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

A Phase 3, Randomized, Open-label Study of NKTR-214 Combined With Nivolumab Versus Nivolumab in Participants With Previously Untreated Unresectable 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

Study Overview

• Status: Completed
• Conditions: Melanoma
• Intervention / Treatment: Biological: Nivolumab; Biological: NKTR-214

• Study Type: Interventional
• Enrollment (Actual): 783
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combination; NKTR-214 + Nivolumab	Biological: Nivolumab; Specified dose on specified days; Other Names: BMS-936558; Opdivo; Biological: NKTR-214; Specified dose on specified days; Other Names: BMS-986321; Bempegaldesleukin
Experimental: Monotherapy; Nivolumab	Biological: Nivolumab; Specified dose on specified days; Other Names: BMS-936558; Opdivo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From date of randomization to disease progression (Up to 37 months)
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.	From date of randomization to disease progression, or death, whichever comes first (Up to 37 months)
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.	From date of randomization to date of death (Up to 37 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From date of randomization to disease progression (Up to 37 months)
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.	From date of randomization to disease progression, or death, whichever is earlier (Up to 37 months)
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.	From date of randomization to disease progression (Up to 37 months)
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.	From date of randomization to disease progression (Up to 37 months)
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.	From date of randomization to disease progression, or death, whichever comes first (Up to 37 months)
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.	From date of randomization to disease progression (Up to 37 months)
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.	From date of randomization to disease progression, or death, whichever is earlier (Up to 37 months)
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.	From date of randomization to disease progression (Up to 37 months)
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.	From date of randomization to disease progression (Up to 37 months)
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.	From date of randomization to disease progression, or death, whichever comes first (Up to 37 months)
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.	From date of randomization to date of death (Up to 37 months)
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.	From first dose to 30 days post last dose (Average of 8 months and a maximum up to 35 months)
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	From first dose to 100 days post last dose (Average of 10 months and a maximum up to 37 months)

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Collaborators: Nektar Therapeutics
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

General 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.

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2018
• Primary Completion (Actual): November 19, 2021
• Study Completion (Actual): September 6, 2023

Study Registration Dates

• First Submitted: August 16, 2018
• First Submitted That Met QC Criteria: August 16, 2018
• First Posted (Actual): August 17, 2018

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 11, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Nivolumab; Immunotherapy; NKTR-214; bempegaldesleukin (BEMPEG: NKTR-214)
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Nivolumab
• Other Study ID Numbers: CA045-001; 2018-001423-40 (EudraCT Number); 17-214-08 (Other Identifier: Nektar Therapeutics)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No