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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03899155
Ethics application status
Date submitted
1/04/2019
Date registered
2/04/2019
Date last updated
19/11/2024

Titles & IDs
Public title
Pan Tumor Rollover Study
Scientific title
Pan-Tumor Study for Long-term Treatment of Cancer Patients Who Have Participated in BMS Sponsored Trials Investigating Nivolumab and Other Cancer Therapies
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
Treatment: Drugs - Ipilimumab
Treatment: Drugs - Cabozantinib
Treatment: Drugs - Trametinib
Treatment: Drugs - Relatlimab
Treatment: Drugs - Nivolumab + Relatlimab
Treatment: Drugs - Capecitabine
Treatment: Drugs - Bevacizumab
Treatment: Drugs - Temozolomide
Treatment: Drugs - Rucaparib
Treatment: Drugs - Daratumumab
Treatment: Drugs - Regorafinib
Treatment: Drugs - Leucovorin
Treatment: Drugs - Fluorouracil
Treatment: Drugs - Oxaliplatin
Treatment: Drugs - Enzalutamide
Treatment: Drugs - Sunitinib
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Pembrolizumab

Experimental: A1: Nivolumab Monotherapy Dose 1 -

Experimental: A2: Nivolumab Monotherapy Dose 2 -

Experimental: B1: Nivolumab + Ipilimumab -

Experimental: B2: Nivolumab + Ipilimumab + Cabozantinib -

Experimental: B3: Nivolumab + Ipilimumab + Trametinib -

Experimental: C1: Relatlimab + Nivolumab Fixed Dose Combination Dose 1 -

Experimental: C3: Relatlimab + Nivolumab Fixed Dose Combination Dose 2 -

Experimental: C2: Relatlimab + Nivolumab Single Agent Vial (SAV) Dose 1 -

Experimental: C4: Relatlimab + Nivolumab SAV Dose 2 -

Experimental: C5: Relatlimab + Nivolumab + Ipilimumab -

Experimental: C6: Relatlimab + Nivolumab + Capecitabine -

Experimental: C7: Relatlimab + Nivolumab SAV Dose 3 -

Experimental: C10: Relatlimab + Nivolumab SAV Dose 4 -

Experimental: C12: Relatlimab + Nivolumab SAV Dose 5 -

Experimental: C8: Relatlimab + Nivolumab SAV + PDCT Dose 1 -

Experimental: C9: Relatlimab + Nivolumab SAV + Bevacizumab -

Experimental: C11: Relatlimab + Nivolumab SAV + PDCT Dose 2 -

Experimental: D1: Nivolumab + Temozolomide -

Experimental: D2: Nivolumab + Rucaparib -

Experimental: D3: Nivolumab + Daratumumab -

Experimental: D4: Nivolumab + Bevacizumab -

Experimental: E1: Bevacizumab Monotherapy -

Experimental: E2: Regorafinib Monotherapy -

Experimental: E4: Leucovorin + Oxaliplatin + Fluorouracil -

Experimental: E5: Enzalutamide Monotherapy -

Experimental: E6: Sunitinib Monotherapy -

Experimental: E7: Rucaparib Monotherapy -

Experimental: E8: Capecitabine Monotherapy -

Experimental: E9: Cabozantinib Monotherapy -

Experimental: E10: Pemetrexed Monotherapy -

Experimental: E11: Pembrolizumab Monotherapy -

Experimental: E3: Leucovorin + Fluorouracil -


Treatment: Drugs: Nivolumab
Specified dose on specified days

Treatment: Drugs: Ipilimumab
Specified dose on specified days

Treatment: Drugs: Cabozantinib
Specified dose on specified days

Treatment: Drugs: Trametinib
Specified dose on specified days

Treatment: Drugs: Relatlimab
Specified dose on specified days

Treatment: Drugs: Nivolumab + Relatlimab
Specified dose on specified days

Treatment: Drugs: Capecitabine
Specified dose on specified days

Treatment: Drugs: Bevacizumab
Specified dose on specified days

Treatment: Drugs: Temozolomide
Specified dose on specified days

Treatment: Drugs: Rucaparib
Specified dose on specified days

Treatment: Drugs: Daratumumab
Specified dose on specified days

Treatment: Drugs: Regorafinib
Specified dose on specified days

Treatment: Drugs: Leucovorin
Specified dose on specified days

Treatment: Drugs: Fluorouracil
Specified dose on specified days

Treatment: Drugs: Oxaliplatin
Specified dose on specified days

Treatment: Drugs: Enzalutamide
Specified dose on specified days

Treatment: Drugs: Sunitinib
Specified dose on specified days

Treatment: Drugs: Pemetrexed
Specified dose on specified days

Treatment: Drugs: Pembrolizumab
Specified dose on specified days
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 135 Days after discontinuation of treatment
Primary outcome [2] 0 0
Incidence of drug related AEs
Timepoint [2] 0 0
From Day 1 up to 135 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 135 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 135 Days after discontinuation of treatment
Primary outcome [5] 0 0
Incidence of Select AEs
Timepoint [5] 0 0
From Day 1 up to 135 Days after discontinuation of treatment
Primary outcome [6] 0 0
Incidence of Immune-Mediated AEs
Timepoint [6] 0 0
From Day 1 up to 135 Days after discontinuation of treatment
Primary outcome [7] 0 0
Incidence of Death
Timepoint [7] 0 0
From signature of Informed Consent up to 135 Days after discontinuation of treatment

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

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
9/08/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
25/08/2029
Actual
Sample size
Target
1500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
North Coast Area Health Service NCAHS - The North Coast Cancer Institute NCCI - Coffs Harbour Health Campus - Coffs Harbour
Recruitment hospital [2] 0 0
Melanoma Institute Australia - North Sydney
Recruitment hospital [3] 0 0
Local Institution - 0009 - Sydney
Recruitment hospital [4] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [5] 0 0
Westmead Hospital - Westmead
Recruitment hospital [6] 0 0
Gallipoli Medical Foundation - Greenslopes
Recruitment hospital [7] 0 0
Local Institution - 0372 - Greenslopes
Recruitment hospital [8] 0 0
Local Institution - South Brisbane
Recruitment hospital [9] 0 0
Tasman Oncology Research Ltd - Southport
Recruitment hospital [10] 0 0
Local Institution - Adelaide
Recruitment hospital [11] 0 0
Local Institution - 0196 - Elizabeth Vale
Recruitment hospital [12] 0 0
St Vincents Hospital Melbourne - Fitzroy
Recruitment hospital [13] 0 0
Cabrini Hospital Malvern - Malvern
Recruitment hospital [14] 0 0
Local Institution - 0174 - Murdoch
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
2298 - Waratah
Recruitment postcode(s) [5] 0 0
2145 - Westmead
Recruitment postcode(s) [6] 0 0
4120 - Greenslopes
Recruitment postcode(s) [7] 0 0
4101 - South Brisbane
Recruitment postcode(s) [8] 0 0
4215 - Southport
Recruitment postcode(s) [9] 0 0
5000 - Adelaide
Recruitment postcode(s) [10] 0 0
05112 - Elizabeth Vale
Recruitment postcode(s) [11] 0 0
3065 - Fitzroy
Recruitment postcode(s) [12] 0 0
3144 - Malvern
Recruitment postcode(s) [13] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Minnesota
Country [14] 0 0
United States of America
State/province [14] 0 0
Missouri
Country [15] 0 0
United States of America
State/province [15] 0 0
Nebraska
Country [16] 0 0
United States of America
State/province [16] 0 0
New Hampshire
Country [17] 0 0
United States of America
State/province [17] 0 0
New Mexico
Country [18] 0 0
United States of America
State/province [18] 0 0
New York
Country [19] 0 0
United States of America
State/province [19] 0 0
North Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Ohio
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United States of America
State/province [21] 0 0
Oklahoma
Country [22] 0 0
United States of America
State/province [22] 0 0
Pennsylvania
Country [23] 0 0
United States of America
State/province [23] 0 0
South Carolina
Country [24] 0 0
United States of America
State/province [24] 0 0
Tennessee
Country [25] 0 0
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Texas
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Utah
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United States of America
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Washington
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Wisconsin
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Argentina
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Buenos Aires
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Tucuman
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Tucumán
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Caba
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Cordoba
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Liege
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SP
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State/province [56] 0 0
Nova Scotia
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Ontario
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Quebec
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Araucania
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Jilin
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State/province [69] 0 0
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State/province [70] 0 0
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State/province [71] 0 0
Zhejiang
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Hangzhou
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NY
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Hradec Kralove
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State/province [76] 0 0
Olomouc
Country [77] 0 0
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State/province [77] 0 0
Odense C
Country [78] 0 0
Finland
State/province [78] 0 0
Helsinki
Country [79] 0 0
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State/province [79] 0 0
Gironde
Country [80] 0 0
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State/province [80] 0 0
Meurthe-Et-Moselle
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Clermont-Ferrand
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Creteil
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Dijon Cedex
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La Tronche
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State/province [85] 0 0
Lille Cedex
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State/province [86] 0 0
Marseille Cedex 20
Country [87] 0 0
France
State/province [87] 0 0
Marseille
Country [88] 0 0
France
State/province [88] 0 0
Montpellier
Country [89] 0 0
France
State/province [89] 0 0
Nantes
Country [90] 0 0
France
State/province [90] 0 0
Paris Cedex 15
Country [91] 0 0
France
State/province [91] 0 0
Paris
Country [92] 0 0
France
State/province [92] 0 0
Pierre-Benite Cedex
Country [93] 0 0
France
State/province [93] 0 0
Rennes
Country [94] 0 0
France
State/province [94] 0 0
Toulon
Country [95] 0 0
France
State/province [95] 0 0
Toulouse Cedex
Country [96] 0 0
France
State/province [96] 0 0
Villejuif
Country [97] 0 0
Germany
State/province [97] 0 0
Bayern
Country [98] 0 0
Germany
State/province [98] 0 0
Hessen
Country [99] 0 0
Germany
State/province [99] 0 0
Niedersachsen
Country [100] 0 0
Germany
State/province [100] 0 0
Nordrhein-westfalen
Country [101] 0 0
Germany
State/province [101] 0 0
Nordrhein-Westfalen
Country [102] 0 0
Germany
State/province [102] 0 0
Aachen
Country [103] 0 0
Germany
State/province [103] 0 0
Berlin
Country [104] 0 0
Germany
State/province [104] 0 0
Cologne
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Germany
State/province [105] 0 0
Freiburg
Country [106] 0 0
Germany
State/province [106] 0 0
Gera
Country [107] 0 0
Germany
State/province [107] 0 0
Goettingen
Country [108] 0 0
Germany
State/province [108] 0 0
Gottingen
Country [109] 0 0
Germany
State/province [109] 0 0
Hamburg
Country [110] 0 0
Germany
State/province [110] 0 0
Heidelberg
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Germany
State/province [111] 0 0
Heilbronn
Country [112] 0 0
Germany
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Jena
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Germany
State/province [113] 0 0
Kiel
Country [114] 0 0
Germany
State/province [114] 0 0
Koeln
Country [115] 0 0
Germany
State/province [115] 0 0
Loewenstein
Country [116] 0 0
Germany
State/province [116] 0 0
Luebeck
Country [117] 0 0
Germany
State/province [117] 0 0
Mainz
Country [118] 0 0
Germany
State/province [118] 0 0
Tubingen
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Germany
State/province [119] 0 0
Tuebingen
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Greece
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Crete
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Greece
State/province [121] 0 0
Athens
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Greece
State/province [122] 0 0
Patras
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Greece
State/province [123] 0 0
Piraeus
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Greece
State/province [124] 0 0
Thessaloniki
Country [125] 0 0
Hong Kong
State/province [125] 0 0
Hong Kong
Country [126] 0 0
Hungary
State/province [126] 0 0
Heves
Country [127] 0 0
Hungary
State/province [127] 0 0
Budapest
Country [128] 0 0
Hungary
State/province [128] 0 0
Debrecen
Country [129] 0 0
Ireland
State/province [129] 0 0
Dublin
Country [130] 0 0
Ireland
State/province [130] 0 0
Limerick
Country [131] 0 0
Israel
State/province [131] 0 0
Haifa
Country [132] 0 0
Israel
State/province [132] 0 0
Jerusalem
Country [133] 0 0
Israel
State/province [133] 0 0
Petach Tikva
Country [134] 0 0
Israel
State/province [134] 0 0
Ramat Gan
Country [135] 0 0
Israel
State/province [135] 0 0
Tiqwa
Country [136] 0 0
Italy
State/province [136] 0 0
Fc
Country [137] 0 0
Italy
State/province [137] 0 0
MI
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Italy
State/province [138] 0 0
RM
Country [139] 0 0
Italy
State/province [139] 0 0
Bari
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Italy
State/province [140] 0 0
Bergamo
Country [141] 0 0
Italy
State/province [141] 0 0
Candiolo
Country [142] 0 0
Italy
State/province [142] 0 0
Catania
Country [143] 0 0
Italy
State/province [143] 0 0
Genova
Country [144] 0 0
Italy
State/province [144] 0 0
Meldola
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Italy
State/province [145] 0 0
Milano
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Italy
State/province [146] 0 0
Milan
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State/province [147] 0 0
Modena
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Italy
State/province [148] 0 0
Napoli
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Padova
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Ravenna
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Siena
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Italy
State/province [152] 0 0
Terni
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Torino
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Aichi
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Japan
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Aomori
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Japan
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Chiba
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Japan
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Hyogo
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Japan
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Ibaraki
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Ishikawa
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Japan
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Kanagawa
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Japan
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Miyagi
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Niigata
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Japan
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Japan
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Tokyo
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Fukuoka
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
State/province [169] 0 0
Seongnam-si
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Korea, Republic of
State/province [170] 0 0
Seoul
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Korea, Republic of
State/province [171] 0 0
Suwon Si
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Mexico
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Guanajuato
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Mexico
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Jalisco
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Mexico
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Michoacan
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Mexico
State/province [176] 0 0
Nuevo Leon
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Mexico
State/province [177] 0 0
Queretaro
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Mexico
State/province [178] 0 0
Ciudad de Mexico
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Mexico
State/province [179] 0 0
Oaxaca
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Netherlands
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Noord-Holland
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Netherlands
State/province [181] 0 0
Rotterdam
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New Zealand
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Auckland
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New Zealand
State/province [183] 0 0
Christchurch
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New Zealand
State/province [184] 0 0
Dunedin
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New Zealand
State/province [185] 0 0
Tauranga
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Norway
State/province [186] 0 0
Bergen
Country [187] 0 0
Norway
State/province [187] 0 0
Oslo
Country [188] 0 0
Peru
State/province [188] 0 0
Lima
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Poland
State/province [189] 0 0
Kujawsko-pomorskie
Country [190] 0 0
Poland
State/province [190] 0 0
Lubelskie
Country [191] 0 0
Poland
State/province [191] 0 0
Gdansk
Country [192] 0 0
Poland
State/province [192] 0 0
Krakow
Country [193] 0 0
Poland
State/province [193] 0 0
Kraków
Country [194] 0 0
Poland
State/province [194] 0 0
Lodz
Country [195] 0 0
Poland
State/province [195] 0 0
Lublin
Country [196] 0 0
Poland
State/province [196] 0 0
Poznan
Country [197] 0 0
Poland
State/province [197] 0 0
Warsaw
Country [198] 0 0
Poland
State/province [198] 0 0
Warszawa
Country [199] 0 0
Portugal
State/province [199] 0 0
Lisboa
Country [200] 0 0
Portugal
State/province [200] 0 0
Lisbon
Country [201] 0 0
Portugal
State/province [201] 0 0
Porto
Country [202] 0 0
Puerto Rico
State/province [202] 0 0
San Juan
Country [203] 0 0
Romania
State/province [203] 0 0
Bucharest
Country [204] 0 0
Romania
State/province [204] 0 0
Cluj Napoca
Country [205] 0 0
Romania
State/province [205] 0 0
Cluj-Napoca
Country [206] 0 0
Romania
State/province [206] 0 0
Craiova
Country [207] 0 0
Romania
State/province [207] 0 0
Oradea
Country [208] 0 0
Russian Federation
State/province [208] 0 0
Krasnodar Region
Country [209] 0 0
Russian Federation
State/province [209] 0 0
Krasnoyarsk
Country [210] 0 0
Russian Federation
State/province [210] 0 0
Moscow
Country [211] 0 0
Spain
State/province [211] 0 0
Guipuzcoa
Country [212] 0 0
Spain
State/province [212] 0 0
Madrid
Country [213] 0 0
Spain
State/province [213] 0 0
Navarra
Country [214] 0 0
Spain
State/province [214] 0 0
A Coruna
Country [215] 0 0
Spain
State/province [215] 0 0
Alicante
Country [216] 0 0
Spain
State/province [216] 0 0
Badalona
Country [217] 0 0
Spain
State/province [217] 0 0
Barcelona
Country [218] 0 0
Spain
State/province [218] 0 0
Burgos
Country [219] 0 0
Spain
State/province [219] 0 0
Granada
Country [220] 0 0
Spain
State/province [220] 0 0
Malaga
Country [221] 0 0
Spain
State/province [221] 0 0
Santa Cruz de Tenerife
Country [222] 0 0
Spain
State/province [222] 0 0
Santander
Country [223] 0 0
Spain
State/province [223] 0 0
Sevilla
Country [224] 0 0
Spain
State/province [224] 0 0
Valencia
Country [225] 0 0
Sweden
State/province [225] 0 0
Goteborg
Country [226] 0 0
Sweden
State/province [226] 0 0
Malmoe
Country [227] 0 0
Sweden
State/province [227] 0 0
Umea
Country [228] 0 0
Switzerland
State/province [228] 0 0
Basel
Country [229] 0 0
Switzerland
State/province [229] 0 0
Zurich
Country [230] 0 0
Taiwan
State/province [230] 0 0
Tainan
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Taiwan
State/province [231] 0 0
Taipei
Country [232] 0 0
Turkey
State/province [232] 0 0
Ankara
Country [233] 0 0
United Kingdom
State/province [233] 0 0
Greater London
Country [234] 0 0
United Kingdom
State/province [234] 0 0
Greater Manchester
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United Kingdom
State/province [235] 0 0
Hampshire
Country [236] 0 0
United Kingdom
State/province [236] 0 0
Kent
Country [237] 0 0
United Kingdom
State/province [237] 0 0
Middlesex
Country [238] 0 0
United Kingdom
State/province [238] 0 0
Scotland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Exelixis
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Novartis
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Commercial sector/industry
Name [3] 0 0
Clovis Oncology, Inc.
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Commercial sector/industry
Name [4] 0 0
Janssen Pharmaceuticals
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Main Objective of this study is to examine long-term safety of nivolumab monotherapy including combinations and other cancer therapies in various tumor types.
Trial website
https://clinicaltrials.gov/study/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
BMS Study Connect Contact http://www.bmsstudyconnect.com/
Address 0 0
Country 0 0
Phone 0 0
855-907-3286
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

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