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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
30/06/2020

Titles & IDs
Public title
Pan Tumor Nivolumab Rollover Study
Scientific title
Pan-Tumor Study for Long Term Follow-up of Cancer Survivors Who Have Participated in Trials Investigating Nivolumab
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 Dose 1 - Specified Dose on Specified Days

Experimental: Nivolumab Dose 2 - Specified Dose on Specified Days


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
Incidence of Adverse Events (AEs)
Timepoint [1] 0 0
From Day 1 up to 100 Days after discontinuation of treatment
Primary outcome [2] 0 0
Incidence of drug related AEs
Timepoint [2] 0 0
From Day 1 up to 100 Days after discontinuation of treatment
Primary outcome [3] 0 0
Incidence of AEs leading to Discontinuation
Timepoint [3] 0 0
From Day 1 up to 100 Days after discontinuation of treatment
Primary outcome [4] 0 0
Incidence of Serious Adverse Events (SAEs)
Timepoint [4] 0 0
From signature of Informed Consent up to 100 Days after discontinuation of treatment
Primary outcome [5] 0 0
Incidence of Select AEs
Timepoint [5] 0 0
From Day 1 up to 100 Days after discontinuation of treatment
Primary outcome [6] 0 0
Incidence of Immune-Mediated AEs
Timepoint [6] 0 0
From Day 1 up to 100 Days after discontinuation of treatment
Primary outcome [7] 0 0
Incidence of Death
Timepoint [7] 0 0
From signature of Informed Consent 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 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

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 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
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 - Northmead
Recruitment hospital [4] 0 0
Local Institution - Sydney
Recruitment hospital [5] 0 0
Local Institution - Waratah
Recruitment hospital [6] 0 0
Local Institution - Greenslopes
Recruitment hospital [7] 0 0
Local Institution - South Brisbane
Recruitment hospital [8] 0 0
Local Institution - Adelaide
Recruitment hospital [9] 0 0
Local Institution - Elizabeth Vale
Recruitment hospital [10] 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
2152 - Northmead
Recruitment postcode(s) [4] 0 0
2050 - Sydney
Recruitment postcode(s) [5] 0 0
2298 - Waratah
Recruitment postcode(s) [6] 0 0
4120 - Greenslopes
Recruitment postcode(s) [7] 0 0
4101 - South Brisbane
Recruitment postcode(s) [8] 0 0
5000 - Adelaide
Recruitment postcode(s) [9] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [10] 0 0
3144 - Malvern
Recruitment outside Australia
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California
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Connecticut
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District of Columbia
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Kentucky
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Massachusetts
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Michigan
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Minnesota
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Missouri
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Nebraska
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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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Ohio
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Pennsylvania
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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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Tucuman
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Argentina
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Caba
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Argentina
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Cordoba
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Austria
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Linz
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Austria
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Vienna
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Austria
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Wels
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Belgium
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Yvoir
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Brazil
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RIO Grande DO SUL
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Chile
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Chile
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Chile
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Anhui
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Beijing
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Guangdong
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China
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Heilongjiang
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China
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Hunan
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Jilin
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Grenoble
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Lille Cedex
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France
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Marseille Cedex 20
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France
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Marseille
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France
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Montpellier
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Paris
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France
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Pierre-Benite Cedex
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France
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Rennes
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France
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Toulon
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France
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Toulouse Cedex
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France
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Villejuif
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Germany
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Aachen
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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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Gottingen
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Germany
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Heidelberg
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Germany
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Jena
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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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Tuebingen
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Greece
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Athens
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Greece
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Patras
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Greece
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Thessaloniki
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Hungary
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Budapest
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Hungary
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Debrecen
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Ireland
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Limerick
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Israel
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Haifa
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Israel
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Petach Tikva
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Israel
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Ramat Gan
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Italy
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Bari
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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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Meldola
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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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Ravenna
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Italy
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Roma
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Italy
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Siena
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Japan
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Hyogo
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Japan
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Osaka
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Korea, Republic of
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Seodaemun-Gu
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Korea, Republic of
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Yeongtong-Gu, Suwon-Si
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Mexico
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Distrito Federal
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Mexico
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Guanajuato
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Mexico
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Michioacan
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Netherlands
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Rotterdam
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Norway
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Bergen
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Norway
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Oslo
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Peru
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Lima
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Gdansk
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Lodz
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Lublin
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Portugal
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Lisboa
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Portugal
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Lisbon
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Portugal
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Porto
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Romania
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Bucharest
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Romania
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Cluj Napoca
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Romania
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Cluj-Napoca
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Romania
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Oradea
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Russian Federation
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Moscow
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Spain
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A Coruna
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Spain
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Alicante
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Spain
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Barcelona
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Spain
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Burgos
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Spain
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Granada
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Spain
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Madrid
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Spain
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Malaga
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Spain
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San Sebastian
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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
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Switzerland
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Basel
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Switzerland
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Zuerich
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Taiwan
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Tainan
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United Kingdom
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Hampshire
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Northwood

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