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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma

  • Clinicaltrials.gov identifier

    NCT03635983

  • Recruitment Status

    Recruiting

  • First Posted

    August 17, 2018

  • Last update posted

    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
  • Allocation: Randomized
  • 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

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT03635983 History of Changes
  • Other Study ID Numbers: CA045-001, 2018-001423-40, 17-214-08
  • First Posted: August 17, 2018 Key Record Dates
  • 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: bempegaldesleukin (BEMPEG: NKTR-214)
    Immunotherapy
    Nivolumab
    NKTR-214
  • Additional relevant MeSH terms: Melanoma