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

March 23, 2026 updated by: Bristol-Myers Squibb

A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy With Nivolumab Versus Placebo After Complete Resection of Stage IIB/C Melanoma

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
790

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
Approved

Approved

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 for sale to the public. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Waratah, New South Wales, Australia, 2298
        • Local Institution - 0018
      • Westmead, New South Wales, Australia, 2145
        • Local Institution - 0025
      • Wollstonecraft, New South Wales, Australia, 2065
        • Local Institution - 0016
    • Queensland
      • Cairns, Queensland, Australia, 4870
        • Local Institution - 0105
      • Greenslopes, Queensland, Australia, 4120
        • Local Institution - 0017
      • Herston, Queensland, Australia, 4029
        • Local Institution - 0024
      • Southport, Queensland, Australia, 4120
        • Local Institution - 0138
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Local Institution - 0019
      • Geelong, Victoria, Australia, 3220
        • Local Institution - 0125
      • Malvern, Victoria, Australia, 3144
        • Local Institution - 0128
      • Melbourne, Victoria, Australia, 3004
        • Local Institution - 0106
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Local Institution - 0104
  • Austria
      • Graz, Austria, 8036
        • Local Institution - 0049
      • Innsbruck, Austria, 6020
        • Local Institution - 0051
      • Salzburg, Austria, 5020
        • Local Institution - 0050
      • Vienna, Austria, 1090
        • Local Institution - 0048
  • Belgium
      • Charleroi, Belgium, 6000
        • Local Institution - 0028
      • Ghent, Belgium, 9000
        • Local Institution - 0011
      • Kortrijk, Belgium, 8500
        • Local Institution - 0008
      • Liège, Belgium, 4000
        • Local Institution - 0010
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Local Institution - 0134
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Local Institution - 0133
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Local Institution - 0131
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Local Institution - 0142
      • Kingston, Ontario, Canada, K7L 2V7
        • Local Institution - 0124
      • Toronto, Ontario, Canada, M5G 2M9
        • Local Institution - 0140
    • Quebec
      • Montreal, Quebec, Canada, H2X 3E4
        • Local Institution - 0116
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Local Institution - 0123
  • Czechia
      • Ostrava-Poruba, Czechia, 708 52
        • Local Institution - 0075
      • Prague, Czechia, 100 34
        • Local Institution - 0073
    • Praha 2
      • Prague, Praha 2, Czechia, 12808
        • Local Institution - 0074
  • Denmark
      • Aarhus N, Denmark, 8200
        • Local Institution - 0007
      • Herlev, Denmark, 2730
        • Local Institution - 0012
      • Odense, Denmark, 5000
        • Local Institution - 0013
  • Finland
      • Turku, Finland, 20251
        • Local Institution - 0110
    • Etelä-Suomen Lääni
      • Helsinki, Etelä-Suomen Lääni, Finland, 00290
        • Local Institution - 0014
    • Pirkanmaa
      • Tampere, Pirkanmaa, Finland, 33520
        • Local Institution - 0015
  • France
      • Besançon, France, 25030
        • Local Institution - 0129
      • Bordeaux, France, 33075
        • Local Institution - 0112
      • Lille, France, 59037
        • Local Institution - 0111
      • Marseille, France, 13011
        • Local Institution - 0033
      • Nantes, France, 44000
        • Local Institution - 0035
      • Nice, France, 06200
        • Local Institution - 0130
      • Paris, France, 75475
        • Local Institution - 0036
      • Pierre-Bénite, France, 69495
        • Local Institution - 0032
      • Villejuif, France, 94800
        • Local Institution - 0034
    • Finistère
      • Brest, Finistère, France, 29200
        • Local Institution - 0113
  • Germany
      • Bonn, Germany, 53127
        • Local Institution - 0072
      • Buxtehude, Germany, 21614
        • Local Institution - 0061
      • Dresden, Germany, 01307
        • Local Institution - 0098
      • Essen, Germany, 45122
        • Local Institution - 0054
      • Gera, Germany, 07548
        • Local Institution - 0062
      • Göttingen, Germany, 37075
        • Local Institution - 0114
      • Hanover, Germany, 30625
        • Local Institution - 0060
      • Heidelberg, Germany, 69120
        • Local Institution - 0055
      • Lübeck, Germany, 23538
        • Local Institution - 0057
      • Mainz, Germany, 55131
        • Local Institution - 0100
      • Regensburg, Germany, 93053
        • Local Institution - 0102
      • Tübingen, Germany, 72076
        • Local Institution - 0058
    • Bavaria
      • München, Bavaria, Germany, 81377
        • Local Institution - 0056
  • Greece
      • Athens, Greece, 115 27
        • Local Institution - 0082
      • Thessaloniki, Greece, 57100
        • Local Institution - 0083
    • Attikí
      • Athens, Attikí, Greece, 185 47
        • Local Institution - 0084
  • Italy
      • Bergamo, Italy, 24127
        • Local Institution - 0040
      • Milan, Italy, 20133
        • Local Institution - 0037
      • Milan, Italy, 20141
        • Local Institution - 0146
      • Naples, Italy, 80131
        • Local Institution - 0101
      • Padova, Italy, 35128
        • Local Institution - 0039
      • Perugia, Italy, 06132
        • Local Institution - 0145
      • Siena, Italy, 53100
        • Local Institution - 0038
    • Sicily
      • Palermo, Sicily, Italy, 90127
        • Local Institution - 0046
  • Netherlands
      • Breda, Netherlands, 4819 EV
        • Local Institution - 0107
      • Groningen, Netherlands, 9700RB
        • Local Institution - 0001
      • Rotterdam, Netherlands, 3015 AA
        • Local Institution - 0030
      • Utrecht, Netherlands, 3584 CX
        • Local Institution - 0002
  • Norway
      • Bergen, Norway, 5021
        • Local Institution - 0063
      • Grålum, Norway, 1714
        • Local Institution - 0027
      • Oslo, Norway, 0310
        • Local Institution - 0005
  • Poland
      • Gdansk, Poland, 80-214
        • Local Institution - 0023
      • Warsaw, Poland, 02-781
        • Local Institution - 0022
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 60-569
        • Local Institution - 0103
  • Romania
      • Cluj-Napoca, Romania, 400015
        • Local Institution - 0047
      • Craiova, Romania, 200542
        • Local Institution - 0020
      • Sector 2, Romania, 022328
        • Local Institution - 0021
  • Spain
      • A Coruña, Spain, 15006
        • Local Institution - 0067
      • Badalona, Spain, 08916
        • Local Institution - 0065
      • Madrid, Spain, 28034
        • Local Institution - 0066
      • Madrid, Spain, 28046
        • Local Institution - 0070
      • Málaga, Spain, 29010
        • Local Institution - 0068
      • Santander, Spain, 39008
        • Local Institution - 0064
      • Valencia, Spain, 46009
        • Local Institution - 0069
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 08028
        • Local Institution - 0071
  • Sweden
      • Örebro, Sweden, 701 85
        • Local Institution - 0026
    • Östergötlands Län [se-05]
      • Linköping, Östergötlands Län [se-05], Sweden, 581 85
        • Local Institution - 0003
  • Switzerland
      • Lausanne, Switzerland, 1011
        • Local Institution - 0053
      • Zurich, Switzerland, 8091
        • Local Institution - 0052
  • United Kingdom
      • Cardiff, United Kingdom, CF14 2TL
        • Local Institution - 0044
      • Southampton, United Kingdom, SO16 6YD
        • Local Institution - 0095
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-3300
        • Local Institution - 0088
    • Arizona
      • Tucson, Arizona, United States, 85724-5024
        • Local Institution - 0126
    • Arkansas
      • Springdale, Arkansas, United States, 72762
        • Local Institution - 0087
    • California
      • Los Angeles, California, United States, 90025
        • Local Institution - 0080
      • San Francisco, California, United States, 94115
        • Local Institution - 0077
      • San Francisco, California, United States, 94115
        • Local Institution - 0119
      • San Jose, California, United States, 95119
        • Local Institution - 0122
      • Vallejo, California, United States, 94589
        • Local Institution - 0120
      • Vallejo, California, United States, 94589-2441
        • Local Institution - 0121
      • Vallejo, California, United States, 94589
        • Local Institution - 0109
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Local Institution - 0091
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20057
        • Local Institution - 0089
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Local Institution - 0141
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Local Institution - 0132
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • Local Institution - 0135
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Local Institution - 0078
      • Boston, Massachusetts, United States, 02215
        • Local Institution - 0127
      • Boston, Massachusetts, United States, 02215
        • Local Institution - 0143
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Local Institution - 0151
      • Robbinsdale, Minnesota, United States, 55407
        • Local Institution - 0081
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Local Institution - 0079
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Local Institution - 0093
    • New York
      • New York, New York, United States, 10016
        • Local Institution - 0094
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Local Institution - 0086
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Local Institution - 0099
    • Oregon
      • Portland, Oregon, United States, 97213
        • Local Institution - 0076
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Local Institution - 0092
      • Pittsburgh, Pennsylvania, United States, 15232
        • Local Institution - 0031
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Local Institution - 0148
    • Texas
      • Austin, Texas, United States, 78731
        • Local Institution - 0144
      • Dallas, Texas, United States, 75246
        • Local Institution - 0085
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Local Institution - 0090

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Other: Placebo
Specified dose on specified days
Experimental: Nivolumab
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recurrence Free Survival (RFS)
Time Frame: From randomization up to the date of first recurrence, new primary melanoma, or death (whatever the cause), whichever occurs first (up to 32 months)
Recurrence Free Survival (RFS) is defined as the time between the date of randomization and the date of first recurrence (local, regional or distant metastasis), new primary melanoma (including melanoma in situ), or death (whatever the cause), whichever occurs first. For participants who remain alive and whose disease has not recurred or did not die, RFS will be censored on the date of last evaluable disease assessment. For those participants who remained alive and had no recorded post-randomization tumor assessment, RFS will be censored on the day of randomization.
From randomization up to the date of first recurrence, new primary melanoma, or death (whatever the cause), whichever occurs first (up to 32 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Distant Metastasis-Free Survival (DMFS)
Time Frame: From randomization up to the date of first distant metastasis or date of death (whatever the cause), whichever occurs first (up to approximately 32 months)
Investigator-assessed distant metastasis-free survival (DMFS) is defined as the time between the date of randomization and the date of first distant metastasis or date of death (whatever the cause), whichever occurs first. Participants with no baseline disease assessment, no on-study disease assessments and no death, and no distant metastasis and no death will be censored. Participants with no baseline disease assessment and no on-study disease assessments and death are censored on the date of randomization. Participants with no recurrence and no death will be censored on the date of their last evaluable disease assessment.
From randomization up to the date of first distant metastasis or date of death (whatever the cause), whichever occurs first (up to approximately 32 months)
Duration of Treatment on Next Line Therapy Per Investigator Assessment
Time Frame: From first dose date of next-line therapy to last dose date of next-line therapy (up to approximately 32 months)
Duration of treatment is an investigator-assessed outcome of next-line therapy (NLT) defined as the time from first dose date of NLT to last dose date of NLT. Participants who did not stop the NLT were censored.
From first dose date of next-line therapy to last dose date of next-line therapy (up to approximately 32 months)
Progression-Free Survival Through Next-Line Therapy
Time Frame: From randomization to recurrence/objective disease progression after the start of the next-line therapy, or to the start of a second next-line systemic therapy, or to death from any cause, whichever occurs first (up to approximately 32 months)
Progression-free survival through next-line therapy (PFS2) is defined as the time from randomization to recurrence/objective disease progression after the start of the next-line of systemic anti-cancer therapy, or to the start of a second next-line systemic therapy, or to death from any cause, whichever occurs first. Participants who did not receive subsequent systemic anti-cancer therapy who died will be considered as having the event on the date of death. Participants who received subsequent systemic anti-cancer therapy who had a disease progression after the start of therapy will be considered as having the event on the date of disease progression. Participants who died or started second next-line therapy, the date of death or start date of second next-line therapy will be the event date, whichever is earlier. Participants who did not experience disease progression, death, or second next-line therapy will be censored on the last known alive date.
From randomization to recurrence/objective disease progression after the start of the next-line therapy, or to the start of a second next-line systemic therapy, or to death from any cause, whichever occurs first (up to approximately 32 months)
Number of Participants Experiencing Adverse Events (AEs)
Time Frame: From first dose up to 30 days post last dose of the blinded phase (up to 13 months)
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.
From first dose up to 30 days post last dose of the blinded phase (up to 13 months)
Number of Participants Experiencing Adverse Events Leading to Discontinuation
Time Frame: From first dose up to 30 days post last dose of the blinded phase (up to 13 months)
An Adverse Event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure.
From first dose up to 30 days post last dose of the blinded phase (up to 13 months)
Number of Participants Experiencing Select Adverse Events
Time Frame: From first dose up to 30 days post last dose of the blinded phase (up to 13 months)
The number of participants experiencing all-cause select adverse events (AEs). An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure.
From first dose up to 30 days post last dose of the blinded phase (up to 13 months)
Number of Participants Experiencing Serious Adverse Events (SAEs)
Time Frame: From first dose up to 30 days post last dose of the blinded phase (up to 13 months)
A Serious Adverse Events (SAE) is defined as any untoward or unfavorable medical occurrence in a participants that results in death, is life threatening, or places the participant at immediate risk of death from the event as it occurred, requires or prolongs hospitalization, causes persistent or significant disability or incapacity, results in congenital anomalies or birth defects, and is another condition which investigators judge to represent significant hazards.
From first dose up to 30 days post last dose of the blinded phase (up to 13 months)
Number of Participants Experiencing Death
Time Frame: From first dose up to 30 days post last dose of the blinded phase (up to 13 months)
All study participants who died during the blinded phase of the study following treatment.
From first dose up to 30 days post last dose of the blinded phase (up to 13 months)
Number of Participants Experiencing Grade 3 or 4 Laboratory Abnormalities in Selected Hematology Parameters
Time Frame: From first dose up to 30 days post last dose of the blinded phase (up to 13 months)
The number of participants experiencing Grade 3 or 4 laboratory abnormalities in the specific pre-determined hematology tests.
From first dose up to 30 days post last dose of the blinded phase (up to 13 months)
Number of Participants Experiencing Laboratory Abnormalities in Selected Liver Parameters
Time Frame: From first dose up to 30 days post last dose of the blinded phase (up to 13 months)
The number of participants experiencing laboratory abnormalities in the specific pre-determined liver tests.
From first dose up to 30 days post last dose of the blinded phase (up to 13 months)
Overall Survival (OS)
Time Frame: From randomization up to the date of death or the last date the participant was known to be alive
OS is defined as the time between the date of randomization and the date of death. For those without documentation of death, OS will be censored on the last date the participant was known to be alive.
From randomization up to the date of death or the last date the participant was known to be alive

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 28, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 28, 2022

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 29, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 20, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 23, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CA209-76K
  • 2019-001230-34 (EudraCT Number)
  • U1111-1229-8927 (Other Identifier: UTN Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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