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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03635983
Registration number
NCT03635983
Ethics application status
Date submitted
16/08/2018
Date registered
17/08/2018
Date last updated
18/10/2023
Titles & IDs
Public title
A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma
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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
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Secondary ID [1]
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0
2018-001423-40
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Secondary ID [2]
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CA045-001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Melanoma
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Condition category
Condition code
Cancer
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0
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Malignant melanoma
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR)
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Assessment method [1]
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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.
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Timepoint [1]
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From date of randomization to disease progression (Up to 37 months)
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Primary outcome [2]
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Progression-free Survival (PFS) Per Blinded Independent Central Review (BICR)
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Assessment method [2]
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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.
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Timepoint [2]
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From date of randomization to disease progression, or death, whichever comes first (Up to 37 months)
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Primary outcome [3]
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Overall Survival (OS)
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Assessment method [3]
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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.
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Timepoint [3]
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From date of randomization to date of death (Up to 37 months)
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Secondary outcome [1]
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Clinical Benefit Rate (CBR) Per Blinded Independent Central Review (BICR)
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Assessment method [1]
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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.
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Timepoint [1]
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From date of randomization to disease progression (Up to 37 months)
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Secondary outcome [2]
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Duration of Response (DoR) Per Blinded Independent Central Review (BICR)
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Assessment method [2]
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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.
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Timepoint [2]
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From date of randomization to disease progression, or death, whichever is earlier (Up to 37 months)
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Secondary outcome [3]
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Time to Objective Response (TTR) Per Blinded Independent Central Review (BICR)
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Assessment method [3]
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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.
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Timepoint [3]
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From date of randomization to disease progression (Up to 37 months)
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Secondary outcome [4]
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Objective Response Rate (ORR) Per Investigator
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Assessment method [4]
0
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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.
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Timepoint [4]
0
0
From date of randomization to disease progression (Up to 37 months)
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Secondary outcome [5]
0
0
Progression-free Survival (PFS) Per Investigator
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Assessment method [5]
0
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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.
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Timepoint [5]
0
0
From date of randomization to disease progression, or death, whichever comes first (Up to 37 months)
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Secondary outcome [6]
0
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Clinical Benefit Rate (CBR) Per Investigator
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Assessment method [6]
0
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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.
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Timepoint [6]
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From date of randomization to disease progression (Up to 37 months)
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Secondary outcome [7]
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Duration of Response (DoR) Per Investigator
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Assessment method [7]
0
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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.
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Timepoint [7]
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0
From date of randomization to disease progression, or death, whichever is earlier (Up to 37 months)
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Secondary outcome [8]
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Time to Objective Response (TTR) Per Investigator
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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.
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Timepoint [8]
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From date of randomization to disease progression (Up to 37 months)
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Secondary outcome [9]
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Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) by Baseline PD-L1 Status
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Assessment method [9]
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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.
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Timepoint [9]
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From date of randomization to disease progression (Up to 37 months)
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Secondary outcome [10]
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Progression-free Survival (PFS) Per Blinded Independent Central Review (BICR) by Baseline PD-L1 Status
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Assessment method [10]
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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.
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Timepoint [10]
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From date of randomization to disease progression, or death, whichever comes first (Up to 37 months)
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Secondary outcome [11]
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Overall Survival (OS) by Baseline PD-L1 Status
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Assessment method [11]
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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.
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Timepoint [11]
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From date of randomization to date of death (Up to 37 months)
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Secondary outcome [12]
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Number of Participants With Adverse Events (AEs)
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Assessment method [12]
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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.
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Timepoint [12]
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From first dose to 30 days post last dose (Average of 8 months and a maximum up to 35 months)
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Secondary outcome [13]
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Number of Participants With On-Treatment Laboratory Parameters That Worsened Relative to Baseline
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Assessment method [13]
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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
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Timepoint [13]
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From first dose to 100 days post last dose (Average of 10 months and a maximum up to 37 months)
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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
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Minimum age
12
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/09/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
6/09/2023
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Sample size
Target
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Accrual to date
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Final
783
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Local Institution - 0146 - Coffs Harbour
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Recruitment hospital [2]
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Local Institution - 0053 - North Sydney
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Recruitment hospital [3]
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Local Institution - 0058 - Cairns
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Recruitment hospital [4]
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Local Institution - Greenslopes
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Recruitment hospital [5]
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Local Institution - 0056 - Woolloongabba
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Recruitment hospital [6]
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Local Institution - 0172 - Elizabeth Vale
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Recruitment hospital [7]
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Local Institution - 0054 - Melbourne
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Recruitment hospital [8]
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Local Institution - 0143 - Melbourne
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Recruitment hospital [9]
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Local Institution - 0057 - Nedlands
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Recruitment hospital [10]
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Local Institution - 0097 - Nedlands
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Recruitment postcode(s) [1]
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2450 - Coffs Harbour
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Recruitment postcode(s) [2]
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2060 - North Sydney
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Recruitment postcode(s) [3]
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4870 - Cairns
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Recruitment postcode(s) [4]
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4120 - Greenslopes
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Recruitment postcode(s) [5]
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4102 - Woolloongabba
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Recruitment postcode(s) [6]
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5112 - Elizabeth Vale
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Recruitment postcode(s) [7]
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3000 - Melbourne
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Recruitment postcode(s) [8]
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3004 - Melbourne
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Recruitment postcode(s) [9]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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United States of America
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California
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Colorado
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Connecticut
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Florida
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Georgia
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Kentucky
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United States of America
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Massachusetts
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Michigan
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Buenos Aires
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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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Oulun Lääni
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Leipzig
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Muenchen
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Münster
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Tuebingen
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Floresti
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Tauton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Other collaborator category [1]
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Nektar Therapeutics
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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
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03635983
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Contacts
Principal investigator
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Bristol-Myers Squibb
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Bristol-Myers Squibb
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03635983
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