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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)

  • Clinicaltrials.gov identifier

    NCT04410445

  • Recruitment Status

    Recruiting

  • First Posted

    June 1, 2020

  • Last update posted

    October 1, 2021

Study Description

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.

  • Condition or Disease:Melanoma (Skin)
    Melanoma Stage IV
    Melanoma Stage III
    Melanoma
  • Intervention/Treatment: Biological: Bempegaldesleukin
    Biological: Nivolumab
  • Phase: Phase 3

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 Design

  • Study Type: Interventional
  • Estimated Enrollment: 950 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: Patients will be randomized in a 1:1 ratio to one of two treatment arms
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • 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)
  • Actual Study Start Date: July 2020
  • Estimated Primary Completion Date: July 2027
  • Estimated Study Completion Date: July 2027

Arms and interventions

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: Bempegaldesleukin
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days
Active Comparator: Nivolumab
Arm B: Participants will receive nivolumab IV alone every 4 weeks.
Biological: Nivolumab
Specified dose on specified days

Outcome Measures

  • Primary Outcome Measures: 1. RFS of bempegaldesleukin plus nivolumab versus nivolumab alone by BICR, is defined as the time between date of randomization and date of first recurrence, new primary melanoma, or all-cause death [ Time Frame: Approximately up to 60 months ]
  • Secondary Outcome Measures: 1. Overall Survival (OS) defined as the time between the date of randomization and the date of death due to any cause [ Time Frame: Approximately up to 83 months ]
  • 2. Distant metastasis-free survival (DMFS) by BICR and by Investigator in patients who have Stage IIIA (LN metastasis > 1 mm) or IIIB/C/D melanoma at study entry. [ Time Frame: Approximately up to 60 months ]
    To evaluate distant metastasis-free survival (DMFS) by BICR and by Investigator in patients who have Stage IIIA (LN metastasis > 1 mm) or IIIB/C/D melanoma at study entry. Distant Metastasis Free Survival is defined as the time between the date of randomization and the date of first distant metastasis or date of death due to any cause.
  • 3. Overall safety and tolerability of bempegaldesleukin plus nivolumab will be measured by the incidence of AEs, SAEs, deaths, and laboratory abnormalities using CTCAE Version 5.0 criteria [ Time Frame: Approximately up to 60 months ]
  • 4. Patient Reported Outcomes will be measured by changes from baseline in scores for the global health/quality of life and physical functioning subscales of the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire [ Time Frame: Approximately up to 60 months ]
  • 5. The predictive strength of PD-L1 expression as a biomarker will be measured by the endpoint RFS by BICR based on PD-L1 expression level [ Time Frame: Approximately up to 60 months ]
  • 6. RFS by Investigator will be measured similarly to the primary endpoint, but recurrence and new primary melanoma will be decided by the Investigator [ Time Frame: Approximately up to 60 months ]
  • 7. Time to disease progression after the next line of treatment for study patients following discontinuation of bempegaldesleukin plus nivolumab versus nivolumab [ Time Frame: Approximately up to 60 months ]
    To evaluate time to disease progression after the next line of treatment for study patients following discontinuation of bempegaldesleukin plus nivolumab versus nivolumab

Eligibility Criteria

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

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.

Contacts and Locations

Contacts

Contact: Nektar Recruitment 855-482-8676 StudyInquiry@nektar.com

Contact: Medical Affairs medicalaffairs@nektar.com

Locations

United States, Arizona
Honor Health
Scottsdale

United States, California
Kaiser Foundation Hospital, Inpatient Pharmacy
Anaheim

United States, California
Kaiser Permanente
Fontana

United States, California
St. Joseph Heritage Healthcare
Fullerton

United States, California
Hematology Oncology Medical Group of Orange County, Inc.
Orange

United States, California
University of California Irvine
Orange

United States, California
Emad Ibrahim, MD, Inc
Redlands

United States, California
Kaiser Permanente
Riverside

United States, California
Southern California Permanente Medical Group
Riverside

United States, California
San Francisco Oncology Associates
San Francisco

United States, California
California Cancer Associates for Research and Excellence
San Marcos

United States, California
Kaiser Permanente
San Marcos

United States, California
Angeles Clinic and Research Institute
Santa Monica

United States, California
John Wayne Cancer Institute
Santa Monica

United States, California
Investigator Site - Site #0215
Whittier

United States, Colorado
Rocky Mountain Cancer Centers (Littleton) - USOR
Aurora

United States, Colorado
University of Colorado - Cancer Center - PPDS
Aurora

United States, District of Columbia
MedStar Georgetown University Hospital
Washington

United States, Florida
Orlando Health Cancer Institute
Longwood

United States, Illinois
Rush University Medical Center
Chicago

United States, Indiana
Goshen Center For Cancer Care
Goshen

United States, Kentucky
University of Kentucky
Lexington

United States, Louisiana
Ochsner Clinic Foundation
New Orleans

United States, Massachusetts
Massachusetts General Hospital
Boston

United States, Minnesota
Mayo Clinic - PIN
Rochester

United States, Missouri
Washington University School of Medicine
Saint Louis

United States, Montana
Frontier Cancer Center and Blood Institute
Billings

United States, Nebraska
Nebraska Cancer Specialists
Omaha

United States, Nebraska
Nebraska Methodist Hospital
Omaha

United States, Nebraska
University of Nebraska Medical Center
Omaha

United States, New Jersey
Atlantic Health System
Morristown

United States, New York
NYU Langone Medical Center
New York

United States, New York
Columbia University Medical Center - PIN
New York

United States, New York
Icahn School of Medicine at Mount Sinai
New York

United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill

United States, North Carolina
Duke Cancer Institute
Durham

United States, Ohio
University Hospitals Cleveland Medical Center
Cleveland

United States, Ohio
The Cleveland Clinic Foundation
Cleveland

United States, Oregon
Providence Cancer Institute, Franz Clinic
Portland

United States, Oregon
Oregon Health and Science University
Portland

United States, Pennsylvania
Lehigh Valley Physician Group (LVPG) - Hematology Oncology
Allentown

United States, Pennsylvania
Penn State Milton S Hershey Medical Center
Hershey

United States, Pennsylvania
Jefferson University Hospital
Philadelphia

United States, Pennsylvania
H Lee Moffitt Cancer Center and Research Institute
Pittsburgh

United States, Pennsylvania
Hillman Cancer Center
Pittsburgh

United States, South Carolina
Prisma Health Cancer Institute
Greenville

United States, Tennessee
SCRI Tennessee Oncology Chattanooga
Chattanooga

United States, Tennessee
University of Tennessee Medical Center
Knoxville

United States, Tennessee
SCRI Tennessee Oncology Nashville
Nashville

United States, Tennessee
Vanderbilt University Medical Center
Nashville

United States, Texas
Texas Oncology (Loop) - USOR
Dallas

United States, Texas
University of Texas Southwestern Medical Center
Dallas

United States, Texas
MD Anderson Cancer Center
Houston

United States, Utah
Utah Cancer Specialists (Salt Lake City)
Salt Lake City

United States, Virginia
University of Virginia Cancer Center
Charlottesville

United States, Virginia
Inova Schar Cancer Institute
Fairfax

United States, Virginia
Blue Ridge Cancer Care - USOR
Roanoke

United States, Washington
Seattle Cancer Care Alliance
Seattle

United States, Washington
Northwest Medical Specialties
Tacoma

United States, Wisconsin
University of Wisconsin
Madison

Australia
Royal Adelaide Hospital
Adelaide

Australia
Cairns Hospital
Cairns

Australia
Icon Cancer Care Wesley
Chermside

Australia
Gallipoli Medical Research Foundation
Greenslopes

Australia
Austin Health
Heidelberg

Australia
Alfred Hospital
Melbourne

Australia
Affinity Clinical Research
Nedlands

Australia
Sir Charles Gairdner Hospital
Nedlands

Australia
Melanoma Institute Australia
North Sydney

Australia
Gold Coast University Hospital
Southport

Australia
Tasman Oncology Research
Southport

Australia
Blacktown Hospital
Westmead

Australia
Princess Alexandra Hospital
Woolloongabba

Austria
Medizinische Universität Graz
Graz

Austria
Ordensklinikum Linz, Krankenhaus der Elisabethinen GmbH
Lienz

Austria
Landeskrankenhaus Feldkirch
Rankweil

Austria
Salzburger Landeskliniken
Salzburg

Austria
Universitätsklinikum St. Pölten
St.Pölten

Austria
Allgemeines Krankenhaus der Stadt Wien
Vienna

Czechia
Mou/Mmci - Ppds
Brno

Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové

Czechia
Krajska nemocnice Liberec, a.s.
Liberec

Czechia
Fakultni nemocnice Olomouc
Olomouc

Czechia
Fakultni nemocnice Ostrava
Ostrava Poruba

Czechia
Nemocnice Na Bulovce
Prague

Czechia
Vseobecna Fakultni Nemocnice V Praze
Praha

France
Centre Hospitalier Universitaire (CHU) Amiens-Picardie - Hopital Sud
Amiens

France
CHU Angers
Angers

France
Hôpital Saint-André
Bordeau

France
CHRU de Tours
Chambray-lès-Tours

France
CHU Estaing
Clermont-Ferrand

France
Hôpital Albert Michallon La Tronche
La Tronche

France
CHRU Lille
Lille

France
Hôtel Dieu - Nantes
Nantes

France
CHU de Nice
Nice

France
Hôpital Saint Louis
Paris

France
Groupe Hospitalier Bichat Claude Bernard
Paris

France
Hospices Civils de Lyon
Pierre-Bénite

France
EDOG - Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer - PPDS
Rennes

France
Hôpital Charles Nicolle
Rouen

France
Centre Hospitalier Universitaire de Saint Etienne
Saint-Priest-en-Jarez

France
Institut Gustave Roussy
Villejuif

Germany
Charité - Universitätsmedizin Berlin
Berlin

Germany
Ruhr Universität Bochum
Bochum

Germany
Elben Klinken Stade - Buxtehude
Buxtehude

Germany
Universitätsklinikum Carl Gustav Carus an der TU Dresden
Dresden

Germany
Helios Klinikum Erfurt
Erfurt

Germany
Universitätsklinikum Essen
Essen

Germany
SRH Wald-Klinikum Gera GmbH
Gera

Germany
Universitatsklinikum Halle (Saale)
Halle

Germany
Universitätsklinikum Hamburg Eppendorf
Hamburg

Germany
Medizinische Hochschule Hannover
Hannover

Germany
SLK Kliniken Heilbronn GmbH
Heilbronn

Germany
Universitatsklinikum Schleswig-Holstein
Kiel

Germany
Uniklinik Köln
Köln

Germany
Universitatsklinikum Leipzig
Leipzig

Germany
Klinikum der Stadt Ludwigshafen gGmbH
Ludwigshafen

Germany
Universitätsklinik Magdeburg
Magdeburg

Germany
Klinikum Mannheim Universitätsklinikum gGmbH
Mannheim

Germany
Universitatsklinikum Munster
Münster

Germany
Fachklinik Hornheide
Münster

Germany
University Clinic Regensburg
Regensburg

Germany
Helios Klinikum Schwerin
Schwerin

Germany
Universitätsklinikum Tübingen
Tübingen

Germany
Universitätsklinikum Ulm
Ulm

Germany
Universitätsklinikum Würzburg
Würzburg

Greece
Laiko General Hospital of Athens
Ampelokipoi

Greece
Henry Dunant Hospital
Athens

Greece
Metropolitan Hospital - First Oncology Clinic
Athens

Greece
Metropolitan Hospital - Fourth Oncology Clinic
Athens

Greece
Pepagni Hospital
Heraklion

Greece
Medical Center of Athens
Maroúsi

Greece
Interbalkan Medical Center of Thessaloniki
Pylaía

Greece
Theageneio Anticancer Oncology Hospital of Thessaloniki
Thessaloníki

Greece
Papageorgiou General Hospital of Thessaloniki
Thessaloníki

Greece
Bioclinic Thessaloniki (Galinos clinic)
Thessaloníki

Israel
HaEmek Medical Center
Afula

Israel
Soroka University Medical Centre
Be'er Sheva

Israel
Rambam Medical Center - PPDS
Haifa

Israel
Hadassah Medical Center - PPDS
Jerusalem

Israel
Rabin Medical Center - PPDS
Petah tikva

Israel
Sheba Medical Center - PPDS
Ramat Gan

Italy
IRCCS Giovanni Paolo II Istituto Oncologico
Bari

Italy
Fondazione del Piemonte per l'Oncologia (IRCCS)
Candiolo

Italy
Ospedale Policlinico San Martino
Genova

Italy
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS
Meldola

Italy
Istituto Europeo Di Oncologia
Milano

Italy
Azienda Ospedaliero Universitaria Di Modena Policlinico
Modena

Italy
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale
Napoli

Italy
Azienda Ospedaliera Universitaria Senese
Siena

Netherlands
VU Medisch Centrum
Amsterdam

Netherlands
Zuyderland Medisch Centrum
Heerlen

Netherlands
Medisch Centrum Leeuwarden
Leeuwarden

Netherlands
Leiden University Medical Center
Leiden

Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen

Netherlands
Universitair Medisch Centrum Utrecht
Utrecht

Netherlands
Isala Klinieken
Zwolle

New Zealand
Christchurch Hospital
Christchurch

New Zealand
Dunedin Hospital
Dunedin

New Zealand
Auckland City Hospital
Heidelberg

New Zealand
Tauranga Hospital
Tauranga

New Zealand
Wellington Hospital
Wellington

Poland
Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie w Bialymstoku
Białystok

Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy
Bydgoszcz

Poland
Uniwersyteckie Centrum Kliniczne
Gdańsk

Poland
NZOZ NEUROMED M. I M. Nastaj Spolka Partnerska
Lublin

Poland
Szpital Kliniczny im. Heliodora Swiecickiego w Poznaniu
Poznań

Portugal
Centro Hospitalar E Universitário de Coimbra EPE
Coimbra

Portugal
Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria
Lisboa

Portugal
Hospital CUF Tejo
Lisboa

Portugal
Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.
Lisbon

Portugal
Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS
Porto

Romania
Onco Clinic Consult SA
Bucharest

Romania
Oncology Center Sfantul Nectarie
Cluj-Napoca

Romania
Medisprof SRL
Craiova

Romania
Affidea Romania SRL
Dolj

Russian Federation
Chelyabinsk Regional Clinical Oncology Dispensary
Chelyabinsk

Russian Federation
Clinical Oncology Centre #1
Krasnodar

Russian Federation
Krasnoyarsk Regional Oncology Center n.a. A.I. Kryzhanovskiy
Krasnoyarsk

Russian Federation
Kursk Regional Oncology Centre
Kursk

Russian Federation
PMI Euromedservice
Pushkin

Russian Federation
Ryazan Regional Clinical Oncology Dispensary
Ryazan'

Russian Federation
FSBI National Medical Research Center of Oncology n.a. N.N.Petrov of MHRF
Saint Petersburg

Russian Federation
Railway Clinical Hospital JSC RZhD
Saint Petersburg

Russian Federation
Regional Clinical Oncology Hospital
Yaroslavl

Spain
Hospital Universitario A Coruña
A Coruña

Spain
Hospital Universitario Germans Trias i Pujol
Badalona

Spain
Hospital de La Santa Creu i Sant Pau
Barcelona

Spain
Hospital Universitari Dexeus - Grupo Quironsalud
Barcelona

Spain
Hospital Universitario Vall d'Hebron - PPDS
Barcelona

Spain
ICO l'Hospitalet - Hospital Duran i Reynals
Córdoba

Spain
Hospital Universitario Virgen de La Arrixaca
El Palmar

Spain
Hospital Universitario de Jaen
Jaén

Spain
C.H. Regional Reina Sofia - PPDS
L'Hospitalet De Llobregat

Spain
Hospital Universitario 12 de Octubre
Madrid

Spain
Hospital Universitario HM Sanchinarro - CIOCC
Madrid

Spain
Hospital Universitario Virgen de la Victoria
Málaga

Spain
Hospital Universitario Virgen Macarena
Sevilla

Spain
Consorcio Hospital General Universitario de Valencia
Valencia

United Kingdom
Addenbrooke's Hospital
Cambridge

United Kingdom
Castle Hill Hospital
Cottingham

United Kingdom
Leicester Royal Infirmary
Leicester

United Kingdom
Nottingham City Hospital
Nottingham

United Kingdom
Royal Cornwall Hospital
Truro

Sponsors and Collaborators

Nektar Therapeutics

Bristol-Myers Squibb

Investigators

Study Director: Study Director Nektar Therapeutics

More Information

  • Responsible Party: Nektar Therapeutics
  • ClinicalTrials.gov Identifier: NCT04410445 History of Changes
  • Other Study ID Numbers: 20-214-29/CA045-022
  • First Posted: June 1, 2020 Key Record Dates
  • Last Update Posted: October 1, 2021
  • Last Verified: September 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: Undecided
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Nektar Therapeutics: Checkpoint Inhibitor
    Post Resection
    High Risk of Recurrence Melanoma
    Resectable Melanoma
    Skin Cancer
    Adjuvant
    NIVO
    Opdivo®
    BEMPEG
    Nivolumab
    Immunotherapy
    IL-2
    Bempegaldesleukin
    NKTR-214
    IL-2 Receptor Agonist
    CD122-Biased Cytokine
    CD122-Biased Agonist
  • Additional relevant MeSH terms: Recurrence Melanoma