Study Stopped
(Sponsor decision)
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
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)
1 other identifier
interventional
765
16 countries
199
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2020
199 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2020
CompletedFirst Posted
Study publicly available on registry
June 1, 2020
CompletedStudy Start
First participant enrolled
July 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 22, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 22, 2022
CompletedResults Posted
Study results publicly available
April 21, 2023
CompletedApril 21, 2023
March 1, 2023
2.2 years
May 27, 2020
February 27, 2023
March 31, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recurrence-free Survival (RFS) by Blinded Independent Central Review (BICR) of Bempegaldesleukin Plus Nivolumab Versus Nivolumab Alone.
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 Outcomes (8)
Overall Survival (OS) of Bempegaldesleukin Plus Nivolumab Versus Nivolumab Alone
Up to 21 months
Distant Metastasis-Free Survival (DMFS) by Investigator in Patients Who Are Stage III at Study Entry.
Up to 21 months
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
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
From baseline, up to approximately 6 months
Programmed Death-Ligand 1 (PD-L1) Expression as a Predictive Biomarker for Recurrence-free Survival (RFS)
Up to 21 months
- +3 more secondary outcomes
Study Arms (2)
Combination of bempegaldesleukin (NKTR-214) + nivolumab
EXPERIMENTALArm A: Participants will receive bempegaldesleukin (NKTR-214) IV in combination with nivolumab every 3 weeks.
Nivolumab
ACTIVE COMPARATORArm B: Participants will receive nivolumab IV alone every 4 weeks.
Interventions
Specified dose on specified days
Specified dose on specified days
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nektar Therapeuticslead
- Bristol-Myers Squibbcollaborator
Study Sites (212)
Honor Health
Scottsdale, Arizona, 85258, United States
Banner MD Anderson Cancer Center
Little Rock, Arkansas, 72205, United States
Kaiser Foundation Hospital, Inpatient Pharmacy
Anaheim, California, 92805, United States
Kaiser Permanente
Fontana, California, 92335, United States
St. Joseph Heritage Healthcare
Fullerton, California, 92835, United States
Hematology Oncology Medical Group of Orange County, Inc.
Orange, California, 92868, United States
University of California Irvine
Orange, California, 92868, United States
Emad Ibrahim, MD, Inc
Redlands, California, 92373, United States
Kaiser Permanente
Riverside, California, 92505, United States
Southern California Permanente Medical Group
Riverside, California, 92505, United States
San Francisco Oncology Associates
San Francisco, California, 94115, United States
California Cancer Associates for Research and Excellence
San Marcos, California, 92069, United States
Kaiser Permanente
San Marcos, California, 92078, United States
Angeles Clinic and Research Institute
Santa Monica, California, 90404, United States
John Wayne Cancer Institute
Santa Monica, California, 90404, United States
Rocky Mountain Cancer Centers (Littleton) - USOR
Aurora, Colorado, 80012, United States
University of Colorado - Cancer Center - PPDS
Aurora, Colorado, 80045, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Orlando Health Cancer Institute
Longwood, Florida, 32750, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Goshen Center For Cancer Care
Goshen, Indiana, 46526, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Mayo Clinic - PIN
Rochester, Minnesota, 55905, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Frontier Cancer Center and Blood Institute
Billings, Montana, 59102, United States
Nebraska Cancer Specialists
Omaha, Nebraska, 68130, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68130, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Atlantic Health System
Morristown, New Jersey, 07960, United States
NYU Langone Medical Center
New York, New York, 10016, United States
Columbia University Medical Center - PIN
New York, New York, 10021, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 32750, United States
Duke Cancer Institute
Durham, North Carolina, 27710, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Providence Cancer Institute, Franz Clinic
Portland, Oregon, 97213, United States
Oregon Health and Science University
Portland, Oregon, 97216, United States
Lehigh Valley Physician Group (LVPG) - Hematology Oncology
Allentown, Pennsylvania, 18103, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
H Lee Moffitt Cancer Center and Research Institute
Pittsburgh, Pennsylvania, 15232, United States
Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
Prisma Health Cancer Institute
Greenville, South Carolina, 29605, United States
SCRI Tennessee Oncology Chattanooga
Chattanooga, Tennessee, 37404, United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920, United States
SCRI Tennessee Oncology Nashville
Nashville, Tennessee, 37203, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Department of Pharmacy Investigational Drug Services
Dallas, Texas, 75235, United States
Texas Oncology (Loop) - USOR
Dallas, Texas, 75246, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Utah Cancer Specialists (Salt Lake City)
Salt Lake City, Utah, 90603, United States
University of Virginia Cancer Center
Charlottesville, Virginia, 22903, United States
Inova Schar Cancer Institute
Fairfax, Virginia, 22031, United States
Blue Ridge Cancer Care - USOR
Roanoke, Virginia, 24014, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
Northwest Medical Specialties
Tacoma, Washington, 98405, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
Royal Adelaide Hospital
Adelaide, 5000, Australia
Cairns Hospital
Cairns, 4870, Australia
Icon Cancer Care Wesley
Chermside, 4032, Australia
Gallipoli Medical Research Foundation
Greenslopes, 4120, Australia
Austin Health
Heidelberg, 3084, Australia
Alfred Hospital
Melbourne, 3004, Australia
Affinity Clinical Research
Nedlands, 6009, Australia
Sir Charles Gairdner Hospital
Nedlands, 6009, Australia
Melanoma Institute Australia
North Sydney, 2000, Australia
Gold Coast University Hospital
Southport, 4215, Australia
Tasman Oncology Research
Southport, 4215, Australia
Blacktown Hospital
Westmead, 2145, Australia
Princess Alexandra Hospital
Woolloongabba, 4102, Australia
Medizinische Universität Graz
Graz, 8036, Austria
Ordensklinikum Linz, Krankenhaus der Elisabethinen GmbH
Lienz, Austria
Landeskrankenhaus Feldkirch
Rankweil, 6830, Austria
Salzburger Landeskliniken
Salzburg, Austria
Universitätsklinikum St. Pölten
Sankt Pölten, 3100, Austria
Allgemeines Krankenhaus der Stadt Wien
Vienna, 1090, Austria
Mou/Mmci - Ppds
Brno, 65653, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, Czechia
Krajska nemocnice Liberec, a.s.
Liberec, 46063, Czechia
Fakultni nemocnice Olomouc
Olomouc, 79900, Czechia
Fakultni nemocnice Ostrava
Ostrava Poruba, 70852, Czechia
Vseobecna Fakultni Nemocnice V Praze
Prague, 12808, Czechia
Nemocnice Na Bulovce
Prague, 16000, Czechia
Centre Hospitalier Universitaire (CHU) Amiens-Picardie - Hopital Sud
Amiens, 80054, France
CHU Angers
Angers, 49100, France
Hôpital Saint-André
Bordeau, France
CHRU de Tours
Chambray-lès-Tours, France
CHU Estaing
Clermont-Ferrand, 63003, France
Hôpital Albert Michallon La Tronche
La Tronche, 38043, France
CHRU Lille
Lille, 59037, France
Hôtel Dieu - Nantes
Nantes, 44093, France
CHU de Nice
Nice, 6202, France
Hôpital Saint Louis
Paris, 75475, France
Groupe Hospitalier Bichat Claude Bernard
Paris, 75877, France
Hospices Civils de Lyon
Pierre-Bénite, 69310, France
EDOG - Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer - PPDS
Rennes, 35042, France
Hôpital Charles Nicolle
Rouen, 76031, France
Centre Hospitalier Universitaire de Saint Etienne
Saint-Priest-en-Jarez, 42055, France
Institut Gustave Roussy
Villejuif, 94801, France
Charité - Universitätsmedizin Berlin
Berlin, 10117, Germany
Ruhr Universität Bochum
Bochum, 44791, Germany
Elben Klinken Stade - Buxtehude
Buxtehude, 21614, Germany
Uniklinik Köln
Cologne, 50937, Germany
Universitätsklinikum Carl Gustav Carus an der TU Dresden
Dresden, 81307, Germany
Helios Klinikum Erfurt
Erfurt, 99089, Germany
Universitätsklinikum Essen
Essen, 45147, Germany
SRH Wald-Klinikum Gera GmbH
Gera, 7548, Germany
Universitatsklinikum Halle (Saale)
Halle, 6097, Germany
Universitätsklinikum Hamburg Eppendorf
Hamburg, 20246, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
University Clinic Heidelberg
Heidelberg, 69120, Germany
SLK Kliniken Heilbronn GmbH
Heilbronn, 74078, Germany
Universitatsklinikum Schleswig-Holstein
Kiel, 24105, Germany
Universitatsklinikum Leipzig
Leipzig, 04103, Germany
Klinikum der Stadt Ludwigshafen gGmbH
Ludwigshafen, 67063, Germany
Universitätsklinik Magdeburg
Magdeburg, 39014, Germany
Klinikum Mannheim Universitätsklinikum gGmbH
Mannheim, 76297, Germany
Universitatsklinikum Munster
Münster, 48149, Germany
Fachklinik Hornheide
Münster, 48157, Germany
University Clinic Regensburg
Regensburg, 93053, Germany
Helios Klinikum Schwerin
Schwerin, 19049, Germany
Universitätsklinikum Tübingen
Tübingen, 76297, Germany
Universitätsklinikum Ulm
Ulm, 89081, Germany
Universitätsklinikum Würzburg
Würzburg, 97080, Germany
Laiko General Hospital of Athens
Ampelokipoi, 11526, Greece
Henry Dunant Hospital
Athens, 11526, Greece
Metropolitan Hospital - First Oncology Clinic
Athens, 18547, Greece
Metropolitan Hospital - Fourth Oncology Clinic
Athens, 18547, Greece
Pepagni Hospital
Heraklion, 71110, Greece
Medical Center of Athens
Marousi, 15125, Greece
Interbalkan Medical Center of Thessaloniki
Pylaia, TK57001, Greece
Theageneio Anticancer Oncology Hospital of Thessaloniki
Thessaloniki, 54645, Greece
Papageorgiou General Hospital of Thessaloniki
Thessaloniki, 56429, Greece
Bioclinic Thessaloniki (Galinos clinic)
Thessaloniki, 86, Greece
HaEmek Medical Center
Afula, 18101, Israel
Soroka University Medical Centre
Beersheba, 8410501, Israel
Rambam Medical Center - PPDS
Haifa, 31096, Israel
Hadassah Medical Center - PPDS
Jerusalem, 9574425, Israel
Rabin Medical Center - PPDS
Petah Tikva, 49100, Israel
Sheba Medical Center - PPDS
Ramat Gan, Israel
IRCCS Giovanni Paolo II Istituto Oncologico
Bari, 70124, Italy
ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, Italy
Fondazione del Piemonte per l'Oncologia (IRCCS)
Candiolo, 10060, Italy
Ospedale Policlinico San Martino
Genova, Italy
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS
Meldola, 47014, Italy
Istituto Europeo Di Oncologia
Milan, 20141, Italy
Istituto Nazionale Dei Tumori
Milan, Italy
Azienda Ospedaliero Universitaria Di Modena Policlinico
Modena, 41100, Italy
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale
Napoli, 80131, Italy
Istituto Oncologico Veneto - I.R.C.C.S.
Padua, 35128, Italy
Azienda Ospedaliera Universitaria Senese
Siena, 53100, Italy
VU Medisch Centrum
Amsterdam, 1081HV, Netherlands
Zuyderland Medisch Centrum
Heerlen, 6419, Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, 8934, Netherlands
Leiden University Medical Center
Leiden, 2333ZA, Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, 6525GA, Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, 3584, Netherlands
Maxima Medisch Centrum
Veldhoven, Netherlands
Isala Klinieken
Zwolle, 8025AB, Netherlands
Christchurch Hospital
Christchurch, 8140, New Zealand
Dunedin Hospital
Dunedin, 9054, New Zealand
Auckland City Hospital
Heidelberg, 3084, New Zealand
Tauranga Hospital
Tauranga, 3143, New Zealand
Wellington Hospital
Wellington, 6021, New Zealand
Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie w Bialymstoku
Bialystok, 15-027, Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy
Bydgoszcz, 85796, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, 80952, Poland
NZOZ NEUROMED M. I M. Nastaj Spolka Partnerska
Lublin, 20064, Poland
Szpital Kliniczny im. Heliodora Swiecickiego w Poznaniu
Poznan, 60780, Poland
Centro Hospitalar E Universitário de Coimbra EPE
Coimbra, 3004-561, Portugal
Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.
Lisbon, 1099-023, Portugal
Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria
Lisbon, 1649-035, Portugal
Hospital CUF Tejo
Lisbon, 1649-035, Portugal
Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS
Porto, 4200-072, Portugal
Affidea Romania SRL
Bucharest, 022328, Romania
S.C. Medisprof SRL
Cluj-Napoca, 400641, Romania
S.C. Onco Clinic Consult SA
Craiova, 200094, Romania
Oncology Center Sfantul Nectarie
Craiova, 200347, Romania
Chelyabinsk Regional Clinical Oncology Dispensary
Chelyabinsk, 454087, Russia
Clinical Oncology Centre #1
Krasnodar, 350040, Russia
Krasnoyarsk Regional Oncology Center n.a. A.I. Kryzhanovskiy
Krasnoyarsk, 660133, Russia
Kursk Regional Oncology Centre
Kursk, 305524, Russia
PMI Euromedservice
Pushkin, 196603, Russia
Ryazan Regional Clinical Oncology Dispensary
Ryazan, 390011, Russia
FSBI National Medical Research Center of Oncology n.a. N.N.Petrov of MHRF
Saint Petersburg, 191758, Russia
Railway Clinical Hospital JSC RZhD
Saint Petersburg, 195271, Russia
Regional Clinical Oncology Hospital
Yaroslavl, 150040, Russia
Hospital Universitario A Coruña
A Coruña, 15006, Spain
Hospital Universitario Germans Trias i Pujol
Badalona, 08911, Spain
Hospital de La Santa Creu i Sant Pau
Barcelona, 08025, Spain
Hospital Universitari Dexeus - Grupo Quironsalud
Barcelona, 08028, Spain
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, 08035, Spain
ICO l'Hospitalet - Hospital Duran i Reynals
Córdoba, 14004, Spain
Hospital Universitario Virgen de La Arrixaca
El Palmar, Spain
Hospital Universitario de Jaen
Jaén, 23007, Spain
C.H. Regional Reina Sofia - PPDS
L'Hospitalet de Llobregat, 08904, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario HM Sanchinarro - CIOCC
Madrid, 28050, Spain
Hospital General Universitario Gregorio Maranon
Madrid, 4628007, Spain
Hospital Universitario Virgen de la Victoria
Málaga, 29789, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Consorcio Hospital General Universitario de Valencia
Valencia, Spain
Addenbrooke's Hospital
Cambridge, CB20QQ, United Kingdom
Castle Hill Hospital
Cottingham, HU165JQ, United Kingdom
Leicester Royal Infirmary
Leicester, LE15WW, United Kingdom
Nottingham City Hospital
Nottingham, BG72UH, United Kingdom
Royal Cornwall Hospital
Truro, TR13LJ, United Kingdom
Related Publications (1)
Eggermont AM, Ascierto PA, Khushalani NI, Schadendorf D, Boland G, Weber J, Lewis KD, Johnson D, Rivalland G, Khattak A, Majem M, Gogas H, Long GV, Currie SL, Chien D, Tagliaferri MA, Carlino MS, Diab A. PIVOT-12: a phase III study of adjuvant bempegaldesleukin plus nivolumab in resected stage III/IV melanoma at high risk for recurrence. Future Oncol. 2022 Mar;18(8):903-913. doi: 10.2217/fon-2021-1286. Epub 2022 Jan 25.
PMID: 35073733DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Nektar Therapeutics
Study Officials
- STUDY DIRECTOR
Study Director
Nektar Therapeutics
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2020
First Posted
June 1, 2020
Study Start
July 27, 2020
Primary Completion
September 22, 2022
Study Completion
September 22, 2022
Last Updated
April 21, 2023
Results First Posted
April 21, 2023
Record last verified: 2023-03