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Trial record 1 of 1 for:    CheckMate 76K adjuvant immunotherapy nivolumab | melanoma
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Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma (CheckMate76K)

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ClinicalTrials.gov Identifier: NCT04099251
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : December 6, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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 Intervention/treatment Phase
Melanoma Biological: Nivolumab Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 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 25, 2019
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : January 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Nivolumab
specified dose on specified days
Biological: Nivolumab
specified dose on specified days
Other Name: Opdivo

Placebo Comparator: Placebo
placebo equivalent specified dose on specified days
Other: Placebo
Matched placebo specified dose on specified days




Primary Outcome Measures :
  1. Recurrence-Free Survival (RFS) [ Time Frame: approxiatemately 51 months ]
  2. Number of other safety biomarkers [ Time Frame: Up to 5 years ]

Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: Up to 5 years ]
  2. Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: Up to 5 years ]
  3. Number of Participants with Adverse Events (AEs) [ Time Frame: Up to 5 years ]
  4. Distant Metastases-Free Survival (DMFS) [ Time Frame: Up to 5 years ]
  5. Objective Response Rates (ORR) [ Time Frame: Up to 5 years ]
  6. Outcomes on Next-Line therapies (Objective response rate [if applicable], Duration of treatment on next-line therapies, Progression-Free Survival 2) [ Time Frame: Up to 5 years ]
  7. Incidence of change in Vital Signs [ Time Frame: Up to 5 years ]
  8. Incidence of change in Electrocardiograms (ECGs) [ Time Frame: Up to 5 years ]
  9. Incidence of change in biomarkers [ Time Frame: Up to 5 years ]
  10. Incidence of change in clinical laboratory values [ Time Frame: Up to 5 years ]


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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
  • 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

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.

Other protocol defined inclusion/exclusion criteria could apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04099251


Contacts
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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 #.

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Locations
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United States, Alabama
Local Institution Not yet recruiting
Birmingham, Alabama, United States, 35249
Contact: Site 0088         
United States, Arizona
Local Institution Not yet recruiting
Tucson, Arizona, United States, 85724-5024
Contact: Site 0126         
United States, Arkansas
Highlands Oncology Group, P.A. Recruiting
Rogers, Arkansas, United States, 72758
Contact: J Thaddeus Beck, Site 0087    479-872-8130      
United States, California
Local Institution Not yet recruiting
Los Angeles, California, United States, 90025
Contact: Site 0080         
Local Institution Not yet recruiting
Oakland, California, United States, 94611
Contact: Site 0121         
Local Institution Not yet recruiting
Roseville, California, United States, 95661
Contact: Site 0120         
Local Institution Not yet recruiting
San Francisco, California, United States, 94115
Contact: Site 0077         
Local Institution Not yet recruiting
San Francisco, California, United States, 94115
Contact: Site 0119         
Local Institution Not yet recruiting
San Jose, California, United States, 95119
Contact: Site 0122         
Local Institution Not yet recruiting
Vallejo, California, United States, 94589-2441
Contact: Site 0109         
United States, Colorado
Local Institution Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: Site 0091         
United States, District of Columbia
Local Institution Not yet recruiting
Washington, District of Columbia, United States, 20007
Contact: Site 0089         
United States, Illinois
Local Institution Not yet recruiting
Chicago, Illinois, United States, 60611
Contact: Site 0132         
United States, Maryland
Local Institution Not yet recruiting
Baltimore, Maryland, United States, 21237
Contact: Site 0135         
United States, Massachusetts
Local Institution Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Site 0127         
Local Institution Not yet recruiting
Boston, Massachusetts, United States, 02215
Contact: Site 0078         
United States, Minnesota
Allina Health Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Thomas Amatruda, Site 0081    763-236-5619      
United States, Nebraska
Nebraska Cancer Specialists Recruiting
Omaha, Nebraska, United States, 68130
Contact: Ralph Hauke, Site 0079    402-691-6971      
United States, New Jersey
John Theurer Cancer Center at Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Andrew Pecora, Site 0093    551-996-5809      
United States, New York
Local Institution Not yet recruiting
New York, New York, United States, 10016
Contact: Site 0094         
United States, North Carolina
Local Institution Not yet recruiting
Charlotte, North Carolina, United States, 28204
Contact: Site 0086         
United States, Ohio
Local Institution Not yet recruiting
Cleveland, Ohio, United States, 44195
Contact: Site 0099         
United States, Oregon
Local Institution Not yet recruiting
Portland, Oregon, United States, 97213
Contact: Site 0076         
United States, Pennsylvania
Local Institution Not yet recruiting
Allentown, Pennsylvania, United States, 18103
Contact: Site 0092         
Local Institution Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Site 0031         
United States, Texas
Local Institution Not yet recruiting
Dallas, Texas, United States, 75246
Contact: Site 0085         
United States, Utah
Local Institution Not yet recruiting
Salt Lake City, Utah, United States, 84112
Contact: Site 0136         
United States, Virginia
Local Institution Not yet recruiting
Fairfax, Virginia, United States, 22031
Contact: Site 0090         
Australia, New South Wales
Melanoma Institute Australia Recruiting
North Sydney, New South Wales, Australia, 2060
Contact: Georgina Long, Site 0016    +61299117210      
Local Institution Not yet recruiting
Northmead, New South Wales, Australia, 2145
Contact: Site 0025         
Calvary Mater Newcastle Recruiting
Waratah, New South Wales, Australia, 2298
Contact: Andre Van Der Westhuizen, Site 0018    +61249211561      
Australia, Queensland
Local Institution Not yet recruiting
Cairns, Queensland, Australia, 4870
Contact: Site 0105         
Local Institution Not yet recruiting
Herston, Queensland, Australia, 4029
Contact: Site 0024         
Australia, Victoria
Local Institution Not yet recruiting
Box Hill, Victoria, Australia, 3128
Contact: Site 0019         
Greenslopes Private Hospital Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Victoria Atkinson, Site 0017         
Local Institution Not yet recruiting
Melbourne, Victoria, Australia, 3004
Contact: Site 0106         
Australia, Western Australia
Local Institution Not yet recruiting
Nedlands, Western Australia, Australia, 6009
Contact: Site 0104         
Austria
Med University Graz Dermatology Recruiting
Graz, Austria, 8036
Contact: Erika Richtig, Site 0049         
Local Institution Not yet recruiting
Innsbruck, Austria, 6020
Contact: Site 0051         
Local Institution Recruiting
Salzburg, Austria, 5020
Contact: Site 0050         
Local Institution Not yet recruiting
Wien, Austria, 1090
Contact: Site 0048         
Belgium
Local Institution Not yet recruiting
Charleroi, Belgium, 6000
Contact: Site 0028         
Local Institution Not yet recruiting
Edegem, Belgium, 2650
Contact: Site 0009         
Local Institution Not yet recruiting
Gent, Belgium, 9000
Contact: Site 0011         
Local Institution Recruiting
Kortrijk, Belgium, 8500
Contact: Site 0008         
Local Institution Not yet recruiting
Liege, Belgium, 4000
Contact: Site 0010         
Canada, Alberta
Local Institution Not yet recruiting
Calgary, Alberta, Canada, T2N 4N2
Contact: Site 0134         
Canada, British Columbia
Local Institution Not yet recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Site 0133         
Canada, New Brunswick
Local Institution Not yet recruiting
Fredericton, New Brunswick, Canada, E3B 5N5
Contact: Site 0115         
Canada, Nova Scotia
Local Institution Not yet recruiting
Halifax, Nova Scotia, Canada, B3H 1V7
Contact: Site 0131         
Canada, Ontario
Local Institution Not yet recruiting
Kingston, Ontario, Canada, K7L 2V7
Contact: Site 0124         
Canada, Quebec
Local Institution Not yet recruiting
Montreal, Quebec, Canada, H2X 0C1
Contact: Site 0116         
Local Institution Not yet recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Site 0123         
Czechia
Local Institution Not yet recruiting
Ostrava-Poruba, Czechia, 708 52
Contact: Site 0075         
Dermatovenerologicka klinika 3. LF UK a FNKV Recruiting
Praha 10, Czechia, 100 34
Contact: Petr Arenberger, Site 0073    +420267163000      
Local Institution Not yet recruiting
Praha 2, Czechia, 128 08
Contact: Site 0074         
Denmark
Local Institution Not yet recruiting
Aarhus N, Denmark, 8200
Contact: Site 0007         
Local Institution Not yet recruiting
Herlev, Denmark, 2730
Contact: Site 0012         
Local Institution Not yet recruiting
Odense, Denmark, 5000
Contact: Site 0013         
Finland
Local Institution Not yet recruiting
Helsinki, Finland, 00290
Contact: Site 0014         
Local Institution Not yet recruiting
Tampere, Finland, 33521
Contact: Site 0015         
Local Institution Not yet recruiting
Turku, Finland, 20520
Contact: Site 0110         
France
Local Institution Not yet recruiting
Besancon Cedex, France, 25030
Contact: Site 0129         
Local Institution Not yet recruiting
Bordeaux, France, 33075
Contact: Site 0112         
Local Institution Not yet recruiting
Brest, France, 29200
Contact: Site 0113         
Hopital Claude Huriez Recruiting
LILLE Cedex, France, 59037
Contact: Laurent Mortier, Site 0111         
Hopital De La Timone Recruiting
Marseille Cedex 5, France, 13385
Contact: Jean-Jacques Grob, Site 0033         
Hotel Dieu - Chu De Nantes Recruiting
Nantes, France, 44093
Contact: Brigitte Dreno, Site 0035         
Hopital De L Archet Recruiting
Nice, France, 06200
Contact: Henri Montaudie, Site 0130         
Hopital Saint Louis Recruiting
Paris, France, 75475
Contact: Celeste Lebbe, Site 0036         
Centre Hospitalier Lyon Sud Recruiting
Pierre Benite Cedex, France, 69495
Contact: Stephane Dalle, Site 0032         
Institut Gustave Roussy Recruiting
Villejuif, France, 94800
Contact: Caroline Robert, Site 0034         
Germany
Local Institution Not yet recruiting
Bonn, Germany, 53127
Contact: Site 0072         
Local Institution Not yet recruiting
Buxtehude, Germany, 21614
Contact: Site 0061         
Local Institution Not yet recruiting
Dresden, Germany, 01307
Contact: Site 0098         
Local Institution Not yet recruiting
Essen, Germany, 45122
Contact: Site 0054         
Local Institution Not yet recruiting
Gera, Germany, 07548
Contact: Site 0062         
Local Institution Not yet recruiting
Hannover, Germany, 30625
Contact: Site 0060         
Local Institution Not yet recruiting
Heidelberg, Germany, 69120
Contact: Site 0055         
Local Institution Not yet recruiting
Lubeck, Germany, 23538
Contact: Site 0057         
Local Institution Not yet recruiting
Mainz, Germany, 55131
Contact: Site 0100         
Local Institution Not yet recruiting
Muenchen, Germany, 80337
Contact: Site 0056         
Local Institution Not yet recruiting
Regensburg, Germany, 93053
Contact: Site 0102         
Local Institution Not yet recruiting
Tuebingen, Germany, 72076
Contact: Site 0058         
Greece
Local Institution Not yet recruiting
Athens, Greece, 11526
Contact: Site 0082         
Metropolitan Hospital Recruiting
Neo Faliro, Greece, 18547
Contact: Dimitrios Bafaloukos, Site 0084         
Local Institution Recruiting
Thessaloniki, Greece, 57001
Contact: Site 0083         
Italy
Local Institution Not yet recruiting
Bergamo, Italy, 24127
Contact: Site 0040         
Local Institution Not yet recruiting
Milano, Italy, 20133
Contact: Site 0037         
Local Institution Not yet recruiting
Napoli, Italy, 80131
Contact: Site 0101         
Local Institution Not yet recruiting
Padova, Italy, 35128
Contact: Site 0039         
Local Institution Not yet recruiting
Palermo, Italy, 90127
Contact: Site 0046         
Local Institution Not yet recruiting
Siena, Italy, 53100
Contact: Site 0038         
Netherlands
Local Institution Not yet recruiting
Breda, Netherlands, 4818CK
Contact: Site 0107         
Local Institution Not yet recruiting
Groningen, Netherlands, 9700RB
Contact: Site 0001         
Local Institution Not yet recruiting
Rotterdam, Netherlands, 3008 AE
Contact: Site 0030         
Local Institution Not yet recruiting
Utrecht, Netherlands, 3584 CX
Contact: Site 0002         
Norway
Local Institution Not yet recruiting
Bergen, Norway, 5021
Contact: Site 0063         
Local Institution Not yet recruiting
Gralum, Norway, 1714
Contact: Site 0027         
Local Institution Not yet recruiting
Oslo, Norway, 0379
Contact: Site 0005         
Poland
Klinika Onkologii i Radioterapii Recruiting
Gdansk, Poland, 80-214
Contact: Jacek Jassem, Site 0023    +48585844408      
Local Institution Not yet recruiting
Poznan, Poland, 60-780
Contact: Site 0103         
Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow Recruiting
Warszawa, Poland, 02-781
Contact: Piotr Rutkowski, Site 0022    +48225462603      
Romania
Local Institution Not yet recruiting
Bucharest, Romania, 020122
Contact: Site 0021         
Local Institution Not yet recruiting
Cluj-Napoca, Romania, 400015
Contact: Site 0047         
Local Institution Not yet recruiting
Craiova, Romania, 200347
Contact: Site 0020         
Spain
Local Institution Not yet recruiting
Badalona, Barcelona, Spain, 08916
Contact: Site 0065         
Local Institution Not yet recruiting
A Coruna, Spain, 15006
Contact: Site 0067         
Local Institution Not yet recruiting
Barcelona, Spain, 08028
Contact: Site 0071         
Local Institution Not yet recruiting
Madrid, Spain, 28034
Contact: Site 0066         
Local Institution Not yet recruiting
Madrid, Spain, 28046
Contact: Site 0070         
Local Institution Not yet recruiting
Malaga, Spain, 29010
Contact: Site 0068         
H. U. Marques de Valdecilla Recruiting
Santander, Spain, 39008
Contact: Almudena Garcia Casta?o, Site 0064         
Instituto Valenciano De Oncologia Recruiting
Valencia, Spain, 46009
Contact: Virtudes Soriano, Site 0069         
Sweden
Local Institution Not yet recruiting
Gavle, Sweden, 801 87
Contact: Site 0004         
Local Institution Not yet recruiting
Linkoping, Sweden, 581 85
Contact: Site 0003         
Local Institution Not yet recruiting
Orebro, Sweden, 701 85
Contact: Site 0026         
Switzerland
Local Institution Not yet recruiting
Lausanne, Switzerland, 1011
Contact: Site 0053         
United Kingdom
Local Institution Not yet recruiting
Cardiff, Glamorgan, United Kingdom, CF14 2TL
Contact: Site 0044         
Local Institution Not yet recruiting
London, Greater London, United Kingdom, NW3 2QG
Contact: Site 0045         
Local Institution Not yet recruiting
London, Greater London, United Kingdom, SW17 0RE
Contact: Site 0108         
Local Institution Not yet recruiting
Southampton, Hampshire, United Kingdom, SO16 6YD
Contact: Site 0095         
Local Institution Not yet recruiting
Glasgow, Lanarkshire, United Kingdom, G12 0YN
Contact: Site 0096         
Local Institution Not yet recruiting
Edinburgh, United Kingdom, EH4 2XU
Contact: Site 0041         
Local Institution Not yet recruiting
Leicester, United Kingdom, LE1 5WW
Contact: Site 0043         
Local Institution Not yet recruiting
Stoke-on-Trent, United Kingdom, ST4 6QG
Contact: Site 0042         
Sponsors and Collaborators
Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04099251     History of Changes
Other Study ID Numbers: CA209-76K
2019-001230-34 ( EudraCT Number )
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: December 6, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Melanoma
Nevi and Melanomas
Nivolumab
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Antineoplastic Agents, Immunological
Antineoplastic Agents