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AzTrials

MelanomaPhase 3PIVOT-12NCT04410445

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

A Phase 3 study testing Bempegaldesleukin and Nivolumab in people with Melanoma and Melanoma Stage III, run by Nektar Therapeutics at 212 sites in 17 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Melanoma, Melanoma Stage III, Melanoma Stage IV
What is being tested?
Bempegaldesleukin and Nivolumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
765 participants
Where
212 sitesin 17 countries
Study dates
27 Jul 2020to 22 Sep 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

212 sites in 17 countries.

212 sites in 17 countries

United States62 sites

  • Lehigh Valley Physician Group (LVPG) - Hematology Oncology

    Allentown, Pennsylvania, 18103

  • Kaiser Foundation Hospital, Inpatient Pharmacy

    Anaheim, California, 92805

  • Rocky Mountain Cancer Centers (Littleton) - USOR

    Aurora, Colorado, 80012

  • University of Colorado - Cancer Center - PPDS

    Aurora, Colorado, 80045

  • Frontier Cancer Center and Blood Institute

    Billings, Montana, 59102

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 32750

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22903

  • SCRI Tennessee Oncology Chattanooga

    Chattanooga, Tennessee, 37404

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Department of Pharmacy Investigational Drug Services

    Dallas, Texas, 75235

  • Texas Oncology (Loop) - USOR

    Dallas, Texas, 75246

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Duke Cancer Institute

    Durham, North Carolina, 27710

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031

  • Kaiser Permanente

    Fontana, California, 92335

  • St. Joseph Heritage Healthcare

    Fullerton, California, 92835

  • Goshen Center For Cancer Care

    Goshen, Indiana, 46526

  • Prisma Health Cancer Institute

    Greenville, South Carolina, 29605

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

  • University of Kentucky

    Lexington, Kentucky, 40536

  • Banner MD Anderson Cancer Center

    Little Rock, Arkansas, 72205

  • Orlando Health Cancer Institute

    Longwood, Florida, 32750

  • University of Wisconsin

    Madison, Wisconsin, 53792

  • Atlantic Health System

    Morristown, New Jersey, 07960

  • SCRI Tennessee Oncology Nashville

    Nashville, Tennessee, 37203

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • NYU Langone Medical Center

    New York, New York, 10016

  • Columbia University Medical Center - PIN

    New York, New York, 10021

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68130

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Hematology Oncology Medical Group of Orange County, Inc.

    Orange, California, 92868

  • University of California Irvine

    Orange, California, 92868

  • Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • H Lee Moffitt Cancer Center and Research Institute

    Pittsburgh, Pennsylvania, 15232

  • Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • Providence Cancer Institute, Franz Clinic

    Portland, Oregon, 97213

  • Oregon Health and Science University

    Portland, Oregon, 97216

  • Emad Ibrahim, MD, Inc

    Redlands, California, 92373

  • Kaiser Permanente

    Riverside, California, 92505

  • Southern California Permanente Medical Group

    Riverside, California, 92505

  • Blue Ridge Cancer Care - USOR

    Roanoke, Virginia, 24014

  • Mayo Clinic - PIN

    Rochester, Minnesota, 55905

  • Utah Cancer Specialists (Salt Lake City)

    Salt Lake City, Utah, 90603

  • San Francisco Oncology Associates

    San Francisco, California, 94115

  • California Cancer Associates for Research and Excellence

    San Marcos, California, 92069

  • Kaiser Permanente

    San Marcos, California, 92078

  • Angeles Clinic and Research Institute

    Santa Monica, California, 90404

  • John Wayne Cancer Institute

    Santa Monica, California, 90404

  • Honor Health

    Scottsdale, Arizona, 85258

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Northwest Medical Specialties

    Tacoma, Washington, 98405

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

Other trials in United States

Germany25 sites

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117

  • Ruhr Universität Bochum

    Bochum, 44791

  • Elben Klinken Stade - Buxtehude

    Buxtehude, 21614

  • Uniklinik Köln

    Cologne, 50937

  • Universitätsklinikum Carl Gustav Carus an der TU Dresden

    Dresden, 81307

  • Helios Klinikum Erfurt

    Erfurt, 99089

  • Universitätsklinikum Essen

    Essen, 45147

  • SRH Wald-Klinikum Gera GmbH

    Gera, 7548

  • Universitatsklinikum Halle (Saale)

    Halle, 6097

  • Universitätsklinikum Hamburg Eppendorf

    Hamburg, 20246

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • University Clinic Heidelberg

    Heidelberg, 69120

  • SLK Kliniken Heilbronn GmbH

    Heilbronn, 74078

  • Universitatsklinikum Schleswig-Holstein

    Kiel, 24105

  • Universitatsklinikum Leipzig

    Leipzig, 04103

  • Klinikum der Stadt Ludwigshafen gGmbH

    Ludwigshafen, 67063

  • Universitätsklinik Magdeburg

    Magdeburg, 39014

  • Klinikum Mannheim Universitätsklinikum gGmbH

    Mannheim, 76297

  • Universitatsklinikum Munster

    Münster, 48149

  • Fachklinik Hornheide

    Münster, 48157

  • University Clinic Regensburg

    Regensburg, 93053

  • Helios Klinikum Schwerin

    Schwerin, 19049

  • Universitätsklinikum Tübingen

    Tübingen, 76297

  • Universitätsklinikum Ulm

    Ulm, 89081

  • Universitätsklinikum Würzburg

    Würzburg, 97080

Other trials in Germany

France16 sites

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

    Amiens, 80054

  • CHU Angers

    Angers, 49100

  • Hôpital Saint-André

    Bordeau

  • CHRU de Tours

    Chambray-lès-Tours

  • CHU Estaing

    Clermont-Ferrand, 63003

  • Hôpital Albert Michallon La Tronche

    La Tronche, 38043

  • CHRU Lille

    Lille, 59037

  • Hôtel Dieu - Nantes

    Nantes, 44093

  • CHU de Nice

    Nice, 6202

  • Hôpital Saint Louis

    Paris, 75475

  • Groupe Hospitalier Bichat Claude Bernard

    Paris, 75877

  • Hospices Civils de Lyon

    Pierre-Bénite, 69310

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

    Rennes, 35042

  • Hôpital Charles Nicolle

    Rouen, 76031

  • Centre Hospitalier Universitaire de Saint Etienne

    Saint-Priest-en-Jarez, 42055

  • Institut Gustave Roussy

    Villejuif, 94801

Other trials in France

Spain15 sites

  • Hospital Universitario A Coruña

    A Coruña, 15006

  • Hospital Universitario Germans Trias i Pujol

    Badalona, 08911

  • Hospital de La Santa Creu i Sant Pau

    Barcelona, 08025

  • Hospital Universitari Dexeus - Grupo Quironsalud

    Barcelona, 08028

  • Hospital Universitario Vall d'Hebron - PPDS

    Barcelona, 08035

  • ICO l'Hospitalet - Hospital Duran i Reynals

    Córdoba, 14004

  • Hospital Universitario Virgen de La Arrixaca

    El Palmar

  • Hospital Universitario de Jaen

    Jaén, 23007

  • C.H. Regional Reina Sofia - PPDS

    L'Hospitalet de Llobregat, 08904

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario HM Sanchinarro - CIOCC

    Madrid, 28050

  • Hospital General Universitario Gregorio Maranon

    Madrid, 4628007

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29789

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Consorcio Hospital General Universitario de Valencia

    Valencia

Other trials in Spain

Australia13 sites

  • Royal Adelaide Hospital

    Adelaide, 5000

  • Cairns Hospital

    Cairns, 4870

  • Icon Cancer Care Wesley

    Chermside, 4032

  • Gallipoli Medical Research Foundation

    Greenslopes, 4120

  • Austin Health

    Heidelberg, 3084

  • Alfred Hospital

    Melbourne, 3004

  • Affinity Clinical Research

    Nedlands, 6009

  • Sir Charles Gairdner Hospital

    Nedlands, 6009

  • Melanoma Institute Australia

    North Sydney, 2000

  • Gold Coast University Hospital

    Southport, 4215

  • Tasman Oncology Research

    Southport, 4215

  • Blacktown Hospital

    Westmead, 2145

  • Princess Alexandra Hospital

    Woolloongabba, 4102

Other trials in Australia

Italy11 sites

  • IRCCS Giovanni Paolo II Istituto Oncologico

    Bari, 70124

  • ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII

    Bergamo

  • Fondazione del Piemonte per l'Oncologia (IRCCS)

    Candiolo, 10060

  • Ospedale Policlinico San Martino

    Genova

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

    Meldola, 47014

  • Istituto Europeo Di Oncologia

    Milan, 20141

  • Istituto Nazionale Dei Tumori

    Milan

  • Azienda Ospedaliero Universitaria Di Modena Policlinico

    Modena, 41100

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

    Naples, 80131

  • Istituto Oncologico Veneto - I.R.C.C.S.

    Padova, 35128

  • Azienda Ospedaliera Universitaria Senese

    Siena, 53100

Other trials in Italy

Greece10 sites

  • Laiko General Hospital of Athens

    Ampelokipoi, 11526

  • Henry Dunant Hospital

    Athens, 11526

  • Metropolitan Hospital - First Oncology Clinic

    Athens, 18547

  • Metropolitan Hospital - Fourth Oncology Clinic

    Athens, 18547

  • Pepagni Hospital

    Heraklion, 71110

  • Medical Center of Athens

    Marousi, 15125

  • Interbalkan Medical Center of Thessaloniki

    Pylaia, TK57001

  • Theageneio Anticancer Oncology Hospital of Thessaloniki

    Thessaloniki, 54645

  • Papageorgiou General Hospital of Thessaloniki

    Thessaloniki, 56429

  • Bioclinic Thessaloniki (Galinos clinic)

    Thessaloniki, 86

Other trials in Greece

Russia9 sites

  • Chelyabinsk Regional Clinical Oncology Dispensary

    Chelyabinsk, 454087

  • Clinical Oncology Centre #1

    Krasnodar, 350040

  • Krasnoyarsk Regional Oncology Center n.a. A.I. Kryzhanovskiy

    Krasnoyarsk, 660133

  • Kursk Regional Oncology Centre

    Kursk, 305524

  • PMI Euromedservice

    Pushkin, 196603

  • Ryazan Regional Clinical Oncology Dispensary

    Ryazan, 390011

  • FSBI National Medical Research Center of Oncology n.a. N.N.Petrov of MHRF

    Saint Petersburg, 191758

  • Railway Clinical Hospital JSC RZhD

    Saint Petersburg, 195271

  • Regional Clinical Oncology Hospital

    Yaroslavl, 150040

Other trials in Russia

Netherlands8 sites

  • VU Medisch Centrum

    Amsterdam, 1081HV

  • Zuyderland Medisch Centrum

    Heerlen, 6419

  • Medisch Centrum Leeuwarden

    Leeuwarden, 8934

  • Leiden University Medical Center

    Leiden, 2333ZA

  • Radboud University Nijmegen Medical Centre

    Nijmegen, 6525GA

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584

  • Maxima Medisch Centrum

    Veldhoven

  • Isala Klinieken

    Zwolle, 8025AB

Other trials in Netherlands

Czechia7 sites

  • Mou/Mmci - Ppds

    Brno, 65653

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové

  • Krajska nemocnice Liberec, a.s.

    Liberec, 46063

  • Fakultni nemocnice Olomouc

    Olomouc, 79900

  • Fakultni nemocnice Ostrava

    Ostrava Poruba, 70852

  • Vseobecna Fakultni Nemocnice V Praze

    Prague, 12808

  • Nemocnice Na Bulovce

    Prague, 16000

Other trials in Czechia

Austria6 sites

  • Medizinische Universität Graz

    Graz, 8036

  • Ordensklinikum Linz, Krankenhaus der Elisabethinen GmbH

    Lienz

  • Landeskrankenhaus Feldkirch

    Rankweil, 6830

  • Salzburger Landeskliniken

    Salzburg

  • Universitätsklinikum St. Pölten

    Sankt Pölten, 3100

  • Allgemeines Krankenhaus der Stadt Wien

    Vienna, 1090

Other trials in Austria

Israel6 sites

  • HaEmek Medical Center

    Afula, 18101

  • Soroka University Medical Centre

    Beersheba, 8410501

  • Rambam Medical Center - PPDS

    Haifa, 31096

  • Hadassah Medical Center - PPDS

    Jerusalem, 9574425

  • Rabin Medical Center - PPDS

    Petah Tikva, 49100

  • Sheba Medical Center - PPDS

    Ramat Gan

Other trials in Israel

New Zealand5 sites

  • Christchurch Hospital

    Christchurch, 8140

  • Dunedin Hospital

    Dunedin, 9054

  • Auckland City Hospital

    Heidelberg, 3084

  • Tauranga Hospital

    Tauranga, 3143

  • Wellington Hospital

    Wellington, 6021

Other trials in New Zealand

Poland5 sites

  • Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie w Bialymstoku

    Bialystok, 15-027

  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy

    Bydgoszcz, 85796

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80952

  • NZOZ NEUROMED M. I M. Nastaj Spolka Partnerska

    Lublin, 20064

  • Szpital Kliniczny im. Heliodora Swiecickiego w Poznaniu

    Poznan, 60780

Other trials in Poland

Portugal5 sites

  • Centro Hospitalar E Universitário de Coimbra EPE

    Coimbra, 3004-561

  • Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.

    Lisbon, 1099-023

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

    Lisbon, 1649-035

  • Hospital CUF Tejo

    Lisbon, 1649-035

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

    Porto, 4200-072

Other trials in Portugal

United Kingdom5 sites

  • Addenbrooke's Hospital

    Cambridge, CB20QQ

  • Castle Hill Hospital

    Cottingham, HU165JQ

  • Leicester Royal Infirmary

    Leicester, LE15WW

  • Nottingham City Hospital

    Nottingham, BG72UH

  • Royal Cornwall Hospital

    Truro, TR13LJ

Other trials in United Kingdom

Romania4 sites

  • Affidea Romania SRL

    Bucharest, 022328

  • S.C. Medisprof SRL

    Cluj-Napoca, 400641

  • S.C. Onco Clinic Consult SA

    Craiova, 200094

  • Oncology Center Sfantul Nectarie

    Craiova, 200347

Other trials in Romania

About this study

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)

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.

Read the 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.

Being tested
Bempegaldesleukin, Nivolumab
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
Medical subject headings
Melanoma, Skin Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BempegaldesleukinBiological

    Also called NKTR-214, BMS-986321

    Specified dose on specified days

  • NivolumabBiological

    Also called Opdivo®, BMS-936558

    Specified dose on specified days

Study groups in NCT04410445
Study groupRoleWhat they receive
Combination of bempegaldesleukin (NKTR-214) + nivolumabExperimentalArm A: Participants will receive bempegaldesleukin (NKTR-214) IV in combination with nivolumab every 3 weeks.
Receives: Biological: Bempegaldesleukin; Biological: Nivolumab
NivolumabActive comparatorArm B: Participants will receive nivolumab IV alone every 4 weeks.
Receives: Biological: Nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 21 months

Secondary outcomes (8)

  1. Overall Survival (OS) of Bempegaldesleukin Plus Nivolumab Versus Nivolumab Alone

    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.

    Measured: Up to 21 months

  2. Distant Metastasis-Free Survival (DMFS) by Investigator in Patients Who Are Stage III at Study Entry.

    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.

    Measured: Up to 21 months

  3. Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    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.

    Measured: Approximately up to 21 months

  4. 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

    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.

    Measured: From baseline, up to approximately 6 months

  5. Programmed Death-Ligand 1 (PD-L1) Expression as a Predictive Biomarker for Recurrence-free Survival (RFS)

    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.

    Measured: Up to 21 months

  6. Recurrence-free Survival (RFS) by Investigator of Bempegaldesleukin Plus Nivolumab Versus Nivolumab Alone.

    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.

    Measured: Up to 21 months

  7. Time to Disease Progression After the Next Line of Treatment for Study Patients Following Discontinuation of Bempegaldesleukin Plus Nivolumab Versus Nivolumab

    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.

    Measured: Up to 21 months

  8. Distant Metastasis-Free Survival (DMFS) by Blinded Independent Central Review (BICR) in Patients Who Are Stage III at Study Entry.

    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.

    Measured: Up to 21 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2020
  2. Study start27 Jul 2020
  3. Primary completion22 Sep 2022
  4. Study completion22 Sep 2022

Why it stopped: (Sponsor decision)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients will be randomized in a 1:1 ratio to one of two treatment arms
Masking
None (open label)
Enrolment
765 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04410445
Sponsor's protocol ID
20-214-29/CA045-022
Acronym
PIVOT-12
Status last verified
Mar 2023
First submitted
27 May 2020
Last updated
21 Apr 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 35073733

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bempegaldesleukin and Nivolumab in people with Melanoma and Melanoma Stage III, run by Nektar Therapeutics at 212 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 212 sites in United States, Germany, France, Spain, Australia and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence-free Survival (RFS) by Blinded Independent Central Review (BICR) of Bempegaldesleukin Plus Nivolumab Versus Nivolumab Alone. (time frame: Up to 21 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04410445, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2023.

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