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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03899155




Registration number
NCT03899155
Ethics application status
Date submitted
1/04/2019
Date registered
2/04/2019
Date last updated
2/07/2019

Titles & IDs
Public title
Pan Tumor Nivolumab Rollover Study
Scientific title
A Phase 4 Pan-Tumor Study of Long Term Follow up for Cancer Survivors Treated With Nivolumab or Nivolumab Combination Therapy
Secondary ID [1] 0 0
2018-004362-34
Secondary ID [2] 0 0
CA209-8TT
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Nivolumab

Experimental: Nivolumab 480 mg IV Every 4 Weeks - Participants will receive 480 mg nivolumab as a 30-minute infusion on Day 1 of each treatment cycle every 4 weeks until progression, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first.

Experimental: Nivolumab 240 mg IV Every 2 Weeks - Participants will receive 240 mg nivolumab as a 30-minute infusion on Day 1 of each treatment cycle every 2 weeks until progression, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first. Participants will be dosed at least 12 days from the previous dose.


Treatment: Drugs: Nivolumab
Solution for IV Injection

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Adverse Events (AEs)
Timepoint [1] 0 0
From Day 1 up to 100 Days after discontinuation of treatment
Primary outcome [2] 0 0
Number of Participants With AEs Related to Treatment
Timepoint [2] 0 0
From Day 1 up to 100 Days after discontinuation of treatment
Primary outcome [3] 0 0
Number of Participants With AEs Leading to Discontinuation
Timepoint [3] 0 0
From Day 1 up to 100 Days after discontinuation of treatment
Primary outcome [4] 0 0
Number of Participants With Serious AEs (SAEs) and Death
Timepoint [4] 0 0
From signature of Informed Consent up to 100 Days after discontinuation of treatment
Primary outcome [5] 0 0
Number of Participants With Select AEs
Timepoint [5] 0 0
From Day 1 up to 100 Days after discontinuation of treatment

Eligibility
Key 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 Protocol
are not eligible to receive nivolumab in this study. These participants may be
enrolled for safety and survival follow-up only.

- Participant is eligible as per the Parent Protocol
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-

- Participant ineligibility as per Parent Protocol.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Local Institution - Coffs Harbour
Recruitment hospital [2] 0 0
Local Institution - North Sydney
Recruitment hospital [3] 0 0
Local Institution - Sydney
Recruitment hospital [4] 0 0
Local Institution - Greenslopes
Recruitment hospital [5] 0 0
Local Institution - Adelaide
Recruitment hospital [6] 0 0
Local Institution - Malvern
Recruitment postcode(s) [1] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [2] 0 0
2060 - North Sydney
Recruitment postcode(s) [3] 0 0
2050 - Sydney
Recruitment postcode(s) [4] 0 0
4120 - Greenslopes
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
3144 - Malvern
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
State/province [2] 0 0
Florida
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United States of America
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Kentucky
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United States of America
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Massachusetts
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United States of America
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Missouri
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New Hampshire
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New Mexico
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New York
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North Carolina
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Pennsylvania
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South Carolina
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Tennessee
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Utah
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Virginia
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United States of America
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Caba
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Canada
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British Columbia
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Canada
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Nova Scotia
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Canada
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Quebec
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Chile
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Valparaiso
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Chile
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Santaigo
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Chile
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Santiago
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Denmark
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Odense C
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Finland
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Helsinki
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France
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Bordeaux
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France
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Grenoble
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France
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Lille
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France
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Montpellier
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France
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Paris
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France
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TOULOUSE Cedex 9
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France
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Villejuif
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Germany
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Gera
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Germany
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Goettingen
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Germany
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Heidelberg
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Germany
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Kiel
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Germany
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Koeln
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Germany
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Mainz
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Germany
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Tubingen
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Greece
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Athens
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Greece
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Neo Faliro
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Israel
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Ramat-gan
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Italy
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BA
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Italy
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Bergamo
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Italy
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Genova
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Italy
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Milano
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Italy
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Napoli
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Italy
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Padova
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Italy
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Roma
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Italy
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Siena
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Mexico
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Michioacan
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Norway
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Oslo
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Poland
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Gdansk
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Poland
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Lodz
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Poland
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Warszawa
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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San Sabastian Gipuzkoa
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Spain
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Valencia
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Sweden
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Goteborg
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Sweden
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Malmoe
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Sweden
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Umea

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Main Objective of this study is to examine long-term safety of nivolumab in participants on
treatment and in follow up.
Trial website
https://clinicaltrials.gov/show/NCT03899155
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Recruiting sites have contact information. Please contact the sites directly. If there is no contact information available,
Address 0 0
Country 0 0
Phone 0 0
please email
Fax 0 0
Email 0 0
Clinical.Trials@bms.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03899155