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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
21/06/2024

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)
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)
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)
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)
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)
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)
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
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
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
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
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
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
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
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
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)
Timepoint [12] 0 0
From first dose to 30 days post last dose (Average of 8 months and a maximum up to 35 months)
Secondary outcome [13] 0 0
Number of Participants With On-Treatment Laboratory Parameters That Worsened Relative to Baseline
Timepoint [13] 0 0
From first dose to 100 days post last dose (Average of 10 months and a maximum up to 37 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
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Arizona
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California
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Colorado
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Connecticut
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Massachusetts
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Michigan
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Missouri
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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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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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Distrito Federal
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Caba
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Cordoba
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Graz
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KYS
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Barcelona
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Valencia
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Lausanne
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Zuerich
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United Kingdom
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Hampshire
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Midlothian
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Surrey
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Belfast
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Cambridge
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Cottingham
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Liverpool
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London
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Manchester
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United Kingdom
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Tauton

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
Nektar Therapeutics
Address [1] 0 0
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
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT03635983