History of Changes for Study: NCT04099251

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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Study Record Versions

Version	Submitted Date	Changes
1	September 20, 2019	None (earliest Version on record)
2	October 21, 2019	Study Status and Contacts/Locations
3	November 11, 2019	Recruitment Status, Contacts/Locations, Study Status and Oversight
4	November 15, 2019	Contacts/Locations and Study Status
5	November 25, 2019	Contacts/Locations and Study Status
6	November 26, 2019	Contacts/Locations and Study Status
7	December 4, 2019	Contacts/Locations and Study Status
8	December 10, 2019	Contacts/Locations and Study Status
9	December 18, 2019	Contacts/Locations and Study Status
10	December 23, 2019	Contacts/Locations and Study Status
11	January 6, 2020	Contacts/Locations and Study Status
12	January 10, 2020	Contacts/Locations, Eligibility and Study Status
13	January 16, 2020	Contacts/Locations and Study Status
14	January 22, 2020	Contacts/Locations and Study Status
15	January 29, 2020	Contacts/Locations and Study Status
16	February 7, 2020	Contacts/Locations and Study Status
17	February 14, 2020	Contacts/Locations and Study Status
18	February 21, 2020	Contacts/Locations and Study Status
19	February 28, 2020	Contacts/Locations and Study Status
20	March 3, 2020	Study Status and Contacts/Locations
21	March 9, 2020	Contacts/Locations and Study Status
22	March 17, 2020	Contacts/Locations and Study Status
23	March 23, 2020	Contacts/Locations and Study Status
24	March 30, 2020	Contacts/Locations and Study Status
25	June 16, 2020	Contacts/Locations and Study Status
26	June 19, 2020	Contacts/Locations and Study Status
27	July 2, 2020	Contacts/Locations and Study Status
28	July 17, 2020	Contacts/Locations and Study Status
29	August 6, 2020	Contacts/Locations and Study Status
30	August 10, 2020	Contacts/Locations and Study Status
31	August 17, 2020	Contacts/Locations and Study Status
32	August 21, 2020	Contacts/Locations and Study Status
33	September 9, 2020	Contacts/Locations and Study Status
34	October 6, 2020	Contacts/Locations and Study Status
35	October 9, 2020	Contacts/Locations and Study Status
36	October 14, 2020	Contacts/Locations and Study Status
37	October 21, 2020	Contacts/Locations and Study Status
38	October 29, 2020	Contacts/Locations and Study Status
39	October 30, 2020	Contacts/Locations and Study Status
40	November 16, 2020	Contacts/Locations and Study Status
41	June 23, 2021	Contacts/Locations, Outcome Measures, Study Status, Arms and Interventions, Study Design and Study Identification
42	July 12, 2021	Contacts/Locations and Study Status
43	July 23, 2021	Contacts/Locations and Study Status
44	November 12, 2021	Recruitment Status, Contacts/Locations, Study Status, Study Design and References
45	December 13, 2021	Study Status and Contacts/Locations
46	February 16, 2022	Study Status, Contacts/Locations and Eligibility
47	March 17, 2022	Study Status and Contacts/Locations
48	May 25, 2022	Contacts/Locations and Study Status
49	July 5, 2022	Contacts/Locations and Study Status
50	September 1, 2022	Contacts/Locations and Study Status
51	December 13, 2022	Contacts/Locations, Study Status and References
52	January 12, 2023	Contacts/Locations and Study Status
53	March 9, 2023	Contacts/Locations and Study Status
54	June 26, 2023	Quality Control Review has not concluded Returned: July 17, 2023 Outcome Measures, Study Status, References, Contacts/Locations, Document Section
55	July 25, 2023	Study Status, Adverse Events, Outcome Measures
56	September 5, 2023	Study Status
57	October 11, 2023	Contacts/Locations and Study Status
58	November 8, 2023	References, Study Status and Contacts/Locations
59	November 9, 2023	Study Status

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	CA209-76K
Brief Title:	Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma (CheckMate76K)
Official Title:	A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy With Nivolumab Versus Placebo After Complete Resection of Stage IIB/C Melanoma
Secondary IDs:	2019-001230-34 [EudraCT Number]

Study Status


Record Verification:	September 2019
Overall Status:	Not yet recruiting
Study Start:	October 16, 2019
Primary Completion:	January 1, 2024 [Anticipated]
Study Completion:	January 1, 2024 [Anticipated]

First Submitted:	September 20, 2019
First Submitted that Met QC Criteria:	September 20, 2019
First Posted:	September 23, 2019 [Actual]

Last Update Submitted that Met QC Criteria:	September 20, 2019
Last Update Posted:	September 23, 2019 [Actual]

Sponsor/Collaborators


Sponsor:	Bristol-Myers Squibb
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	Yes
U.S. FDA-regulated Device:	No
Data Monitoring:	Yes

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.
Detailed Description:

Conditions


Conditions:	Melanoma
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 3
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	Triple (Participant, Care Provider, Investigator)
Allocation:	Randomized
Enrollment:	1000 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: Nivolumab specified dose on specified days	Biological: Nivolumab specified dose on specified days Other Names: Opdivo
Placebo Comparator: Placebo placebo equivalent specified dose on specified days	Placebo Matched placebo specified dose on specified days

Outcome Measures


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 ]

Eligibility


Minimum Age:	12 Years
Maximum Age:
Sex:	All
Gender Based:
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.

Contacts/Locations


Central Contact Person:	Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, Telephone: please email Email: Clinical.Trials@bms.com
Central Contact Backup:	First line of the email MUST contain NCT # and Site #.
Locations:	United States, Alabama
	Local Institution Birmingham, Alabama, United States, 35249 Contact:Contact: Site 0088
	United States, Arkansas
	Local Institution Rogers, Arkansas, United States, 72758 Contact:Contact: Site 0087
	United States, California
	Local Institution Los Angeles, California, United States, 90025 Contact:Contact: Site 0080
	Local Institution Oakland, California, United States, 94611 Contact:Contact: Site 0121
	Local Institution Roseville, California, United States, 95661 Contact:Contact: Site 0120
	Local Institution San Francisco, California, United States, 94115 Contact:Contact: Site 0077
	Local Institution San Francisco, California, United States, 94115 Contact:Contact: Site 0119
	Local Institution San Jose, California, United States, 95119 Contact:Contact: Site 0122
	Local Institution Vallejo, California, United States, 94589-2441 Contact:Contact: Site 0109
	United States, Colorado
	Local Institution Aurora, Colorado, United States, 80045 Contact:Contact: Site 0091
	United States, District of Columbia
	Local Institution Washington, District of Columbia, United States, 20007 Contact:Contact: Site 0089
	United States, Massachusetts
	Local Institution Boston, Massachusetts, United States, 02215 Contact:Contact: Site 0078
	United States, Minnesota
	Local Institution Minneapolis, Minnesota, United States, 55407 Contact:Contact: Site 0081
	United States, Nebraska
	Local Institution Omaha, Nebraska, United States, 68130 Contact:Contact: Site 0079
	United States, New Jersey
	Local Institution Hackensack, New Jersey, United States, 07601 Contact:Contact: Site 0093
	United States, New York
	Local Institution New York, New York, United States, 10016 Contact:Contact: Site 0094
	United States, North Carolina
	Local Institution Charlotte, North Carolina, United States, 28204 Contact:Contact: Site 0086
	United States, Ohio
	Local Institution Cleveland, Ohio, United States, 44195 Contact:Contact: Site 0099
	United States, Oregon
	Local Institution Portland, Oregon, United States, 97213 Contact:Contact: Site 0076
	United States, Pennsylvania
	Local Institution Allentown, Pennsylvania, United States, 18103 Contact:Contact: Site 0092
	Local Institution Pittsburgh, Pennsylvania, United States, 15232 Contact:Contact: Site 0031
	United States, Texas
	Local Institution Dallas, Texas, United States, 75246 Contact:Contact: Site 0085
	United States, Virginia
	Local Institution Fairfax, Virginia, United States, 22031 Contact:Contact: Site 0090
	Australia, New South Wales
	Local Institution North Sydney, New South Wales, Australia, 2060 Contact:Contact: Site 0016
	Local Institution Northmead, New South Wales, Australia, 2145 Contact:Contact: Site 0025
	Local Institution Waratah, New South Wales, Australia, 2298 Contact:Contact: Site 0018
	Australia, Queensland
	Local Institution Cairns, Queensland, Australia, 4870 Contact:Contact: Site 0105
	Local Institution Herston, Queensland, Australia, 4029 Contact:Contact: Site 0024
	Australia, Victoria
	Local Institution Box Hill, Victoria, Australia, 3128 Contact:Contact: Site 0019
	Local Institution Melbourne, Victoria, Australia, 3004 Contact:Contact: Site 0017
	Local Institution Melbourne, Victoria, Australia, 3004 Contact:Contact: Site 0106
	Australia, Western Australia
	Local Institution Nedlands, Western Australia, Australia, 6009 Contact:Contact: Site 0104
	Belgium
	Local Institution Charleroi, Belgium, 6000 Contact:Contact: Site 0028
	Local Institution Edegem, Belgium, 2650 Contact:Contact: Site 0009
	Local Institution Gent, Belgium, 9000 Contact:Contact: Site 0011
	Local Institution Kortrijk, Belgium, 8500 Contact:Contact: Site 0008
	Local Institution Liège, Belgium, 4000 Contact:Contact: Site 0010
	Canada, New Brunswick
	Local Institution Fredericton, New Brunswick, Canada, E3B 5N5 Contact:Contact: Site 0115
	Canada, Ontario
	Local Institution Kingston, Ontario, Canada, K7L 2V7 Contact:Contact: Site 0124
	Canada, Quebec
	Local Institution Montreal, Quebec, Canada, H2X 0C1 Contact:Contact: Site 0116
	Local Institution Sherbrooke, Quebec, Canada, J1H 5N4 Contact:Contact: Site 0123
	Czechia
	Local Institution Ostrava-Poruba, Czechia, 708 52 Contact:Contact: Site 0075
	Local Institution Praha 10, Czechia, 100 34 Contact:Contact: Site 0073
	Local Institution Praha 2, Czechia, 128 08 Contact:Contact: Site 0074
	Denmark
	Local Institution Aarhus N, Denmark, 8200 Contact:Contact: Site 0007
	Local Institution Herlev, Denmark, 2730 Contact:Contact: Site 0012
	Local Institution Odense, Denmark, 5000 Contact:Contact: Site 0013
	Finland
	Local Institution Helsinki, Finland, 00290 Contact:Contact: Site 0014
	Local Institution Tampere, Finland, 33521 Contact:Contact: Site 0015
	Local Institution Turku, Finland, 20520 Contact:Contact: Site 0110
	France
	Local Institution Marseille Cedex 5, France, 13385 Contact:Contact: Site 0033
	Local Institution Nantes, France, 44093 Contact:Contact: Site 0035
	Local Institution Paris, France, 75475 Contact:Contact: Site 0036
	Local Institution Pierre Benite Cedex, France, 69495 Contact:Contact: Site 0032
	Local Institution Villejuif, France, 94800 Contact:Contact: Site 0034
	Germany
	Local Institution Bonn, Germany, 53127 Contact:Contact: Site 0072
	Local Institution Buxtehude, Germany, 21614 Contact:Contact: Site 0061
	Local Institution Dresden, Germany, 01307 Contact:Contact: Site 0098
	Local Institution Essen, Germany, 45122 Contact:Contact: Site 0054
	Local Institution Gera, Germany, 07548 Contact:Contact: Site 0062
	Local Institution Hannover, Germany, 30625 Contact:Contact: Site 0060
	Local Institution Heidelberg, Germany, 69120 Contact:Contact: Site 0055
	Local Institution Lubeck, Germany, 23538 Contact:Contact: Site 0057
	Local Institution Mainz, Germany, 55131 Contact:Contact: Site 0100
	Local Institution Muenchen, Germany, 80337 Contact:Contact: Site 0056
	Local Institution Regensburg, Germany, 93053 Contact:Contact: Site 0102
	Local Institution Tuebingen, Germany, 72076 Contact:Contact: Site 0058
	Italy
	Local Institution Bergamo, Italy, 24127 Contact:Contact: Site 0040
	Local Institution Milano, Italy, 20133 Contact:Contact: Site 0037
	Local Institution Napoli, Italy, 80131 Contact:Contact: Site 0101
	Local Institution Padova, Italy, 35128 Contact:Contact: Site 0039
	Local Institution Palermo, Italy, 90127 Contact:Contact: Site 0046
	Local Institution Siena, Italy, 53100 Contact:Contact: Site 0038
	Netherlands
	Local Institution Breda, Netherlands, 4818CK Contact:Contact: Site 0107
	Local Institution Groningen, Netherlands, 9700RB Contact:Contact: Site 0001
	Local Institution Rotterdam, Netherlands, 3008 AE Contact:Contact: Site 0030
	Local Institution Utrecht, Netherlands, 3584 CX Contact:Contact: Site 0002
	Norway
	Local Institution Bergen, Norway, 5021 Contact:Contact: Site 0063
	Local Institution Gralum, Norway, 1714 Contact:Contact: Site 0027
	Local Institution Oslo, Norway, 0379 Contact:Contact: Site 0005
	Poland
	Local Institution Gdansk, Poland, 80-214 Contact:Contact: Site 0023
	Local Institution Poznan, Poland, 60-780 Contact:Contact: Site 0103
	Local Institution Warszawa, Poland, 02-781 Contact:Contact: Site 0022
	Romania
	Local Institution Bucharest, Romania, 020122 Contact:Contact: Site 0021
	Local Institution Cluj-Napoca, Romania, 400015 Contact:Contact: Site 0047
	Local Institution Craiova, Romania, 200347 Contact:Contact: Site 0020
	Spain
	Local Institution A Coruna, Spain, 15006 Contact:Contact: Site 0067
	Local Institution Barcelona, Spain, 08028 Contact:Contact: Site 0071
	Local Institution Madrid, Spain, 28034 Contact:Contact: Site 0066
	Local Institution Madrid, Spain, 28046 Contact:Contact: Site 0070
	Local Institution Malaga, Spain, 29010 Contact:Contact: Site 0068
	Local Institution Santander, Spain, 39008 Contact:Contact: Site 0064
	Local Institution Valencia, Spain, 46009 Contact:Contact: Site 0069
	Spain, Barcelona
	Local Institution Badalona, Barcelona, Spain, 08916 Contact:Contact: Site 0065
	Sweden
	Local Institution Gavle, Sweden, 801 87 Contact:Contact: Site 0004
	Local Institution Linkoping, Sweden, 581 85 Contact:Contact: Site 0003
	Local Institution Orebro, Sweden, 701 85 Contact:Contact: Site 0026
	United Kingdom
	Local Institution Leicester, United Kingdom, LE1 5WW Contact:Contact: Site 0043
	Local Institution Southampton, United Kingdom, SO16 6YD Contact:Contact: Site 0095
	Local Institution Stoke-on-Trent, United Kingdom, ST4 6QG Contact:Contact: Site 0042
	United Kingdom, Glamorgan
	Local Institution Cardiff, Glamorgan, United Kingdom, CF14 2TL Contact:Contact: Site 0044
	United Kingdom, Greater London
	Local Institution London, Greater London, United Kingdom, NW3 2QG Contact:Contact: Site 0045
	Local Institution London, Greater London, United Kingdom, SW17 0RE Contact:Contact: Site 0108
	United Kingdom, Lanarkshire
	Local Institution Glasgow, Lanarkshire, United Kingdom, G12 0YN Contact:Contact: Site 0096
	United Kingdom, Midlothian
	Local Institution Edinburgh, Midlothian, United Kingdom, EH16 4SB Contact:Contact: Site 0041

IPDSharing


Plan to Share IPD:

References


Citations:
Links:	URL: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html Description: BMS Clinical Trial Information
	URL: https://www.bmsstudyconnect.com/s/US/English/USenHome Description: BMS Clinical Trial Patient Recruiting
	URL: https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm Description: FDA Safety Alerts and Recalls
Available IPD/Information: