Clinical trial NCT04410445: Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Melanoma
Melanoma Stage III
Melanoma Stage IV
Melanoma (Skin)
Keywords: CD122-Biased Agonist
CD122-Biased Cytokine
IL-2 Receptor Agonist
NKTR-214
Bempegaldesleukin
IL-2
Immunotherapy
BEMPEG
Nivolumab
Opdivo®
NIVO
Adjuvant
Skin Cancer
Resectable Melanoma
High Risk of Recurrence Melanoma
Post Resection
Checkpoint Inhibitor
Lead sponsor: Nektar Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2020-06-01
Enrollment: 765
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized in a 1:1 ratio to one of two treatment arms
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Recurrence-free Survival (RFS) by Blinded Independent Central Review (BICR) of Bempegaldesleukin Plus Nivolumab Versus Nivolumab Alone.
timeFrame: Up to 21 months
Secondary outcomes:
measure: Overall Survival (OS) of Bempegaldesleukin Plus Nivolumab Versus Nivolumab Alone
timeFrame: Up to 21 months
measure: Distant Metastasis-Free Survival (DMFS) by Investigator in Patients Who Are Stage III at Study Entry.
timeFrame: Up to 21 months
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Approximately up to 21 months
measure: 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
timeFrame: From baseline, up to approximately 6 months
measure: Programmed Death-Ligand 1 (PD-L1) Expression as a Predictive Biomarker for Recurrence-free Survival (RFS)
timeFrame: Up to 21 months
measure: Recurrence-free Survival (RFS) by Investigator of Bempegaldesleukin Plus Nivolumab Versus Nivolumab Alone.
timeFrame: Up to 21 months
measure: Time to Disease Progression After the Next Line of Treatment for Study Patients Following Discontinuation of Bempegaldesleukin Plus Nivolumab Versus Nivolumab
timeFrame: Up to 21 months
measure: Distant Metastasis-Free Survival (DMFS) by Blinded Independent Central Review (BICR) in Patients Who Are Stage III at Study Entry.
timeFrame: Up to 21 months
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Honor Health
state: Arizona
city: Little Rock
country: United States
facility: Banner MD Anderson Cancer Center
state: Arkansas
city: Anaheim
country: United States
facility: Kaiser Foundation Hospital, Inpatient Pharmacy
state: California
city: Fontana
country: United States
facility: Kaiser Permanente
state: California
city: Fullerton
country: United States
facility: St. Joseph Heritage Healthcare
state: California
city: Orange
country: United States
facility: Hematology Oncology Medical Group of Orange County, Inc.
state: California
city: Orange
country: United States
facility: University of California Irvine
state: California
city: Redlands
country: United States
facility: Emad Ibrahim, MD, Inc
state: California
city: Riverside
country: United States
facility: Kaiser Permanente
state: California
city: Riverside
country: United States
facility: Southern California Permanente Medical Group
state: California
city: San Francisco
country: United States
facility: San Francisco Oncology Associates
state: California
city: San Marcos
country: United States
facility: California Cancer Associates for Research and Excellence
state: California
city: San Marcos
country: United States
facility: Kaiser Permanente
state: California
city: Santa Monica
country: United States
facility: Angeles Clinic and Research Institute
state: California
city: Santa Monica
country: United States
facility: John Wayne Cancer Institute
state: California
city: Aurora
country: United States
facility: Rocky Mountain Cancer Centers (Littleton) - USOR
state: Colorado
city: Aurora
country: United States
facility: University of Colorado - Cancer Center - PPDS
state: Colorado
city: Washington
country: United States
facility: MedStar Georgetown University Hospital
state: District of Columbia
city: Longwood
country: United States
facility: Orlando Health Cancer Institute
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Goshen
country: United States
facility: Goshen Center For Cancer Care
state: Indiana
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic - PIN
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Billings
country: United States
facility: Frontier Cancer Center and Blood Institute
state: Montana
city: Omaha
country: United States
facility: Nebraska Cancer Specialists
state: Nebraska
city: Omaha
country: United States
facility: Nebraska Methodist Hospital
state: Nebraska
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Morristown
country: United States
facility: Atlantic Health System
state: New Jersey
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center - PIN
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke Cancer Institute
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Portland
country: United States
facility: Providence Cancer Institute, Franz Clinic
state: Oregon
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Physician Group (LVPG) - Hematology Oncology
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Milton S Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Jefferson University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: H Lee Moffitt Cancer Center and Research Institute
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Hillman Cancer Center
state: Pennsylvania
city: Greenville
country: United States
facility: Prisma Health Cancer Institute
state: South Carolina
city: Chattanooga
country: United States
facility: SCRI Tennessee Oncology Chattanooga
state: Tennessee
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
city: Nashville
country: United States
facility: SCRI Tennessee Oncology Nashville
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Department of Pharmacy Investigational Drug Services
state: Texas
city: Dallas
country: United States
facility: Texas Oncology (Loop) - USOR
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists (Salt Lake City)
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Cancer Center
state: Virginia
city: Fairfax
country: United States
facility: Inova Schar Cancer Institute
state: Virginia
city: Roanoke
country: United States
facility: Blue Ridge Cancer Care - USOR
state: Virginia
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Tacoma
country: United States
facility: Northwest Medical Specialties
state: Washington
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
city: Cairns
country: Australia
facility: Cairns Hospital
city: Chermside
country: Australia
facility: Icon Cancer Care Wesley
city: Greenslopes
country: Australia
facility: Gallipoli Medical Research Foundation
city: Heidelberg
country: Australia
facility: Austin Health
city: Melbourne
country: Australia
facility: Alfred Hospital
city: Nedlands
country: Australia
facility: Affinity Clinical Research
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
city: North Sydney
country: Australia
facility: Melanoma Institute Australia
city: Southport
country: Australia
facility: Gold Coast University Hospital
city: Southport
country: Australia
facility: Tasman Oncology Research
city: Westmead
country: Australia
facility: Blacktown Hospital
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
city: Graz
country: Austria
facility: Medizinische Universität Graz
city: Lienz
country: Austria
facility: Ordensklinikum Linz, Krankenhaus der Elisabethinen GmbH
city: Rankweil
country: Austria
facility: Landeskrankenhaus Feldkirch
city: Salzburg
country: Austria
facility: Salzburger Landeskliniken
city: St.Pölten
country: Austria
facility: Universitätsklinikum St. Pölten
city: Vienna
country: Austria
facility: Allgemeines Krankenhaus der Stadt Wien
city: Brno
country: Czechia
facility: Mou/Mmci - Ppds
city: Hradec Králové
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Liberec
country: Czechia
facility: Krajska nemocnice Liberec, a.s.
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Ostrava Poruba
country: Czechia
facility: Fakultni nemocnice Ostrava
city: Prague
country: Czechia
facility: Nemocnice Na Bulovce
city: Praha
country: Czechia
facility: Vseobecna Fakultni Nemocnice V Praze
city: Amiens
country: France
facility: Centre Hospitalier Universitaire (CHU) Amiens-Picardie - Hopital Sud
city: Angers
country: France
facility: CHU Angers
city: Bordeau
country: France
facility: Hôpital Saint-André
city: Chambray-lès-Tours
country: France
facility: CHRU de Tours
city: Clermont-Ferrand
country: France
facility: CHU Estaing
city: La Tronche
country: France
facility: Hôpital Albert Michallon La Tronche
city: Lille
country: France
facility: CHRU Lille
city: Nantes
country: France
facility: Hôtel Dieu - Nantes
city: Nice
country: France
facility: CHU de Nice
city: Paris
country: France
facility: Hôpital Saint Louis
city: Paris
country: France
facility: Groupe Hospitalier Bichat Claude Bernard
city: Pierre-Bénite
country: France
facility: Hospices Civils de Lyon
city: Rennes
country: France
facility: EDOG - Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer - PPDS
city: Rouen
country: France
facility: Hôpital Charles Nicolle
city: Saint-Priest-en-Jarez
country: France
facility: Centre Hospitalier Universitaire de Saint Etienne
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Bochum
country: Germany
facility: Ruhr Universität Bochum
city: Buxtehude
country: Germany
facility: Elben Klinken Stade - Buxtehude
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden
city: Erfurt
country: Germany
facility: Helios Klinikum Erfurt
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Gera
country: Germany
facility: SRH Wald-Klinikum Gera GmbH
city: Halle
country: Germany
facility: Universitatsklinikum Halle (Saale)
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg Eppendorf
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Heidelberg
country: Germany
facility: University Clinic Heidelberg
city: Heilbronn
country: Germany
facility: SLK Kliniken Heilbronn GmbH
city: Kiel
country: Germany
facility: Universitatsklinikum Schleswig-Holstein
city: Köln
country: Germany
facility: Uniklinik Köln
city: Leipzig
country: Germany
facility: Universitatsklinikum Leipzig
city: Ludwigshafen
country: Germany
facility: Klinikum der Stadt Ludwigshafen gGmbH
city: Magdeburg
country: Germany
facility: Universitätsklinik Magdeburg
city: Mannheim
country: Germany
facility: Klinikum Mannheim Universitätsklinikum gGmbH
city: Münster
country: Germany
facility: Universitatsklinikum Munster
city: Münster
country: Germany
facility: Fachklinik Hornheide
city: Regensburg
country: Germany
facility: University Clinic Regensburg
city: Schwerin
country: Germany
facility: Helios Klinikum Schwerin
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
city: Ampelokipoi
country: Greece
facility: Laiko General Hospital of Athens
city: Athens
country: Greece
facility: Henry Dunant Hospital
city: Athens
country: Greece
facility: Metropolitan Hospital - First Oncology Clinic
city: Athens
country: Greece
facility: Metropolitan Hospital - Fourth Oncology Clinic
city: Heraklion
country: Greece
facility: Pepagni Hospital
city: Maroúsi
country: Greece
facility: Medical Center of Athens
city: Pylaía
country: Greece
facility: Interbalkan Medical Center of Thessaloniki
city: Thessaloníki
country: Greece
facility: Theageneio Anticancer Oncology Hospital of Thessaloniki
city: Thessaloníki
country: Greece
facility: Papageorgiou General Hospital of Thessaloniki
city: Thessaloníki
country: Greece
facility: Bioclinic Thessaloniki (Galinos clinic)
city: Afula
country: Israel
facility: HaEmek Medical Center
city: Be'er Sheva
country: Israel
facility: Soroka University Medical Centre
city: Haifa
country: Israel
facility: Rambam Medical Center - PPDS
city: Jerusalem
country: Israel
facility: Hadassah Medical Center - PPDS
city: Petah tikva
country: Israel
facility: Rabin Medical Center - PPDS
city: Ramat Gan
country: Israel
facility: Sheba Medical Center - PPDS
city: Bari
country: Italy
facility: IRCCS Giovanni Paolo II Istituto Oncologico
city: Bergamo
country: Italy
facility: ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII
city: Candiolo
country: Italy
facility: Fondazione del Piemonte per l'Oncologia (IRCCS)
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS
city: Milano
country: Italy
facility: Istituto Europeo Di Oncologia
city: Milano
country: Italy
facility: Istituto Nazionale Dei Tumori
city: Modena
country: Italy
facility: Azienda Ospedaliero Universitaria Di Modena Policlinico
city: Napoli
country: Italy
facility: Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale
city: Padova
country: Italy
facility: Istituto Oncologico Veneto - I.R.C.C.S.
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese
city: Amsterdam
country: Netherlands
facility: VU Medisch Centrum
city: Heerlen
country: Netherlands
facility: Zuyderland Medisch Centrum
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht
city: Veldhoven
country: Netherlands
facility: Maxima Medisch Centrum
city: Zwolle
country: Netherlands
facility: Isala Klinieken
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: Dunedin
country: New Zealand
facility: Dunedin Hospital
city: Heidelberg
country: New Zealand
facility: Auckland City Hospital
city: Tauranga
country: New Zealand
facility: Tauranga Hospital
city: Wellington
country: New Zealand
facility: Wellington Hospital
city: Białystok
country: Poland
facility: Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie w Bialymstoku
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy
city: Gdańsk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Lublin
country: Poland
facility: NZOZ NEUROMED M. I M. Nastaj Spolka Partnerska
city: Poznań
country: Poland
facility: Szpital Kliniczny im. Heliodora Swiecickiego w Poznaniu
city: Coimbra
country: Portugal
facility: Centro Hospitalar E Universitário de Coimbra EPE
city: Lisboa
country: Portugal
facility: Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria
city: Lisboa
country: Portugal
facility: Hospital CUF Tejo
city: Lisbon
country: Portugal
facility: Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.
city: Porto
country: Portugal
facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS
city: Bucharest
country: Romania
facility: Affidea Romania SRL
city: Cluj-Napoca
country: Romania
facility: S.C. Medisprof SRL
city: Craiova
country: Romania
facility: S.C. Onco Clinic Consult SA
city: Craiova
country: Romania
facility: Oncology Center Sfantul Nectarie
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Clinical Oncology Dispensary
city: Krasnodar
country: Russian Federation
facility: Clinical Oncology Centre #1
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsk Regional Oncology Center n.a. A.I. Kryzhanovskiy
city: Kursk
country: Russian Federation
facility: Kursk Regional Oncology Centre
city: Pushkin
country: Russian Federation
facility: PMI Euromedservice
city: Ryazan'
country: Russian Federation
facility: Ryazan Regional Clinical Oncology Dispensary
city: Saint Petersburg
country: Russian Federation
facility: FSBI National Medical Research Center of Oncology n.a. N.N.Petrov of MHRF
city: Saint Petersburg
country: Russian Federation
facility: Railway Clinical Hospital JSC RZhD
city: Yaroslavl
country: Russian Federation
facility: Regional Clinical Oncology Hospital
city: A Coruña
country: Spain
facility: Hospital Universitario A Coruña
city: Badalona
country: Spain
facility: Hospital Universitario Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital de La Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitari Dexeus - Grupo Quironsalud
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron - PPDS
city: Córdoba
country: Spain
facility: ICO l'Hospitalet - Hospital Duran i Reynals
city: El Palmar
country: Spain
facility: Hospital Universitario Virgen de La Arrixaca
city: Jaén
country: Spain
facility: Hospital Universitario de Jaen
city: L'Hospitalet De Llobregat
country: Spain
facility: C.H. Regional Reina Sofia - PPDS
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario HM Sanchinarro - CIOCC
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Valencia
country: Spain
facility: Consorcio Hospital General Universitario de Valencia
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
city: Cottingham
country: United Kingdom
facility: Castle Hill Hospital
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
Study officials:
affiliation: Nektar Therapeutics
name: Study Director
role: STUDY_DIRECTOR
References:
citation: 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.