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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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Pan Tumor Nivolumab Rollover Study

  • Clinicaltrials.gov identifier

    NCT03899155

  • Recruitment Status

    Recruiting

  • First Posted

    April 2, 2019

  • Last update posted

    May 13, 2022

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
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Pan Tumor Nivolumab Rollover Study
  • 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 Adverse Events (AEs) [ 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 AEs leading to Discontinuation [ 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, Colorado
University of Colorado
Aurora

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-James Graham Brown Cancer Center
Louisville

United States, Maryland
Johns Hopkins
Baltimore

United States, Massachusetts
Local Institution
Boston

United States, Massachusetts
Dana_Farber Cancer Institute (DFCI)
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
Local Institution - 0045
Coffs Harbour

Australia, New South Wales
Local Institution - 0062
North Sydney

Australia, New South Wales
Chris OBrien Lifehouse Hospital
Sydney

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, Tasmania
Calvary Mater Newcastle
Waratah

Australia, Victoria
Cabrini Hospital Malvern
Malvern

Austria
Local Institution
Graz

Austria
Local Institution - 0149
Linz

Austria
Allgemeine Krankenhaus Wien
Vienna

Austria
Klinikum Wels- Grieskirchen
Wels

Belgium
Universitair Ziekenhuis Gent
Gent

Belgium
UZ Brussel Campus Jette
Jette

Belgium
Local Institution
Liege

Belgium
Cliniques Universitaires UCL de Mont-Godinne (CHU)
Yvoir

Brazil, RIO Grande DO SUL
ONCOSITE - Centro de Pesquisa Clinica em Oncologia
Ijui

Brazil, RIO Grande DO SUL
Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre

Brazil, SAO Paulo
Local Institution
Barretos

Brazil, SAO Paulo
Local Institution
Porto Alegre

Brazil, SAO Paulo
Local Institution - 0262
Sao Jose do Rio Preto

Brazil
Local Institution
Rio de Janeiro

Canada, Alberta
Cross Cancer Institute
Edmonton

Canada, British Columbia
Local Institution
Vancouver

Canada, Nova Scotia
Local Institution
Halifax

Canada, Ontario
Local Institution - 0168
Oshawa

Canada, Quebec
Local Institution
Montreal

Chile, Metropolitana
Fundacion Arturo Lopez Perez
Santiago

Chile, Metropolitana
Local Institution
Santiago

Chile, Metropolitana
Local Institution - 0101
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 City

China, Hunan
Local Institution
Changsha

China, Jilin
Local Institution
Changchun City

China, Shanghai
Local Institution
Shanghai

China, Shanghai
Local Institution
Shanghai

Czechia
Local Institution - 0243
Hradec Kralove

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
Local Institution - 0074
Dijon Cedex

France
Centre Georges-Francois Leclerc
Dijon Cedex

France
Local Institution - 0010
La Tronche

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
Local Institution - 0028
Paris

France
Local Institution - 0084
Pierre Benite Cedax

France
Local Institution
Rennes

France
Local Institution - 0156
Toulon

France
Local Institution
Toulouse Cedex

France
Local Institution - 0029
Villejuif

Germany, Niedersachsen
Local Institution - 0249
Buxtehude

Germany
Universitaetsklinikum Aachen
Aachen

Germany
Local Institution
Berlin

Germany
Local Institution - 0250
Essen

Germany
Local Institution
Gera

Germany
SRH Wald-Klinikum Gera GmbH
Gera

Germany
Local Institution
Goettingen

Germany
Universitatsmedizin Gottingen
Gottingen

Germany
Local Institution - 0241
Hamburg

Germany
Local Institution
Heidelberg

Germany
Local Institution - 0148
Heidelberg

Germany
Local Institution
Heilbronn

Germany
Local Institution - 0216
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
Local Institution
Munchen

Germany
Local Institution - 0277
Tuebingen

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
Local Institution - 0215
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 - 0190
Haifa

Israel
Local Institution
Jerusalem

Israel
Local Institution
Petach Tikva

Israel
Local Institution - 0052
Tel Hashomer

Italy, RM
Local Institution - 0033
Roma

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 - 0267
Milano

Italy
Local Institution
Milano

Italy
Local Institution - 0096
Milan

Italy
Istituto Nazionale dei Tumori
Napoli

Italy
Istituto Nazionale Tumori - Fondazione Pascale Italy
Napoli

Italy
Istituto Oncologico Veneto
Padova

Italy
Local Institution - 0180
Ravenna

Italy
Local Institution - 0003
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
Local Institution - 0222
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 - 0224
Fukuoka

Korea, Republic of
Local Institution
Seongnam-si

Korea, Republic of
Local Institution - 0206
Seoul

Korea, Republic of
Local Institution
Suwon Si

Mexico, Ciudad De Mexico
Local Institution - 0181
Tlalpan

Mexico, Guanajuato
Local Institution
Leon

Mexico, Michoacan
Hospital Victoria Medical Center
Morelia

Netherlands
Local Institution
Rotterdam

New Zealand
Local Institution - 0268
Dunedin

Norway
Haukeland Universitetssjukehus
Bergen

Norway
Radiumhospitalet
Oslo

Peru, Lima
Centro de Investigacion Clinica Montesur
Santiago de Surco

Poland
Local Institution - 0120
Gdansk

Poland
Wojewodzkie Centrum Onkologii
Gdansk

Poland
Local Institution - 0031
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, Dolj
Local Institution - 0265
Craiova

Romania
Local Institution - 0129
Bucharest

Romania
Institutul Oncologic Prof. Dr. I. Chiricuta
Cluj Napoca

Romania
Local Institution
Cluj Napoca

Romania
Cardiomed SRL
Cluj-Napoca

Romania
Local Institution - 0133
Oradea

Russian Federation
N.N. Blokhin National Medical Research Center of Oncology
Moscow

Russian Federation
VitaMed LLC
Moscow

Spain, Guipuzcoa
Local Institution - 0047
San Sebastian

Spain
Local Institution - 0122
A Coruna

Spain
Local Institution - 0173
Alicante

Spain
Local Institution - 0123
Badalona

Spain
Hospital Universitari Vall d Hebron
Barcelona

Spain
Local Institution - 0026
Barcelona

Spain
Local Institution - 0225
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
Hospital Ramon y Cajal
Madrid

Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid

Spain
Local Institution - 0116
Madrid

Spain
Local Institution
Madrid

Spain
Hospital Universitario HM Sanchinarro
Madrid

Spain
Hospital Regional Universitario Carlos Haya
Malaga

Spain
Local Institution
Santa Cruz de Tenerife

Spain
Local Institution - 0274
Sevilla

Spain
Fundacio Investigao Hospital General Universitario de Valencia FiHgU
Valencia

Spain
Local Institution - 0117
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, Greater London
Local Institution - 0141
London

United Kingdom, Greater London
Local Institution - 0272
London

United Kingdom, Hampshire
Southampton General Hospital
Southampton

United Kingdom, Kent
Local Institution
Maidstone

United Kingdom, Middlesex
Local Institution - 0161
Northwood

United Kingdom
Local Institution - 0086
London

United Kingdom
The Christie Hospital
Manchester

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT03899155 History of Changes
  • Other Study ID Numbers: CA209-8TT, 2018-004362-34
  • First Posted: April 2, 2019 Key Record Dates
  • Last Update Posted: May 13, 2022
  • Last Verified: May 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