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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
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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
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/study/NCT03635983
Trial related presentations / publications
Khushalani NI, Diab A, Ascierto PA, Larkin J, Sandhu S, Sznol M, Koon HB, Jarkowski A, Zhou M, Statkevich P, Geese WJ, Long GV. Bempegaldesleukin plus nivolumab in untreated, unresectable or metastatic melanoma: Phase III PIVOT IO 001 study design. Future Oncol. 2020 Oct;16(28):2165-2175. doi: 10.2217/fon-2020-0351. Epub 2020 Jul 29.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03635983