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Pan Tumor Nivolumab Rollover Study

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03899155
Collaborator
(none)
800
Enrollment
254
Locations
2
Arms
72.5
Anticipated Duration (Months)
3.1
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Main Objective of this study is to examine long-term safety of nivolumab in participants on treatment and in follow up.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
800 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pan-Tumor Study for Long Term Follow-up of Cancer Survivors Who Have Participated in Trials Investigating Nivolumab
Actual Study Start Date :
Aug 9, 2019
Anticipated Primary Completion Date :
Aug 25, 2025
Anticipated Study Completion Date :
Aug 25, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Nivolumab Dose 1

Specified Dose on Specified Days

Drug: Nivolumab
Solution for IV Injection
Other Names:
  • BMS-936558-01

    		•
    Experimental: Nivolumab Dose 2

    Specified Dose on Specified Days

    Drug: Nivolumab
    Solution for IV Injection
    Other Names:
  • BMS-936558-01

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of Adverse Events (AEs) [From Day 1 up to 100 Days after discontinuation of treatment]

    2. Incidence of drug related AEs [From Day 1 up to 100 Days after discontinuation of treatment]

    3. Incidence of AEs leading to Discontinuation [From Day 1 up to 100 Days after discontinuation of treatment]

    4. Incidence of Serious Adverse Events (SAEs) [From signature of Informed Consent up to 100 Days after discontinuation of treatment]

    5. Incidence of Select AEs [From Day 1 up to 100 Days after discontinuation of treatment]

    6. Incidence of Immune-Mediated AEs [From Day 1 up to 100 Days after discontinuation of treatment]

    7. Incidence of Death [From signature of Informed Consent up to 100 Days after discontinuation of treatment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria: -

    • Signed Written Informed Consent

    • Participants who have completed treatment with nivolumab, progressed on prior nivolumab treatment or discontinued nivolumab due to toxicity in the Parent Study are not eligible to receive nivolumab in this study. These participants may be enrolled for safety and survival follow-up only.

    • Participant is eligible for nivolumab treatment as per the Parent Study, and/or Investigator assessed clinical benefit, or

    • Participant is in or has completed the follow-up phase of the Parent Study i) Participant has completed or discontinued treatment, or ii) Participant has progressed on treatment, and/or iii) Participant is on subsequent therapy Exclusion Criteria: -

    • Participant is not eligible for nivolumab treatment as per the Parent Study

    • Participants not receiving clinical benefit as assessed by the Investigator (participant is still eligible for study if entering survival follow-up only)

    • 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

    • Participants in survival follow-up have no exclusion criteria.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Innovative Clinical Research Institute Lynwood California United States 90262
    2 Local Institution San Francisco California United States 94115
    3 UCSF Medical Center - Helen Diller Family Comprehensive Cancer Center - Melanoma Center San Francisco California United States 94143
    4 University of Colorado Aurora Colorado United States 80045
    5 Local Institution New Haven Connecticut United States 06520
    6 Georgetown-Lombardi Comprehensive Cancer Center Washington District of Columbia United States 20007-2113
    7 Local Institution Orlando Florida United States 32806
    8 H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc. Tampa Florida United States 33612
    9 Local Institution Atlanta Georgia United States 31192
    10 The University of Chicago Medical Center Chicago Illinois United States 60637
    11 Local Institution Maywood Illinois United States 60153
    12 University of Kansas Cancer Center Westwood Kansas United States 66205
    13 Cancer Center of Kansas Wichita Kansas United States 67214-3728
    14 University of Louisville-James Graham Brown Cancer Center Louisville Kentucky United States 40202
    15 Johns Hopkins Baltimore Maryland United States 21287
    16 Local Institution Boston Massachusetts United States 02114
    17 Dana_Farber Cancer Institute (DFCI) Boston Massachusetts United States 02215
    18 Local Institution Boston Massachusetts United States 02215
    19 Local Institution Ann Arbor Michigan United States 48109
    20 Allina Health Minneapolis Minnesota United States 55407-3723
    21 Local Institution Saint Louis Missouri United States 63110
    22 GU Research Network/Urology Cancer Center Omaha Nebraska United States 68130
    23 Dartmouth-Hitchcock Medical Center Lebanon New Hampshire United States 03756
    24 Local Institution Albuquerque New Mexico United States 87131
    25 Roswell Park Cancer Institute Buffalo New York United States 14263
    26 Local Institution New York New York United States 10016
    27 Local Institution New York New York United States 10065
    28 Local Institution New York New York United States 10065
    29 Local Institution New York New York United States 10065
    30 Levine Cancer Center Charlotte North Carolina United States 28204
    31 Duke University Durham North Carolina United States 27705
    32 Oncology Hematology Care Cincinnati Ohio United States 45242
    33 Local Institution Cleveland Ohio United States 44106
    34 The Ohio University Columbus Ohio United States 43210
    35 Lehigh Valley Hospital Allentown Pennsylvania United States 18103
    36 St. Lukes University Health Network Easton Pennsylvania United States 18045
    37 Allegheny Valley Hospital Natrona Heights Pennsylvania United States 15065
    38 Local Institution Philadelphia Pennsylvania United States 19104
    39 Local Institution Philadelphia Pennsylvania United States 19111
    40 Hillman Cancer Center- U of Pitts Cancer Institute Pittsburgh Pennsylvania United States 15213
    41 Charleston Oncology Charleston South Carolina United States 29414
    42 Local Institution Greenville South Carolina United States 29615
    43 Local Institution Chattanooga Tennessee United States 37404
    44 Tennessee Oncology - Nashville Nashville Tennessee United States 37203
    45 Local Institution Dallas Texas United States 75390
    46 Local Institution Salt Lake City Utah United States 84112
    47 Local Institution Charlottesville Virginia United States 22908
    48 Local Institution Madison Wisconsin United States 53792
    49 UW Health - UW Carbone Cancer Center - Medical Oncology Clinic Madison Wisconsin United States 53792
    50 Centro Oncologico y de Investigacion Buenos Aires Berazategui Buenos Aires Argentina 1880
    51 Instituto Fleming Caba Buenos Aires Argentina 1426
    52 Local Institution - 0191 San Miguel De Tucuman Tucuman Argentina 4000
    53 Local Institution Buenos Aires Argentina C1199 ABH
    54 Local Institution Caba Argentina C1426ANZ
    55 Local Institution Cordoba Argentina X5004FHP
    56 Local Institution - 0045 Coffs Harbour New South Wales Australia 2450
    57 Local Institution - 0062 North Sydney New South Wales Australia 2060
    58 Chris OBrien Lifehouse Hospital Sydney New South Wales Australia 2050
    59 Local Institution - 0208 Westmead New South Wales Australia 2145
    60 Local Institution Greenslopes Queensland Australia 4120
    61 Local Institution South Brisbane Queensland Australia 4101
    62 Local Institution Adelaide South Australia Australia 5000
    63 Lyell McEwin Hospital Elizabeth Vale South Australia Australia 5112
    64 Calvary Mater Newcastle Waratah Tasmania Australia 2298
    65 Cabrini Hospital Malvern Malvern Victoria Australia 3144
    66 Local Institution Graz Austria 8036
    67 Local Institution - 0149 Linz Austria 4020
    68 Allgemeine Krankenhaus Wien Vienna Austria 1090
    69 Klinikum Wels- Grieskirchen Wels Austria 4600
    70 Universitair Ziekenhuis Gent Gent Belgium 9000
    71 UZ Brussel Campus Jette Jette Belgium 1780
    72 Local Institution Liege Belgium 4000
    73 Cliniques Universitaires UCL de Mont-Godinne (CHU) Yvoir Belgium 5530
    74 Local Institution - 0155 Ijui RIO Grande DO SUL Brazil 98700-000
    75 Irmandade da Santa Casa de Misericordia de Porto Alegre Porto Alegre RIO Grande DO SUL Brazil 90050-170
    76 Local Institution - 0264 Barretos SAO Paulo Brazil 14784-400
    77 Local Institution Porto Alegre SAO Paulo Brazil 90035-903
    78 Local Institution - 0262 Sao Jose do Rio Preto SAO Paulo Brazil 15090-000
    79 Local Institution - 0263 São Paulo SAO Paulo Brazil 01308-050
    80 Local Institution - 0302 Sao Paulo SP Brazil 01246-000
    81 Local Institution Rio de Janeiro Brazil 20220-410
    82 Local Institution - 0258 Rio de Janeiro Brazil 22793-080
    83 Cross Cancer Institute Edmonton Alberta Canada T6G1Z2
    84 Local Institution Vancouver British Columbia Canada V5Z 1L3
    85 Local Institution Halifax Nova Scotia Canada B3H1V7
    86 Local Institution - 0168 Oshawa Ontario Canada L1G 2B9
    87 Local Institution Montreal Quebec Canada H4A 3J1
    88 Fundacion Arturo Lopez Perez Santiago Metropolitana Chile 7500921
    89 Local Institution Santiago Metropolitana Chile 7500921
    90 Local Institution - 0101 Santiago Metropolitana Chile 8420383
    91 Local Institution VinadelMar Valparaiso Chile 2540364
    92 Local Institution Hefei Anhui China 230031
    93 Local Institution Beijing Beijing China 100853
    94 Local Institution Guangzhou Guangdong China 510080
    95 Local Institution Harbin City Heilongjiang China 150081
    96 Local Institution - 0245 Harbin Heilongjiang China 150040
    97 Local Institution Changsha Hunan China 410000
    98 Local Institution Changchun City Jilin China 130012
    99 Local Institution Shanghai Shanghai China 200025
    100 Local Institution Shanghai Shanghai China 200433
    101 Local Institution - 0243 Hradec Kralove Czechia 500 05
    102 Local Institution Olomouc Czechia 779 00
    103 Local Institution Odense C Denmark 5000
    104 Local Institution Helsinki Finland 00029
    105 Centre Hospitalier Universitaire de Bordeaux Hospital Saint Andre Bordeaux France 33075
    106 Centre Hospitalier Intercommunal de Creteil CHIC Creteil France 94010
    107 Local Institution - 0074 Dijon Cedex France 21000
    108 Centre Georges-Francois Leclerc Dijon Cedex France 21079
    109 Local Institution - 0010 La Tronche France 38700
    110 Pole Biologie Pathologie Genetique - CHU de Lille Lille Cedex France 59037
    111 APHM - Hopital Nord Marseille Cedex 20 France 13915
    112 APHM - Hopital de la Timone Marseille France 13385
    113 Local Institution - 0182 Montpellier France 34090
    114 Local Institution Montpellier France 34295
    115 Local Institution - 0300 Nantes France 44093
    116 Hopital europeen Georges Pompidou HEGP Paris Cedex 15 France 75908
    117 Local Institution - 0028 Paris France 75010
    118 Local Institution - 0301 Paris France 75018
    119 Local Institution - 0084 Pierre Benite Cedax France 69495
    120 Local Institution Rennes France 35033
    121 Local Institution - 0156 Toulon France 83 056
    122 Local Institution Toulouse Cedex France 31059
    123 Local Institution - 0029 Villejuif France 94800
    124 Local Institution - 0249 Buxtehude Niedersachsen Germany 21614
    125 Local Institution - 0250 Essen Nordrhein-Westfalen Germany 45147
    126 Universitaetsklinikum Aachen Aachen Germany 52074
    127 Local Institution - 0248 Berlin Germany 10117
    128 Local Institution - 0080 Gera Germany 07548
    129 Local Institution Gera Germany 07548
    130 Local Institution Goettingen Germany 37075
    131 Universitatsmedizin Gottingen Gottingen Germany 37075
    132 Local Institution - 0241 Hamburg Germany 20246
    133 Local Institution Heidelberg Germany 69120
    134 Local Institution - 0148 Heidelberg Germany 69126
    135 Local Institution Heilbronn Germany 74078
    136 Local Institution - 0216 Jena Germany 07747
    137 Local Institution Kiel Germany 24105
    138 Unv Schleswig-Holstein Campus Kiel Kiel Germany 24105
    139 Local Institution Koeln Germany 50937
    140 Local Institution - 0089 Mainz Germany 55131
    141 Local Institution Mainz Germany 55131
    142 Local Institution Munchen Germany 80337
    143 Local Institution - 0017 Tuebingen Germany 72076
    144 Local Institution - 0277 Tuebingen Germany 72076
    145 Local Institution - 0126 Athens Greece 11527
    146 Local Institution Athens Greece 11527
    147 General Hospital of Athens Alexandra Athens Greece 11528
    148 Local Institution Patras Greece 26504
    149 Local Institution - 0042 Piraeus Greece 185 47
    150 Local Institution - 0215 Thessaloniki Greece 57001
    151 Local Institution Budapest Hungary 1121
    152 Orszagos Koranyi TBC es Pulmonologiai Intezet Budapest Hungary 1121
    153 DE Klinikai Kozpont Debrecen Hungary 4032
    154 Local Institution Dublin Ireland Dublin 7
    155 Local Institution Limerick Ireland V94 F858
    156 Local Institution - 0190 Haifa Israel 3109601
    157 Local Institution Jerusalem Israel 91120
    158 Local Institution Petach Tikva Israel 49100
    159 Local Institution - 0052 Ramat gan Israel 5262000
    160 Local Institution - 0033 Roma RM Italy 00144
    161 Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari Bari Italy 70124
    162 Local Institution Bergamo Italy 24127
    163 Local Institution Genova Italy 16132
    164 Local Institution Meldola Italy 47014
    165 Local Institution Milano Italy 20133
    166 IRCCS Istituto Europeo di Oncologia Milano Italy 20141
    167 Local Institution - 0267 Milano Italy 20141
    168 Local Institution Milano Italy 20141
    169 Local Institution - 0096 Milan Italy 20133
    170 Istituto Nazionale dei Tumori Napoli Italy 80131
    171 Local Institution - 0073 Napoli Italy 80131
    172 Istituto Oncologico Veneto Padova Italy 35128
    173 Local Institution - 0180 Ravenna Italy 48121
    174 Local Institution - 0003 Siena Italy 53100
    175 Local Institution - 0220 Nagoya Aichi Japan 4648681
    176 Hirosaki University Hospital Hirosaki Aomori Japan 036-8563
    177 Local Institution - 0211 Kobe shi Hyogo Japan 6500047
    178 University of Tsukuba Hospital Tsukuba Ibaraki Japan 305-8576
    179 Local Institution Kanazawa-shi Ishikawa Japan 920-8641
    180 Local Institution - 0222 Natori-shi Miyagi Japan 9811293
    181 Niigata Cancer Center Hospital Chuo-ku Niigata-shi Niigata Japan 961-8566
    182 Niigata University Medical and Dental Hospital Niigata-Shi Niigata Japan 951-8510
    183 Kindai University Hospital Osakasayama Osaka Japan 5898511
    184 Osaka Medical and Pharmaceutical University Hospital Takatsuki shi Osaka Japan 5698686
    185 National Cancer Central Hospital Chuo-ku Tokyo Japan 104-0045
    186 Local Institution - 0217 Koto-Ku Tokyo Japan 135-8550
    187 Keio University Hospital Shinjuku Tokyo Japan 160-8582
    188 Local Institution - 0224 Fukuoka Japan 11111
    189 Local Institution Seongnam-si Korea, Republic of 463-707
    190 Local Institution - 0206 Seoul Korea, Republic of 03722
    191 Local Institution Suwon Si Korea, Republic of 16499
    192 Local Institution - 0181 Tlalpan Ciudad De Mexico Mexico 14050
    193 Local Institution Leon Guanajuato Mexico 37000
    194 Hospital Victoria Medical Center Morelia Michoacan Mexico 58240
    195 Local Institution Rotterdam Netherlands 3015 CE
    196 Local Institution - 0268 Dunedin New Zealand 9016
    197 Haukeland Universitetssjukehus Bergen Norway 5021
    198 Radiumhospitalet Oslo Norway 0379
    199 Centro de Investigacion Clinica Montesur Santiago de Surco Lima Peru L33
    200 Local Institution - 0120 Gdansk Poland 80-214
    201 Wojewodzkie Centrum Onkologii Gdansk Poland 80219
    202 Local Institution - 0031 Lodz Poland 90-302
    203 Local Institution - 0118 Lublin Poland 20-064
    204 Centrum Medyczne Pratia Poznan Poznan Poland 60-185
    205 Local Institution Warsaw Poland 02-781
    206 Wojskowy Instytut Medyczny Warsaw Poland 04-141
    207 Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology Warszawa Poland 02-781
    208 Centro Hospitalar de Lisboa Norte EPE - HPV Lisboa Portugal 1769-001
    209 Instituto Portugues de Oncologio de Lisboa Lisbon Portugal 4200-072
    210 Local Institution Porto Portugal
    211 Local Institution - 0265 Craiova Jud. DOLJ Romania 200347
    212 Local Institution - 0129 Bucharest Romania 022328
    213 Local Institution - 0135 Cluj Napoca Romania 400015
    214 Local Institution Cluj Napoca Romania 400641
    215 Cardiomed SRL Cluj-Napoca Romania 400015
    216 Local Institution - 0133 Oradea Romania 410469
    217 N.N. Blokhin National Medical Research Center of Oncology Moscow Russian Federation 115478
    218 VitaMed LLC Moscow Russian Federation 121309
    219 Local Institution - 0047 San Sebastian Guipuzcoa Spain 20014
    220 Local Institution - 0122 A Coruna Spain 15006
    221 Local Institution - 0173 Alicante Spain 03010
    222 Local Institution - 0123 Badalona Spain 08916
    223 Hospital Universitari Vall d Hebron Barcelona Spain 08035
    224 Local Institution - 0026 Barcelona Spain 08036
    225 Local Institution - 0225 Barcelona Spain 08908
    226 Local Institution Barcelona Spain 8025
    227 Hospital Universitario de Burgos Burgos Spain 09006
    228 Local Institution Granada Spain 18014
    229 Local Institution - 0273 Madrid Spain 28007
    230 Centro Oncologico MD ANDERSON Internacional Espana Madrid Spain 28033
    231 Local Institution Madrid Spain 28033
    232 Hospital Ramon y Cajal Madrid Spain 28034
    233 Hospital Universitario Fundacion Jimenez Diaz Madrid Spain 28040
    234 Local Institution - 0116 Madrid Spain 28041
    235 Local Institution Madrid Spain 28046
    236 Local Institution - 0097 Madrid Spain 28050
    237 Hospital Regional Universitario Carlos Haya Malaga Spain 29010
    238 Local Institution Santa Cruz de Tenerife Spain 38230
    239 Local Institution - 0274 Sevilla Spain 41009
    240 Fundacio Investigao Hospital General Universitario de Valencia FiHgU Valencia Spain 46014
    241 Local Institution - 0117 Valencia Spain 46026
    242 Local Institution Goteborg Sweden SE-41345
    243 Local Institution Malmoe Sweden 205 02
    244 Local Institution Umea Sweden 901 85
    245 Local Institution - 0119 Basel Switzerland 4031
    246 UniversitaetsSpital Zuerich - Dermatology Zurich Switzerland CH - 8058
    247 Local Institution Tainan Taiwan 704
    248 Local Institution - 0141 London Greater London United Kingdom N18 1QX
    249 Local Institution - 0272 London Greater London United Kingdom SM2 5PT
    250 Southampton General Hospital Southampton Hampshire United Kingdom SO16 6YD
    251 Local Institution Maidstone Kent United Kingdom ME16 9QQ
    252 Local Institution - 0161 Northwood Middlesex United Kingdom HA6 2RN
    253 Local Institution - 0086 London United Kingdom SW3 6JJ
    254 The Christie Hospital Manchester United Kingdom M20 4BX

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT03899155
    Other Study ID Numbers:
    • CA209-8TT
    • 2018-004362-34
    First Posted:
    Apr 2, 2019
    Last Update Posted:
    Aug 18, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Nivolumab

    Study Results

    No Results Posted as of Aug 18, 2022