CancerPhase 2NCT03899155
Pan Tumor Rollover Study
A Phase 2 study testing Nivolumab, Ipilimumab and Cabozantinib in people with Cancer, run by Bristol-Myers Squibb at 399 sites in 38 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Nivolumab, Ipilimumab and Cabozantinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 399 sitesin 38 countries
- Study dates
- 9 Aug 2019to 25 Aug 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Other protocol-defined Inclusion/Exclusion Criteria apply
Trial locations and contacts
399 sites in 38 countries. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
399 sites in 38 countries
United States59 sites, 7 recruiting
- Withdrawn
Local Institution
Albuquerque, New Mexico, 87131
- Completed
Local Institution - 0037
Allentown, Pennsylvania, 18103
- Completed
Local Institution - 0143
Ann Arbor, Michigan, 48109-5008
- Completed
Local Institution - 0233
Aurora, Colorado, 80045
- Completed
Local Institution - 0092
Baltimore, Maryland, 21287
- Completed
Local Institution - 0039
Boston, Massachusetts, 02114
- Recruiting
Dana_Farber Cancer Institute (DFCI)
Boston, Massachusetts, 02215
David Reardon, Site 0082, 617-632-2166
- Withdrawn
Local Institution - 0081
Boston, Massachusetts, 02215
- Completed
Local Institution - 0128
Buffalo, New York, 14263
- Completed
Local Institution - 0228
Charleston, South Carolina, 29414
- Completed
Local Institution - 0204
Charlotte, North Carolina, 28204
- Withdrawn
Local Institution
Charlottesville, Virginia, 22908
- Withdrawn
Local Institution
Chattanooga, Tennessee, 37404
- Completed
Local Institution - 0105
Chicago, Illinois, 60637
- Recruiting
Oncology Hematology Care
Cincinnati, Ohio, 45242
Patrick Ward, Site 0085, 513-751-2273
- Completed
Local Institution - 0408
Cincinnati, Ohio, 45267
- Withdrawn
Local Institution
Cleveland, Ohio, 44106
- Recruiting
The Ohio University
Columbus, Ohio, 43210
Asrar Alahmadi, Site 0103, 202-361-4528
- Withdrawn
Local Institution
Dallas, Texas, 75390
- Completed
Local Institution - 0016
Durham, North Carolina, 27705
- Completed
Local Institution - 0054
Easton, Pennsylvania, 18045
- Withdrawn
Local Institution
Greenville, South Carolina, 29615
- Withdrawn
Local Institution - 0364
Houston, Texas, 77030-4000
- Completed
Local Institution - 0220
Huntsville, Alabama, 35801
- Recruiting
Lancaster General Health
Lancaster, Pennsylvania, 17601
Samuel Kerr, Site 0400, 717-215-9561
- Completed
Local Institution - 0014
Lebanon, New Hampshire, 03756
- Recruiting
University of Louisville-James Graham Brown Cancer Center
Louisville, Kentucky, 40202
Jason Chesney, Site 0059, 502-562-2280
- Withdrawn
Innovative Clinical Research Institute
Lynwood, California, 90262
- Completed
Local Institution - 0065
Madison, Wisconsin, 53792
- Withdrawn
Local Institution - 0124
Madison, Wisconsin, 53792
- Withdrawn
Local Institution
Maywood, Illinois, 60153
- Recruiting
NYU Langone Hematology Oncology Associates-Mineola
Mineola, New York, 11501
Jeffery Schneider, Site 0413, 516-578-2408
- Completed
Local Institution - 0100
Minneapolis, Minnesota, 55407-3723
- Recruiting
Tennesse Oncology
Nashville, Tennessee, 37203
David Spigel, Site 0130, 615-320-5090
- Withdrawn
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
- Withdrawn
Allegheny Valley Hospital
Natrona Heights, Pennsylvania, 15065
- Withdrawn
Local Institution - 0095
New Haven, Connecticut, 06520
- Withdrawn
Local Institution
New York, New York, 10016
- Completed
Local Institution - 0185
New York, New York, 10065
- Withdrawn
Local Institution - 0202
New York, New York, 10065
- Withdrawn
Local Institution
New York, New York, 10065
- Withdrawn
Florida Cancer Affiliates
Ocala, Florida, 34474
- Completed
Local Institution - 0205
Omaha, Nebraska, 68130
- Withdrawn
Local Institution
Orlando, Florida, 32806
- Completed
Local Institution - 0279
Park Ridge, Illinois, 60068
- Withdrawn
Local Institution
Philadelphia, Pennsylvania, 19104
- Withdrawn
Local Institution - 0162
Philadelphia, Pennsylvania, 19111
- Completed
Local Institution - 0110
Pittsburgh, Pennsylvania, 15213
- Withdrawn
Public Hospital of King County District 1 Valley Medical Center
Renton, Washington, 98055
- Completed
Local Institution - 0055
Salt Lake City, Utah, 84112-5550
- Withdrawn
Local Institution
San Francisco, California, 94115
- Completed
Local Institution - 0099
San Francisco, California, 94143
- Withdrawn
Local Institution
St Louis, Missouri, 63110
- Completed
Local Institution - 0024
Tampa, Florida, 33612
- Withdrawn
University of Arizona College of Medicine
Tucson, Arizona, 85724
- Withdrawn
Local Institution - 0246
Tulsa, Oklahoma, 74146
- Completed
Local Institution - 0088
Washington D.C., District of Columbia, 20007-2113
- Completed
Local Institution - 0186
Westwood, Kansas, 66205
- Completed
Local Institution - 0165
Wichita, Kansas, 67214-3728
Spain33 sites, 11 recruiting
- Completed
Local Institution - 0122
A Coruña, 15006
- Withdrawn
Local Institution - 0382
A Coruña, 15706
- Completed
Local Institution - 0173
Alicante, 03010
- Recruiting
Catalan Institute of Badalona Hospital Germans Trias i Pujol ICO
Badalona, 08916
Enric Carcereny, Site 0123, 34934978925
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Margarita Majem Tarruella, Site 0384, 34935565651
- Recruiting
Hospital Universitari Vall d Hebron
Barcelona, 08035
Eva Munoz, Site 0091, +34932746085
- Recruiting
Hospital Clinic de Barcelona
Barcelona, 08036
Maria Reig, Site 0323, 34932279803
- Completed
Local Institution - 0026
Barcelona, 08036
- Completed
Local Institution - 0225
Barcelona, 08908
- Withdrawn
Local Institution
Barcelona, 8025
- Completed
Local Institution - 0146
Burgos, 09006
- Completed
Local Institution - 0047
Donostia / San Sebastian, Guipuzcoa, 20014
- Withdrawn
Local Institution - 0144
Granada, 18014
- Withdrawn
Local Institution - 0273
Madrid, 28007
- Withdrawn
Local Institution - 0357
Madrid, 28009
- Recruiting
Clinica Universidad de Navarra Madrid
Madrid, 28027
Ignacio Melero Bermejo, Site 0360, 34948255400
- Completed
Local Institution - 0008
Madrid, 28033
- Withdrawn
Local Institution
Madrid, 28033
- Completed
Local Institution - 0027
Madrid, 28034
- Recruiting
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040
Manuel Domine Gomez, Site 0112, 34915504800
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
Luis Paz-Ares Rodriguez, Site 0116, 3491434914692313
- Completed
Local Institution - 0380
Madrid, 28046
- Withdrawn
Local Institution
Madrid, 28046
- Recruiting
Hospital Universitario HM Sanchinarro
Madrid, 28050
Juan Rodriguez Moreno, Site 0097, 34917567984
- Completed
Local Institution - 0287
Majadahonda, Madrid, 28220
- Completed
Local Institution - 0192
Málaga, 29010
- Recruiting
Clinica Universidad de Navarra
Pamplona, Navarre, 31008
Ignacio Melero Bermejo, Site 0353, 34948255400
- Withdrawn
Local Institution
Santa Cruz de Tenerife, 38230
- Recruiting
Hospital Universitario Marques de Valdecilla
Santander, 39008
Ignacio Jose Duran Martinez, Site 0352, 34942202515
- Completed
Local Institution - 0274
Seville, 41009
- Completed
Local Institution - 0294
Seville, 41013
- Recruiting
Hospital General Universitario de Valencia
Valencia, 46014
Alfonso Berrocal, Site 0020
- Completed
Local Institution - 0117
Valencia, 46026
Germany31 sites, 7 recruiting
- Recruiting
Universitaetsklinikum Aachen
Aachen, 52074
Matthias Saar, Site 0163, 0049241800
- Completed
Local Institution - 0248
Berlin, 10117
- Completed
Local Institution - 0249
Buxtehude, 21614
- Withdrawn
Local Institution - 0296
Cologne, 50937
- Withdrawn
Local Institution
Cologne, 50937
- Recruiting
Evangelische Kliniken Essen Mitte. Evang. Huyssens-Stiftung Essen-Huttrop
Essen, North Rhine-Westphalia, 45136
Sebastian Ertl, Site 0402, 4920117424001
- Completed
Local Institution - 0250
Essen, North Rhine-Westphalia, 45147
- Withdrawn
Local Institution - 0375
Essen, North Rhine-Westphalia, 45147
- Recruiting
University of Freiburg
Freiburg im Breisgau, 79106
Roland Roelz, Site 0315, 004976127050230
- Withdrawn
Local Institution
Gera, 07548
- Recruiting
SRH Wald-Klinikum Gera GmbH
Gera, 07548
Sabine Sell, Site 0080, 493658287758
- Completed
Local Institution - 0076
Göttingen, 37075
- Withdrawn
Local Institution
Göttingen, 37075
- Completed
Local Institution - 0241
Hamburg, 20246
- Withdrawn
Local Institution
Heidelberg, 69120
- Recruiting
Thoraxklinik
Heidelberg, 69126
Helge Bischoff, Site 0148, 4962213961304
- Completed
Local Institution - 0342
Heidelberg, D-69120
- Recruiting
SLK-Kliniken Heilbronn GmbH
Heilbronn, 74078
Uwe Martens, Site 0285, 4971314928700
- Recruiting
Universitaetsklinikum Jena - Klinik und Poliklinik fuer Urologie
Jena, 07747
Marc-Oliver Grimm, Site 0216, +49(0)36419329901
- Completed
Local Institution - 0288
Kassel, 34125
- Completed
Local Institution - 0072
Kiel, 24105
- Withdrawn
Local Institution
Kiel, 24105
- Withdrawn
Local Institution - 0386
Löwenstein, Baden-Wurttemberg, 74245
- Withdrawn
Local Institution - 0298
Löwenstein, 74245
- Withdrawn
Local Institution - 0098
Lübeck, 23538
- Completed
Local Institution - 0089
Mainz, 55131
- Withdrawn
Local Institution
Mainz, 55131
- Completed
Local Institution - 0276
Munich, Bavaria, 80337
- Withdrawn
Local Institution - 0332
Nuremberg, Bavaria, 90419
- Completed
Local Institution - 0017
Tübingen, 72076
- Withdrawn
Local Institution - 0277
Tübingen, 72076
Italy27 sites, 5 recruiting
- Completed
Local Institution - 0034
Bari, 70124
- Completed
Local Institution - 0002
Bergamo, 24127
- Withdrawn
Local Institution - 0326
Candiolo, 10060
- Completed
Local Institution - 0359
Catania, 95123
- Completed
Local Institution - 0251
Genova, 16132
- Withdrawn
Local Institution
Genova, 16132
- Recruiting
IRCCS - Istituto Scientifico Romagnolo per lo Studio dei Tumori - Dino Amadori - Srl
Meldola, Fc, 47014
Angelo Delmonte, Site 0361, +393487469100
- Withdrawn
Local Institution - 0108
Meldola, 47014
- Withdrawn
Local Institution - 0303
Meldola, 47014
- Recruiting
Fondazione IRCCS istituto Neurologico Carlo Besta;
Milan, 20133
Elena Anghileri, Site 0312, 00390223942285
- Completed
Local Institution - 0096
Milan, 20133
- Withdrawn
Local Institution - 0351
Milan, 20133
- Withdrawn
Local Institution
Milan, 20133
- Completed
Local Institution - 0071
Milan, 20141
- Completed
Local Institution - 0267
Milan, 20141
- Withdrawn
Local Institution
Milan, 20141
- Withdrawn
Local Institution - 0327
Modena, 41124
- Completed
Local Institution - 0073
Naples, 80131
- Completed
Local Institution - 0218
Naples, 80131
- Withdrawn
Local Institution - 0292
Naples, 80138
- Recruiting
Istituto Oncologico Veneto
Padova, 35128
Umberto Basso, Site 0067, +39-049-8215953
- Completed
Local Institution - 0180
Ravenna, 48121
- Recruiting
Istituto Nazionale dei Tumori Regina Elena
Roma, RM, 00144
Michelangelo Russillo, Site 0033, 0652662745
- Withdrawn
Local Institution - 0333
Rozzano, MI, 20089
- Completed
Local Institution - 0003
Siena, 53100
- Withdrawn
Local Institution - 0291
Terni, 05100
- Recruiting
Azienda Ospedaliera Citta della Salute e della Scienza
Torino, 10126
Alessia Pellerino, Site 0313, +390116334904
France25 sites, 9 recruiting
- Completed
Local Institution - 0006
Bordeaux, Gironde, 33075
- Recruiting
Centre Jean Perrin
Clermont-Ferrand, 63011
Hakim Mahammedi, Site 0345, 33473278131
- Completed
Local Institution - 0107
Créteil, 94010
- Completed
Local Institution - 0074
Dijon, 21000
- Completed
Local Institution - 0109
Dijon, 21079
- Recruiting
CHU Grenobles Alpes
La Tronche, 38700
Julie Charles, Site 0010, +33476766493
- Recruiting
Pole Biologie Pathologie Genetique - CHU de Lille
Lille, 59037
Laurent Mortier, Site 0011
- Recruiting
APHM - Hopital de la Timone
Marseille, 13385
Caroline Gaudy, Site 0125, 33491387991
- Completed
Local Institution - 0153
Marseille, 13915
- Recruiting
CHU Montpellier
Montpellier, 34090
Lea Fornero, Site 0182, 0665849187
- Withdrawn
Local Institution
Montpellier, 34295
- Withdrawn
Local Institution - 0300
Nantes, 44093
- Completed
Local Institution - 0341
Nantes, 44093
- Completed
Local Institution - 0028
Paris, 75010
- Withdrawn
Local Institution - 0301
Paris, 75018
- Completed
Local Institution - 0167
Paris, 75908
- Withdrawn
Local Institution - 0387
Paris, Île-de-France Region, 75005
- Recruiting
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
Stephane Dalle, Site 0084, 3333478861679
- Withdrawn
Local Institution
Rennes, 35033
- Recruiting
CHU de Saint-Etienne - Hopital Nord
Saint-Priest-en-Jarez, 42270
Pierre CORNILLON, Site 0401, +477917000
- Recruiting
Hopital Foch
Suresnes, 92151
CHRISTINE ABRAHAM, Site 0392, +33676018749
- Completed
Local Institution - 0156
Toulon, 83 056
- Withdrawn
Local Institution
Toulouse, 31059
- Completed
Local Institution - 0362
Vandœuvre-lès-Nancy, Meurthe-Et-Moselle, 54500
- Recruiting
Institut Gustave Roussy
Villejuif, 94805
Caroline Robert, Site 0029, 33142114210
China23 sites, 11 recruiting
- Withdrawn
Local Institution - 0198
Beijing, Beijing Municipality, 100853
- Recruiting
Jilin University (JLU) - First Affiliated Hospital - Cancer Center
Changchun, Jilin, 130061
Wei Li, Site 0307, 8613756661267
- Recruiting
Jilin Cancer Hospital
Changchun, Jilin, 130103
Ying Liu, Site 0194
- Withdrawn
Local Institution - 0172
Changsha, Hunan, 410000
- Recruiting
Xiangya Hospital Central South University
Changsha, Hunan, 410008
Min Li, Site 0309, 8613787103054
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410011
Shanzhi Gu, Site 0316, +73188651669
- Withdrawn
Local Institution
Guangzhou, Guangdong, 510080
- Recruiting
Nanfang Hospital; Southern Medical University
Guangzhou, Guangdong, 510515
Ya-Bing Guo, Site 0383, 862061641945
- Recruiting
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, 310016
Enguo Chen, Site 0304, 13588706779
- Completed
Local Institution - 0306
Hangzhou, 310003
- Withdrawn
Local Institution - 0245
Harbin, Heilongjiang, 150040
- Recruiting
Harbin Medical University - Cancer Hospital
Harbin, Heilongjiang, 150081
Yuxian Bai, Site 0317, 8613945095085
- Completed
Local Institution - 0160
Harbin, Heilongjiang, 150081
- Withdrawn
Local Institution - 0169
Hefei, Anhui, 230031
- Withdrawn
Local Institution - 0348
Nanjing, Jiangsu, 210009
- Recruiting
Jiangsu Cancer Hospital
Nanjing, 210009
Qing Zou, Site 0390, 13905173337
- Completed
Local Institution - 0223
Shanghai, Shanghai Municipality, 200025
- Recruiting
Fudan University - Shanghai Cancer Center FUSCC
Shanghai, Shanghai Municipality, 200032
Xianghua Wu, Site 0305, 8613482888167
- Withdrawn
Local Institution - 0278
Shanghai, Shanghai Municipality, 200032
- Withdrawn
Local Institution - 0325
Shanghai, Shanghai Municipality, 200032
- Completed
Local Institution - 0188
Shanghai, Shanghai Municipality, 200433
- Recruiting
Tangdu Hospital of Fourth Military Medical University
Xi'an, Shaanxi, 710038
Haichuan Su, Site 0318
- Recruiting
Xian International Medical Center Hospital
Xi'an, Shan3XI, 710700
Guohong Han, Site 0395, 86+8613991969930
Japan23 sites, 10 recruiting
- Recruiting
Tokyo Women's Medical University - Adachi Medical Center
Adachi-Ku, Tokyo, 1238558
Tsunenori Kondo, Site 0406
- Recruiting
Institute of Science Tokyo Hospital
Bunkyo-Ku, Tokyo, 1138519
Shohei Fukuda, Site 0404, 81358035295
- Recruiting
Chiba Cancer Center
Chiba, Chiba, 2608717
Atsushi Komaru, Site 0409, 81432645431
- Completed
Local Institution - 0235
Chuo-ku, Tokyo, 1040045
- Recruiting
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582
Takashi Matsumoto, Site 0393, 81926425603
- Withdrawn
Local Institution - 0224
Fukuoka, 11111
- Recruiting
Hamamatsu University Hospital
Hamamatsu, Shizuoka, 431-3192
Teruo Inamoto, Site 0391, 0534362306
- Completed
Local Institution - 0242
Hirosaki-shi, Aomori, 036-8563
- Recruiting
Hiroshima University Hospital
Hiroshima, 7348551
Tomokazu Kawaoka, Site 0319, 81822575555
- Withdrawn
Local Institution - 0219
Kanazawa, Ishikawa-ken, 920-8641
- Recruiting
National Cancer Center Hospital East
Kashiwa-Shi, Chiba, 2778577
Toshihiko Doi, Site 0356, 81335422511
- Completed
Local Institution - 0211
Kobe, Hyōgo, 6500047
- Completed
Local Institution - 0217
Koto-Ku, Tokyo, 135-8550
- Recruiting
Ehime Prefectural Central Hospital
Matsuyama, Ehime, 7900024
Fujimasa Tada, Site 0394
- Recruiting
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, 7910280
Katsuyoshi Hashine, Site 0397, 81899991111
- Completed
Local Institution - 0222
Natori-shi, Miyagi, 981-1293
- Completed
Local Institution - 0230
Niigata, Niigata, 9518566
- Completed
Local Institution - 0236
Niigata, 951-8520
- Completed
Local Institution - 0214
Sayama, Osaka, 5898511
- Completed
Local Institution - 0239
Shinjuku, Tokyo, 160-8582
- Completed
Local Institution - 0212
Takatsuki, Osaka, 569-8686
- Completed
Local Institution - 0240
Tsukuba, Ibaraki, 305-8576
- Recruiting
Yokohama City University Medical Center
Yokohama, Kanagawa, 2320024
Manabu Morimoto, Site 0368, 81452615656
Australia15 sites, 5 recruiting
- Withdrawn
Local Institution
Adelaide, South Australia, 5000
- Recruiting
BRICC - Ballarat Health Services
Ballarat, Victoria, 3350
Wasek Faisal, Site 0411
- Completed
Local Institution - 0045
Coffs Harbour, New South Wales, 2450
- Completed
Local Institution - 0196
Elizabeth Vale, South Australia, 05112
- Completed
Local Institution - 0365
Fitzroy, Victoria, 3065
- Recruiting
Gallipoli Medical Foundation
Greenslopes, Queensland, 4120
Victoria Atkinson, Site 0021, 0448632604
- Withdrawn
Local Institution - 0372
Greenslopes, Queensland, 4120
- Recruiting
Cabrini Hospital Malvern
Malvern, Victoria, 3144
Benjamin Brady, Site 0005, 0395086161
- Withdrawn
Local Institution - 0174
Murdoch, Western Australia, 6150
- Recruiting
Melanoma Institute Australia
North Sydney, New South Wales, 2060
Georgina Long, Site 0062, 61299117336
- Withdrawn
Local Institution
South Brisbane, Queensland, 4101
- Recruiting
Tasman Oncology Research Ltd
Southport, Queensland, 4215
Andrew Hill, Site 0347, +61756132480
- Completed
Local Institution - 0009
Sydney, New South Wales, 2050
- Completed
Local Institution - 0193
Waratah, New South Wales, 2298
- Completed
Local Institution - 0208
Westmead, New South Wales, 2145
Brazil15 sites, 5 recruiting
- Completed
Local Institution - 0264
Barretos, São Paulo, 14784-400
- Completed
Local Institution - 0260
Belo Horizonte, Minas Gerais, 30130090
- Recruiting
ONCOSITE - Centro de Pesquisa Clinica em Oncologia
Ijuí, Rio Grande do Sul, 98700-000
Fabio Franke, Site 0155, +5555991592101
- Withdrawn
Local Institution - 0379
Passo Fundo, Rio Grande do Sul, 99010-080
- Not yet recruiting
Local Institution - 0093
Porto Alegre, Rio Grande do Sul, 90035-903
Site 0093
- Recruiting
Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90050-170
Rodrigo Pereira, Site 0113, 555133598619
- Recruiting
Hospital Sao Lucas Da Pucrs
Porto Alegre, Rio Grande do Sul, 90610-000
Carlos Barrios, Site 0331, +555133203039
- Withdrawn
Local Institution - 0399
Porto Alegre, Rio Grande do Sul, 91350-250
- Completed
Local Institution - 0266
Rio de Janeiro, 20220-280
- Completed
Local Institution - 0258
Rio de Janeiro, 22775-001
- Completed
Local Institution - 0262
São José do Rio Preto, São Paulo, 15090-000
- Recruiting
ICESP - Instituto do Cancer do Estado de Soo Paulo
São Paulo, São Paulo, 01246-000
Olavo Feher, Site 0302, 551138932684
- Withdrawn
Local Institution - 0263
São Paulo, São Paulo, 01308-050
- Completed
Local Institution - 0355
São Paulo, São Paulo, 01327-001
- Withdrawn
Local Institution - 0340
São Paulo, 01308-060
Poland15 sites, 6 recruiting
- Withdrawn
Local Institution - 0336
Biała Podlaska, 21-500
- Recruiting
Centrum Onkologii im. Prof. Franciszka Lukaszczyka
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796
Bogdan Zurawski, Site 0358, +48501446778
- Completed
Local Institution - 0120
Gdansk, 80-214
- Recruiting
Wojewodzkie Centrum Onkologii
Gdansk, 80219
Joanna Wojcik-Tomaszewska, Site 0069, 4858505993747
- Withdrawn
Local Institution - 0377
Krakow, 30-510
- Completed
Local Institution - 0252
Krakow, 31-115
- Withdrawn
Local Institution - 0373
Krakow, 31-501
- Recruiting
Instytut MSF Sp zoo
Lodz, 90-302
Ewa Kalinka, Site 0031
- Completed
Local Institution - 0118
Lublin, 20-064
- Recruiting
Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie
Olsztyn, Warmian-Masurian Voivodeship, 10-357
Andrzej Kazarnowicz, Site 0414, 48895322973
- Completed
Local Institution - 0178
Poznan, 60-185
- Recruiting
Wojskowy Instytut Medyczny
Warsaw, 0 4-141
Renata Duchnowska, Site 0132, +48602609988
- Withdrawn
Local Institution - 0328
Warsaw, 02-776
- Withdrawn
Local Institution
Warsaw, 02-781
- Recruiting
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Warsaw, 02-781
Dariusz Kowalski, Site 0151, 48225463066
Mexico14 sites, 6 recruiting
- Recruiting
Cryptex Investigacion Clinica Sa de Cv
Cuauhtémoc, Mexico City, 06100
Daniel Motola Kuba, Site 0337, 5215585815263
- Withdrawn
Local Institution - 0152
León, Guanajuato, 37000
- Completed
Local Institution - 0346
México, 14080
- Withdrawn
Local Institution - 0410
Mexico City, 03810
- Recruiting
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, 14080
Maria Bourlon, Site 0344, 5215554386271
- Withdrawn
Local Institution - 0286
Monterrey, Nuevo León, 64040
- Withdrawn
Local Institution - 0354
Monterrey, Nuevo León, 64460
- Recruiting
I Can Oncology Center
Monterrey, Nuevo León, 64710
Yamil Alonso Lopez Chuken, Site 0396
- Completed
Local Institution - 0007
Morelia, Michoacán, 58240
- Recruiting
Centro de Investigacion Clinica de Oaxaca
Oaxaca City, Oaxaca, CP68020
Roberto Romero Diaz, Site 0369, +529512570569
- Withdrawn
Local Institution - 0343
Querétaro City, Querétaro, 76000
- Recruiting
Centro Potosino de Investigacion Medica S.C.
San Luis Potosí City, 78250
Pedro Figueroa Martinez, Site 0367, 4444479873
- Withdrawn
Local Institution - 0181
Tlalpan, Mexico City, 14050
- Recruiting
Investigación Biomédica para el Desarrollo de Fármacos S.A de C.V
Zapopan, Jalisco, 45070
EMILIO MURILLO, Site 0338, +523311938595
Argentina11 sites, 6 recruiting
- Completed
Local Institution - 0199
Berazategui, Buenos Aires, 1880
- Withdrawn
Local Institution - 0201
Buenos Aires, C1199 ABH
- Recruiting
Instituto Fleming
Buenos Aires, C1426ANZ
Matias Chacon, Site 0030, +541138850425
- Withdrawn
Local Institution
CABA, C1426ANZ
- Recruiting
Fundacion Richardet Longo - IONC
Córdoba, X 5002HWE
Martin Richardet, Site 0349, 5493516165267
- Withdrawn
Local Institution - 0170
Córdoba, X5004FHP
- Recruiting
Instituto Medico Rio Cuarto
Río Cuarto, Córdoba Province, 5800
Alejo Lingua, Site 0415, 54351153819050
- Recruiting
Sanatorio Parque
Rosario, Santa Fe Province, 2000
Gaston Lucas Martinengo, Site 0407
- Recruiting
CAIPO Centro para la Atencion Integral del Paciente Oncologico
San Miguel de Tucumán, Tucumán Province, 4000
Felipe Salvador Palazzo, Site 0376, 543814018300
- Completed
Local Institution - 0191
San Miguel de Tucumán, Tucumán Province, 4000
- Recruiting
Centro de Investigaciones Clinicas. Clinica Viedma S.A.
Viedma, Río Negro Province, 8500
Ruben Kowalyszyn, Site 0405, 5492920601693
United Kingdom10 sites, 1 recruiting
- Withdrawn
Local Institution - 0299
Edinburgh, Scotland, EH4 2XU
- Withdrawn
Local Institution - 0259
Glasgow, G12 0YN
- Completed
Local Institution - 0141
London, Greater London, N18 1QX
- Recruiting
University College Hospital
London, Greater London, NW1 2PG
Paul Mulholland, Site 0314, +44 20 3456 7890
- Completed
Local Institution - 0272
London, Greater London, SM2 5PT
- Completed
Local Institution - 0086
London, Greater London, SW3 6JJ
- Withdrawn
Local Institution - 0231
Maidstone, Kent, ME16 9QQ
- Completed
Local Institution - 0115
Manchester, Greater Manchester, M20 4BX
- Completed
Local Institution - 0161
Northwood, Middlesex, HA6 2RN
- Completed
Local Institution - 0195
Southampton, Hampshire, SO16 6YD
Greece9 sites, 1 recruiting
- Recruiting
Alexandra Hospital
Athens, Attica, 11528
Michail Liontos, Site 0381, 3021232162845
- Completed
Local Institution - 0022
Athens, 11527
- Completed
Local Institution - 0126
Athens, 11527
- Completed
Local Institution - 0171
Athens, 11528
- Completed
Local Institution - 0042
Athens, 18547
- Withdrawn
Local Institution - 0295
Athens, 18547
- Withdrawn
Local Institution - 0244
Heraklion, Crete, 710 03
- Withdrawn
Local Institution
Pátrai, 26504
- Completed
Local Institution - 0215
Thessaloniki, 57001
Romania9 sites, 5 recruiting
- Completed
Local Institution - 0310
Bucharest, Sector 2, 021389
- Recruiting
Institutul Oncologic Bucuresti IOB
Bucharest, 022328
Aurelia Alexandru, Site 0129, 40723289606
- Recruiting
Institutul Oncologic Prof. Dr. I. Chiricuta
Cluj-Napoca, Cluj, 400015
Tudor Ciuleanu, Site 0135, 40745646368
- Completed
Local Institution - 0127
Cluj-Napoca, 400-641
- Completed
Local Institution - 0189
Cluj-Napoca, 400015
- Recruiting
Onco Clinic Consult SA
Craiova, Dolj, 200508
Patricia Visan, Site 0378, +40724280084
- Recruiting
Centrul de Oncologie Sf Nectarie
Craiova, Dolj, 200542
Michael Schenker, Site 0265, 40727774974
- Completed
Local Institution - 0133
Oradea, 410469
- Recruiting
Sc Sigmedical Srl
Suceava, 720214
Doina Ganea, Site 0374, +40722423653
Canada7 sites, 2 recruiting
- Recruiting
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Quincy Chu, Site 0111, 7804328248
- Withdrawn
Local Institution
Halifax, Nova Scotia, B3H1V7
- Withdrawn
Local Institution - 0040
Montreal, Quebec, H4A 3J1
- Withdrawn
Local Institution - 0308
Montreal, Quebec, H4J 1C5
- Completed
Local Institution - 0168
Oshawa, Ontario, L1G 2B9
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Marcus Butler, Site 0280, 4169464628
- Withdrawn
Local Institution
Vancouver, British Columbia, V5Z 1L3
South Korea7 sites, 2 recruiting
- Recruiting
National Cancer Center
Gyeonggi-do, 10408
BoHyun Kim, Site 0320
- Withdrawn
Local Institution - 0389
Seongnam-si, Gyeonggi-do, 13532
- Completed
Local Institution - 0221
Seongnam-si, 463-707
- Recruiting
Asan Medical Center
Seoul, Songpa-gu, 05505
Min-Hee Ryu, Site 0322, 82230105935
- Completed
Local Institution - 0206
Seoul, 03722
- Completed
Local Institution - 0324
Seoul, 110 - 744
- Completed
Local Institution - 0207
Suwon, 16499
Belgium6 sites
- Withdrawn
Local Institution - 0329
Brussels, 1000
- Completed
Local Institution - 0232
Ghent, 9000
- Completed
Local Institution - 0139
Jette, 1090
- Withdrawn
Local Institution - 0261
Liège, 4000
- Withdrawn
Local Institution - 0293
Sint-Niklaas, 9100
- Completed
Local Institution - 0157
Yvoir, 5530
Chile6 sites, 3 recruiting
- Recruiting
Orlandi Oncologia
Providencia, Santiago Metropolitan, 7500713
Francisco Orlandi Jorquera, Site 0398, 5656224339699
- Recruiting
Bradford Hill Centro de Investigacion Clinica
Santiago, Santiago Metropolitan, 0
Mauricio Burotto, Site 0101
- Recruiting
Fundacion Arturo Lopez Perez
Santiago, Santiago Metropolitan, 7500921
Mauricio Mahave, Site 0019, 5624205100
- Withdrawn
Local Institution
Santiago, Santiago Metropolitan, 7500921
- Completed
Local Institution - 0363
Temuco, Araucania, 4780000
- Withdrawn
Local Institution - 0079
Viña del Mar, 2540364
Austria5 sites, 1 recruiting
- Completed
Local Institution - 0254
Graz, Styria, 8036
- Recruiting
Ordensklinikum Linz GmbH Elisabethinen
Linz, Upper Austria, 4020
Clemens Mayr, Site 0149, 4373276764600
- Completed
Local Institution - 0104
Vienna, 1090
- Completed
Local Institution - 0321
Vienna, 1090
- Completed
Local Institution - 0145
Wels, 4600
Czechia5 sites, 1 recruiting
- Withdrawn
Local Institution - 0371
Brno, 656 53
- Recruiting
FNHK Klinika onkologie a radioterapie
Hradec Králové, 500 05
Jindrich Kopecky, Site 0243, +420495832176
- Withdrawn
Local Institution - 0150
Olomouc, 779 00
- Withdrawn
Local Institution - 0253
Prague, 11000
- Completed
Local Institution - 0275
Prague, 128 00
Israel5 sites
- Completed
Local Institution - 0190
Haifa, 3109601
- Completed
Local Institution - 0270
Jerusalem, 91120
- Withdrawn
Local Institution
Petah Tikva, 49100
- Completed
Local Institution - 0052
Ramat Gan, 52621
- Withdrawn
Local Institution - 0350
Tiqwa, 49100
Hungary4 sites
- Completed
Local Institution - 0159
Budapest, 1121
- Withdrawn
Local Institution - 0226
Budapest, 1121
- Completed
Local Institution - 0187
Debrecen, 4032
- Completed
Local Institution - 0290
Gyöngyössolymos, Heves County, 3233
New Zealand4 sites, 1 recruiting
- Recruiting
Auckland City Hospital
Auckland, 1142
Edward Gane, Site 0370, 6921548371
- Withdrawn
Local Institution - 0271
Christchurch, 8011
- Completed
Local Institution - 0268
Dunedin, 9016
- Completed
Local Institution - 0269
Tauranga, 3112
Russia4 sites
- Withdrawn
Local Institution - 0257
Krasnodar, Krasnodarskiy Kray, 350040
- Withdrawn
Local Institution - 0256
Krasnoyarsk, 660133
- Terminated
N.N. Blokhin National Medical Research Center of Oncology
Moscow, 115478
- Terminated
VitaMed LLC
Moscow, 121309
Taiwan4 sites, 2 recruiting
- Recruiting
Taichung Veterans General Hospital
Taichung, 40705
Teng-Yu Lee, Site 0388, 8864235925253309
- Completed
Local Institution - 0197
Tainan, 704
- Completed
Local Institution - 0412
Taipei, 10002
- Recruiting
Taipei Veterans General Hospital TPVGH
Taipei, 11217
Yi-Hsiang Huang, Site 0366, +886938590872
Portugal3 sites
- Completed
Local Institution - 0184
Lisbon, 1769-001
- Completed
Local Institution - 0177
Lisbon, 4200-072
- Withdrawn
Local Institution - 0142
Porto, 4200319
Sweden3 sites
- Withdrawn
Local Institution
Gothenburg, SE-41345
- Withdrawn
Local Institution - 0036
Malmö, 205 02
- Withdrawn
Local Institution
Umeå, 901 85
Switzerland3 sites
- Completed
Local Institution - 0119
Basel, 4031
- Withdrawn
Local Institution - 0403
Sankt Gallen, 9007
- Completed
Local Institution - 0083
Zurich, CH - 8058
Ireland2 sites
- Withdrawn
Local Institution - 0227
Dublin, Dublin 7
- Withdrawn
Local Institution
Limerick, V94 F858
Netherlands2 sites
- Withdrawn
Local Institution - 0335
Amsterdam, North Holland, 1066 CX
- Withdrawn
Local Institution
Rotterdam, 3015 CE
Norway2 sites
- Completed
Local Institution - 0213
Bergen, 5021
- Completed
Local Institution - 0048
Oslo, N-0379
Peru2 sites, 1 recruiting
- Not yet recruiting
Local Institution - 0385
Lima, 15076
Site 0385
- Completed
Local Institution - 0179
Santiago de Surco, Lima region, 15023
Puerto Rico2 sites, 2 recruiting
- Recruiting
FDI Clinical Research
San Juan, PR, 00927
Mirelis Acosta-Rivera, Site 0334, 7877520003545
- Not yet recruiting
Local Institution - 0416
San Juan, 918
Site 0416
Hong Kong1 site, 1 recruiting
- Recruiting
Queen Mary Hospital
Hong Kong, 000000
Thomas Yau, Site 0339, 85222554249
Turkey (Türkiye)1 site
- Withdrawn
Local Institution - 0330
Ankara, 06010
About this study
Official title: Pan-Tumor Study for Long-term Treatment of Cancer Patients Who Have Participated in BMS Sponsored Trials Investigating Nivolumab and Other Cancer Therapies
Main Objective of this study is to examine long-term safety of nivolumab monotherapy including combinations and other cancer therapies in various tumor types.
- Conditions
- Cancer
- Being tested
- Nivolumab, Ipilimumab, Cabozantinib, Trametinib, Relatlimab
- Keywords
- Rollover, pan-tumor
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Also called BMS-936558-01
Specified dose on specified days
IpilimumabDrug
Specified dose on specified days
CabozantinibDrug
Specified dose on specified days
TrametinibDrug
Specified dose on specified days
RelatlimabDrug
Also called BMS-986016-01
Specified dose on specified days
Nivolumab + RelatlimabDrug
Also called BMS-986213
Specified dose on specified days
CapecitabineDrug
Specified dose on specified days
BevacizumabDrug
Specified dose on specified days
TemozolomideDrug
Specified dose on specified days
RucaparibDrug
Specified dose on specified days
DaratumumabDrug
Specified dose on specified days
RegorafinibDrug
Specified dose on specified days
LeucovorinDrug
Specified dose on specified days
FluorouracilDrug
Specified dose on specified days
OxaliplatinDrug
Specified dose on specified days
EnzalutamideDrug
Specified dose on specified days
SunitinibDrug
Specified dose on specified days
PemetrexedDrug
Specified dose on specified days
PembrolizumabDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| A1: Nivolumab Monotherapy Dose 1 | Experimental | Not described Receives: Drug: Nivolumab |
| A2: Nivolumab Monotherapy Dose 2 | Experimental | Not described Receives: Drug: Nivolumab |
| B1: Nivolumab + Ipilimumab | Experimental | Not described Receives: Drug: Nivolumab; Drug: Ipilimumab |
| B2: Nivolumab + Ipilimumab + Cabozantinib | Experimental | Not described Receives: Drug: Nivolumab; Drug: Ipilimumab; Drug: Cabozantinib |
| B3: Nivolumab + Ipilimumab + Trametinib | Experimental | Not described Receives: Drug: Nivolumab; Drug: Ipilimumab; Drug: Trametinib |
| C1: Relatlimab + Nivolumab Fixed Dose Combination Dose 1 | Experimental | Not described Receives: Drug: Nivolumab + Relatlimab |
| C3: Relatlimab + Nivolumab Fixed Dose Combination Dose 2 | Experimental | Not described Receives: Drug: Nivolumab + Relatlimab |
| C2: Relatlimab + Nivolumab Single Agent Vial (SAV) Dose 1 | Experimental | Not described Receives: Drug: Nivolumab; Drug: Relatlimab |
| C4: Relatlimab + Nivolumab SAV Dose 2 | Experimental | Not described Receives: Drug: Nivolumab; Drug: Relatlimab |
| C5: Relatlimab + Nivolumab + Ipilimumab | Experimental | Not described Receives: Drug: Nivolumab; Drug: Ipilimumab |
| C6: Relatlimab + Nivolumab + Capecitabine | Experimental | Not described Receives: Drug: Nivolumab + Relatlimab; Drug: Capecitabine |
| C7: Relatlimab + Nivolumab SAV Dose 3 | Experimental | Not described Receives: Drug: Nivolumab; Drug: Relatlimab |
| C10: Relatlimab + Nivolumab SAV Dose 4 | Experimental | Not described Receives: Drug: Nivolumab; Drug: Relatlimab |
| C12: Relatlimab + Nivolumab SAV Dose 5 | Experimental | Not described Receives: Drug: Nivolumab; Drug: Relatlimab |
| C8: Relatlimab + Nivolumab SAV + PDCT Dose 1 | Experimental | Not described Receives: Drug: Nivolumab; Drug: Relatlimab |
| C9: Relatlimab + Nivolumab SAV + Bevacizumab | Experimental | Not described Receives: Drug: Nivolumab; Drug: Relatlimab; Drug: Bevacizumab |
| C11: Relatlimab + Nivolumab SAV + PDCT Dose 2 | Experimental | Not described Receives: Drug: Nivolumab; Drug: Relatlimab |
| D1: Nivolumab + Temozolomide | Experimental | Not described Receives: Drug: Nivolumab; Drug: Temozolomide |
| D2: Nivolumab + Rucaparib | Experimental | Not described Receives: Drug: Nivolumab; Drug: Rucaparib |
| D3: Nivolumab + Daratumumab | Experimental | Not described Receives: Drug: Nivolumab; Drug: Daratumumab |
| D4: Nivolumab + Bevacizumab | Experimental | Not described Receives: Drug: Nivolumab |
| E1: Bevacizumab Monotherapy | Experimental | Not described Receives: Drug: Bevacizumab |
| E2: Regorafinib Monotherapy | Experimental | Not described Receives: Drug: Regorafinib |
| E4: Leucovorin + Oxaliplatin + Fluorouracil | Experimental | Not described Receives: Drug: Leucovorin; Drug: Fluorouracil; Drug: Oxaliplatin |
| E5: Enzalutamide Monotherapy | Experimental | Not described Receives: Drug: Enzalutamide |
| E6: Sunitinib Monotherapy | Experimental | Not described Receives: Drug: Sunitinib |
| E7: Rucaparib Monotherapy | Experimental | Not described Receives: Drug: Rucaparib |
| E8: Capecitabine Monotherapy | Experimental | Not described Receives: Drug: Capecitabine |
| E9: Cabozantinib Monotherapy | Experimental | Not described Receives: Drug: Cabozantinib |
| E10: Pemetrexed Monotherapy | Experimental | Not described Receives: Drug: Pemetrexed |
| E11: Pembrolizumab Monotherapy | Experimental | Not described Receives: Drug: Pembrolizumab |
| E3: Leucovorin + Fluorouracil | Experimental | Not described Receives: Drug: Leucovorin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs)
Measured: From Day 1 up to 135 Days after discontinuation of treatment
Incidence of drug related AEs
Measured: From Day 1 up to 135 Days after discontinuation of treatment
Incidence of AEs leading to Discontinuation
Measured: From Day 1 up to 135 Days after discontinuation of treatment
Incidence of Serious Adverse Events (SAEs)
Measured: From signature of Informed Consent up to 135 Days after discontinuation of treatment
Incidence of Select AEs
Measured: From Day 1 up to 135 Days after discontinuation of treatment
Incidence of Immune-Mediated AEs
Measured: From Day 1 up to 135 Days after discontinuation of treatment
Incidence of Death
Measured: From signature of Informed Consent up to 135 Days after discontinuation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start9 Aug 2019
- Primary completion25 Aug 2029 (estimated)
- Study completion25 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Exelixis, Novartis, Clovis Oncology, Inc., Janssen Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03899155
- Sponsor's protocol ID
- CA209-8TT
- Other IDs
- 2018-004362-34, 2018
- Status last verified
- Sep 2026
- First submitted
- 1 Apr 2019
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pan-Tumor Study for Long-term Treatment of Cancer Patients Who Have Participated in BMS Sponsored Trials Investigating Nivolumab and Other Cancer Therapies
- ClinicalTrials.gov ID
- NCT03899155
- Acronym / sponsor ID
- CA209-8TT
- Conditions
- Cancer
- Keywords
- Rollover, pan-tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Exelixis, Novartis, Clovis Oncology, Inc., Janssen Pharmaceuticals
- Study start
- 9 Aug 2019 (actual)
- Primary completion
- 25 Aug 2029 (estimated)
- Study completion
- 25 Aug 2029 (estimated)
- First posted
- 2 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Main Objective of this study is to examine long-term safety of nivolumab monotherapy including combinations and other cancer therapies in various tumor types.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 32
| Arm | Type | Receives |
|---|---|---|
| A1: Nivolumab Monotherapy Dose 1 | Experimental | Drug: Nivolumab |
| A2: Nivolumab Monotherapy Dose 2 | Experimental | Drug: Nivolumab |
| B1: Nivolumab + Ipilimumab | Experimental | Drug: Nivolumab, Drug: Ipilimumab |
| B2: Nivolumab + Ipilimumab + Cabozantinib | Experimental | Drug: Nivolumab, Drug: Ipilimumab, Drug: Cabozantinib |
| B3: Nivolumab + Ipilimumab + Trametinib | Experimental | Drug: Nivolumab, Drug: Ipilimumab, Drug: Trametinib |
| C1: Relatlimab + Nivolumab Fixed Dose Combination Dose 1 | Experimental | Drug: Nivolumab + Relatlimab |
| C3: Relatlimab + Nivolumab Fixed Dose Combination Dose 2 | Experimental | Drug: Nivolumab + Relatlimab |
| C2: Relatlimab + Nivolumab Single Agent Vial (SAV) Dose 1 | Experimental | Drug: Nivolumab, Drug: Relatlimab |
| C4: Relatlimab + Nivolumab SAV Dose 2 | Experimental | Drug: Nivolumab, Drug: Relatlimab |
| C5: Relatlimab + Nivolumab + Ipilimumab | Experimental | Drug: Nivolumab, Drug: Ipilimumab |
| C6: Relatlimab + Nivolumab + Capecitabine | Experimental | Drug: Nivolumab + Relatlimab, Drug: Capecitabine |
| C7: Relatlimab + Nivolumab SAV Dose 3 | Experimental | Drug: Nivolumab, Drug: Relatlimab |
| C10: Relatlimab + Nivolumab SAV Dose 4 | Experimental | Drug: Nivolumab, Drug: Relatlimab |
| C12: Relatlimab + Nivolumab SAV Dose 5 | Experimental | Drug: Nivolumab, Drug: Relatlimab |
| C8: Relatlimab + Nivolumab SAV + PDCT Dose 1 | Experimental | Drug: Nivolumab, Drug: Relatlimab |
| C9: Relatlimab + Nivolumab SAV + Bevacizumab | Experimental | Drug: Nivolumab, Drug: Relatlimab, Drug: Bevacizumab |
| C11: Relatlimab + Nivolumab SAV + PDCT Dose 2 | Experimental | Drug: Nivolumab, Drug: Relatlimab |
| D1: Nivolumab + Temozolomide | Experimental | Drug: Nivolumab, Drug: Temozolomide |
| D2: Nivolumab + Rucaparib | Experimental | Drug: Nivolumab, Drug: Rucaparib |
| D3: Nivolumab + Daratumumab | Experimental | Drug: Nivolumab, Drug: Daratumumab |
| D4: Nivolumab + Bevacizumab | Experimental | Drug: Nivolumab |
| E1: Bevacizumab Monotherapy | Experimental | Drug: Bevacizumab |
| E2: Regorafinib Monotherapy | Experimental | Drug: Regorafinib |
| E4: Leucovorin + Oxaliplatin + Fluorouracil | Experimental | Drug: Leucovorin, Drug: Fluorouracil, Drug: Oxaliplatin |
| E5: Enzalutamide Monotherapy | Experimental | Drug: Enzalutamide |
| E6: Sunitinib Monotherapy | Experimental | Drug: Sunitinib |
| E7: Rucaparib Monotherapy | Experimental | Drug: Rucaparib |
| E8: Capecitabine Monotherapy | Experimental | Drug: Capecitabine |
| E9: Cabozantinib Monotherapy | Experimental | Drug: Cabozantinib |
| E10: Pemetrexed Monotherapy | Experimental | Drug: Pemetrexed |
| E11: Pembrolizumab Monotherapy | Experimental | Drug: Pembrolizumab |
| E3: Leucovorin + Fluorouracil | Experimental | Drug: Leucovorin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
- Other protocol-defined Inclusion/Exclusion Criteria apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivolumabAlso: BMS-936558-01Specified dose on specified days | Drug | A1: Nivolumab Monotherapy Dose 1, A2: Nivolumab Monotherapy Dose 2, B1: Nivolumab + Ipilimumab, B2: Nivolumab + Ipilimumab + Cabozantinib, B3: Nivolumab + Ipilimumab + Trametinib, C10: Relatlimab + Nivolumab SAV Dose 4, C11: Relatlimab + Nivolumab SAV + PDCT Dose 2, C12: Relatlimab + Nivolumab SAV Dose 5, C2: Relatlimab + Nivolumab Single Agent Vial (SAV) Dose 1, C4: Relatlimab + Nivolumab SAV Dose 2, C5: Relatlimab + Nivolumab + Ipilimumab, C7: Relatlimab + Nivolumab SAV Dose 3, C8: Relatlimab + Nivolumab SAV + PDCT Dose 1, C9: Relatlimab + Nivolumab SAV + Bevacizumab, D1: Nivolumab + Temozolomide, D2: Nivolumab + Rucaparib, D3: Nivolumab + Daratumumab, D4: Nivolumab + Bevacizumab |
| IpilimumabSpecified dose on specified days | Drug | B1: Nivolumab + Ipilimumab, B2: Nivolumab + Ipilimumab + Cabozantinib, B3: Nivolumab + Ipilimumab + Trametinib, C5: Relatlimab + Nivolumab + Ipilimumab |
| CabozantinibSpecified dose on specified days | Drug | B2: Nivolumab + Ipilimumab + Cabozantinib, E9: Cabozantinib Monotherapy |
| TrametinibSpecified dose on specified days | Drug | B3: Nivolumab + Ipilimumab + Trametinib |
| RelatlimabAlso: BMS-986016-01Specified dose on specified days | Drug | C10: Relatlimab + Nivolumab SAV Dose 4, C11: Relatlimab + Nivolumab SAV + PDCT Dose 2, C12: Relatlimab + Nivolumab SAV Dose 5, C2: Relatlimab + Nivolumab Single Agent Vial (SAV) Dose 1, C4: Relatlimab + Nivolumab SAV Dose 2, C7: Relatlimab + Nivolumab SAV Dose 3, C8: Relatlimab + Nivolumab SAV + PDCT Dose 1, C9: Relatlimab + Nivolumab SAV + Bevacizumab |
| Nivolumab + RelatlimabAlso: BMS-986213Specified dose on specified days | Drug | C1: Relatlimab + Nivolumab Fixed Dose Combination Dose 1, C3: Relatlimab + Nivolumab Fixed Dose Combination Dose 2, C6: Relatlimab + Nivolumab + Capecitabine |
| CapecitabineSpecified dose on specified days | Drug | C6: Relatlimab + Nivolumab + Capecitabine, E8: Capecitabine Monotherapy |
| BevacizumabSpecified dose on specified days | Drug | C9: Relatlimab + Nivolumab SAV + Bevacizumab, E1: Bevacizumab Monotherapy |
| TemozolomideSpecified dose on specified days | Drug | D1: Nivolumab + Temozolomide |
| RucaparibSpecified dose on specified days | Drug | D2: Nivolumab + Rucaparib, E7: Rucaparib Monotherapy |
| DaratumumabSpecified dose on specified days | Drug | D3: Nivolumab + Daratumumab |
| RegorafinibSpecified dose on specified days | Drug | E2: Regorafinib Monotherapy |
| LeucovorinSpecified dose on specified days | Drug | E3: Leucovorin + Fluorouracil, E4: Leucovorin + Oxaliplatin + Fluorouracil |
| FluorouracilSpecified dose on specified days | Drug | E4: Leucovorin + Oxaliplatin + Fluorouracil |
| OxaliplatinSpecified dose on specified days | Drug | E4: Leucovorin + Oxaliplatin + Fluorouracil |
| EnzalutamideSpecified dose on specified days | Drug | E5: Enzalutamide Monotherapy |
| SunitinibSpecified dose on specified days | Drug | E6: Sunitinib Monotherapy |
| PemetrexedSpecified dose on specified days | Drug | E10: Pemetrexed Monotherapy |
| PembrolizumabSpecified dose on specified days | Drug | E11: Pembrolizumab Monotherapy |
Primary outcome
Incidence of Adverse Events (AEs)
Time frame: From Day 1 up to 135 Days after discontinuation of treatment
Incidence of drug related AEs
Time frame: From Day 1 up to 135 Days after discontinuation of treatment
Incidence of AEs leading to Discontinuation
Time frame: From Day 1 up to 135 Days after discontinuation of treatment
Incidence of Serious Adverse Events (SAEs)
Time frame: From signature of Informed Consent up to 135 Days after discontinuation of treatment
Incidence of Select AEs
Time frame: From Day 1 up to 135 Days after discontinuation of treatment
Incidence of Immune-Mediated AEs
Time frame: From Day 1 up to 135 Days after discontinuation of treatment
Incidence of Death
Time frame: From signature of Informed Consent up to 135 Days after discontinuation of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
Bristol-Myers Squibb study director
Bristol-Myers Squibb
399 sites in 38 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab, Ipilimumab and Cabozantinib in people with Cancer, run by Bristol-Myers Squibb at 399 sites in 38 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 399 sites in United States, Spain, Germany, Italy, France and 33 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (AEs) (time frame: From Day 1 up to 135 Days after discontinuation of treatment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.