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

Primary Purpose

Melanoma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
NKTR-214
Nivolumab
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma focused on measuring NKTR-214, Nivolumab, Immunotherapy, bempegaldesleukin (BEMPEG: NKTR-214)

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Local Institution - 0187
  • Local Institution - 0014
  • Local Institution - 0122
  • Local Institution - 0051
  • Local Institution - 0065
  • Local Institution - 0017
  • Local Institution - 0153
  • Local Institution - 0112
  • Local Institution - 0012
  • Local Institution - 0019
  • Local Institution - 0018
  • Local Institution - 0188
  • Local Institution - 0186
  • Local Institution - 0135
  • Local Institution - 0016
  • Local Institution - 0185
  • Local Institution - 0141
  • Local Institution - 0037
  • Local Institution - 0011
  • Local Institution - 0013
  • St. Luke's Hospital & Health Network
  • Local Institution - 0015
  • Local Institution - 0001
  • Local Institution - 0064
  • Local Institution - 0109
  • Local Institution - 0107
  • Local Institution - 0183
  • Local Institution - 0108
  • Local Institution - 0157
  • Local Institution - 0146
  • Local Institution - 0053
  • Local Institution - 0058
  • Local Institution
  • Local Institution - 0056
  • Local Institution - 0172
  • Local Institution - 0054
  • Local Institution - 0143
  • Local Institution - 0057
  • Local Institution - 0097
  • Local Institution - 0034
  • Local Institution - 0035
  • Local Institution - 0033
  • Local Institution - 0083
  • Local Institution - 0084
  • Local Institution - 0085
  • Local Institution - 0168
  • Local Institution - 0125
  • Local Institution - 0124
  • Local Institution - 0127
  • Local Institution - 0171
  • Local Institution - 0126
  • Local Institution - 0182
  • Local Institution - 0169
  • Local Institution - 0068
  • Local Institution - 0139
  • Local Institution - 0066
  • Local Institution - 0067
  • Local Institution - 0041
  • Local Institution - 0121
  • Local Institution
  • Local Institution - 0174
  • Local Institution - 0173
  • Local Institution - 0094
  • Local Institution - 0093
  • Local Institution - 0091
  • Local Institution - 0092
  • Local Institution - 0166
  • Local Institution - 0167
  • Local Institution - 0165
  • Centre Hospitalier Universitaire de Bordeaux Hospital Saint Andre
  • Hopital Claude Huriez
  • Hopital Saint Eloi
  • Hotel Dieu - Chu De Nantes
  • Chu De Nice Hopital De Cimiez
  • Hopital Saint Louis
  • Centre Hospitalier Lyon Sud
  • CHU Charles Nicolle
  • Hopital Nord - CHU de Saint-Etienne
  • Institut Claudius Regaud
  • Institute Gustave Roussy
  • Local Institution - 0031
  • Local Institution - 0029
  • Local Institution - 0192
  • Local Institution - 0026
  • Local Institution - 0030
  • Local Institution - 0023
  • Local Institution - 0024
  • Local Institution - 0020
  • Local Institution - 0028
  • Local Institution - 0022
  • Local Institution - 0021
  • Local Institution - 0027
  • Local Institution - 0060
  • Local Institution - 0025
  • Local Institution - 0032
  • Local Institution - 0038
  • Local Institution - 0039
  • Local Institution - 0040
  • Local Institution - 0136
  • Local Institution - 0129
  • Local Institution - 0128
  • Local Institution - 0130
  • Local Institution - 0098
  • Local Institution - 0088
  • Local Institution - 0089
  • Istituto Europeo di Oncologia IRCCS
  • Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
  • IRCCS Giovanni Paolo II Istituto Oncologico
  • ASST Papa Giovanni XXIII
  • IRST Meldola
  • IRCCS Istituto Nazionale Tumori Milano
  • Instituto Nazionale Tumori Fondazione G. Pascale
  • Istituto Oncologico Veneto IOV
  • Azienda Ospedaliera Universitaria Senese
  • Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia
  • Local Institution - 0175
  • Local Institution - 0176
  • Local Institution - 0177
  • Local Institution - 0180
  • Local Institution - 0178
  • Local Institution - 0179
  • Local Institution - 0181
  • Local Institution - 0101
  • Local Institution - 0102
  • Local Institution - 0099
  • Local Institution - 0100
  • Local Institution - 0147
  • Local Institution - 0159
  • Local Institution - 0063
  • Local Institution - 0062
  • Local Institution - 0152
  • Local Institution - 0090
  • Local Institution - 0134
  • Local Institution - 0133
  • Local Institution - 0162
  • Local Institution - 0070
  • Local Institution - 0071
  • Local Institution - 0120
  • Local Institution - 0149
  • Local Institution - 0086
  • Local Institution - 0111
  • Local Institution - 0148
  • Local Institution - 0116
  • Local Institution - 0115
  • Local Institution - 0123
  • Local Institution - 0190
  • Local Institution
  • Local Institution - 0118
  • Local Institution - 0114
  • Local Institution - 0119
  • Local Institution - 0117
  • Local Institution - 0163
  • Local Institution - 0164
  • Local Institution - 0104
  • Local Institution - 0105
  • Local Institution - 0036
  • Local Institution - 0132
  • Local Institution
  • Local Institution - 0131
  • Local Institution - 0078
  • Local Institution - 0076
  • Local Institution - 0079
  • Local Institution - 0137
  • Local Institution - 0077
  • Local Institution - 0074
  • Local Institution - 0075
  • Local Institution - 0142

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Combination

Monotherapy

Arm Description

NKTR-214 + Nivolumab

Nivolumab

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR)
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.
Progression-free Survival (PFS) Per Blinded Independent Central Review (BICR)
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.
Overall Survival (OS)
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 Outcome Measures

Clinical Benefit Rate (CBR) Per Blinded Independent Central Review (BICR)
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.
Duration of Response (DoR) Per Blinded Independent Central Review (BICR)
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.
Time to Objective Response (TTR) Per Blinded Independent Central Review (BICR)
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.
Objective Response Rate (ORR) Per Investigator
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.
Progression-free Survival (PFS) Per Investigator
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.
Clinical Benefit Rate (CBR) Per Investigator
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.
Duration of Response (DoR) Per Investigator
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.
Time to Objective Response (TTR) Per Investigator
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.
Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) by Baseline PD-L1 Status
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.
Progression-free Survival (PFS) Per Blinded Independent Central Review (BICR) by Baseline PD-L1 Status
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.
Overall Survival (OS) by Baseline PD-L1 Status
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.
Number of Participants With Adverse Events (AEs)
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.
Number of Participants With On-Treatment Laboratory Parameters That Worsened Relative to Baseline
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

Full Information

First Posted
August 16, 2018
Last Updated
October 11, 2023
Sponsor
Bristol-Myers Squibb
Collaborators
Nektar Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT03635983
Brief Title
A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
September 21, 2018 (Actual)
Primary Completion Date
November 19, 2021 (Actual)
Study Completion Date
September 6, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
Collaborators
Nektar Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
NKTR-214, Nivolumab, Immunotherapy, bempegaldesleukin (BEMPEG: NKTR-214)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
783 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Combination
Arm Type
Experimental
Arm Description
NKTR-214 + Nivolumab
Arm Title
Monotherapy
Arm Type
Experimental
Arm Description
Nivolumab
Intervention Type
Biological
Intervention Name(s)
NKTR-214
Other Intervention Name(s)
Bempegaldesleukin, BMS-986321
Intervention Description
Specified dose on specified days
Intervention Type
Biological
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
Opdivo, BMS-936558
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR)
Description
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.
Time Frame
From date of randomization to disease progression (Up to 37 months)
Title
Progression-free Survival (PFS) Per Blinded Independent Central Review (BICR)
Description
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.
Time Frame
From date of randomization to disease progression, or death, whichever comes first (Up to 37 months)
Title
Overall Survival (OS)
Description
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.
Time Frame
From date of randomization to date of death (Up to 37 months)
Secondary Outcome Measure Information:
Title
Clinical Benefit Rate (CBR) Per Blinded Independent Central Review (BICR)
Description
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.
Time Frame
From date of randomization to disease progression (Up to 37 months)
Title
Duration of Response (DoR) Per Blinded Independent Central Review (BICR)
Description
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.
Time Frame
From date of randomization to disease progression, or death, whichever is earlier (Up to 37 months)
Title
Time to Objective Response (TTR) Per Blinded Independent Central Review (BICR)
Description
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.
Time Frame
From date of randomization to disease progression (Up to 37 months)
Title
Objective Response Rate (ORR) Per Investigator
Description
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.
Time Frame
From date of randomization to disease progression (Up to 37 months)
Title
Progression-free Survival (PFS) Per Investigator
Description
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.
Time Frame
From date of randomization to disease progression, or death, whichever comes first (Up to 37 months)
Title
Clinical Benefit Rate (CBR) Per Investigator
Description
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.
Time Frame
From date of randomization to disease progression (Up to 37 months)
Title
Duration of Response (DoR) Per Investigator
Description
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.
Time Frame
From date of randomization to disease progression, or death, whichever is earlier (Up to 37 months)
Title
Time to Objective Response (TTR) Per Investigator
Description
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.
Time Frame
From date of randomization to disease progression (Up to 37 months)
Title
Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) by Baseline PD-L1 Status
Description
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.
Time Frame
From date of randomization to disease progression (Up to 37 months)
Title
Progression-free Survival (PFS) Per Blinded Independent Central Review (BICR) by Baseline PD-L1 Status
Description
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.
Time Frame
From date of randomization to disease progression, or death, whichever comes first (Up to 37 months)
Title
Overall Survival (OS) by Baseline PD-L1 Status
Description
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.
Time Frame
From date of randomization to date of death (Up to 37 months)
Title
Number of Participants With Adverse Events (AEs)
Description
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.
Time Frame
From first dose to 30 days post last dose (Average of 8 months and a maximum up to 35 months)
Title
Number of Participants With On-Treatment Laboratory Parameters That Worsened Relative to Baseline
Description
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
Time Frame
From first dose to 100 days post last dose (Average of 10 months and a maximum up to 37 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 0187
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Local Institution - 0014
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Local Institution - 0122
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Local Institution - 0051
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Local Institution - 0065
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Local Institution - 0017
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Local Institution - 0153
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Local Institution - 0112
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Local Institution - 0012
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322-1013
Country
United States
Facility Name
Local Institution - 0019
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Local Institution - 0018
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Local Institution - 0188
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Local Institution - 0186
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Local Institution - 0135
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Local Institution - 0016
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Local Institution - 0185
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Local Institution - 0141
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Local Institution - 0037
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Local Institution - 0011
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Local Institution - 0013
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
St. Luke's Hospital & Health Network
City
Easton
State/Province
Pennsylvania
ZIP/Postal Code
18045
Country
United States
Facility Name
Local Institution - 0015
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Local Institution - 0001
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Local Institution - 0064
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Local Institution - 0109
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
1430
Country
Argentina
Facility Name
Local Institution - 0107
City
Buenos Aires
State/Province
Ciudad Autónoma De Buenos Aires
ZIP/Postal Code
C1118AAT
Country
Argentina
Facility Name
Local Institution - 0183
City
Buenos Aires
State/Province
Distrito Federal
ZIP/Postal Code
C1017
Country
Argentina
Facility Name
Local Institution - 0108
City
Caba
ZIP/Postal Code
1426
Country
Argentina
Facility Name
Local Institution - 0157
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Local Institution - 0146
City
Coffs Harbour
State/Province
New South Wales
ZIP/Postal Code
2450
Country
Australia
Facility Name
Local Institution - 0053
City
North Sydney
State/Province
New South Wales
ZIP/Postal Code
2060
Country
Australia
Facility Name
Local Institution - 0058
City
Cairns
State/Province
Queensland
ZIP/Postal Code
4870
Country
Australia
Facility Name
Local Institution
City
Greenslopes
State/Province
Queensland
ZIP/Postal Code
4120
Country
Australia
Facility Name
Local Institution - 0056
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Local Institution - 0172
City
Elizabeth Vale
State/Province
South Australia
ZIP/Postal Code
5112
Country
Australia
Facility Name
Local Institution - 0054
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
Local Institution - 0143
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Local Institution - 0057
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Local Institution - 0097
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Local Institution - 0034
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Local Institution - 0035
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Local Institution - 0033
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Local Institution - 0083
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Local Institution - 0084
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
Local Institution - 0085
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
Local Institution - 0168
City
Fortaleza
State/Province
Ceara
ZIP/Postal Code
60130-241
Country
Brazil
Facility Name
Local Institution - 0125
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30130-090
Country
Brazil
Facility Name
Local Institution - 0124
City
Ijui
State/Province
RIO Grande DO SUL
ZIP/Postal Code
98700-000
Country
Brazil
Facility Name
Local Institution - 0127
City
Porto Alegre
State/Province
RIO Grande DO SUL
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Local Institution - 0171
City
Itajai
State/Province
Santa Catarina
ZIP/Postal Code
88301-220
Country
Brazil
Facility Name
Local Institution - 0126
City
Barretos
State/Province
Sao Paulo
ZIP/Postal Code
14780-070
Country
Brazil
Facility Name
Local Institution - 0182
City
Rio De Janeiro
ZIP/Postal Code
20231-050
Country
Brazil
Facility Name
Local Institution - 0169
City
Sao Paulo
ZIP/Postal Code
01509-010
Country
Brazil
Facility Name
Local Institution - 0068
City
Abbotsford
State/Province
British Columbia
ZIP/Postal Code
V2S 0C2
Country
Canada
Facility Name
Local Institution - 0139
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Facility Name
Local Institution - 0066
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Local Institution - 0067
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2G 1G3
Country
Canada
Facility Name
Local Institution - 0041
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Local Institution - 0121
City
Edmonton
ZIP/Postal Code
T6X 1E8
Country
Canada
Facility Name
Local Institution
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Local Institution - 0174
City
Recoleta
State/Province
Metropolitana
ZIP/Postal Code
0
Country
Chile
Facility Name
Local Institution - 0173
City
Santiago
State/Province
Metropolitana
ZIP/Postal Code
8330024
Country
Chile
Facility Name
Local Institution - 0094
City
Brno
ZIP/Postal Code
656 53
Country
Czechia
Facility Name
Local Institution - 0093
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Local Institution - 0091
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Local Institution - 0092
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Local Institution - 0166
City
Tampere
State/Province
Oulun Lääni
ZIP/Postal Code
FI-33520
Country
Finland
Facility Name
Local Institution - 0167
City
KYS
ZIP/Postal Code
70029
Country
Finland
Facility Name
Local Institution - 0165
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
Centre Hospitalier Universitaire de Bordeaux Hospital Saint Andre
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Hopital Claude Huriez
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Hopital Saint Eloi
City
Montpellier Cedex 05
ZIP/Postal Code
34295
Country
France
Facility Name
Hotel Dieu - Chu De Nantes
City
Nantes Cedex 1
ZIP/Postal Code
44093
Country
France
Facility Name
Chu De Nice Hopital De Cimiez
City
Nice
ZIP/Postal Code
06200
Country
France
Facility Name
Hopital Saint Louis
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Benite
ZIP/Postal Code
69310
Country
France
Facility Name
CHU Charles Nicolle
City
Rouen
ZIP/Postal Code
76000
Country
France
Facility Name
Hopital Nord - CHU de Saint-Etienne
City
Saint Priest en Jarez
ZIP/Postal Code
42270
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Institute Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Local Institution - 0031
City
Buxtehude
ZIP/Postal Code
21614
Country
Germany
Facility Name
Local Institution - 0029
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Local Institution - 0192
City
Erfurt
ZIP/Postal Code
99089
Country
Germany
Facility Name
Local Institution - 0026
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Local Institution - 0030
City
Goettingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Local Institution - 0023
City
Hamburg
ZIP/Postal Code
20251
Country
Germany
Facility Name
Local Institution - 0024
City
Hannover
ZIP/Postal Code
D30625
Country
Germany
Facility Name
Local Institution - 0020
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Local Institution - 0028
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Local Institution - 0022
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Local Institution - 0021
City
Muenchen
ZIP/Postal Code
80337
Country
Germany
Facility Name
Local Institution - 0027
City
Münster
ZIP/Postal Code
48157
Country
Germany
Facility Name
Local Institution - 0060
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Local Institution - 0025
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Local Institution - 0032
City
Wuerzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Local Institution - 0038
City
Athens
ZIP/Postal Code
11526
Country
Greece
Facility Name
Local Institution - 0039
City
Neo Faliro
ZIP/Postal Code
18547
Country
Greece
Facility Name
Local Institution - 0040
City
Thessaloniki
ZIP/Postal Code
57001
Country
Greece
Facility Name
Local Institution - 0136
City
Wilton
State/Province
Cork
ZIP/Postal Code
0
Country
Ireland
Facility Name
Local Institution - 0129
City
Dublin 7
State/Province
Dublin
ZIP/Postal Code
0
Country
Ireland
Facility Name
Local Institution - 0128
City
Dublin
ZIP/Postal Code
4
Country
Ireland
Facility Name
Local Institution - 0130
City
Dublin
ZIP/Postal Code
Dublin 7
Country
Ireland
Facility Name
Local Institution - 0098
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Local Institution - 0088
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Local Institution - 0089
City
Ramat-gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Istituto Europeo di Oncologia IRCCS
City
Milan
State/Province
Lombardia
ZIP/Postal Code
20141
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10126
Country
Italy
Facility Name
IRCCS Giovanni Paolo II Istituto Oncologico
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
ASST Papa Giovanni XXIII
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
IRST Meldola
City
Meldola (fc)
ZIP/Postal Code
47014
Country
Italy
Facility Name
IRCCS Istituto Nazionale Tumori Milano
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Instituto Nazionale Tumori Fondazione G. Pascale
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Istituto Oncologico Veneto IOV
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Senese
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia
City
Torino
ZIP/Postal Code
10060
Country
Italy
Facility Name
Local Institution - 0175
City
Ciudad de Mexico
State/Province
Distrito Federal
ZIP/Postal Code
03100
Country
Mexico
Facility Name
Local Institution - 0176
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45070
Country
Mexico
Facility Name
Local Institution - 0177
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Local Institution - 0180
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64710
Country
Mexico
Facility Name
Local Institution - 0178
City
Cancún
State/Province
Quintana Roo
ZIP/Postal Code
77500
Country
Mexico
Facility Name
Local Institution - 0179
City
Puebla
ZIP/Postal Code
72424
Country
Mexico
Facility Name
Local Institution - 0181
City
San Luis Potosi
ZIP/Postal Code
78200
Country
Mexico
Facility Name
Local Institution - 0101
City
Amsterdam
ZIP/Postal Code
1066CX
Country
Netherlands
Facility Name
Local Institution - 0102
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Local Institution - 0099
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
Local Institution - 0100
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
Local Institution - 0147
City
Untrecht
ZIP/Postal Code
3584CX
Country
Netherlands
Facility Name
Local Institution - 0159
City
Auckland
ZIP/Postal Code
1142
Country
New Zealand
Facility Name
Local Institution - 0063
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Local Institution - 0062
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Local Institution - 0152
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Local Institution - 0090
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Local Institution - 0134
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Local Institution - 0133
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Local Institution - 0162
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Local Institution - 0070
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Local Institution - 0071
City
Craiova
ZIP/Postal Code
200542
Country
Romania
Facility Name
Local Institution - 0120
City
Floresti
ZIP/Postal Code
407280
Country
Romania
Facility Name
Local Institution - 0149
City
Krasnoyarsk
ZIP/Postal Code
660133
Country
Russian Federation
Facility Name
Local Institution - 0086
City
Moscow
ZIP/Postal Code
105229
Country
Russian Federation
Facility Name
Local Institution - 0111
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Local Institution - 0148
City
Moscow
ZIP/Postal Code
121309
Country
Russian Federation
Facility Name
Local Institution - 0116
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Local Institution - 0115
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Local Institution - 0123
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Local Institution - 0190
City
Doniostia - San Sebastian
ZIP/Postal Code
20014
Country
Spain
Facility Name
Local Institution
City
Donostia
ZIP/Postal Code
20014
Country
Spain
Facility Name
Local Institution - 0118
City
Jaén
ZIP/Postal Code
23007
Country
Spain
Facility Name
Local Institution - 0114
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Local Institution - 0119
City
Santiago Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Local Institution - 0117
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Local Institution - 0163
City
Gothenburg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Local Institution - 0164
City
Lund
ZIP/Postal Code
222 42
Country
Sweden
Facility Name
Local Institution - 0104
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Local Institution - 0105
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Local Institution - 0036
City
Zuerich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Local Institution - 0132
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Local Institution
City
Edinburgh
State/Province
Midlothian
ZIP/Postal Code
EH16 4SB
Country
United Kingdom
Facility Name
Local Institution - 0131
City
Sutton.
State/Province
Surrey
ZIP/Postal Code
SM25PT
Country
United Kingdom
Facility Name
Local Institution - 0078
City
Belfast
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Facility Name
Local Institution - 0076
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Local Institution - 0079
City
Cottingham
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Facility Name
Local Institution - 0137
City
Liverpool
ZIP/Postal Code
L7 8YA
Country
United Kingdom
Facility Name
Local Institution - 0077
City
London
ZIP/Postal Code
SW17 0RE
Country
United Kingdom
Facility Name
Local Institution - 0074
City
London
ZIP/Postal Code
SW36JJ
Country
United Kingdom
Facility Name
Local Institution - 0075
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Local Institution - 0142
City
Tauton
ZIP/Postal Code
TA1 5DA
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
32723187
Citation
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.
Results Reference
derived
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting

Learn more about this trial

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

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