Back to resultsStudy 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)
Primary Purpose
Melanoma, Melanoma Stage III, Melanoma Stage IV
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bempegaldesleukin
Nivolumab
Sponsored by
About this trial
This is an interventional treatment trial for Melanoma focused on measuring 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
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.
Sites / Locations
- Honor Health
- Banner MD Anderson Cancer Center
- Kaiser Foundation Hospital, Inpatient Pharmacy
- Kaiser Permanente
- St. Joseph Heritage Healthcare
- Hematology Oncology Medical Group of Orange County, Inc.
- University of California Irvine
- Emad Ibrahim, MD, Inc
- Kaiser Permanente
- Southern California Permanente Medical Group
- San Francisco Oncology Associates
- California Cancer Associates for Research and Excellence
- Kaiser Permanente
- Angeles Clinic and Research Institute
- John Wayne Cancer Institute
- Rocky Mountain Cancer Centers (Littleton) - USOR
- University of Colorado - Cancer Center - PPDS
- MedStar Georgetown University Hospital
- Orlando Health Cancer Institute
- Rush University Medical Center
- Goshen Center For Cancer Care
- University of Kentucky
- Ochsner Clinic Foundation
- Massachusetts General Hospital
- Mayo Clinic - PIN
- Washington University School of Medicine
- Frontier Cancer Center and Blood Institute
- Nebraska Cancer Specialists
- Nebraska Methodist Hospital
- University of Nebraska Medical Center
- Hackensack University Medical Center
- Atlantic Health System
- NYU Langone Medical Center
- Columbia University Medical Center - PIN
- Icahn School of Medicine at Mount Sinai
- University of North Carolina at Chapel Hill
- Duke Cancer Institute
- University Hospitals Cleveland Medical Center
- The Cleveland Clinic Foundation
- Providence Cancer Institute, Franz Clinic
- Oregon Health and Science University
- Lehigh Valley Physician Group (LVPG) - Hematology Oncology
- Penn State Milton S Hershey Medical Center
- Jefferson University Hospital
- H Lee Moffitt Cancer Center and Research Institute
- Hillman Cancer Center
- Prisma Health Cancer Institute
- SCRI Tennessee Oncology Chattanooga
- University of Tennessee Medical Center
- SCRI Tennessee Oncology Nashville
- Vanderbilt University Medical Center
- Department of Pharmacy Investigational Drug Services
- Texas Oncology (Loop) - USOR
- University of Texas Southwestern Medical Center
- MD Anderson Cancer Center
- Utah Cancer Specialists (Salt Lake City)
- University of Virginia Cancer Center
- Inova Schar Cancer Institute
- Blue Ridge Cancer Care - USOR
- Seattle Cancer Care Alliance
- Northwest Medical Specialties
- University of Wisconsin
- Royal Adelaide Hospital
- Cairns Hospital
- Icon Cancer Care Wesley
- Gallipoli Medical Research Foundation
- Austin Health
- Alfred Hospital
- Affinity Clinical Research
- Sir Charles Gairdner Hospital
- Melanoma Institute Australia
- Gold Coast University Hospital
- Tasman Oncology Research
- Blacktown Hospital
- Princess Alexandra Hospital
- Medizinische Universität Graz
- Ordensklinikum Linz, Krankenhaus der Elisabethinen GmbH
- Landeskrankenhaus Feldkirch
- Salzburger Landeskliniken
- Universitätsklinikum St. Pölten
- Allgemeines Krankenhaus der Stadt Wien
- Mou/Mmci - Ppds
- Fakultni nemocnice Hradec Kralove
- Krajska nemocnice Liberec, a.s.
- Fakultni nemocnice Olomouc
- Fakultni nemocnice Ostrava
- Nemocnice Na Bulovce
- Vseobecna Fakultni Nemocnice V Praze
- Centre Hospitalier Universitaire (CHU) Amiens-Picardie - Hopital Sud
- CHU Angers
- Hôpital Saint-André
- CHRU de Tours
- CHU Estaing
- Hôpital Albert Michallon La Tronche
- CHRU Lille
- Hôtel Dieu - Nantes
- CHU de Nice
- Hôpital Saint Louis
- Groupe Hospitalier Bichat Claude Bernard
- Hospices Civils de Lyon
- EDOG - Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer - PPDS
- Hôpital Charles Nicolle
- Centre Hospitalier Universitaire de Saint Etienne
- Institut Gustave Roussy
- Charité - Universitätsmedizin Berlin
- Ruhr Universität Bochum
- Elben Klinken Stade - Buxtehude
- Universitätsklinikum Carl Gustav Carus an der TU Dresden
- Helios Klinikum Erfurt
- Universitätsklinikum Essen
- SRH Wald-Klinikum Gera GmbH
- Universitatsklinikum Halle (Saale)
- Universitätsklinikum Hamburg Eppendorf
- Medizinische Hochschule Hannover
- University Clinic Heidelberg
- SLK Kliniken Heilbronn GmbH
- Universitatsklinikum Schleswig-Holstein
- Uniklinik Köln
- Universitatsklinikum Leipzig
- Klinikum der Stadt Ludwigshafen gGmbH
- Universitätsklinik Magdeburg
- Klinikum Mannheim Universitätsklinikum gGmbH
- Universitatsklinikum Munster
- Fachklinik Hornheide
- University Clinic Regensburg
- Helios Klinikum Schwerin
- Universitätsklinikum Tübingen
- Universitätsklinikum Ulm
- Universitätsklinikum Würzburg
- Laiko General Hospital of Athens
- Henry Dunant Hospital
- Metropolitan Hospital - First Oncology Clinic
- Metropolitan Hospital - Fourth Oncology Clinic
- Pepagni Hospital
- Medical Center of Athens
- Interbalkan Medical Center of Thessaloniki
- Theageneio Anticancer Oncology Hospital of Thessaloniki
- Papageorgiou General Hospital of Thessaloniki
- Bioclinic Thessaloniki (Galinos clinic)
- HaEmek Medical Center
- Soroka University Medical Centre
- Rambam Medical Center - PPDS
- Hadassah Medical Center - PPDS
- Rabin Medical Center - PPDS
- Sheba Medical Center - PPDS
- IRCCS Giovanni Paolo II Istituto Oncologico
- ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII
- Fondazione del Piemonte per l'Oncologia (IRCCS)
- Ospedale Policlinico San Martino
- Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS
- Istituto Europeo Di Oncologia
- Istituto Nazionale Dei Tumori
- Azienda Ospedaliero Universitaria Di Modena Policlinico
- Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale
- Istituto Oncologico Veneto - I.R.C.C.S.
- Azienda Ospedaliera Universitaria Senese
- VU Medisch Centrum
- Zuyderland Medisch Centrum
- Medisch Centrum Leeuwarden
- Leiden University Medical Center
- Radboud University Nijmegen Medical Centre
- Universitair Medisch Centrum Utrecht
- Maxima Medisch Centrum
- Isala Klinieken
- Christchurch Hospital
- Dunedin Hospital
- Auckland City Hospital
- Tauranga Hospital
- Wellington Hospital
- Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie w Bialymstoku
- Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy
- Uniwersyteckie Centrum Kliniczne
- NZOZ NEUROMED M. I M. Nastaj Spolka Partnerska
- Szpital Kliniczny im. Heliodora Swiecickiego w Poznaniu
- Centro Hospitalar E Universitário de Coimbra EPE
- Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria
- Hospital CUF Tejo
- Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.
- Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS
- Affidea Romania SRL
- S.C. Medisprof SRL
- S.C. Onco Clinic Consult SA
- Oncology Center Sfantul Nectarie
- Chelyabinsk Regional Clinical Oncology Dispensary
- Clinical Oncology Centre #1
- Krasnoyarsk Regional Oncology Center n.a. A.I. Kryzhanovskiy
- Kursk Regional Oncology Centre
- PMI Euromedservice
- Ryazan Regional Clinical Oncology Dispensary
- FSBI National Medical Research Center of Oncology n.a. N.N.Petrov of MHRF
- Railway Clinical Hospital JSC RZhD
- Regional Clinical Oncology Hospital
- Hospital Universitario A Coruña
- Hospital Universitario Germans Trias i Pujol
- Hospital de La Santa Creu i Sant Pau
- Hospital Universitari Dexeus - Grupo Quironsalud
- Hospital Universitario Vall d'Hebron - PPDS
- ICO l'Hospitalet - Hospital Duran i Reynals
- Hospital Universitario Virgen de La Arrixaca
- Hospital Universitario de Jaen
- C.H. Regional Reina Sofia - PPDS
- Hospital Universitario 12 de Octubre
- Hospital Universitario HM Sanchinarro - CIOCC
- Hospital General Universitario Gregorio Maranon
- Hospital Universitario Virgen de la Victoria
- Hospital Universitario Virgen Macarena
- Consorcio Hospital General Universitario de Valencia
- Addenbrooke's Hospital
- Castle Hill Hospital
- Leicester Royal Infirmary
- Nottingham City Hospital
- Royal Cornwall Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Combination of bempegaldesleukin (NKTR-214) + nivolumab
Nivolumab
Arm Description
Arm A: Participants will receive bempegaldesleukin (NKTR-214) IV in combination with nivolumab every 3 weeks.
Arm B: Participants will receive nivolumab IV alone every 4 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT04410445
First Posted
May 27, 2020
Last Updated
March 31, 2023
Sponsor
Nektar Therapeutics
Collaborators
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT04410445
Brief Title
Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence
Acronym
PIVOT-12
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
(Sponsor decision)
Study Start Date
July 27, 2020 (Actual)
Primary Completion Date
September 22, 2022 (Actual)
Study Completion Date
September 22, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nektar Therapeutics
Collaborators
Bristol-Myers Squibb
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized in a 1:1 ratio to one of two treatment arms
Masking
None (Open Label)
Allocation
Randomized
Enrollment
765 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Combination of bempegaldesleukin (NKTR-214) + nivolumab
Arm Type
Experimental
Arm Description
Arm A: Participants will receive bempegaldesleukin (NKTR-214) IV in combination with nivolumab every 3 weeks.
Arm Title
Nivolumab
Arm Type
Active Comparator
Arm Description
Arm B: Participants will receive nivolumab IV alone every 4 weeks.
Intervention Type
Biological
Intervention Name(s)
Bempegaldesleukin
Other Intervention Name(s)
NKTR-214, BMS-986321
Intervention Description
Specified dose on specified days
Intervention Type
Biological
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
Opdivo®, BMS-936558
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Recurrence-free Survival (RFS) by Blinded Independent Central Review (BICR) of Bempegaldesleukin Plus Nivolumab Versus Nivolumab Alone.
Description
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.
Time Frame
Up to 21 months
Secondary Outcome Measure Information:
Title
Overall Survival (OS) of Bempegaldesleukin Plus Nivolumab Versus Nivolumab Alone
Description
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.
Time Frame
Up to 21 months
Title
Distant Metastasis-Free Survival (DMFS) by Investigator in Patients Who Are Stage III at Study Entry.
Description
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.
Time Frame
Up to 21 months
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Description
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.
Time Frame
Approximately up to 21 months
Title
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
Description
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.
Time Frame
From baseline, up to approximately 6 months
Title
Programmed Death-Ligand 1 (PD-L1) Expression as a Predictive Biomarker for Recurrence-free Survival (RFS)
Description
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.
Time Frame
Up to 21 months
Title
Recurrence-free Survival (RFS) by Investigator of Bempegaldesleukin Plus Nivolumab Versus Nivolumab Alone.
Description
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.
Time Frame
Up to 21 months
Title
Time to Disease Progression After the Next Line of Treatment for Study Patients Following Discontinuation of Bempegaldesleukin Plus Nivolumab Versus Nivolumab
Description
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.
Time Frame
Up to 21 months
Title
Distant Metastasis-Free Survival (DMFS) by Blinded Independent Central Review (BICR) in Patients Who Are Stage III at Study Entry.
Description
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.
Time Frame
Up to 21 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Nektar Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Honor Health
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Banner MD Anderson Cancer Center
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Kaiser Foundation Hospital, Inpatient Pharmacy
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Facility Name
Kaiser Permanente
City
Fontana
State/Province
California
ZIP/Postal Code
92335
Country
United States
Facility Name
St. Joseph Heritage Healthcare
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Hematology Oncology Medical Group of Orange County, Inc.
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
University of California Irvine
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Emad Ibrahim, MD, Inc
City
Redlands
State/Province
California
ZIP/Postal Code
92373
Country
United States
Facility Name
Kaiser Permanente
City
Riverside
State/Province
California
ZIP/Postal Code
92505
Country
United States
Facility Name
Southern California Permanente Medical Group
City
Riverside
State/Province
California
ZIP/Postal Code
92505
Country
United States
Facility Name
San Francisco Oncology Associates
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
California Cancer Associates for Research and Excellence
City
San Marcos
State/Province
California
ZIP/Postal Code
92069
Country
United States
Facility Name
Kaiser Permanente
City
San Marcos
State/Province
California
ZIP/Postal Code
92078
Country
United States
Facility Name
Angeles Clinic and Research Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
John Wayne Cancer Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Rocky Mountain Cancer Centers (Littleton) - USOR
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
University of Colorado - Cancer Center - PPDS
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
MedStar Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Orlando Health Cancer Institute
City
Longwood
State/Province
Florida
ZIP/Postal Code
32750
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Goshen Center For Cancer Care
City
Goshen
State/Province
Indiana
ZIP/Postal Code
46526
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Mayo Clinic - PIN
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Frontier Cancer Center and Blood Institute
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Nebraska Cancer Specialists
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Nebraska Methodist Hospital
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Atlantic Health System
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Columbia University Medical Center - PIN
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
32750
Country
United States
Facility Name
Duke Cancer Institute
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Providence Cancer Institute, Franz Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97216
Country
United States
Facility Name
Lehigh Valley Physician Group (LVPG) - Hematology Oncology
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Penn State Milton S Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
H Lee Moffitt Cancer Center and Research Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Prisma Health Cancer Institute
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
SCRI Tennessee Oncology Chattanooga
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
University of Tennessee Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
SCRI Tennessee Oncology Nashville
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Department of Pharmacy Investigational Drug Services
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Texas Oncology (Loop) - USOR
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Utah Cancer Specialists (Salt Lake City)
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
90603
Country
United States
Facility Name
University of Virginia Cancer Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Inova Schar Cancer Institute
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Blue Ridge Cancer Care - USOR
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Northwest Medical Specialties
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Royal Adelaide Hospital
City
Adelaide
ZIP/Postal Code
5000
Country
Australia
Facility Name
Cairns Hospital
City
Cairns
ZIP/Postal Code
4870
Country
Australia
Facility Name
Icon Cancer Care Wesley
City
Chermside
ZIP/Postal Code
4032
Country
Australia
Facility Name
Gallipoli Medical Research Foundation
City
Greenslopes
ZIP/Postal Code
4120
Country
Australia
Facility Name
Austin Health
City
Heidelberg
ZIP/Postal Code
3084
Country
Australia
Facility Name
Alfred Hospital
City
Melbourne
ZIP/Postal Code
3004
Country
Australia
Facility Name
Affinity Clinical Research
City
Nedlands
ZIP/Postal Code
6009
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
ZIP/Postal Code
6009
Country
Australia
Facility Name
Melanoma Institute Australia
City
North Sydney
ZIP/Postal Code
2000
Country
Australia
Facility Name
Gold Coast University Hospital
City
Southport
ZIP/Postal Code
4215
Country
Australia
Facility Name
Tasman Oncology Research
City
Southport
ZIP/Postal Code
4215
Country
Australia
Facility Name
Blacktown Hospital
City
Westmead
ZIP/Postal Code
2145
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
ZIP/Postal Code
4102
Country
Australia
Facility Name
Medizinische Universität Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Ordensklinikum Linz, Krankenhaus der Elisabethinen GmbH
City
Lienz
Country
Austria
Facility Name
Landeskrankenhaus Feldkirch
City
Rankweil
ZIP/Postal Code
6830
Country
Austria
Facility Name
Salzburger Landeskliniken
City
Salzburg
Country
Austria
Facility Name
Universitätsklinikum St. Pölten
City
St.Pölten
ZIP/Postal Code
3100
Country
Austria
Facility Name
Allgemeines Krankenhaus der Stadt Wien
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Mou/Mmci - Ppds
City
Brno
ZIP/Postal Code
65653
Country
Czechia
Facility Name
Fakultni nemocnice Hradec Kralove
City
Hradec Králové
Country
Czechia
Facility Name
Krajska nemocnice Liberec, a.s.
City
Liberec
ZIP/Postal Code
46063
Country
Czechia
Facility Name
Fakultni nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
79900
Country
Czechia
Facility Name
Fakultni nemocnice Ostrava
City
Ostrava Poruba
ZIP/Postal Code
70852
Country
Czechia
Facility Name
Nemocnice Na Bulovce
City
Prague
ZIP/Postal Code
16000
Country
Czechia
Facility Name
Vseobecna Fakultni Nemocnice V Praze
City
Praha
ZIP/Postal Code
12808
Country
Czechia
Facility Name
Centre Hospitalier Universitaire (CHU) Amiens-Picardie - Hopital Sud
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
CHU Angers
City
Angers
ZIP/Postal Code
49100
Country
France
Facility Name
Hôpital Saint-André
City
Bordeau
Country
France
Facility Name
CHRU de Tours
City
Chambray-lès-Tours
Country
France
Facility Name
CHU Estaing
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Hôpital Albert Michallon La Tronche
City
La Tronche
ZIP/Postal Code
38043
Country
France
Facility Name
CHRU Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hôtel Dieu - Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
CHU de Nice
City
Nice
ZIP/Postal Code
6202
Country
France
Facility Name
Hôpital Saint Louis
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Groupe Hospitalier Bichat Claude Bernard
City
Paris
ZIP/Postal Code
75877
Country
France
Facility Name
Hospices Civils de Lyon
City
Pierre-Bénite
ZIP/Postal Code
69310
Country
France
Facility Name
EDOG - Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer - PPDS
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
Hôpital Charles Nicolle
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Centre Hospitalier Universitaire de Saint Etienne
City
Saint-Priest-en-Jarez
ZIP/Postal Code
42055
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94801
Country
France
Facility Name
Charité - Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Ruhr Universität Bochum
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Elben Klinken Stade - Buxtehude
City
Buxtehude
ZIP/Postal Code
21614
Country
Germany
Facility Name
Universitätsklinikum Carl Gustav Carus an der TU Dresden
City
Dresden
ZIP/Postal Code
81307
Country
Germany
Facility Name
Helios Klinikum Erfurt
City
Erfurt
ZIP/Postal Code
99089
Country
Germany
Facility Name
Universitätsklinikum Essen
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
SRH Wald-Klinikum Gera GmbH
City
Gera
ZIP/Postal Code
7548
Country
Germany
Facility Name
Universitatsklinikum Halle (Saale)
City
Halle
ZIP/Postal Code
6097
Country
Germany
Facility Name
Universitätsklinikum Hamburg Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
University Clinic Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
SLK Kliniken Heilbronn GmbH
City
Heilbronn
ZIP/Postal Code
74078
Country
Germany
Facility Name
Universitatsklinikum Schleswig-Holstein
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Uniklinik Köln
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Universitatsklinikum Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Klinikum der Stadt Ludwigshafen gGmbH
City
Ludwigshafen
ZIP/Postal Code
67063
Country
Germany
Facility Name
Universitätsklinik Magdeburg
City
Magdeburg
ZIP/Postal Code
39014
Country
Germany
Facility Name
Klinikum Mannheim Universitätsklinikum gGmbH
City
Mannheim
ZIP/Postal Code
76297
Country
Germany
Facility Name
Universitatsklinikum Munster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Fachklinik Hornheide
City
Münster
ZIP/Postal Code
48157
Country
Germany
Facility Name
University Clinic Regensburg
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Helios Klinikum Schwerin
City
Schwerin
ZIP/Postal Code
19049
Country
Germany
Facility Name
Universitätsklinikum Tübingen
City
Tübingen
ZIP/Postal Code
76297
Country
Germany
Facility Name
Universitätsklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Universitätsklinikum Würzburg
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Laiko General Hospital of Athens
City
Ampelokipoi
ZIP/Postal Code
11526
Country
Greece
Facility Name
Henry Dunant Hospital
City
Athens
ZIP/Postal Code
11526
Country
Greece
Facility Name
Metropolitan Hospital - First Oncology Clinic
City
Athens
ZIP/Postal Code
18547
Country
Greece
Facility Name
Metropolitan Hospital - Fourth Oncology Clinic
City
Athens
ZIP/Postal Code
18547
Country
Greece
Facility Name
Pepagni Hospital
City
Heraklion
ZIP/Postal Code
71110
Country
Greece
Facility Name
Medical Center of Athens
City
Maroúsi
ZIP/Postal Code
15125
Country
Greece
Facility Name
Interbalkan Medical Center of Thessaloniki
City
Pylaía
ZIP/Postal Code
TK57001
Country
Greece
Facility Name
Theageneio Anticancer Oncology Hospital of Thessaloniki
City
Thessaloníki
ZIP/Postal Code
54645
Country
Greece
Facility Name
Papageorgiou General Hospital of Thessaloniki
City
Thessaloníki
ZIP/Postal Code
56429
Country
Greece
Facility Name
Bioclinic Thessaloniki (Galinos clinic)
City
Thessaloníki
ZIP/Postal Code
86
Country
Greece
Facility Name
HaEmek Medical Center
City
Afula
ZIP/Postal Code
18101
Country
Israel
Facility Name
Soroka University Medical Centre
City
Be'er Sheva
ZIP/Postal Code
8410501
Country
Israel
Facility Name
Rambam Medical Center - PPDS
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Hadassah Medical Center - PPDS
City
Jerusalem
ZIP/Postal Code
9574425
Country
Israel
Facility Name
Rabin Medical Center - PPDS
City
Petah tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Sheba Medical Center - PPDS
City
Ramat Gan
Country
Israel
Facility Name
IRCCS Giovanni Paolo II Istituto Oncologico
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII
City
Bergamo
Country
Italy
Facility Name
Fondazione del Piemonte per l'Oncologia (IRCCS)
City
Candiolo
ZIP/Postal Code
10060
Country
Italy
Facility Name
Ospedale Policlinico San Martino
City
Genova
Country
Italy
Facility Name
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Facility Name
Istituto Europeo Di Oncologia
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Istituto Nazionale Dei Tumori
City
Milano
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Di Modena Policlinico
City
Modena
ZIP/Postal Code
41100
Country
Italy
Facility Name
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Istituto Oncologico Veneto - I.R.C.C.S.
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Senese
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
VU Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1081HV
Country
Netherlands
Facility Name
Zuyderland Medisch Centrum
City
Heerlen
ZIP/Postal Code
6419
Country
Netherlands
Facility Name
Medisch Centrum Leeuwarden
City
Leeuwarden
ZIP/Postal Code
8934
Country
Netherlands
Facility Name
Leiden University Medical Center
City
Leiden
ZIP/Postal Code
2333ZA
Country
Netherlands
Facility Name
Radboud University Nijmegen Medical Centre
City
Nijmegen
ZIP/Postal Code
6525GA
Country
Netherlands
Facility Name
Universitair Medisch Centrum Utrecht
City
Utrecht
ZIP/Postal Code
3584
Country
Netherlands
Facility Name
Maxima Medisch Centrum
City
Veldhoven
Country
Netherlands
Facility Name
Isala Klinieken
City
Zwolle
ZIP/Postal Code
8025AB
Country
Netherlands
Facility Name
Christchurch Hospital
City
Christchurch
ZIP/Postal Code
8140
Country
New Zealand
Facility Name
Dunedin Hospital
City
Dunedin
ZIP/Postal Code
9054
Country
New Zealand
Facility Name
Auckland City Hospital
City
Heidelberg
ZIP/Postal Code
3084
Country
New Zealand
Facility Name
Tauranga Hospital
City
Tauranga
ZIP/Postal Code
3143
Country
New Zealand
Facility Name
Wellington Hospital
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie w Bialymstoku
City
Białystok
ZIP/Postal Code
15-027
Country
Poland
Facility Name
Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy
City
Bydgoszcz
ZIP/Postal Code
85796
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdańsk
ZIP/Postal Code
80952
Country
Poland
Facility Name
NZOZ NEUROMED M. I M. Nastaj Spolka Partnerska
City
Lublin
ZIP/Postal Code
20064
Country
Poland
Facility Name
Szpital Kliniczny im. Heliodora Swiecickiego w Poznaniu
City
Poznań
ZIP/Postal Code
60780
Country
Poland
Facility Name
Centro Hospitalar E Universitário de Coimbra EPE
City
Coimbra
ZIP/Postal Code
3004-561
Country
Portugal
Facility Name
Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Hospital CUF Tejo
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.
City
Lisbon
ZIP/Postal Code
1099-023
Country
Portugal
Facility Name
Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Affidea Romania SRL
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
S.C. Medisprof SRL
City
Cluj-Napoca
ZIP/Postal Code
400641
Country
Romania
Facility Name
S.C. Onco Clinic Consult SA
City
Craiova
ZIP/Postal Code
200094
Country
Romania
Facility Name
Oncology Center Sfantul Nectarie
City
Craiova
ZIP/Postal Code
200347
Country
Romania
Facility Name
Chelyabinsk Regional Clinical Oncology Dispensary
City
Chelyabinsk
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
Clinical Oncology Centre #1
City
Krasnodar
ZIP/Postal Code
350040
Country
Russian Federation
Facility Name
Krasnoyarsk Regional Oncology Center n.a. A.I. Kryzhanovskiy
City
Krasnoyarsk
ZIP/Postal Code
660133
Country
Russian Federation
Facility Name
Kursk Regional Oncology Centre
City
Kursk
ZIP/Postal Code
305524
Country
Russian Federation
Facility Name
PMI Euromedservice
City
Pushkin
ZIP/Postal Code
196603
Country
Russian Federation
Facility Name
Ryazan Regional Clinical Oncology Dispensary
City
Ryazan'
ZIP/Postal Code
390011
Country
Russian Federation
Facility Name
FSBI National Medical Research Center of Oncology n.a. N.N.Petrov of MHRF
City
Saint Petersburg
ZIP/Postal Code
191758
Country
Russian Federation
Facility Name
Railway Clinical Hospital JSC RZhD
City
Saint Petersburg
ZIP/Postal Code
195271
Country
Russian Federation
Facility Name
Regional Clinical Oncology Hospital
City
Yaroslavl
ZIP/Postal Code
150040
Country
Russian Federation
Facility Name
Hospital Universitario A Coruña
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Universitario Germans Trias i Pujol
City
Badalona
ZIP/Postal Code
08911
Country
Spain
Facility Name
Hospital de La Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Universitari Dexeus - Grupo Quironsalud
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron - PPDS
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
ICO l'Hospitalet - Hospital Duran i Reynals
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Universitario Virgen de La Arrixaca
City
El Palmar
Country
Spain
Facility Name
Hospital Universitario de Jaen
City
Jaén
ZIP/Postal Code
23007
Country
Spain
Facility Name
C.H. Regional Reina Sofia - PPDS
City
L'Hospitalet De Llobregat
ZIP/Postal Code
08904
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario HM Sanchinarro - CIOCC
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
4628007
Country
Spain
Facility Name
Hospital Universitario Virgen de la Victoria
City
Málaga
ZIP/Postal Code
29789
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Consorcio Hospital General Universitario de Valencia
City
Valencia
Country
Spain
Facility Name
Addenbrooke's Hospital
City
Cambridge
ZIP/Postal Code
CB20QQ
Country
United Kingdom
Facility Name
Castle Hill Hospital
City
Cottingham
ZIP/Postal Code
HU165JQ
Country
United Kingdom
Facility Name
Leicester Royal Infirmary
City
Leicester
ZIP/Postal Code
LE15WW
Country
United Kingdom
Facility Name
Nottingham City Hospital
City
Nottingham
ZIP/Postal Code
BG72UH
Country
United Kingdom
Facility Name
Royal Cornwall Hospital
City
Truro
ZIP/Postal Code
TR13LJ
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35073733
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.
Results Reference
derived
Learn more about this trial
Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence
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