Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence (PIVOT-12)

March 31, 2023 updated by: Nektar Therapeutics

A Phase 3, Randomized, Open-label Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence (PIVOT-12)

The main purpose of this study is to compare the efficacy of bempegaldesleukin plus nivolumab versus nivolumab in patients with completely resected Stage IIIA/B/C/D, or Stage IV cutaneous melanoma who are at high risk for recurrence.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The main purpose of this study is to compare the efficacy, as measured by recurrence-free survival (RFS) by blinded independent central review (BICR), of bempegaldesleukin plus nivolumab versus nivolumab in patients with completely resected Stage IIIA (lymph node [LN] metastasis > 1 mm), Stage IIIB/C/D, or Stage IV (American Joint Committee on Cancer [AJCC] 8th edition) cutaneous melanoma with no evidence of disease (NED) who are at high risk for recurrence.

Study Type

Interventional

Enrollment (Actual)

765

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Adelaide, Australia, 5000
        • Royal Adelaide Hospital
      • Cairns, Australia, 4870
        • Cairns Hospital
      • Chermside, Australia, 4032
        • Icon Cancer Care Wesley
      • Greenslopes, Australia, 4120
        • Gallipoli Medical Research Foundation
      • Heidelberg, Australia, 3084
        • Austin Health
      • Melbourne, Australia, 3004
        • Alfred Hospital
      • Nedlands, Australia, 6009
        • Sir Charles Gairdner Hospital
      • Nedlands, Australia, 6009
        • Affinity Clinical Research
      • North Sydney, Australia, 2000
        • Melanoma Institute Australia
      • Southport, Australia, 4215
        • Gold Coast University Hospital
      • Southport, Australia, 4215
        • Tasman Oncology Research
      • Westmead, Australia, 2145
        • Blacktown Hospital
      • Woolloongabba, Australia, 4102
        • Princess Alexandra Hospital
  • Austria
      • Graz, Austria, 8036
        • Medizinische Universität Graz
      • Lienz, Austria
        • Ordensklinikum Linz, Krankenhaus der Elisabethinen GmbH
      • Rankweil, Austria, 6830
        • Landeskrankenhaus Feldkirch
      • Salzburg, Austria
        • Salzburger Landeskliniken
      • St.Pölten, Austria, 3100
        • Universitätsklinikum St. Pölten
      • Vienna, Austria, 1090
        • Allgemeines Krankenhaus Der Stadt Wien
  • Czechia
      • Brno, Czechia, 65653
        • Mou/Mmci - Ppds
      • Hradec Králové, Czechia
        • Fakultni Nemocnice Hradec Kralove
      • Liberec, Czechia, 46063
        • Krajska nemocnice Liberec, a.s.
      • Olomouc, Czechia, 79900
        • Fakultni nemocnice Olomouc
      • Ostrava Poruba, Czechia, 70852
        • Fakultni nemocnice Ostrava
      • Prague, Czechia, 16000
        • Nemocnice Na Bulovce
      • Praha, Czechia, 12808
        • Vseobecna Fakultni Nemocnice V Praze
  • France
      • Amiens, France, 80054
        • Centre Hospitalier Universitaire (CHU) Amiens-Picardie - Hopital Sud
      • Angers, France, 49100
        • CHU Angers
      • Bordeau, France
        • Hopital Saint-Andre
      • Chambray-lès-Tours, France
        • CHRU de Tours
      • Clermont-Ferrand, France, 63003
        • CHU Estaing
      • La Tronche, France, 38043
        • Hôpital Albert Michallon La Tronche
      • Lille, France, 59037
        • CHRU Lille
      • Nantes, France, 44093
        • Hôtel Dieu - Nantes
      • Nice, France, 6202
        • Chu de Nice
      • Paris, France, 75475
        • Hopital Saint Louis
      • Paris, France, 75877
        • Groupe Hospitalier Bichat Claude Bernard
      • Pierre-Bénite, France, 69310
        • Hospices Civils de Lyon
      • Rennes, France, 35042
        • EDOG - Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer - PPDS
      • Rouen, France, 76031
        • Hopital Charles Nicolle
      • Saint-Priest-en-Jarez, France, 42055
        • Centre Hospitalier Universitaire de Saint Etienne
      • Villejuif, France, 94801
        • Institut Gustave Roussy
  • Germany
      • Berlin, Germany, 10117
        • Charité - Universitätsmedizin Berlin
      • Bochum, Germany, 44791
        • Ruhr Universitat Bochum
      • Buxtehude, Germany, 21614
        • Elben Klinken Stade - Buxtehude
      • Dresden, Germany, 81307
        • Universitätsklinikum Carl Gustav Carus an der TU Dresden
      • Erfurt, Germany, 99089
        • Helios Klinikum Erfurt
      • Essen, Germany, 45147
        • Universitätsklinikum Essen
      • Gera, Germany, 7548
        • SRH Wald-Klinikum Gera GmbH
      • Halle, Germany, 6097
        • Universitätsklinikum Halle (Saale)
      • Hamburg, Germany, 20246
        • Universitatsklinikum Hamburg Eppendorf
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Heidelberg, Germany, 69120
        • University Clinic Heidelberg
      • Heilbronn, Germany, 74078
        • SLK Kliniken Heilbronn GmbH
      • Kiel, Germany, 24105
        • Universitätsklinikum Schleswig-Holstein
      • Köln, Germany, 50937
        • Uniklinik Köln
      • Leipzig, Germany, 04103
        • Universitatsklinikum Leipzig
      • Ludwigshafen, Germany, 67063
        • Klinikum der Stadt Ludwigshafen gGmbH
      • Magdeburg, Germany, 39014
        • Universitätsklinik Magdeburg
      • Mannheim, Germany, 76297
        • Klinikum Mannheim Universitätsklinikum gGmbH
      • Münster, Germany, 48149
        • Universitätsklinikum Münster
      • Münster, Germany, 48157
        • Fachklinik Hornheide
      • Regensburg, Germany, 93053
        • University Clinic Regensburg
      • Schwerin, Germany, 19049
        • Helios Klinikum Schwerin
      • Tübingen, Germany, 76297
        • Universitätsklinikum Tübingen
      • Ulm, Germany, 89081
        • Universitätsklinikum Ulm
      • Würzburg, Germany, 97080
        • Universitätsklinikum Würzburg
  • Greece
      • Ampelokipoi, Greece, 11526
        • Laiko General Hospital of Athens
      • Athens, Greece, 11526
        • Henry Dunant hospital
      • Athens, Greece, 18547
        • Metropolitan Hospital - First Oncology Clinic
      • Athens, Greece, 18547
        • Metropolitan Hospital - Fourth Oncology Clinic
      • Heraklion, Greece, 71110
        • Pepagni Hospital
      • Maroúsi, Greece, 15125
        • Medical Center of Athens
      • Pylaía, Greece, TK57001
        • Interbalkan Medical Center of Thessaloniki
      • Thessaloníki, Greece, 54645
        • Theageneio Anticancer Oncology Hospital of Thessaloniki
      • Thessaloníki, Greece, 56429
        • Papageorgiou General Hospital of Thessaloniki
      • Thessaloníki, Greece, 86
        • Bioclinic Thessaloniki (Galinos Clinic)
  • Israel
      • Afula, Israel, 18101
        • HaEmek Medical Center
      • Be'er Sheva, Israel, 8410501
        • Soroka University Medical Centre
      • Haifa, Israel, 31096
        • Rambam Medical Center - PPDS
      • Jerusalem, Israel, 9574425
        • Hadassah Medical Center - PPDS
      • Petah tikva, Israel, 49100
        • Rabin Medical Center - PPDS
      • Ramat Gan, Israel
        • Sheba Medical Center - PPDS
  • Italy
      • Bari, Italy, 70124
        • IRCCS Giovanni Paolo II Istituto Oncologico
      • Bergamo, Italy
        • ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII
      • Candiolo, Italy, 10060
        • Fondazione del Piemonte per l'Oncologia (IRCCS)
      • Genova, Italy
        • Ospedale Policlinico San Martino
      • Meldola, Italy, 47014
        • Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS
      • Milano, Italy, 20141
        • Istituto Europeo Di Oncologia
      • Milano, Italy
        • Istituto Nazionale dei Tumori
      • Modena, Italy, 41100
        • Azienda Ospedaliero Universitaria Di Modena Policlinico
      • Napoli, Italy, 80131
        • Istituto Nazionale per lo studio e la cura dei tumori Fondazione Giovanni Pascale
      • Padova, Italy, 35128
        • Istituto Oncologico Veneto - I.R.C.C.S.
      • Siena, Italy, 53100
        • Azienda Ospedaliera Universitaria Senese
  • Netherlands
      • Amsterdam, Netherlands, 1081HV
        • VU Medisch Centrum
      • Heerlen, Netherlands, 6419
        • Zuyderland Medisch Centrum
      • Leeuwarden, Netherlands, 8934
        • Medisch Centrum Leeuwarden
      • Leiden, Netherlands, 2333ZA
        • Leiden University Medical Center
      • Nijmegen, Netherlands, 6525GA
        • Radboud University Nijmegen Medical Centre
      • Utrecht, Netherlands, 3584
        • Universitair Medisch Centrum Utrecht
      • Veldhoven, Netherlands
        • Maxima Medisch Centrum
      • Zwolle, Netherlands, 8025AB
        • Isala Klinieken
  • New Zealand
      • Christchurch, New Zealand, 8140
        • Christchurch Hospital
      • Dunedin, New Zealand, 9054
        • Dunedin Hospital
      • Heidelberg, New Zealand, 3084
        • Auckland City Hospital
      • Tauranga, New Zealand, 3143
        • Tauranga Hospital
      • Wellington, New Zealand, 6021
        • Wellington Hospital
  • Poland
      • Białystok, Poland, 15-027
        • Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie w Bialymstoku
      • Bydgoszcz, Poland, 85796
        • Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy
      • Gdańsk, Poland, 80952
        • Uniwersyteckie Centrum Kliniczne
      • Lublin, Poland, 20064
        • NZOZ NEUROMED M. I M. Nastaj Spolka Partnerska
      • Poznań, Poland, 60780
        • Szpital Kliniczny im. Heliodora Swiecickiego w Poznaniu
  • Portugal
      • Coimbra, Portugal, 3004-561
        • Centro Hospitalar e Universitario de Coimbra EPE
      • Lisboa, Portugal, 1649-035
        • Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria
      • Lisboa, Portugal, 1649-035
        • Hospital CUF Tejo
      • Lisbon, Portugal, 1099-023
        • Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.
      • Porto, Portugal, 4200-072
        • Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS
  • Romania
      • Bucharest, Romania, 022328
        • Affidea Romania SRL
      • Cluj-Napoca, Romania, 400641
        • S.C. MedisProf SRL
      • Craiova, Romania, 200347
        • Oncology Center Sfantul Nectarie
      • Craiova, Romania, 200094
        • S.C. Onco Clinic Consult SA
  • Russian Federation
      • Chelyabinsk, Russian Federation, 454087
        • Chelyabinsk Regional Clinical Oncology Dispensary
      • Krasnodar, Russian Federation, 350040
        • Clinical Oncology Centre #1
      • Krasnoyarsk, Russian Federation, 660133
        • Krasnoyarsk Regional Oncology Center n.a. A.I. Kryzhanovskiy
      • Kursk, Russian Federation, 305524
        • Kursk Regional Oncology Centre
      • Pushkin, Russian Federation, 196603
        • PMI Euromedservice
      • Ryazan', Russian Federation, 390011
        • Ryazan Regional Clinical Oncology Dispensary
      • Saint Petersburg, Russian Federation, 191758
        • FSBI National Medical Research Center of Oncology n.a. N.N.Petrov of MHRF
      • Saint Petersburg, Russian Federation, 195271
        • Railway Clinical Hospital JSC RZhD
      • Yaroslavl, Russian Federation, 150040
        • Regional Clinical Oncology Hospital
  • Spain
      • A Coruña, Spain, 15006
        • Hospital Universitario A Coruña
      • Badalona, Spain, 08911
        • Hospital Universitario Germans Trias i Pujol
      • Barcelona, Spain, 08025
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d'Hebron - PPDS
      • Barcelona, Spain, 08028
        • Hospital Universitari Dexeus - Grupo Quirónsalud
      • Córdoba, Spain, 14004
        • ICO l'Hospitalet - Hospital Duran i Reynals
      • El Palmar, Spain
        • Hospital Universitario Virgen de la Arrixaca
      • Jaén, Spain, 23007
        • Hospital Universitario de Jaen
      • L'Hospitalet De Llobregat, Spain, 08904
        • C.H. Regional Reina Sofia - PPDS
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28050
        • Hospital Universitario HM Sanchinarro - CIOCC
      • Madrid, Spain, 4628007
        • Hospital General Universitario Gregorio Marañon
      • Málaga, Spain, 29789
        • Hospital Universitario Virgen de la Victoria
      • Sevilla, Spain, 41009
        • Hospital Universitario Virgen Macarena
      • Valencia, Spain
        • Consorcio Hospital General Universitario de Valencia
  • United Kingdom
      • Cambridge, United Kingdom, CB20QQ
        • Addenbrooke's Hospital
      • Cottingham, United Kingdom, HU165JQ
        • Castle Hill Hospital
      • Leicester, United Kingdom, LE15WW
        • Leicester Royal Infirmary
      • Nottingham, United Kingdom, BG72UH
        • Nottingham City Hospital
      • Truro, United Kingdom, TR13LJ
        • Royal Cornwall Hospital
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Honor Health
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Banner MD Anderson Cancer Center
    • California
      • Anaheim, California, United States, 92805
        • Kaiser Foundation Hospital, Inpatient Pharmacy
      • Fontana, California, United States, 92335
        • Kaiser Permanente
      • Fullerton, California, United States, 92835
        • St. Joseph Heritage Healthcare
      • Orange, California, United States, 92868
        • University of California Irvine
      • Orange, California, United States, 92868
        • Hematology Oncology Medical Group of Orange County, Inc.
      • Redlands, California, United States, 92373
        • Emad Ibrahim, Md, Inc
      • Riverside, California, United States, 92505
        • Kaiser Permanente
      • Riverside, California, United States, 92505
        • Southern California Permanente Medical Group
      • San Francisco, California, United States, 94115
        • San Francisco Oncology Associates
      • San Marcos, California, United States, 92069
        • California Cancer Associates for Research and Excellence
      • San Marcos, California, United States, 92078
        • Kaiser Permanente
      • Santa Monica, California, United States, 90404
        • John Wayne Cancer Institute
      • Santa Monica, California, United States, 90404
        • Angeles Clinic and Research Institute
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Rocky Mountain Cancer Centers (Littleton) - USOR
      • Aurora, Colorado, United States, 80045
        • University of Colorado - Cancer Center - PPDS
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • MedStar Georgetown University Hospital
    • Florida
      • Longwood, Florida, United States, 32750
        • Orlando Health Cancer Institute
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
    • Indiana
      • Goshen, Indiana, United States, 46526
        • Goshen Center for Cancer Care
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic - PIN
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • Montana
      • Billings, Montana, United States, 59102
        • Frontier Cancer Center and Blood Institute
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center
      • Omaha, Nebraska, United States, 68130
        • Nebraska Cancer Specialists
      • Omaha, Nebraska, United States, 68130
        • Nebraska Methodist Hospital
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
      • Morristown, New Jersey, United States, 07960
        • Atlantic Health System
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, United States, 10016
        • NYU Langone Medical Center
      • New York, New York, United States, 10021
        • Columbia University Medical Center - PIN
    • North Carolina
      • Chapel Hill, North Carolina, United States, 32750
        • University of North Carolina at Chapel Hill
      • Durham, North Carolina, United States, 27710
        • Duke Cancer Institute
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic Foundation
    • Oregon
      • Portland, Oregon, United States, 97213
        • Providence Cancer Institute, Franz Clinic
      • Portland, Oregon, United States, 97216
        • Oregon Health and Science University
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Physician Group (LVPG) - Hematology Oncology
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Milton S Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19107
        • Jefferson University Hospital
      • Pittsburgh, Pennsylvania, United States, 15232
        • Hillman Cancer Center
      • Pittsburgh, Pennsylvania, United States, 15232
        • H Lee Moffitt Cancer Center and Research Institute
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Prisma Health Cancer Institute
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • SCRI Tennessee Oncology Chattanooga
      • Knoxville, Tennessee, United States, 37920
        • University of Tennessee Medical Center
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
      • Nashville, Tennessee, United States, 37203
        • SCRI Tennessee Oncology Nashville
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
      • Dallas, Texas, United States, 75235
        • Department of Pharmacy Investigational Drug Services
      • Dallas, Texas, United States, 75246
        • Texas Oncology (LOOP) - USOR
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
    • Utah
      • Salt Lake City, Utah, United States, 90603
        • Utah Cancer Specialists (Salt Lake City)
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia Cancer Center
      • Fairfax, Virginia, United States, 22031
        • Inova Schar Cancer Institute
      • Roanoke, Virginia, United States, 24014
        • Blue Ridge Cancer Care - USOR
    • Washington
      • Seattle, Washington, United States, 98109
        • Seattle Cancer Care Alliance
      • Tacoma, Washington, United States, 98405
        • Northwest Medical Specialties
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female patients, age 12 years or older at the time of signing the informed consent form (age 18 years or older where local regulations, countries, and/or institutional policies do not allow for patients < 18 years of age (adolescents) to participate). In regions where adolescents are not allowed to participate in the study due to age restrictions, enrolled patients must be ≥ 18 years of age.
  • Histologically confirmed Stage IIIA (LN metastasis > 1 mm), IIIB/C/D, or IV (M1a/b/c/d) cutaneous melanoma by AJCC (8th edition) at study entry that has been completely surgically resected within 12 weeks prior to randomization.
  • Tumor tissue available from biopsy or resected disease must be provided to central laboratory for PD-L1 status analysis. Must have PD-L1 expression classification for stratification purposes.
  • Disease-free status documented by a complete physical examination and imaging studies within 28 days prior to randomization.

Exclusion Criteria:

  • History of ocular/uveal melanoma or mucosal melanoma.
  • Active, known or suspected autoimmune disease. Patients with Type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
  • Conditions requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
  • Prior therapy for melanoma except surgery for the melanoma lesion(s) and/or adjuvant radiation therapy for central nervous system lesions.
  • Prior therapy with interferon, talimogene laherparepvec (Imylgic®), interleukin-2 (IL-2) directed therapy, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T lymphocyte-associated protein 4 antibody (including ipilimumab or any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways).
  • Prior malignancy active within the previous 3 years except for locally potentially curable cancers that have been apparently cured.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Combination of bempegaldesleukin (NKTR-214) + nivolumab
Arm A: Participants will receive bempegaldesleukin (NKTR-214) IV in combination with nivolumab every 3 weeks.
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo®
Biological: Bempegaldesleukin
Specified dose on specified days
Other Names:
  • NKTR-214
  • BMS-986321
Active Comparator: Nivolumab
Arm B: Participants will receive nivolumab IV alone every 4 weeks.
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
Recurrence-free Survival (RFS) by Blinded Independent Central Review (BICR) of Bempegaldesleukin Plus Nivolumab Versus Nivolumab Alone.
Time Frame: Up to 21 months
Recurrence-free Survival (RFS) of bempegaldesleukin plus nivolumab versus nivolumab alone is determined based on the disease recurrence date provided by Blinded Independent Central Review (BICR) and is defined as the time between date of randomization and date of first recurrence (local, regional, or distant metastasis by BICR), new primary melanoma (by BICR), or all-cause death, whichever occurs first.
Up to 21 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS) of Bempegaldesleukin Plus Nivolumab Versus Nivolumab Alone
Time Frame: Up to 21 months
Overall Survival (OS) is defined as the time between the date of randomization and the date of death due to any cause. Patients who do not have a date of death will be censored on the last date for which a patient was known to be alive.
Up to 21 months
Distant Metastasis-Free Survival (DMFS) by Investigator in Patients Who Are Stage III at Study Entry.
Time Frame: Up to 21 months
Distant metastasis-free survival (DMFS) by Investigator is defined as the time between the date of randomization and the date of first distant metastasis by Investigator or date of death due to any cause, in patients who have Stage III melanoma at study entry.
Up to 21 months
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Approximately up to 21 months
To evaluate safety and tolerability of (NKTR-214) 0.006 mg/kg in combination with nivolumab 360 mg IV infusion (or 4.5 mg/kg IV infusion q3w for patients <40 kg) and nivolumab 480 mg IV infusion (or 6.0 mg/kg IV infusion q4w for patients < 40 kg). Treatment-emergent adverse event (TEAE) is defined as an AE that was not present prior to treatment with study drug but appeared following treatment or was present at treatment start date but worsened during treatment-emergent period. The treatment-emergent period is defined as the period from the date of the first dose of study drug up to 30 days after the date of the last dose of study drug or the day prior to the initiation of subsequent anticancer treatment, whichever occurs first.
Approximately up to 21 months
Changes at 6 Months of Treatment From Baseline in Scores for the Global Health/Quality of Life (GH/QoL) and Physical Functioning Subscales of the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire
Time Frame: From baseline, up to approximately 6 months
The EORTC QLQ-C30 comprises 30 items (i.e. single questions). 24 of which are aggregated into nine multi-item scales, that is, five functioning scales (physical, role, cognitive, emotional and social), three symptom scales (fatigue, pain and nausea/vomiting) and one global health status scale. Participants rate items and a score ranging from 0 to 100 is calculated. A higher score on the global health status/quality of life scale indicates a better level of functioning, and positive changes from baseline indicate improvement. A change of 5 - 10 points is considered a small change, and a change of 10 - 20 points is considered a moderate change. Due to the study termination, results for the mean change from baseline for GH/QoL and the physical functioning subscale were analyzed at approximately 6 months of treatment.
From baseline, up to approximately 6 months
Programmed Death-Ligand 1 (PD-L1) Expression as a Predictive Biomarker for Recurrence-free Survival (RFS)
Time Frame: Up to 21 months
The predictive strength of Programmed Death-Ligand 1 (PD-L1) expression as a biomarker will be measured by the endpoint RFS by BICR based on PD-L1 expression level.
Up to 21 months
Recurrence-free Survival (RFS) by Investigator of Bempegaldesleukin Plus Nivolumab Versus Nivolumab Alone.
Time Frame: Up to 21 months
Recurrence-free Survival by Investigator is defined as the time between the date of randomization and the date of first recurrence (local, regional, or distant metastasis by Investigator), new primary melanoma (by Investigator), or all-cause death, whichever occurs first.
Up to 21 months
Time to Disease Progression After the Next Line of Treatment for Study Patients Following Discontinuation of Bempegaldesleukin Plus Nivolumab Versus Nivolumab
Time Frame: Up to 21 months
Time to disease progression after the next line of treatment is defined as time from randomization to progression per Investigator after the start of next line of therapy or death, whichever occurs first. Patients who were alive and without progression after the next line of therapy can be censored at last known alive date.
Up to 21 months
Distant Metastasis-Free Survival (DMFS) by Blinded Independent Central Review (BICR) in Patients Who Are Stage III at Study Entry.
Time Frame: Up to 21 months
Distant Metastasis-Free Survival (DMFS) by Blinded Independent Central Review (BICR) is defined as the time between the date of randomization and the date of first distant metastasis by BICR or date of death due to any cause, whichever occurs first, in patients who have Stage III melanoma at study entry.
Up to 21 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nektar Therapeutics

Collaborators

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 27, 2020

Primary Completion (Actual)

September 22, 2022

Study Completion (Actual)

September 22, 2022

Study Registration Dates

First Submitted

May 27, 2020

First Submitted That Met QC Criteria

May 27, 2020

First Posted (Actual)

June 1, 2020

Study Record Updates

Last Update Posted (Actual)

April 21, 2023

Last Update Submitted That Met QC Criteria

March 31, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-214-29/CA045-022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Melanoma

Clinical Trials on Nivolumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe