Cancer Clinical Trial
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.
| Status | Recruiting |
| Enrollment | 1500 |
| Est. completion date | August 25, 2029 |
| Est. primary completion date | August 25, 2029 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Centro Oncologico y de Investigacion Buenos Aires | Berazategui | Buenos Aires |
| Argentina | Local Institution - 0201 | Buenos Aires | |
| Argentina | Local Institution | Caba | |
| Argentina | Local Institution - 0030 | Caba | Buenos Aires |
| Argentina | Local Institution - 0170 | Cordoba | |
| Argentina | Local Institution - 0349 | Cordoba | |
| Argentina | Local Institution - 0191 | San Miguel De Tucumán | Tucuman |
| Australia | Local Institution | Adelaide | South Australia |
| Australia | North Coast Area Health Service NCAHS - The North Coast Cancer Institute NCCI - Coffs Harbour Health Campus | Coffs Harbour | New South Wales |
| Australia | Local Institution - 0196 | Elizabeth Vale | South Australia |
| Australia | Local Institution - 0365 | Fitzroy | Victoria |
| Australia | Local Institution | Greenslopes | Queensland |
| Australia | Cabrini Hospital Malvern | Malvern | Victoria |
| Australia | Local Institution - 0062 | North Sydney | New South Wales |
| Australia | Local Institution | South Brisbane | Queensland |
| Australia | Local Institution - 0347 | Southport | Queensland |
| Australia | Local Institution - 0009 | Sydney | New South Wales |
| Australia | Calvary Mater Newcastle | Waratah | New South Wales |
| Australia | Westmead Hospital | Westmead | New South Wales |
| Austria | LKH-Univ. Klinikum Graz | Graz | Steiermark |
| Austria | Ordensklinikum Linz GmbH Elisabethinen | Linz | Upper Austria |
| Austria | Allgemeine Krankenhaus Wien | Vienna | |
| Austria | Local Institution - 0145 | Wels | |
| Austria | Allgemeines Krankenhaus Wien | Wien | |
| Belgium | Local Institution - 0329 | Brussel | |
| Belgium | Universitair Ziekenhuis Gent | Gent | |
| Belgium | UZ Brussel Campus Jette | Jette | |
| Belgium | Local Institution - 0261 | Liege | |
| Belgium | Local Institution - 0293 | Sint-Niklaas | |
| Belgium | Local Institution - 0157 | Yvoir | |
| Brazil | Local Institution - 0264 | Barretos | Sao Paulo |
| Brazil | Local Institution - 0260 | Belo Horizonte | Minas Gerais |
| Brazil | Local Institution - 0155 | Ijui | RIO Grande DO SUL |
| Brazil | Local Institution - 0093 | Porto Alegre | SAO Paulo |
| Brazil | Local Institution - 0113 | Porto Alegre | Rio Grande Do Sul |
| Brazil | Local Institution - 0331 | Porto Alegre | Rio Grande Do Sul |
| Brazil | Local Institution - 0258 | Rio de Janeiro | |
| Brazil | National Cancer Institute (INCA) | Rio De Janeiro | |
| Brazil | Local Institution - 0262 | Sao Jose do Rio Preto | Sao Paulo |
| Brazil | Local Institution - 0302 | Sao Paulo | |
| Brazil | Local Institution - 0340 | Sao Paulo | |
| Brazil | Local Institution - 0355 | Sao Paulo | SP |
| Brazil | Local Institution - 0263 | São Paulo | SAO Paulo |
| Canada | Local Institution - 0111 | Edmonton | Alberta |
| Canada | Local Institution | Halifax | Nova Scotia |
| Canada | Local Institution - 0040 | Montreal | Quebec |
| Canada | Local Institution - 0308 | Montreal | Quebec |
| Canada | Local Institution - 0168 | Oshawa | Ontario |
| Canada | Local Institution - 0280 | Toronto | Ontario |
| Canada | Local Institution | Vancouver | British Columbia |
| Chile | Fundacion Arturo Lopez Perez | Santiago | Metropolitana |
| Chile | Local Institution | Santiago | Metropolitana |
| Chile | Local Institution - 0101 | Santiago | Metropolitana |
| Chile | Local Institution - 0363 | Temuco | Araucania |
| Chile | Local Institution - 0079 | Vina Del Mar | |
| China | Local Institution - 0198 | Beijing | Beijing |
| China | Jilin Cancer Hospital | Changchun | Jilin |
| China | Local Institution - 0307 | Changchun | Jilin |
| China | Hunan Cancer Hospital | Changsha | Hunan |
| China | Local Institution - 0172 | Changsha | Hunan |
| China | Xiangya Hospital Central South University | Changsha | Hunan |
| China | Local Institution | Guangzhou | Guangdong |
| China | Local Institution - 0304 | Hangzhou | Zhejiang |
| China | Local Institution - 0306 | Hangzhou | |
| China | Harbin Medical University - Cancer Hospital | Harbin | Heilongjiang |
| China | Local Institution - 0245 | Harbin | Heilongjiang |
| China | Local Institution - 0160 | Harbin Shi | Heilongjiang |
| China | Local Institution - 0169 | Hefei | Anhui |
| China | Local Institution - 0348 | Nanjing | Jiangsu |
| China | Local Institution - 0188 | Shanghai | Shanghai |
| China | Local Institution - 0223 | Shanghai | Shanghai |
| China | Local Institution - 0278 | Shanghai | Shanghai |
| China | Local Institution - 0305 | Shanghai | Shanghai |
| China | Local Institution - 0325 | Shanghai | Shanghai |
| China | Tangdu Hospital of Fourth Military Medical University | Xian | Shaanxi |
| Czechia | FNHK Klinika onkologie a radioterapie | Hradec Kralove | |
| Czechia | Local Institution - 0150 | Olomouc | |
| Czechia | Univerzita Karlova v Praze a Vseobecna fakultni nemocnice v Praze | Prague | NY |
| Denmark | Local Institution | Odense C | |
| Finland | Local Institution | Helsinki | |
| France | Local Institution - 0006 | Bordeaux | |
| France | Local Institution - 0345 | Clermont-Ferrand | |
| France | Centre Hospitalier Intercommunal de Creteil CHIC | Creteil | |
| France | Centre Georges-Francois Leclerc | Dijon Cedex | |
| France | CHU Dijon | Dijon Cedex | |
| France | CHU Grenobles Alpes | La Tronche | |
| France | Pole Biologie Pathologie Genetique - CHU de Lille | Lille Cedex | |
| France | APHM - Hopital de la Timone | Marseille | |
| France | Local Institution - 0153 | Marseille Cedex 20 | |
| France | Local Institution | Montpellier | |
| France | Local Institution - 0182 | Montpellier | |
| France | Local Institution - 0300 | Nantes | |
| France | Local Institution - 0341 | Nantes | |
| France | Hospital Saint-Louis | Paris | |
| France | Local Institution - 0301 | Paris | |
| France | Hopital europeen Georges Pompidou HEGP | Paris Cedex 15 | |
| France | Centre Hospitalier Lyon Sud | Pierre-Benite Cedex | |
| France | Local Institution | Rennes | |
| France | Hopital Musse | Toulon | |
| France | Local Institution | Toulouse Cedex | |
| France | Local Institution - 0362 | Vandoeuvre-Les-Nancy | Meurthe-Et-Moselle |
| France | Local Institution - 0029 | Villejuif | |
| Germany | Local Institution - 0163 | Aachen | |
| Germany | Charite Universitaetsmedizin Berlin | Berlin | |
| Germany | Elbe Klinikum Buxtehude | Buxtehude | Niedersachsen |
| Germany | Local Institution - 0296 | Cologne | |
| Germany | Universitaetsklinikum Essen | Essen | Nordrhein-Westfalen |
| Germany | University of Freiburg | Freiburg | |
| Germany | Local Institution | Gera | |
| Germany | SRH Wald-Klinikum Gera GmbH | Gera | |
| Germany | Local Institution | Goettingen | |
| Germany | Universitatsmedizin Gottingen | Gottingen | |
| Germany | UKE Neurochirurgische Klinik | Hamburg | |
| Germany | Local Institution | Heidelberg | |
| Germany | Local Institution - 0342 | Heidelberg | |
| Germany | Thoraxklinik | Heidelberg | |
| Germany | Local Institution - 0285 | Heilbronn | |
| Germany | Local Institution - 0216 | Jena | |
| Germany | Klinikum Kassel - Klinik fuer Haematologie, Onkologie und Immunologie | Kassel | Hessen |
| Germany | Local Institution | Kiel | |
| Germany | Unv Schleswig-Holstein Campus Kiel | Kiel | |
| Germany | Local Institution | Koeln | |
| Germany | Local Institution - 0298 | Loewenstein | |
| Germany | Local Institution | Mainz | |
| Germany | Marienhaus Klinikum Mainz | Mainz | |
| Germany | LMU Muenchen | Muenchen | Bayern |
| Germany | Local Institution - 0332 | Nuremberg | Bayern |
| Germany | Universitaetsklinikum Tuebingen | Tubingen | |
| Germany | Local Institution - 0277 | Tuebingen | |
| Greece | General Hospital of Athens Laiko | Athens | |
| Greece | Local Institution - 0126 | Athens | |
| Greece | Local Institution - 0171 | Athens | |
| Greece | Local Institution - 0295 | Athens | |
| Greece | Local Institution - 0244 | Heraklion | Crete |
| Greece | Local Institution | Patras | |
| Greece | Local Institution - 0042 | Piraeus | |
| Greece | Local Institution - 0215 | Thessaloniki | |
| Hong Kong | Local Institution - 0339 | Hong Kong | |
| Hungary | Local Institution - 0226 | Budapest | |
| Hungary | Orszagos Koranyi TBC es Pulmonologiai Intezet | Budapest | |
| Hungary | Local Institution - 0187 | Debrecen | |
| Hungary | Local Institution - 0290 | Gyongyossolymos | Heves |
| Ireland | Local Institution - 0227 | Dublin | |
| Ireland | Local Institution | Limerick | |
| Israel | Rambam Health Care Campus | Haifa | |
| Israel | Local Institution - 0270 | Jerusalem | |
| Israel | Local Institution | Petach Tikva | |
| Israel | Sheba Medical Center | Ramat Gan | |
| Israel | Local Institution - 0350 | Tiqwa | |
| Italy | Local Institution - 0034 | Bari | |
| Italy | Local Institution - 0002 | Bergamo | |
| Italy | Local Institution - 0326 | Candiolo | |
| Italy | Local Institution - 0359 | Catania | |
| Italy | Local Institution | Genova | |
| Italy | Local Institution - 0251 | Genova | |
| Italy | Local Institution | Meldola | |
| Italy | Local Institution - 0303 | Meldola | |
| Italy | Local Institution - 0361 | Meldola | Fc |
| Italy | Fondazione IRCCS istituto Neurologico Carlo Besta, | Milan | |
| Italy | Local Institution - 0096 | Milan | |
| Italy | Local Institution - 0351 | Milan | |
| Italy | IRCCS Istituto Europeo di Oncologia | Milano | |
| Italy | Local Institution | Milano | |
| Italy | Local Institution | Milano | |
| Italy | Local Institution - 0267 | Milano | |
| Italy | Local Institution - 0327 | Modena | |
| Italy | Local Institution - 0073 | Napoli | |
| Italy | Local Institution - 0218 | Napoli | |
| Italy | Local Institution - 0292 | Napoli | |
| Italy | Istituto Oncologico Veneto | Padova | |
| Italy | Local Institution - 0180 | Ravenna | |
| Italy | Local Institution - 0033 | Roma | RM |
| Italy | Local Institution - 0333 | Rozzano | MI |
| Italy | Local Institution - 0003 | Siena | |
| Italy | Local Institution - 0291 | Terni | |
| Italy | Azienda Ospedaliera Citta della Salute e della Scienza | Torino | |
| Japan | Local Institution - 0235 | Chuo-ku | Tokyo |
| Japan | Local Institution - 0230 | Chuo-ku Niigata-shi | Niigata |
| Japan | Local Institution - 0224 | Fukuoka | |
| Japan | Local Institution - 0242 | Hirosaki | Aomori |
| Japan | Local Institution - 0319 | Hiroshima | |
| Japan | Local Institution - 0219 | Kanazawa-shi | Ishikawa |
| Japan | Local Institution - 0356 | Kashiwa-Shi | Chiba |
| Japan | Kobe City Medical Center General Hospital | Kobe shi | Hyogo |
| Japan | The Cancer Institute Hospital of JFCR | Koto-Ku | Tokyo |
| Japan | Aichi Cancer Center Hospital | Nagoya | Aichi |
| Japan | Miyagi Cancer Center | Natori-shi | Miyagi |
| Japan | Local Institution - 0236 | Niigata-Shi | Niigata |
| Japan | Kindai University Hospital | Osakasayama | Osaka |
| Japan | Keio University Hospital | Shinjuku | Tokyo |
| Japan | Local Institution - 0212 | Takatsuki shi | Osaka |
| Japan | University of Tsukuba Hospital | Tsukuba | Ibaraki |
| Korea, Republic of | National Cancer Center | Gyeonggi-do | |
| Korea, Republic of | Local Institution - 0221 | Seongnam-si | |
| Korea, Republic of | Asan Medical Center | Seoul | Songpa-gu |
| Korea, Republic of | Local Institution - 0206 | Seoul | |
| Korea, Republic of | Seoul National University Hospital | Seoul | |
| Korea, Republic of | Local Institution - 0207 | Suwon Si | |
| Mexico | Local Institution - 0337 | Ciudad de Mexico | |
| Mexico | Local Institution - 0344 | Ciudad de Mexico | |
| Mexico | Local Institution - 0346 | Ciudad de Mexico | |
| Mexico | Local Institution - 0152 | Leon | Guanajuato |
| Mexico | Local Institution - 0286 | Monterrey | Nuevo Leon |
| Mexico | Local Institution - 0354 | Monterrey | Nuevo Leon |
| Mexico | Local Institution - 0007 | Morelia | Michoacan |
| Mexico | Local Institution - 0343 | Santiago de Queretaro | Queretaro |
| Mexico | Local Institution - 0181 | Tlalpan | Ciudad De Mexico |
| Mexico | Local Institution - 0338 | Zapopan | Jalisco |
| Netherlands | Local Institution - 0335 | Amsterdam | Noord-Holland |
| Netherlands | Local Institution | Rotterdam | |
| New Zealand | Local Institution - 0271 | Christchurch | |
| New Zealand | Southern District Hospital (SDHB) - Dunedin Hospital | Dunedin | |
| New Zealand | Local Institution - 0269 | Tauranga | |
| Norway | Local Institution - 0213 | Bergen | |
| Norway | Oslo University Hospital | Oslo | |
| Peru | Local Institution - 0179 | Santiago de Surco | Lima |
| Poland | Local Institution - 0336 | Biala Podlaska | Lubelskie |
| Poland | Local Institution - 0358 | Bydgoszcz | Kujawsko-pomorskie |
| Poland | Local Institution - 0120 | Gdansk | |
| Poland | Wojewodzkie Centrum Onkologii | Gdansk | |
| Poland | Narodowy Instytut Onkologii Oddzial w Krakowie | Krakow | |
| Poland | Local Institution - 0031 | Lodz | |
| Poland | Local Institution - 0118 | Lublin | |
| Poland | Local Institution - 0178 | Poznan | |
| Poland | Local Institution | Warsaw | |
| Poland | Local Institution - 0132 | Warsaw | |
| Poland | Local Institution - 0151 | Warszawa | |
| Poland | Local Institution - 0328 | Warszawa | |
| Portugal | Local Institution - 0184 | Lisboa | |
| Portugal | Local Institution - 0177 | Lisbon | |
| Portugal | Local Institution - 0142 | Porto | |
| Puerto Rico | Local Institution - 0334 | San Juan | |
| Romania | Local Institution - 0129 | Bucharest | |
| Romania | Local Institution - 0310 | Bucharest | |
| Romania | Institutul Oncologic Prof. Dr. I. Chiricuta | Cluj Napoca | |
| Romania | Local Institution - 0127 | Cluj Napoca | |
| Romania | Local Institution - 0189 | Cluj-Napoca | |
| Romania | Local Institution - 0265 | Craiova | |
| Romania | Local Institution - 0133 | Oradea | |
| Russian Federation | Local Institution - 0257 | Krasnodar | Krasnodar Region |
| Russian Federation | Local Institution - 0256 | Krasnoyarsk | |
| Russian Federation | N.N. Blokhin National Medical Research Center of Oncology | Moscow | |
| Russian Federation | VitaMed LLC | Moscow | |
| Spain | Hospital Teresa Herrera C.H.U.A.C. | A Coruna | |
| Spain | Local Institution - 0173 | Alicante | |
| Spain | Catalan Institute of Badalona Hospital Germans Trias i Pujol ICO | Badalona | |
| Spain | Hospital Clinic de Barcelona | Barcelona | |
| Spain | Hospital Universitari Vall d Hebron | Barcelona | |
| Spain | Institut Catala dOncologia LHospitalet | Barcelona | |
| Spain | Local Institution | Barcelona | |
| Spain | Local Institution - 0323 | Barcelona | |
| Spain | Local Institution - 0146 | Burgos | |
| Spain | Local Institution | Granada | |
| Spain | Hospital Ramon y Cajal | Madrid | |
| Spain | Hospital Universitario 12 de Octubre | Madrid | |
| Spain | Local Institution | Madrid | |
| Spain | Local Institution | Madrid | |
| Spain | Local Institution - 0008 | Madrid | |
| Spain | Local Institution - 0097 | Madrid | |
| Spain | Local Institution - 0112 | Madrid | |
| Spain | Local Institution - 0273 | Madrid | |
| Spain | Local Institution - 0357 | Madrid | |
| Spain | Local Institution - 0360 | Madrid | |
| Spain | Hospital Universitario Puerta de Hierro de Majadahonda | Majadahonda | Madrid |
| Spain | Hospital Regional Universitario Carlos Haya | Malaga | |
| Spain | Local Institution - 0353 | Pamplona | Navarra |
| Spain | Onkologikoa Of San Sebastian | San Sebastian | Guipuzcoa |
| Spain | Local Institution | Santa Cruz de Tenerife | |
| Spain | Local Institution - 0352 | Santander | |
| Spain | Hospital Universitario Virgen del Roco | Sevilla | |
| Spain | Hospital Universitario Virgen Macarena | Sevilla | |
| Spain | Hospital Universitario y Politecnico de La Fe | Valencia | |
| Spain | Local Institution - 0020 | Valencia | |
| Sweden | Local Institution | Goteborg | |
| Sweden | Local Institution - 0036 | Malmoe | |
| Sweden | Local Institution | Umea | |
| Switzerland | Universitaetsspital Basel - Klinik fuer Onkologie | Basel | |
| Switzerland | Local Institution - 0083 | Zurich | |
| Taiwan | Local Institution - 0197 | Tainan | |
| Taiwan | Local Institution - 0366 | Tapei | |
| Turkey | Local Institution - 0330 | Ankara | |
| United Kingdom | Local Institution - 0299 | Edinburgh | Scotland |
| United Kingdom | Local Institution - 0086 | London | Greater London |
| United Kingdom | Local Institution - 0141 | London | Greater London |
| United Kingdom | Local Institution - 0272 | London | Greater London |
| United Kingdom | University College Hospital | London | Greater London |
| United Kingdom | Local Institution - 0231 | Maidstone | Kent |
| United Kingdom | The Christie Hospital | Manchester | Greater Manchester |
| United Kingdom | Local Institution - 0161 | Northwood | Middlesex |
| United Kingdom | Local Institution - 0195 | Southampton | Hampshire |
| United States | Local Institution | Albuquerque | New Mexico |
| United States | Lehigh Valley Hospital | Allentown | Pennsylvania |
| United States | University of Michigan Rogel Comprehensive Cancer Center UMCCC | Ann Arbor | Michigan |
| United States | University of Colorado | Aurora | Colorado |
| United States | Johns Hopkins | Baltimore | Maryland |
| United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
| United States | Dana_Farber Cancer Institute (DFCI) | Boston | Massachusetts |
| United States | Massachusetts General Hospital | Boston | Massachusetts |
| United States | Roswell Park Cancer Institute | Buffalo | New York |
| United States | Charleston Oncology | Charleston | South Carolina |
| United States | Levine Cancer Center | Charlotte | North Carolina |
| United States | Local Institution | Charlottesville | Virginia |
| United States | Local Institution | Chattanooga | Tennessee |
| United States | Local Institution - 0105 | Chicago | Illinois |
| United States | Oncology Hematology Care | Cincinnati | Ohio |
| United States | Local Institution | Cleveland | Ohio |
| United States | The Ohio University | Columbus | Ohio |
| United States | Local Institution | Dallas | Texas |
| United States | Duke University | Durham | North Carolina |
| United States | St. Lukes University Health Network | Easton | Pennsylvania |
| United States | Local Institution | Greenville | South Carolina |
| United States | Local Institution - 0364 | Houston | Texas |
| United States | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire |
| United States | University of Louisville-James Graham Brown Cancer Center | Louisville | Kentucky |
| United States | Innovative Clinical Research Institute | Lynwood | California |
| United States | Local Institution | Madison | Wisconsin |
| United States | UW Health - UW Carbone Cancer Center - Medical Oncology Clinic | Madison | Wisconsin |
| United States | Local Institution | Maywood | Illinois |
| United States | Allina Health | Minneapolis | Minnesota |
| United States | Tennesse Oncology | Nashville | Tennessee |
| United States | Vanderbilt University Medical Center | Nashville | Tennessee |
| United States | Allegheny Valley Hospital | Natrona Heights | Pennsylvania |
| United States | Local Institution | New Haven | Connecticut |
| United States | Local Institution | New York | New York |
| United States | Local Institution | New York | New York |
| United States | Weill Cornell Medical College | New York | New York |
| United States | Weill Cornell Medical College | New York | New York |
| United States | Florida Cancer Affiliates | Ocala | Florida |
| United States | Local Institution - 0205 | Omaha | Nebraska |
| United States | Local Institution | Orlando | Florida |
| United States | Advocate Medical Group - Park Ridge - Luther Ln - Oncology | Park Ridge | Illinois |
| United States | Fox Chase Cancer Center | Philadelphia | Pennsylvania |
| United States | Local Institution | Philadelphia | Pennsylvania |
| United States | Local Institution - 0110 | Pittsburgh | Pennsylvania |
| United States | Public Hospital of King County District 1 Valley Medical Center | Renton | Washington |
| United States | Local Institution | Saint Louis | Missouri |
| United States | Huntsman Cancer Institute | Salt Lake City | Utah |
| United States | Local Institution | San Francisco | California |
| United States | UCSF Medical Center - Helen Diller Family Comprehensive Cancer Center - Melanoma Center | San Francisco | California |
| United States | H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc. | Tampa | Florida |
| United States | University of Arizona College of Medicine | Tucson | Arizona |
| United States | Georgetown-Lombardi Comprehensive Cancer Center | Washington | District of Columbia |
| United States | University of Kansas Cancer Center | Westwood | Kansas |
| United States | Cancer Center of Kansas | Wichita | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb | Clovis Oncology, Inc., Exelixis, Janssen Pharmaceuticals, Novartis |
United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czechia, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of Adverse Events (AEs) | From Day 1 up to 135 Days after discontinuation of treatment | ||
| Primary | Incidence of drug related AEs | From Day 1 up to 135 Days after discontinuation of treatment | ||
| Primary | Incidence of AEs leading to Discontinuation | From Day 1 up to 135 Days after discontinuation of treatment | ||
| Primary | Incidence of Serious Adverse Events (SAEs) | From signature of Informed Consent up to 135 Days after discontinuation of treatment | ||
| Primary | Incidence of Select AEs | From Day 1 up to 135 Days after discontinuation of treatment | ||
| Primary | Incidence of Immune-Mediated AEs | From Day 1 up to 135 Days after discontinuation of treatment | ||
| Primary | Incidence of Death | From signature of Informed Consent up to 135 Days after discontinuation of treatment |
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