Skip to main content
OpenTrials
Completed

NCT Number: NCT03635983

A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution - 0109, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

NKTR-214

Biological

Specified dose on specified days

Other names: Bempegaldesleukin, BMS-986321

Nivolumab

Biological

Specified dose on specified days

Other names: Opdivo, BMS-936558

Primary outcomes

  1. Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR)

    Time frame: From date of randomization to disease progression (Up to 37 months)

    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.

  2. Progression-free Survival (PFS) Per Blinded Independent Central Review (BICR)

    Time frame: From date of randomization to disease progression, or death, whichever comes first (Up to 37 months)

    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.

  3. Overall Survival (OS)

    Time frame: From date of randomization to date of death (Up to 37 months)

    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.

Secondary outcomes

  1. Clinical Benefit Rate (CBR) Per Blinded Independent Central Review (BICR)

    Time frame: From date of randomization to disease progression (Up to 37 months)

    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.

  2. Duration of Response (DoR) Per Blinded Independent Central Review (BICR)

    Time frame: From date of randomization to disease progression, or death, whichever is earlier (Up to 37 months)

    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.

  3. Time to Objective Response (TTR) Per Blinded Independent Central Review (BICR)

    Time frame: From date of randomization to disease progression (Up to 37 months)

    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.

  4. Objective Response Rate (ORR) Per Investigator

    Time frame: From date of randomization to disease progression (Up to 37 months)

    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.

  5. Progression-free Survival (PFS) Per Investigator

    Time frame: From date of randomization to disease progression, or death, whichever comes first (Up to 37 months)

    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.

  6. Clinical Benefit Rate (CBR) Per Investigator

    Time frame: From date of randomization to disease progression (Up to 37 months)

    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.

  7. Duration of Response (DoR) Per Investigator

    Time frame: From date of randomization to disease progression, or death, whichever is earlier (Up to 37 months)

    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.

  8. Time to Objective Response (TTR) Per Investigator

    Time frame: From date of randomization to disease progression (Up to 37 months)

    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.

  9. Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) by Baseline PD-L1 Status

    Time frame: From date of randomization to disease progression (Up to 37 months)

    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.

  10. Progression-free Survival (PFS) Per Blinded Independent Central Review (BICR) by Baseline PD-L1 Status

    Time frame: From date of randomization to disease progression, or death, whichever comes first (Up to 37 months)

    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.

  11. Overall Survival (OS) by Baseline PD-L1 Status

    Time frame: From date of randomization to date of death (Up to 37 months)

    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.

  12. Number of Participants With Adverse Events (AEs)

    Time frame: From first dose to 30 days post last dose (Average of 11 months and a maximum up to 26 months)

    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.

  13. Number of Participants With On-Treatment Laboratory Parameters That Worsened Relative to Baseline

    Time frame: From first dose to 100 days post last dose (Average of 13 months and a maximum up to 28 months)

    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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • Nektar Therapeutics

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2021
Study completion
2024
First posted
Aug 17, 2018
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.