This website is for US healthcare professionals

close-icon

Log In to Bolder Science

or

Don't have an account? Sign Up

close-icon

Please enter your email address.

You will receive a link to create a new password via email.

Log In

close-icon

Create an Account

or
  • 8 characters minimum
  • First character may not be a number
  • Last character may not be a number
close-icon

Welcome and thank you for creating an account!

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.

Condition Categories

Condition categories are pulled directly from ClinicalTrials.gov. Choose 1 or more condition categories that you are interested in:

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

Set a default location

Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma (CheckMate76K)

  • Clinicaltrials.gov identifier

    NCT04099251

  • Recruitment Status

    Recruiting

  • First Posted

    September 23, 2019

  • Last update posted

    July 26, 2021

Study Description

Brief summary:

The purpose of this study is to determine the effectiveness of nivolumab adjuvant immunotherapy compared to placebo in adults and pediatric participants after complete resection of Stage IIB/C melanoma with no evidence of disease (NED) who are at high risk for recurrence.

  • Condition or Disease:Melanoma
  • Intervention/Treatment: Biological: Nivolumab
    Other: Placebo
  • Phase: Phase 3

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 780 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Triple (Participant, Care Provider, Investigator)
  • Primary Purpose: Treatment
  • Official Title: A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy With Nivolumab Versus Placebo After Complete Resection of Stage IIB/C Melanoma
  • Actual Study Start Date: October 2019
  • Estimated Primary Completion Date: July 2025
  • Estimated Study Completion Date: July 2026

Arms and interventions

Arm Intervention/treatment
Experimental: Nivolumab
Biological: Nivolumab
Specified dose on specified days
Placebo Comparator: Placebo
Other: Placebo
Specified dose on specified days

Outcome Measures

  • Primary Outcome Measures: 1. Recurrence-Free Survival (RFS) [ Time Frame: Approximately 68 months ]
  • Secondary Outcome Measures: 1. Overall survival (OS) [ Time Frame: Up to 7 years ]
  • 2. Occurrence of Adverse Events (AEs) as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5 [ Time Frame: Up to 5 years ]
  • 3. Severity of AEs as defined by NCI CTCAE v5 [ Time Frame: Up to 5 years ]
  • 4. Distant Metastases-Free Survival (DMFS) [ Time Frame: Up to 7 years ]
  • 5. Investigator-assessed outcomes on next-line therapies [Objective response rates (if applicable), Duration of treatment on next-line therapies, Progression-Free Survival 2, End-of-next-line-treatment] [ Time Frame: Up to 7 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

Inclusion Criteria: - Had a negative sentinel lymph node biopsy - Participant has not been previously treated for melanoma - ECOG 0 or 1 - Participants must have been diagnosed with histologically confirmed, Resected, Stage IIB/C cutaneous melanoma Exclusion Criteria: - History of ocular or mucosal melanoma. - Pregnant or nursing women - Participants with active known or suspected autoimmune disease - Known history of allergy or hypersensitivity to study drug components - Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody, or agents that target IL-2 pathways, T-cell stimulators, or checkpoint pathways 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, Alabama
University Of Alabama At Birmingham
Birmingham

United States, Arizona
University of Arizona Cancer Center
Tucson

United States, Arkansas
Highlands Oncology Group, P.A.
Springdale

United States, California
The Angeles Clinic & Research Institute
Los Angeles

United States, California
California Pacific Medical Center Research Institute
San Francisco

United States, California
Kaiser Permanente Medical Center (clinic+DSL)
Vallejo

United States, California
Kaiser Permanente Oakland
Vallejo

United States, California
Kaiser Permanente Oncology Clinical Trials
Vallejo

United States, California
Kaiser Permanente-Oakland
Vallejo

United States, California
Kaiser Permanente
Vallejo

United States, Colorado
University Of Colorado
Aurora

United States, District of Columbia
Georgetown University Medical Center
Washington

United States, Florida
Local Institution
Tampa

United States, Georgia
Northside Hospital
Sandy Springs

United States, Illinois
Northwestern University
Chicago

United States, Maryland
Harry And Jeanette Weinberg Cancer Inst At Franklin Square
Baltimore

United States, Massachusetts
Beth Israel Deaconess Medical Center (BIDMC)
Boston

United States, Massachusetts
Dana Farber Cancer Institute
Boston

United States, Massachusetts
Mass General Hospital
Boston

United States, Minnesota
Allina Health
Minneapolis

United States, Nebraska
Nebraska Cancer Specialists
Omaha

United States, New Jersey
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack

United States, New York
NYU Langone Medical Center
New York

United States, North Carolina
Levine Cancer Institute
Charlotte

United States, North Carolina
Local Institution
Durham

United States, Ohio
The Cleveland Clinic Foundation
Cleveland

United States, Oregon
Providence Portland Medical Center
Portland

United States, Pennsylvania
Lehigh Valley Health Network
Allentown

United States, Pennsylvania
UPMC
Pittsburgh

United States, Tennessee
The West Clinic
Germantown

United States, Texas
Texas Oncology-Central Austin Cancer Center
Austin

United States, Texas
Texas Oncology Sammons Cancer Center
Dallas

United States, Utah
Local Institution
Salt Lake City

United States, Virginia
Inova Schar Cancer Institute
Fairfax

Australia, New South Wales
Melanoma Institute Australia
North Sydney

Australia, New South Wales
Calvary Mater Newcastle
Waratah

Australia, New South Wales
Westmead Hospital
Westmead

Australia, Queensland
Cairns Hospital
Cairns

Australia, Queensland
Greenslopes Private Hospital
Greenslopes

Australia, Queensland
Royal Brisbane and Women's Hospital
Herston

Australia, Queensland
Tasman Oncology Research Pty Ltd
Southport

Australia, Victoria
Box Hill Hospital
Box Hill

Australia, Victoria
Local Institution
Geelong

Australia, Victoria
Cabrini Hospital
Malvern

Australia, Victoria
The Alfred Hospital
Melbourne

Australia, Western Australia
Sir Charles Gairdner Hospital
Nedlands

Austria
Med University Graz Dermatology
Graz

Austria
Med. Universitaet Innsbruck
Innsbruck

Austria
PMU Salzburg
Salzburg

Austria
Local Institution
Wien

Belgium
Local Institution
Charleroi

Belgium
Local Institution
Edegem

Belgium
Local Institution
Gent

Belgium
Local Institution
Kortrijk

Belgium
Local Institution
Liège

Canada, Alberta
Local Institution
Calgary

Canada, British Columbia
Local Institution
Vancouver

Canada, New Brunswick
Local Institution
Fredericton

Canada, Nova Scotia
Nova Scotia Health Authority (Capital District Health Authority)
Halifax

Canada, Ontario
Juravinski Cancer Centre
Hamilton

Canada, Ontario
Local Institution
Kingston

Canada, Ontario
Local Institution
Toronto

Canada, Quebec
Centre integre universitaire de sante et de service sociaux de l'estrie - CHUS
Sherbrooke

Canada
Local Institution
Montreal

Czechia
Kozni oddeleni
Ostrava-Poruba

Czechia
Dermatovenerologicka klinika 3. LF UK a FNKV
Praha 10

Czechia
Dermatovenerologicka klinika VFN a 1. LF UK
Praha 2

Denmark
Local Institution
Aarhus N

Denmark
Local Institution
Herlev

Denmark
Local Institution
Odense

Finland
Local Institution
Helsinki

Finland
Local Institution
Tampere

Finland
Local Institution
Turku

France
Chu Jean Minjoz
Besancon Cedex

France
Hopital Saint Andre
Bordeaux

France
Chu Brest Hopital Morvan
Brest

France
Hopital Claude Huriez
LILLE Cedex

France
Hopital De La Timone
Marseille Cedex 5

France
Hotel Dieu - Chu De Nantes
Nantes

France
Hopital De L Archet
Nice

France
Hopital Saint Louis
Paris

France
Centre Hospitalier Lyon Sud
Pierre Benite Cedex

France
Institut Gustave Roussy
Villejuif

Germany
Universitaetsklinikum Bonn
Bonn

Germany
Elbe Klinikum Buxtehude
Buxtehude

Germany
Universitaetsklinikum Carl Gustav Carus
Dresden

Germany
Universitaetsklinikum Essen
Essen

Germany
SRH Wald-Klinikum Gera GmbH
Gera

Germany
Georg August Universitaet Goettingen
Goettingen

Germany
Medizinische Hochschule Hannover (Hannover Medical School)
Hannover

Germany
Nationales Centrum Fur Tumorerkrankungen (Nct)
Heidelberg

Germany
University Of Lubeck
Lubeck

Germany
University Of Mainz Medical Center
Mainz

Germany
Ludwig-Maximilians-Universitaet
Muenchen

Germany
University Hospital of Regensburg
Regensburg

Germany
Universitaetsklinikum Tuebingen
Tuebingen

Greece
Laiko General Hospital Of Athens
Athens

Greece
Metropolitan Hospital
Neo Faliro

Greece
Interbalkan European Medical Center
Thessaloniki

Italy
Local Institution
Bergamo

Italy
IRCCS Istituto Nazionale Tumori Milano
Milano

Italy
Local Institution
Milano

Italy
Istituto Nazionale Tumori Fondazione Pascale
Napoli

Italy
Istituto Oncologico Veneto IOV
Padova

Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo

Italy
Local Institution
Perugia

Italy
Azienda Ospedaliera Universitaria Senese
Siena

Netherlands
Local Institution
Breda

Netherlands
Local Institution
Groningen

Netherlands
Local Institution
Rotterdam

Netherlands
Local Institution
Utrecht

Norway
Local Institution
Bergen

Norway
Local Institution
Gralum

Norway
Local Institution
Oslo

Poland
Klinika Onkologii i Radioterapii
Gdansk

Poland
Oddzial Onkologii Klinicznej i Doswiadczalnej
Poznan

Poland
Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow
Warszawa

Romania
Local Institution
Bucharest

Romania
Local Institution
Cluj-Napoca

Romania
Local Institution
Craiova

Spain, Barcelona
Hospital Universitari Germans Trias I Pujol
Badalona

Spain
Comp. Hosp. Univ. A Coruna
A Coruna

Spain
Institut Universitari Dexeus
Barcelona

Spain
Hospital Universitario Ramon Y Cajal
Madrid

Spain
Hospital Universitario La Paz
Madrid

Spain
Hospital Regional Universitario De Malaga
Malaga

Spain
H. U. Marques de Valdecilla
Santander

Spain
Instituto Valenciano De Oncologia
Valencia

Sweden
Local Institution
Gavle

Sweden
Linkoping University Hospital
Linkoping

Sweden
Local Institution
Orebro

Switzerland
Chuv
Lausanne

Switzerland
Universitaetsspital Zuerich
Zuerich

United Kingdom
Local Institution
Cardiff

United Kingdom
Local Institution
Edinburgh

United Kingdom
Local Institution
Glasgow

United Kingdom
Local Institution
Leicester

United Kingdom
Local Institution
London

United Kingdom
Local Institution
London

United Kingdom
Local Institution
Southampton

United Kingdom
Local Institution
Stoke-on-Trent

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT04099251 History of Changes
  • Other Study ID Numbers: CA209-76K, 2019-001230-34, U1111-1229-8927
  • First Posted: September 23, 2019 Key Record Dates
  • Last Update Posted: July 26, 2021
  • Last Verified: July 2021
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Melanoma