A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma
Clinicaltrials.gov identifier recruitment status First Posted Last update posted
NCT03635983 Recruiting August 17, 2018 November 17, 2020

study description
Brief Summary

The purpose of the study is to test the effectiveness (how well the drug works), safety, and tolerability of the investigational drug called NKTR-214, when combined with nivolumab versus nivolumab given alone in participants with previously untreated melanoma skin cancer that is either unable to be surgically removed or has spread

Condition or Disease: Melanoma
Intervention/treatment: Biological: NKTR-214
Biological: Nivolumab
Phase: Phase 3
Detailed Description

N/A


study design
Study Type: Interventional
Estimated Enrollment : 764 participants
Intervention Model : Parallel Assignment
Masking: None (Open Label) ()
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Open-label Study of NKTR-214 Combined With Nivolumab Versus Nivolumab in Participants With Previously Untreated Unresectable or Metastatic Melanoma
Actual Study Start Date: September 2018
Estimated Primary Completion Date: April 2022
Estimated Study Completion Date: June 2025

Arms and interventions
Arm Intervention/treatment
Experimental: Combination
NKTR-214 + Nivolumab
Biological: NKTR-214
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days
Experimental: Monotherapy
Nivolumab
Biological: Nivolumab
Specified dose on specified days
outcome measures
Primary Outcome Measures: 1. Overall response rate (ORR) by Blinded Independent Central Review (BICR) [ Time Frame: Approximately 16 months ]
2. Progression-free survival (PFS) by BICR [ Time Frame: Approximately 22 months ]
3. Overall survival (OS) [ Time Frame: Up to 59 months ]
Secondary Outcome Measures: 1. Clinical benefit rate (CBR) [ Time Frame: Approximately 16 months ]
2. Duration of response (DoR) [ Time Frame: Approximately 16 months ]
3. Time to response (TTR) [ Time Frame: Approximately 16 months ]
4. ORR by investigator and in biomarker population [ Time Frame: Approximately 16 months ]
5. PFS by investigator and in biomarker population [ Time Frame: Approximately 22 months ]
6. OS in biomarker population [ Time Frame: Up to 59 months ]
7. Incidence of participants with non-serious Adverse Events (AEs) [ Time Frame: Up to 5 years ]
8. Incidence of participants with Serious Adverse Events (SAEs) [ Time Frame: Up to 5 years ]
9. Incidence of treatment-related AEs [ Time Frame: Up to 5 years ]
10. Incidence of treatment-related SAEs [ Time Frame: Up to 5 years ]
11. Incidence of laboratory abnormalities in blood [ Time Frame: Up to 5 years ]
12. Incidence of laboratory abnormalities in blood serum [ Time Frame: Up to 5 years ]
13. Incidence of laboratory abnormalities in urine [ Time Frame: Up to 5 years ]

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

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

Eastern Cooperative Oncology Group (ECOG) performance status of ≤1 (adults 18 years or older)/Lansky Performance Score ≥ 80% (minors ages 12-17 only) Histologically confirmed stage III (unresectable) or stage IV melanoma Treatment-naive participants (ie, no prior systemic anticancer therapy for unresectable or metastatic melanoma) with the exception of prior adjuvant and/or neoadjuvant treatment for melanoma with approved agents

Exclusion Criteria:

Active brain metastases or leptomeningeal metastases Uveal melanoma Participants with an active, known or suspected autoimmune disease

Other protocol defined inclusion/exclusion criteria could apply


Contacts and Locations
Contacts

Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT # and Site #.

Locations
United States, Arizona Local Institution Tucson
United States, California UC San Diego Moores Cancer Ctr La Jolla
United States, California Local Institution Los Angeles
United States, California Stanford Cancer Center Stanford
United States, Colorado University Of Colorado Aurora
United States, Connecticut Smilow Cancer Center at Yale New Haven Hospital New Haven
United States, Florida Mount Sinai Comprehensive Cancer Center Miami Beach
United States, Florida Sylvester Comprehensive Cancer Center Miami
United States, Florida Moffitt Cancer Center Tampa
United States, Georgia Winship Cancer Institute, Emory University Atlanta
United States, Kentucky University of Louisville Hospital Louisville
United States, Massachusetts Dana-Farber Cancer Institute Boston
United States, Michigan Local Institution Ann Arbor
United States, Minnesota Local Institution Fridley
United States, Minnesota Local Institution Minneapolis
United States, Missouri Washington University School Of Medicine Saint Louis
United States, New Jersey The Cancer Center At Hackensack University Medical Center Hackensack
United States, New Jersey Local Institution New Brunswick
United States, New York Local Institution Buffalo
United States, New York Memorial Sloan Kettering Nassau New York
United States, Ohio Local Institution Cleveland
United States, Ohio Cleveland Clinic Cleveland
United States, Oregon Portland Providence Medical Center Portland
United States, Oregon Oregon Health & Science University Portland
United States, Pennsylvania St. Luke's Hospital & Health Network Easton
United States, Pennsylvania Fox Chase Cancer Center Philadelphia
United States, Texas MD Anderson Cancer Center Houston
United States, Virginia Inova Schar Cancer Institute Fairfax
Argentina, Buenos Aires Hospital Aleman Autonoma
Argentina, Buenos Aires Clinica Adventista Belgrano Ciudad Autonoma de Buenos Aires
Argentina, Distrito Federal Local Institution Buenos Aires
Argentina Local Institution Caba
Argentina Instituto Medico Especialazado Alexander Fleming Caba
Argentina Local Institution Cordoba
Australia, New South Wales Local Institution Coffs Harbour
Australia, New South Wales Local Institution North Sydney
Australia, Queensland Local Institution Cairns
Australia, Queensland Local Institution Greenslopes
Australia, Queensland Local Institution Woolloongabba
Australia, South Australia Local Institution Elizabeth Vale
Australia, Victoria Local Institution Melbourne
Australia, Victoria Local Institution Melbourne
Australia, Western Australia Local Institution Nedlands
Australia, Western Australia Local Institution Nedlands
Austria Med University Graz Dermatology Graz
Austria PMU Salzburg Salzburg
Austria Medizinische Universtaet Wien Wien
Belgium Local Institution Brussels
Belgium Local Institution Hasselt
Belgium Local Institution Leuven
Brazil, Ceara Local Institution Fortaleza
Brazil, Minas Gerais Local Institution Belo Horizonte
Brazil, RIO Grande DO SUL Local Institution Ijui
Brazil, RIO Grande DO SUL Local Institution Porto Alegre
Brazil, Santa Catarina Local Institution Itajai
Brazil, SAO Paulo Local Institution Barretos
Brazil Local Institution Rio De Janeiro
Brazil Local Institution Sao Paulo
Canada, Alberta Local Institution Edmonton
Canada, British Columbia Local Institution Abbotsford
Canada, Newfoundland and Labrador Local Institution St. John's
Canada, Ontario Local Institution Hamilton
Canada, Ontario Local Institution Kitchener
Canada, Ontario Local Institution Toronto
Canada, Ontario Local Institution Toronto
Canada Local Institution Quebec
Chile, Metropolitana Local Institution Santiago
Chile, Metropolitana Local Institution Santiago
Czechia Klinika komplexni onkologicke pece Brno
Czechia Klinika onkologie a radioterapie Hradec Kralove
Czechia Dermatovenerologicka klinika 3. LF UK a FNKV Praha 10
Czechia Dermatovenerologicka klinika VFN a 1. LF UK Praha 2
Finland Local Institution KYS
Finland Local Institution Tampere
Finland Local Institution Turku
France Local Institution Bordeaux
France Hopital Claude Huriez LILLE Cedex
France Hopital Saint Eloi Montpellier Cedex 05
France Hotel Dieu - Chu De Nantes Nantes Cedex 01
France Chu De Nice Hopital De Cimiez Nice Cedex 1
France Hopital Saint Louis Paris
France Centre Hospitalier Lyon Sud Pierre Benite
France Hopital Charles Nicolle C H U Rouen Rouen
France Hopital Nord - CHU de Saint-Etienne Saint Priest en Jarez
France Institut Claudius Regaud Toulouse Cedex 9
France Institut Gustave Roussy Villejuif
Germany Elbe Klinikum Buxtehude Buxtehude
Germany Universitaetsklinikum Carl Gustav Carus Dresden
Germany Universitaetsklinik Essen Essen
Germany Georg August Universitaet Goettingen Goettingen
Germany Universitaets-Krankenhaus Eppendorf Hamburg
Germany Medizinische Hochschule Hannover (Hannover Medical School) Hannover
Germany Nationales Centrum Fuer Tumorerkrakungen (Nct) Heidelberg Heidelberg
Germany Universitaetsklinikum Schleswig-Holstein Kiel
Germany Universitatsklinikum AoR Klinik fur Dermatologie, Venerologie und Allergologie Leipzig
Germany Ludwig-Maximilians-Universitaet Muenchen
Germany Fachklinik Hornheide Muenster
Germany University Hospital of Regensburg Regensburg
Germany Universitaetsklinikum Tuebingen Tuebingen
Germany Univ. Klinikum Wuerzburg Wuerzburg
Greece Laiko General Hospital Of Athens Athens
Greece Metropolitan Hospital Neo Faliro
Greece Interbalkan European Medical Center Thessaloniki
Ireland, Cork Local Institution Wilton
Ireland, Dublin Local Institution Dublin 7
Ireland Local Institution Dublin
Ireland Local Institution Dublin
Ireland Local Institution Galway
Israel Local Institution Beer Sheva
Israel Local Institution Jerusalem
Israel Local Institution Ramat-gan
Italy IRCCS Giovanni Paolo II Istituto Oncologico Bari
Italy Local Institution Bergamo
Italy Local Institution Candiolo, Torino
Italy Local Institution Genova
Italy Local Institution Meldola (fc)
Italy Local Institution Milano
Italy Local Institution Milan
Italy Instituto Nazionale Tumori Fondazione G. Pascale Napoli
Italy Istituto Oncologico Veneto IOV Padova
Italy Azienda Ospedaliera Universitaria Senese Siena
Italy Local Institution Torino
Mexico, Distrito Federal Local Institution Ciudad de Mexico
Mexico, Jalisco Local Institution Zapopan
Mexico, Nuevo LEON Local Institution Monterrey
Mexico, Nuevo LEON Local Institution Monterrey
Mexico, Quintana ROO Local Institution Benito Juarez
Mexico Local Institution Puebla
Mexico Local Institution San Luis Potosi
Netherlands Local Institution Amsterdam
Netherlands Local Institution Amsterdam
Netherlands Local Institution Leiden
Netherlands Local Institution Nijmegen
Netherlands Local Institution Untrecht
New Zealand Local Institution Auckland
New Zealand Local Institution Christchurch
New Zealand Local Institution Wellington
Poland Local Institution Bialystok
Poland Local Institution Bydgoszcz
Poland Local Institution Lublin
Poland Local Institution Warszawa
Poland Local Institution Wroclaw
Portugal Local Institution Lisboa
Portugal Local Institution Porto
Romania Local Institution Bucharest
Romania Local Institution Cluj-Napoca
Romania Local Institution Craiova
Romania Local Institution Floresti
Romania Local Institution Oradea
Russian Federation Local Institution Krasnoyarsk
Russian Federation Local Institution Moscow
Russian Federation Local Institution Moscow
Russian Federation Local Institution Moscow
Spain H. Univ. Vall dHebron Barcelona
Spain Hospital Clinic I Provincial Barcelona
Spain Hospital Universitario Reina Sofia Cordoba
Spain Complejo Hospitalario de Jaen Jaen
Spain Hospital Gral. Univ. Gregorio Maranon Madrid
Spain Hospital Clinico Univ. de Santiago-CHUS Santiago Compostela
Spain Hospital General Universitario De Valencia Valencia
Sweden Local Institution Gothenburg
Sweden Local Institution Lund
Switzerland Universitatsspital Bern, Inselspital Bern
Switzerland Centre Hospitalier Universitaire Vaudois Lausanne
Switzerland Universitaetsspital Zuerich Zuerich
United Kingdom, Greater London Local Institution London
United Kingdom, Hampshire Local Institution Southampton
United Kingdom, Midlothian Local Institution Edinburgh
United Kingdom Local Institution Belfast
United Kingdom Local Institution Cambridge
United Kingdom Local Institution Cottingham
United Kingdom Local Institution Liverpool
United Kingdom Local Institution London
United Kingdom Local Institution Manchester
United Kingdom Local Institution Sutton.
United Kingdom Local Institution Tauton
Sponsors and Collaborators
Bristol-Myers Squibb
Nektar Therapeutics
Investigator
Study Director : Bristol-Myers Squibb Bristol-Myers Squibb
More Information
Other Publications

Khushalani NI, Diab A, Ascierto PA, Larkin J, Sandhu S, Sznol M, Koon HB, Jarkowski A, Zhou M, Statkevich P, Geese WJ, Long GV. Bempegaldesleukin plus nivolumab in untreated, unresectable or metastatic melanoma: Phase III PIVOT IO 001 study design. Future Oncol. 2020 Oct;16(28):2165-2175. doi: 10.2217/fon-2020-0351. Epub 2020 Jul 29.

Responsible Party : Bristol-Myers Squibb
ClinicalTrials.gov Identifier : NCT03635983     
Other Study ID Numbers : CA045-001, 2018-001423-40, 17-214-08
First Posted : August 17, 2018
Last Update Posted : November 17, 2020
Last Verified : November 2020
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb: NKTR-214
Nivolumab
Immunotherapy
bempegaldesleukin (BEMPEG: NKTR-214)
Additional relevant MeSH terms :
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas