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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03635983
Ethics application status
Date submitted
16/08/2018
Date registered
17/08/2018
Date last updated
30/06/2020

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
Other interventions - NKTR-214
Other interventions - Nivolumab

Experimental: Combination - NKTR-214 + Nivolumab

Experimental: Monotherapy - Nivolumab


Other interventions: NKTR-214
Specified dose on specified days

Other interventions: Nivolumab
Specified dose on specified days

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall response rate (ORR) by Blinded Independent Central Review (BICR)
Timepoint [1] 0 0
Approximately 16 months
Primary outcome [2] 0 0
Progression-free survival (PFS) by BICR
Timepoint [2] 0 0
Approximately 22 months
Primary outcome [3] 0 0
Overall survival (OS)
Timepoint [3] 0 0
Up to 59 months
Secondary outcome [1] 0 0
Clinical benefit rate (CBR)
Timepoint [1] 0 0
Approximately 16 months
Secondary outcome [2] 0 0
Duration of response (DoR)
Timepoint [2] 0 0
Approximately 16 months
Secondary outcome [3] 0 0
Time to response (TTR)
Timepoint [3] 0 0
Approximately 16 months
Secondary outcome [4] 0 0
ORR by investigator and in biomarker population
Timepoint [4] 0 0
Approximately 16 months
Secondary outcome [5] 0 0
PFS by investigator and in biomarker population
Timepoint [5] 0 0
Approximately 22 months
Secondary outcome [6] 0 0
OS in biomarker population
Timepoint [6] 0 0
Up to 59 months
Secondary outcome [7] 0 0
Incidence of participants with non-serious Adverse Events (AEs)
Timepoint [7] 0 0
Up to 5 years
Secondary outcome [8] 0 0
Incidence of participants with Serious Adverse Events (SAEs)
Timepoint [8] 0 0
Up to 5 years
Secondary outcome [9] 0 0
Incidence of treatment-related AEs
Timepoint [9] 0 0
Up to 5 years
Secondary outcome [10] 0 0
Incidence of treatment-related SAEs
Timepoint [10] 0 0
Up to 5 years
Secondary outcome [11] 0 0
Incidence of laboratory abnormalities in blood
Timepoint [11] 0 0
Up to 5 years
Secondary outcome [12] 0 0
Incidence of laboratory abnormalities in blood serum
Timepoint [12] 0 0
Up to 5 years
Secondary outcome [13] 0 0
Incidence of laboratory abnormalities in urine
Timepoint [13] 0 0
Up to 5 years

Eligibility
Key inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com



- 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
Gender
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 could 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
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
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NSW,QLD,VIC,WA
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 - Cairns
Recruitment hospital [4] 0 0
Local Institution - Greenslopes
Recruitment hospital [5] 0 0
Local Institution - Woolloongabba
Recruitment hospital [6] 0 0
Local Institution - Melbourne
Recruitment hospital [7] 0 0
Local Institution - 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
4012 - Woolloongabba
Recruitment postcode(s) [6] 0 0
3000 - Melbourne
Recruitment postcode(s) [7] 0 0
3004 - Melbourne
Recruitment postcode(s) [8] 0 0
6009 - Nedlands
Recruitment outside Australia
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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
The purpose of the study is to test the effectiveness (how well the drug works), safety, and
tolerability of the investigational drug called NKTR-214, when combined with nivolumab versus
nivolumab given alone in participants with previously untreated melanoma skin cancer that is
either unable to be surgically removed or has spread
Trial website
https://clinicaltrials.gov/show/NCT03635983
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,
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/NCT03635983