518566, Japan
Local Institution - 0214
Sayama, Osaka, 5898511, Japan
Local Institution - 0212
Takatsuki, Osaka, 569-8686, Japan
Hamamatsu University Hospital
Hamamatsu, Shizuoka, 431-3192, Japan
Tokyo Women's Medical University - Adachi Medical Center
Adachi-Ku, Tokyo, 1238558, Japan
Institute of Science Tokyo Hospital
Bunkyo-Ku, Tokyo, 1138519, Japan
Local Institution - 0235
Chuo-ku, Tokyo, 1040045, Japan
Local Institution - 0217
Koto-Ku, Tokyo, 135-8550, Japan
Local Institution - 0239
Shinjuku, Tokyo, 160-8582, Japan
Local Institution - 0224
Fukuoka, 11111, Japan
Hiroshima University Hospital
Hiroshima, 7348551, Japan
Local Institution - 0236
Niigata, 951-8520, Japan
Local Institution - 0152
León, Guanajuato, 37000, Mexico
Investigación Biomédica para el Desarrollo de Fármacos S.A de C.V
Zapopan, Jalisco, 45070, Mexico
Cryptex Investigacion Clinica Sa de Cv
Cuauhtémoc, Mexico City, 06100, Mexico
Local Institution - 0181
Tlalpan, Mexico City, 14050, Mexico
Local Institution - 0007
Morelia, Michoacán, 58240, Mexico
Local Institution - 0286
Monterrey, Nuevo León, 64040, Mexico
Local Institution - 0354
Monterrey, Nuevo León, 64460, Mexico
I Can Oncology Center
Monterrey, Nuevo León, 64710, Mexico
Centro de Investigacion Clinica de Oaxaca
Oaxaca City, Oaxaca, CP68020, Mexico
Local Institution - 0343
Querétaro City, Querétaro, 76000, Mexico
Local Institution - 0410
Mexico City, 03810, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, 14080, Mexico
Instituto Nacional de Cancerologia
México, 14080, Mexico
Centro Potosino de Investigacion Medica S.C.
San Luis Potosí City, 78250, Mexico
Local Institution - 0335
Amsterdam, North Holland, 1066 CX, Netherlands
Local Institution
Rotterdam, 3015 CE, Netherlands
Auckland City Hospital
Auckland, 1142, New Zealand
Local Institution - 0271
Christchurch, 8011, New Zealand
Local Institution - 0268
Dunedin, 9016, New Zealand
Local Institution - 0269
Tauranga, 3112, New Zealand
Local Institution - 0213
Bergen, 5021, Norway
Local Institution - 0048
Oslo, N-0379, Norway
Local Institution - 0179
Santiago de Surco, Lima region, 15023, Peru
Local Institution - 0385
Lima, 15076, Peru
Centrum Onkologii im. Prof. Franciszka Lukaszczyka
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland
Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie
Olsztyn, Warmian-Masurian Voivodeship, 10-357, Poland
Local Institution - 0336
Biała Podlaska, 21-500, Poland
Local Institution - 0120
Gdansk, 80-214, Poland
Wojewodzkie Centrum Onkologii
Gdansk, 80219, Poland
Local Institution - 0377
Krakow, 30-510, Poland
Local Institution - 0252
Krakow, 31-115, Poland
Local Institution - 0373
Krakow, 31-501, Poland
Instytut MSF Sp zoo
Lodz, 90-302, Poland
Local Institution - 0118
Lublin, 20-064, Poland
Local Institution - 0178
Poznan, 60-185, Poland
Wojskowy Instytut Medyczny
Warsaw, 0 4-141, Poland
Local Institution - 0328
Warsaw, 02-776, Poland
Local Institution
Warsaw, 02-781, Poland
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Warsaw, 02-781, Poland
Local Institution - 0184
Lisbon, 1769-001, Portugal
Local Institution - 0177
Lisbon, 4200-072, Portugal
Local Institution - 0142
Porto, 4200319, Portugal
FDI Clinical Research
San Juan, PR, 00927, Puerto Rico
Local Institution - 0416
San Juan, 918, Puerto Rico
Onco Clinic Consult SA
Craiova, Dolj, 200508, Romania
Centrul de Oncologie Sf Nectarie
Craiova, Dolj, 200542, Romania
Local Institution - 0310
Bucharest, Sector 2, 021389, Romania
Institutul Oncologic Bucuresti IOB
Bucharest, 022328, Romania
Local Institution - 0127
Cluj-Napoca, 400-641, Romania
Institutul Oncologic Prof. Dr. I. Chiricuta
Cluj-Napoca, 400015, Romania
Local Institution - 0189
Cluj-Napoca, 400015, Romania
Local Institution - 0133
Oradea, 410469, Romania
Sc Sigmedical Srl
Suceava, 720214, Romania
Local Institution - 0257
Krasnodar, Krasnodarskiy Kray, 350040, Russia
Local Institution - 0256
Krasnoyarsk, 660133, Russia
N.N. Blokhin National Medical Research Center of Oncology
Moscow, 115478, Russia
VitaMed LLC
Moscow, 121309, Russia
Local Institution - 0389
Seongnam-si, Gyeonggi-do, 13532, South Korea
Asan Medical Center
Seoul, Songpa-gu, 05505, South Korea
National Cancer Center
Gyeonggi-do, 10408, South Korea
Local Institution - 0221
Seongnam-si, 463-707, South Korea
Local Institution - 0206
Seoul, 03722, South Korea
Local Institution - 0324
Seoul, 110 - 744, South Korea
Local Institution - 0207
Suwon, 16499, South Korea
Local Institution - 0047
Donostia / San Sebastian, Guipuzcoa, 20014, Spain
Local Institution - 0287
Majadahonda, Madrid, 28220, Spain
Clinica Universidad de Navarra
Pamplona, Navarre, 31008, Spain
Local Institution - 0122
A Coruña, 15006, Spain
Local Institution - 0382
A Coruña, 15706, Spain
Local Institution - 0173
Alicante, 03010, Spain
Catalan Institute of Badalona Hospital Germans Trias i Pujol ICO
Badalona, 08916, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025, Spain
Hospital Universitari Vall d Hebron
Barcelona, 08035, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Local Institution - 0026
Barcelona, 08036, Spain
Local Institution - 0225
Barcelona, 08908, Spain
Local Institution
Barcelona, 8025, Spain
Local Institution - 0146
Burgos, 09006, Spain
Local Institution - 0144
Granada, 18014, Spain
Local Institution - 0273
Madrid, 28007, Spain
Local Institution - 0357
Madrid, 28009, Spain
Clinica Universidad de Navarra Madrid
Madrid, 28027, Spain
Local Institution - 0008
Madrid, 28033, Spain
Local Institution
Madrid, 28033, Spain
Local Institution - 0027
Madrid, 28034, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Local Institution - 0380
Madrid, 28046, Spain
Local Institution
Madrid, 28046, Spain
Hospital Universitario HM Sanchinarro
Madrid, 28050, Spain
Local Institution - 0192
Málaga, 29010, Spain
Local Institution
Santa Cruz de Tenerife, 38230, Spain
Hospital Universitario Marques de Valdecilla
Santander, 39008, Spain
Local Institution - 0274
Seville, 41009, Spain
Local Institution - 0294
Seville, 41013, Spain
Hospital General Universitario de Valencia
Valencia, 46014, Spain
Hospital Universitario y Politecnico de La Fe
Valencia, 46026, Spain
Local Institution
Gothenburg, SE-41345, Sweden
Local Institution - 0036
Malmö, 205 02, Sweden
Local Institution
Umeå, 901 85, Sweden
Local Institution - 0119
Basel, 4031, Switzerland
Local Institution - 0403
Sankt Gallen, 9007, Switzerland
Local Institution - 0083
Zurich, CH - 8058, Switzerland
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
Local Institution - 0197
Tainan, 704, Taiwan
Local Institution - 0412
Taipei, 10002, Taiwan
Taipei Veterans General Hospital TPVGH
Taipei, 11217, Taiwan
Local Institution - 0330
Ankara, 06010, Turkey (Türkiye)
Local Institution - 0141
London, Greater London, N18 1QX, United Kingdom
University College Hospital
London, Greater London, NW1 2PG, United Kingdom
Local Institution - 0272
London, Greater London, SM2 5PT, United Kingdom
Local Institution - 0086
London, Greater London, SW3 6JJ, United Kingdom
Local Institution - 0115
Manchester, Greater Manchester, M20 4BX, United Kingdom
Local Institution - 0195
Southampton, Hampshire, SO16 6YD, United Kingdom
Local Institution - 0231
Maidstone, Kent, ME16 9QQ, United Kingdom
Local Institution - 0161
Northwood, Middlesex, HA6 2RN, United Kingdom
Local Institution - 0299
Edinburgh, Scotland, EH4 2XU, United Kingdom
Local Institution - 0259
Glasgow, G12 0YN, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Central Study Contacts
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
First line of the email MUST contain NCT # and Site #.
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2019
First Posted
April 2, 2019
Study Start
August 9, 2019
Primary Completion (Estimated)
August 25, 2029
Study Completion (Estimated)
August 25, 2029
Last Updated
June 3, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See Plan Description
- Access Criteria
- See Plan Description
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html