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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03635983




Registration number
NCT03635983
Ethics application status
Date submitted
16/08/2018
Date registered
17/08/2018
Date last updated
1/04/2025

Titles & IDs
Public title
A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma
Scientific title
A Phase 3, Randomized, Open-label Study of NKTR-214 Combined With Nivolumab Versus Nivolumab in Participants With Previously Untreated Unresectable or Metastatic Melanoma
Secondary ID [1] 0 0
2018-001423-40
Secondary ID [2] 0 0
CA045-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - NKTR-214
Treatment: Other - Nivolumab

Experimental: Combination - NKTR-214 + Nivolumab

Experimental: Monotherapy - Nivolumab


Treatment: Other: NKTR-214
Specified dose on specified days

Treatment: Other: Nivolumab
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR)
Assessment method [1] 0 0
ORR is defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) using RECIST v 1.1 per blinded independent central review (BICR) assessment. CR=Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions.
Timepoint [1] 0 0
From date of randomization to disease progression (Up to 37 months)
Primary outcome [2] 0 0
Progression-free Survival (PFS) Per Blinded Independent Central Review (BICR)
Assessment method [2] 0 0
PFS is defined as the time between the date of randomization and the first date of documented tumor progression using RECIST v 1.1 per blinded independent central review (BICR), or death due to any cause, whichever comes first. Progressive disease (PD)=At least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5 mm.
Timepoint [2] 0 0
From date of randomization to disease progression, or death, whichever comes first (Up to 37 months)
Primary outcome [3] 0 0
Overall Survival (OS)
Assessment method [3] 0 0
OS is defined as the time between the date of randomization and the date of death due to any cause. Participants who do not have a date of death will be censored on the last date for which a participant was known to be alive.
Timepoint [3] 0 0
From date of randomization to date of death (Up to 37 months)
Secondary outcome [1] 0 0
Clinical Benefit Rate (CBR) Per Blinded Independent Central Review (BICR)
Assessment method [1] 0 0
CBR, or equivalently the disease control rate (DCR) is defined as the percentage of participants with a best overall response of complete response (CR), partial response (PR), or stable disease (SD) as assessed by blinded independent central review (BICR) using RECIST v 1.1. CR=Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions.SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.
Timepoint [1] 0 0
From date of randomization to disease progression (Up to 37 months)
Secondary outcome [2] 0 0
Duration of Response (DoR) Per Blinded Independent Central Review (BICR)
Assessment method [2] 0 0
DOR is defined for participants who have a confirmed complete response (CR) or partial results (PR) as the date from first documented CR or PR using RECIST v 1.1 to the date of the documentation of disease progression per blinded independent central review (BICR) assessment or death due to any cause, whichever is earlier. CR=Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions.
Timepoint [2] 0 0
From date of randomization to disease progression, or death, whichever is earlier (Up to 37 months)
Secondary outcome [3] 0 0
Time to Objective Response (TTR) Per Blinded Independent Central Review (BICR)
Assessment method [3] 0 0
Time to response (TTR) is defined for participants who had a confirmed complete response (CR) or partial response (PR) as the time from the date of randomization to date of first documented CR or PR per blinded independent central review (BICR) assessment using RECIST v 1.1. CR=Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions.
Timepoint [3] 0 0
From date of randomization to disease progression (Up to 37 months)
Secondary outcome [4] 0 0
Objective Response Rate (ORR) Per Investigator
Assessment method [4] 0 0
ORR is defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) using RECIST v 1.1 per investigator assessment. CR=Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions.
Timepoint [4] 0 0
From date of randomization to disease progression (Up to 37 months)
Secondary outcome [5] 0 0
Progression-free Survival (PFS) Per Investigator
Assessment method [5] 0 0
PFS is defined as the time between the date of randomization and the first date of documented tumor progression using RECIST v 1.1 per investigator, or death due to any cause, whichever comes first. Progressive disease (PD)=At least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5 mm.
Timepoint [5] 0 0
From date of randomization to disease progression, or death, whichever comes first (Up to 37 months)
Secondary outcome [6] 0 0
Clinical Benefit Rate (CBR) Per Investigator
Assessment method [6] 0 0
CBR, or equivalently the disease control rate (DCR) is defined as the percentage of participants with a best overall response of complete response (CR), partial response (PR), or stable disease (SD) as assessed by investigator using RECIST v 1.1. CR=Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions. SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Timepoint [6] 0 0
From date of randomization to disease progression (Up to 37 months)
Secondary outcome [7] 0 0
Duration of Response (DoR) Per Investigator
Assessment method [7] 0 0
DOR is defined for participants who have a confirmed complete response (CR) or partial results (PR) as the date from first documented CR or PR using RECIST v 1.1 to the date of the documentation of disease progression per investigator assessment or death due to any cause, whichever is earlier. CR=Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions.
Timepoint [7] 0 0
From date of randomization to disease progression, or death, whichever is earlier (Up to 37 months)
Secondary outcome [8] 0 0
Time to Objective Response (TTR) Per Investigator
Assessment method [8] 0 0
Time to response (TTR) is defined for participants who had a confirmed complete response (CR) or partial response (PR) as the time from the date of randomization to date of first documented CR or PR per investigator assessment using RECIST v 1.1. CR=Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions.
Timepoint [8] 0 0
From date of randomization to disease progression (Up to 37 months)
Secondary outcome [9] 0 0
Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) by Baseline PD-L1 Status
Assessment method [9] 0 0
ORR by baseline PD-L1 tumor cells expression (PD-L1 negative: \<1%) vs. (PD-L1 positive: \>=1%). ORR is defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) using RECIST v 1.1 per blinded independent central review (BICR) assessment. CR=Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions.
Timepoint [9] 0 0
From date of randomization to disease progression (Up to 37 months)
Secondary outcome [10] 0 0
Progression-free Survival (PFS) Per Blinded Independent Central Review (BICR) by Baseline PD-L1 Status
Assessment method [10] 0 0
PFS by baseline PD-L1 tumor cells expression (PD-L1 negative: \<1%) vs. (PD-L1 positive: \>=1%). PFS is defined as the time between the date of randomization and the first date of documented tumor progression using RECIST v 1.1 per blinded independent central review (BICR), or death due to any cause, whichever comes first. Progressive disease (PD)=At least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5 mm.
Timepoint [10] 0 0
From date of randomization to disease progression, or death, whichever comes first (Up to 37 months)
Secondary outcome [11] 0 0
Overall Survival (OS) by Baseline PD-L1 Status
Assessment method [11] 0 0
OS by baseline PD-L1 tumor cells expression (PD-L1 negative: \<1%) vs. (PD-L1 positive: \>=1%). OS is defined as the time between the date of randomization and the date of death due to any cause. Participants who do not have a date of death will be censored on the last date for which a participant was known to be alive.
Timepoint [11] 0 0
From date of randomization to date of death (Up to 37 months)
Secondary outcome [12] 0 0
Number of Participants With Adverse Events (AEs)
Assessment method [12] 0 0
Number of participants with any grade adverse events (AEs) including treatment-related AEs, AEs leading to discontinuation of any drug, serious adverse events (SAEs), treatment-related SAEs, and deaths from first dose to 30 days post last dose. An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
Timepoint [12] 0 0
From first dose to 30 days post last dose (Average of 11 months and a maximum up to 26 months)
Secondary outcome [13] 0 0
Number of Participants With On-Treatment Laboratory Parameters That Worsened Relative to Baseline
Assessment method [13] 0 0
Number of participants with on-treatment laboratory parameters that worsened relative to baseline. Parameters include hematology, chemistry, liver function, and renal function using worst grade (grade 1-4 and grade 3-4) per national cancer institute (NCI) common terminology criteria for adverse events (CTCAE) v5 criteria. Grade 1=Mild event Grade 2=Moderate event Grade 3=Severe event Grade 4=Life threatening event
Timepoint [13] 0 0
From first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months)

Eligibility
Key inclusion criteria
* Eastern Cooperative Oncology Group (ECOG) performance status of =1 (adults 18 years or older)/Lansky Performance Score = 80% (minors ages 12-17 only)
* Histologically confirmed stage III (unresectable) or stage IV melanoma
* Treatment-naive participants (ie, no prior systemic anticancer therapy for unresectable or metastatic melanoma) with the exception of prior adjuvant and/or neoadjuvant treatment for melanoma with approved agents
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Active brain metastases or leptomeningeal metastases
* Uveal melanoma
* Participants with an active, known or suspected autoimmune disease

Other protocol defined inclusion/exclusion criteria apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/09/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/03/2024
Sample size
Target
Accrual to date
Final
783
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - 0146 - Coffs Harbour
Recruitment hospital [2] 0 0
Local Institution - 0053 - North Sydney
Recruitment hospital [3] 0 0
Local Institution - 0058 - Cairns
Recruitment hospital [4] 0 0
Local Institution - Greenslopes
Recruitment hospital [5] 0 0
Local Institution - 0056 - Woolloongabba
Recruitment hospital [6] 0 0
Local Institution - 0172 - Elizabeth Vale
Recruitment hospital [7] 0 0
Local Institution - 0054 - Melbourne
Recruitment hospital [8] 0 0
Local Institution - 0143 - Melbourne
Recruitment hospital [9] 0 0
Local Institution - 0057 - Nedlands
Recruitment hospital [10] 0 0
Local Institution - 0097 - Nedlands
Recruitment postcode(s) [1] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [2] 0 0
2060 - North Sydney
Recruitment postcode(s) [3] 0 0
4870 - Cairns
Recruitment postcode(s) [4] 0 0
4120 - Greenslopes
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [6] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [7] 0 0
3000 - Melbourne
Recruitment postcode(s) [8] 0 0
3004 - Melbourne
Recruitment postcode(s) [9] 0 0
6009 - Nedlands
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
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Colorado
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State/province [4] 0 0
Connecticut
Country [5] 0 0
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State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
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Massachusetts
Country [9] 0 0
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Michigan
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Minnesota
Country [11] 0 0
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Missouri
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New Jersey
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New York
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Ohio
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Oregon
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Pennsylvania
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Texas
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Virginia
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Argentina
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Buenos Aires
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Argentina
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Ciudad Autónoma De Buenos Aires
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Argentina
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Distrito Federal
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Argentina
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Caba
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Cordoba
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Graz
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Austria
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Bruxelles
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Belgium
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Hasselt
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Leuven
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Ceara
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RIO Grande DO SUL
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Santa Catarina
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Sao Paulo
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Rio De Janeiro
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British Columbia
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Newfoundland and Labrador
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Ontario
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Edmonton
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Quebec
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Chile
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Metropolitana
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Czechia
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Brno
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Czechia
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Hradec Kralove
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Czechia
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Praha 10
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Czechia
State/province [45] 0 0
Praha 2
Country [46] 0 0
Finland
State/province [46] 0 0
Oulun Lääni
Country [47] 0 0
Finland
State/province [47] 0 0
KYS
Country [48] 0 0
Finland
State/province [48] 0 0
Turku
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France
State/province [49] 0 0
Bordeaux
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France
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Lille
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Montpellier Cedex 05
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Nantes Cedex 1
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Nice
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Rouen
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Toulouse Cedex 9
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Villejuif
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Buxtehude
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Erfurt
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Goettingen
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Kiel
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Leipzig
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Muenchen
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Münster
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Regensburg
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Tuebingen
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Wuerzburg
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Neo Faliro
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Thessaloniki
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Cork
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Dublin
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Beer Sheva
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Israel
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Jerusalem
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Israel
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Ramat-gan
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Italy
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Lombardia
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Italy
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Piemonte
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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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Meldola (fc)
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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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Siena
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Italy
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Torino
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Distrito Federal
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Mexico
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Jalisco
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Mexico
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Nuevo LEON
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Quintana Roo
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Puebla
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Mexico
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San Luis Potosi
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Netherlands
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Amsterdam
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Netherlands
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Leiden
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Netherlands
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Nijmegen
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Untrecht
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New Zealand
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Auckland
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New Zealand
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Christchurch
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New Zealand
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Wellington
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Poland
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Bydgoszcz
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Poland
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Warszawa
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Portugal
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Lisboa
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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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Craiova
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Romania
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Floresti
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Russian Federation
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Krasnoyarsk
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Russian Federation
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Moscow
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Spain
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Barcelona
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Spain
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Cordoba
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Spain
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Doniostia - San Sebastian
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Spain
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Donostia
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Spain
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Jaén
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Spain
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Madrid
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Spain
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Santiago Compostela
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Spain
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Valencia
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Sweden
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Gothenburg
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Sweden
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Lund
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Switzerland
State/province [126] 0 0
Bern
Country [127] 0 0
Switzerland
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Lausanne
Country [128] 0 0
Switzerland
State/province [128] 0 0
Zuerich
Country [129] 0 0
United Kingdom
State/province [129] 0 0
Hampshire
Country [130] 0 0
United Kingdom
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Midlothian
Country [131] 0 0
United Kingdom
State/province [131] 0 0
Surrey
Country [132] 0 0
United Kingdom
State/province [132] 0 0
Belfast
Country [133] 0 0
United Kingdom
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Cambridge
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United Kingdom
State/province [134] 0 0
Cottingham
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United Kingdom
State/province [135] 0 0
Liverpool
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United Kingdom
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London
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United Kingdom
State/province [137] 0 0
Manchester
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United Kingdom
State/province [138] 0 0
Tauton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Nektar Therapeutics
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Email 0 0
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Results are available at https://clinicaltrials.gov/study/NCT03635983