Pan Tumor Nivolumab Rollover Study
Clinicaltrials.gov identifier recruitment status First Posted Last update posted
NCT03899155 Recruiting April 2, 2019 November 24, 2021

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: Cancer
Intervention/treatment: Drug: Nivolumab
Phase: Phase 2
Detailed Description

N/A


study design
Study Type: Interventional
Estimated Enrollment : 800 participants
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: August 2019
Estimated Primary Completion Date: August 2025
Estimated Study Completion Date: August 2025

Arms and interventions
Arm Intervention/treatment
Experimental: Nivolumab Dose 1
Specified Dose on Specified Days
Drug: Nivolumab
Solution for IV Injection
Experimental: Nivolumab Dose 2
Specified Dose on Specified Days
Drug: Nivolumab
Solution for IV Injection
outcome measures
Primary Outcome Measures: 1. Incidence of AEs leading to Discontinuation [ Time Frame: From Day 1 up to 100 Days after discontinuation of treatment ]
2. Incidence of drug related AEs [ Time Frame: From Day 1 up to 100 Days after discontinuation of treatment ]
3. Incidence of Adverse Events (AEs) [ Time Frame: From Day 1 up to 100 Days after discontinuation of treatment ]
4. Incidence of Serious Adverse Events (SAEs) [ Time Frame: From signature of Informed Consent up to 100 Days after discontinuation of treatment ]
5. Incidence of Select AEs [ Time Frame: From Day 1 up to 100 Days after discontinuation of treatment ]
6. Incidence of Immune-Mediated AEs [ Time Frame: From Day 1 up to 100 Days after discontinuation of treatment ]
7. Incidence of Death [ Time Frame: From signature of Informed Consent up to 100 Days after discontinuation of treatment ]

Eligibility Criteria
Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria

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
Contacts

Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information available, please email Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT# and Site#

Locations
United States, California Local Institution San Francisco
United States, California UCSF Medical Center - Helen Diller Family Comprehensive Cancer Center - Melanoma Center San Francisco
United States, Connecticut Local Institution New Haven
United States, District of Columbia Georgetown-Lombardi Comprehensive Cancer Center Washington
United States, Florida Local Institution Orlando
United States, Florida H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc. Tampa
United States, Georgia Local Institution Atlanta
United States, Illinois The University of Chicago Medical Center Chicago
United States, Illinois Local Institution Maywood
United States, Kansas University of Kansas Cancer Center Westwood
United States, Kansas Cancer Center of Kansas Wichita
United States, Kentucky University of Louisville Louisville
United States, Maryland Johns Hopkins Baltimore
United States, Massachusetts Local Institution Boston
United States, Massachusetts Local Institution Boston
United States, Massachusetts Local Institution Boston
United States, Michigan Local Institution Ann Arbor
United States, Minnesota Allina Health Minneapolis
United States, Missouri Local Institution Saint Louis
United States, Nebraska GU Research Network/Urology Cancer Center Omaha
United States, New Hampshire Dartmouth-Hitchcock Medical Center Lebanon
United States, New Mexico Local Institution Albuquerque
United States, New York Roswell Park Cancer Institute Buffalo
United States, New York Local Institution New York
United States, New York Local Institution New York
United States, New York Local Institution New York
United States, New York Local Institution New York
United States, North Carolina Levine Cancer Center Charlotte
United States, North Carolina Duke University Durham
United States, Ohio Oncology Hematology Care Cincinnati
United States, Ohio Local Institution Cleveland
United States, Ohio The Ohio University Columbus
United States, Pennsylvania Lehigh Valley Hospital Allentown
United States, Pennsylvania St. Lukes University Health Network Easton
United States, Pennsylvania Local Institution Philadelphia
United States, Pennsylvania Local Institution Philadelphia
United States, Pennsylvania Hillman Cancer Center- U of Pitts Cancer Institute Pittsburgh
United States, South Carolina Charleston Oncology Charleston
United States, South Carolina Local Institution Greenville
United States, Tennessee Local Institution Chattanooga
United States, Tennessee Tennessee Oncology - Nashville Nashville
United States, Texas Local Institution Dallas
United States, Utah Local Institution Salt Lake City
United States, Virginia Local Institution Charlottesville
United States, Wisconsin Local Institution Madison
United States, Wisconsin UW Health - UW Carbone Cancer Center - Medical Oncology Clinic Madison
Argentina, Buenos Aires Centro Oncologico y de Investigacion Buenos Aires Berazategui
Argentina, Buenos Aires Instituto Fleming Caba
Argentina, Tucuman CAIPO Centro para la Atencion Integraldel Paciente Oncologico San Miguel De Tucuman
Argentina Local Institution Buenos Aires
Argentina Local Institution Caba
Argentina Local Institution Cordoba
Australia, New South Wales North Coast Area Health Service NCAHS - The North Coast Cancer Institute NCCI - Coffs Harbour Health Coffs Harbour
Australia, New South Wales Melanoma Institute Australia North Sydney
Australia, New South Wales Chris OBrien Lifehouse Hospital Sydney
Australia, New South Wales Calvary Mater Newcastle Waratah
Australia, New South Wales Westmead Hospital Westmead
Australia, Queensland Local Institution Greenslopes
Australia, Queensland Local Institution South Brisbane
Australia, South Australia Local Institution Adelaide
Australia, South Australia Lyell McEwin Hospital Elizabeth Vale
Australia, Victoria Cabrini Hospital Malvern Malvern
Austria Ordensklinikum Linz GmbH Elisabethinen Linz
Austria Allgemeine Krankenhaus Wien Vienna
Austria Klinikum Wels- Grieskirchen Wels
Belgium Universitair Ziekenhuis Gent Gent
Belgium UZ Brussel Campus Jette Jette
Belgium Cliniques Universitaires UCL de Mont-Godinne (CHU) Yvoir
Brazil, RIO Grande DO SUL Hospital de Caridade de Ijui Ijui
Brazil, RIO Grande DO SUL Irmandade da Santa Casa de Misericordia de Porto Alegre Porto Alegre
Brazil, SAO Paulo Local Institution Porto Alegre
Canada, Alberta Cross Cancer Institute Edmonton
Canada, British Columbia Local Institution Vancouver
Canada, Nova Scotia Local Institution Halifax
Canada, Ontario Durham Regional Cancer Ctr Oshawa
Canada, Quebec Local Institution Montreal
Chile, Metropolitana Local Institution Santiago
Chile, Metropolitana Local Institution Santiago
Chile, Metropolitana Bradford Hill Centro de Investigacion Clinica Santiago
Chile, Valparaiso Local Institution VinadelMar
China, Anhui Local Institution Hefei
China, Beijing Local Institution Beijing
China, Guangdong Local Institution Guangzhou
China, Heilongjiang Local Institution Harbin Shi
China, Hunan Local Institution Changsha
China, Jilin Local Institution Changchun City
China, Shanghai Local Institution Shanghai
China, Shanghai Local Institution Shanghai
Czechia Local Institution Olomouc
Denmark Local Institution Odense C
Finland Local Institution Helsinki
France Centre Hospitalier Universitaire de Bordeaux Hospital Saint Andre Bordeaux
France Centre Hospitalier Intercommunal de Creteil CHIC Creteil
France Centre Georges-Francois Leclerc Dijon Cedex
France Local Institution Dijon Cedex
France CHU Grenobles Alpes Grenoble
France Pole Biologie Pathologie Genetique - CHU de Lille Lille Cedex
France APHM - Hopital Nord Marseille Cedex 20
France APHM - Hopital de la Timone Marseille
France CHU Montpellier Montpellier
France Local Institution Montpellier
France Hopital europeen Georges Pompidou HEGP Paris Cedex 15
France Hospital Saint-Louis Paris
France Centre Hospitalier Lyon Sud Pierre Benite Cedax
France Local Institution Rennes
France Hopital Musse Toulon
France Local Institution Toulouse Cedex
France Institut Gustave Roussy Villejuif
Germany Universitaetsklinikum Aachen Aachen
Germany Local Institution Gera
Germany SRH Wald-Klinikum Gera GmbH Gera
Germany Local Institution Goettingen
Germany Universitatsmedizin Gottingen Gottingen
Germany Local Institution Hamburg
Germany Local Institution Heidelberg
Germany Thoraxklinik Heidelberg
Germany Universitaetsklinikum Jena - Klinik und Poliklinik fuer Urologie Jena
Germany Local Institution Kiel
Germany Unv Schleswig-Holstein Campus Kiel Kiel
Germany Local Institution Koeln
Germany Katholisches Klinikum Mainz Mainz
Germany Local Institution Mainz
Germany Universitaetsklinikum Tuebingen Tuebingen
Greece Local Institution Athens
Greece Sotiria General Hospital of Chest Diseases Athens
Greece General Hospital of Athens Alexandra Athens
Greece Local Institution Patras
Greece Metropolitan Hospital Piraeus
Greece Interbalcan Medical Centre Thessaloniki
Hungary Local Institution Budapest
Hungary Orszagos Koranyi TBC es Pulmonologiai Intezet Budapest
Hungary DE Klinikai Kozpont Debrecen
Ireland Local Institution Dublin
Ireland Local Institution Limerick
Israel Local Institution Haifa
Israel Local Institution Petach Tikva
Israel Local Institution Tel Hashomer
Italy Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari Bari
Italy Local Institution Bergamo
Italy Local Institution Genova
Italy Local Institution Meldola
Italy Local Institution Milano
Italy IRCCS Istituto Europeo di Oncologia Milano
Italy Local Institution Milano
Italy Fondazione IRCCS Istituto Nazionale Tumori Milan
Italy Istituto Nazionale dei Tumori Napoli
Italy Istituto Nazionale Tumori - Fondazione Pascale Italy Napoli
Italy Istituto Oncologico Veneto Padova
Italy AUSL Romagna Ravenna
Italy Istituto Nazionale dei Tumori Regina Elena Roma
Italy Azienda ospedaliero-universitaria Senese di Santa Maria alle Scotte Siena
Japan, Aichi Aichi Cancer Center Hospital Nagoya
Japan, Aomori Hirosaki University Hospital Hirosaki
Japan, Hyogo Kobe City Medical Center General Hospital Kobe shi
Japan, Ibaraki University of Tsukuba Hospital Tsukuba
Japan, Ishikawa Local Institution Kanazawa-shi
Japan, Miyagi Miyagi Cancer Center Natori-shi
Japan, Niigata Niigata Cancer Center Hospital Chuo-ku Niigata-shi
Japan, Niigata Niigata University Medical and Dental Hospital Niigata-Shi
Japan, Osaka Kindai University Hospital Osakasayama
Japan, Osaka Osaka Medical and Pharmaceutical University Hospital Takatsuki shi
Japan, Tokyo National Cancer Central Hospital Chuo-ku
Japan, Tokyo The Cancer Institute Hospital of JFCR Koto-Ku
Japan, Tokyo Keio University Hospital Shinjuku
Japan Local Institution Fukuoka
Korea, Republic of Local Institution Seongnam-si
Korea, Republic of Local Institution Seoul
Korea, Republic of Local Institution Yeongtong-Gu, Suwon-Si
Mexico, Distrito Federal Local Institution Ciudad De Mexico
Mexico, Guanajuato Local Institution Leon
Mexico, Michoacan Hospital Victoria Medical Center Morelia
Netherlands Local Institution Rotterdam
Norway Haukeland Universitetssjukehus Bergen
Norway Radiumhospitalet Oslo
Peru, Lima Centro de Investigacion Clinica Montesur Santiago de Surco
Poland Uniwersyteckie Centrum Kliniczne Gdansk
Poland Wojewodzkie Centrum Onkologii Gdansk
Poland Instytut MSF Sp zoo Lodz
Poland Ms Pneumed Janusz Milanowski Katarzyna Szmygin-Milanowska Sp. J. Lublin
Poland Centrum Medyczne Pratia Poznan Poznan
Poland Local Institution Warsaw
Poland Wojskowy Instytut Medyczny Warsaw
Poland Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology Warszawa
Portugal Centro Hospitalar de Lisboa Norte EPE - HPV Lisboa
Portugal Instituto Portugues de Oncologio de Lisboa Lisbon
Portugal Local Institution Porto
Romania Institutul Oncologic Bucuresti IOB Bucharest
Romania Institutul Oncologic Prof. Dr. I. Chiricuta Cluj Napoca
Romania Local Institution Cluj Napoca
Romania Cardiomed SRL Cluj-Napoca
Romania Sf Nectarie Oncology Center Craiova
Romania SC Pelican Impex SRL Oradea
Russian Federation N.N. Blokhin National Medical Research Center of Oncology Moscow
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 Hospital General Universitario de Alicante Alicante
Spain Catalan Institute of Badalona Hospital Germans Trias i Pujol ICO Badalona
Spain Hospital Universitari Vall d Hebron Barcelona
Spain Hospital Clinic de Barcelona Barcelona
Spain Institut Catala dOncologia LHospitalet Barcelona
Spain Local Institution Barcelona
Spain Hospital Universitario de Burgos Burgos
Spain Local Institution Granada
Spain Centro Oncologico MD ANDERSON Internacional Espana Madrid
Spain Local Institution Madrid
Spain Local Institution Madrid
Spain Hospital Universitario Fundacion Jimenez Diaz Madrid
Spain Hospital 12 de Octubre Madrid
Spain Local Institution Madrid
Spain Hospital Universitario HM Sanchinarro Madrid
Spain Hospital Regional Universitario Carlos Haya Malaga
Spain Onkologikoa Of San Sebastian San Sebastian
Spain Local Institution Santa Cruz de Tenerife
Spain Hospital Universitario Virgen Macarena Sevilla
Spain Fundacio Investigao Hospital General Universitario de Valencia FiHgU Valencia
Spain Hospital Universitario y Politecnico de La Fe Valencia
Sweden Local Institution Goteborg
Sweden Local Institution Malmoe
Sweden Local Institution Umea
Switzerland Universitaetsspital Basel - Klinik fuer Onkologie Basel
Switzerland UniversitaetsSpital Zuerich - Dermatology Zurich
Taiwan Local Institution Tainan
United Kingdom, Hampshire Southampton General Hospital Southampton
United Kingdom, Kent Local Institution Maidstone
United Kingdom North Middlesex University Hospital London
United Kingdom Royal Marsden Hospital Sutton London
United Kingdom Royal Marsden Hospital London
United Kingdom The Christie Hospital Manchester
United Kingdom East &amp, North Hertfordshire NHS Trust Northwood
Sponsors and Collaborators
Bristol-Myers Squibb
Investigator
Study Director : Bristol-Myers Squibb Bristol-Myers Squibb
More Information
Responsible Party : Bristol-Myers Squibb
ClinicalTrials.gov Identifier : NCT03899155     
Other Study ID Numbers : CA209-8TT, 2018-004362-34
First Posted : April 2, 2019
Last Update Posted : November 24, 2021
Last Verified : November 2021
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