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MelanomaPhase 3CheckMate76KNCT04099251

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

A Phase 3 study testing Nivolumab in people with Melanoma, run by Bristol-Myers Squibb at 130 sites in 20 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Melanoma
What is being tested?
Nivolumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
790 participants
Where
130 sitesin 20 countries
Study dates
28 Oct 2019to 30 Nov 2026
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

130 sites in 20 countries.

130 sites in 20 countries

United States32 sites

  • Local Institution - 0092

    Allentown, Pennsylvania, 18103

  • Local Institution - 0141

    Atlanta, Georgia, 30342

  • Local Institution - 0091

    Aurora, Colorado, 80045

  • Local Institution - 0144

    Austin, Texas, 78731

  • Local Institution - 0135

    Baltimore, Maryland, 21237

  • Local Institution - 0088

    Birmingham, Alabama, 35294-3300

  • Local Institution - 0078

    Boston, Massachusetts, 02215

  • Local Institution - 0127

    Boston, Massachusetts, 02215

  • Local Institution - 0143

    Boston, Massachusetts, 02215

  • Local Institution - 0086

    Charlotte, North Carolina, 28204

  • Local Institution - 0132

    Chicago, Illinois, 60611

  • Local Institution - 0099

    Cleveland, Ohio, 44195

  • Local Institution - 0085

    Dallas, Texas, 75246

  • Local Institution - 0090

    Fairfax, Virginia, 22031

  • Local Institution - 0148

    Germantown, Tennessee, 38138

  • Local Institution - 0093

    Hackensack, New Jersey, 07601

  • Local Institution - 0080

    Los Angeles, California, 90025

  • Local Institution - 0151

    Minneapolis, Minnesota, 55407

  • Local Institution - 0094

    New York, New York, 10016

  • Local Institution - 0079

    Omaha, Nebraska, 68130

  • Local Institution - 0031

    Pittsburgh, Pennsylvania, 15232

  • Local Institution - 0076

    Portland, Oregon, 97213

  • Local Institution - 0081

    Robbinsdale, Minnesota, 55407

  • Local Institution - 0077

    San Francisco, California, 94115

  • Local Institution - 0119

    San Francisco, California, 94115

  • Local Institution - 0122

    San Jose, California, 95119

  • Local Institution - 0087

    Springdale, Arkansas, 72762

  • Local Institution - 0126

    Tucson, Arizona, 85724-5024

  • Local Institution - 0121

    Vallejo, California, 94589-2441

  • Local Institution - 0109

    Vallejo, California, 94589

  • Local Institution - 0120

    Vallejo, California, 94589

  • Local Institution - 0089

    Washington D.C., District of Columbia, 20057

Other trials in United States

Germany13 sites

  • Local Institution - 0072

    Bonn, 53127

  • Local Institution - 0061

    Buxtehude, 21614

  • Local Institution - 0098

    Dresden, 01307

  • Local Institution - 0054

    Essen, 45122

  • Local Institution - 0062

    Gera, 07548

  • Local Institution - 0114

    Göttingen, 37075

  • Local Institution - 0060

    Hanover, 30625

  • Local Institution - 0055

    Heidelberg, 69120

  • Local Institution - 0057

    Lübeck, 23538

  • Local Institution - 0100

    Mainz, 55131

  • Local Institution - 0056

    München, Bavaria, 81377

  • Local Institution - 0102

    Regensburg, 93053

  • Local Institution - 0058

    Tübingen, 72076

Other trials in Germany

Australia12 sites

  • Local Institution - 0019

    Box Hill, Victoria, 3128

  • Local Institution - 0105

    Cairns, Queensland, 4870

  • Local Institution - 0125

    Geelong, Victoria, 3220

  • Local Institution - 0017

    Greenslopes, Queensland, 4120

  • Local Institution - 0024

    Herston, Queensland, 4029

  • Local Institution - 0128

    Malvern, Victoria, 3144

  • Local Institution - 0106

    Melbourne, Victoria, 3004

  • Local Institution - 0104

    Nedlands, Western Australia, 6009

  • Local Institution - 0138

    Southport, Queensland, 4120

  • Local Institution - 0018

    Waratah, New South Wales, 2298

  • Local Institution - 0025

    Westmead, New South Wales, 2145

  • Local Institution - 0016

    Wollstonecraft, New South Wales, 2065

Other trials in Australia

France10 sites

  • Local Institution - 0129

    Besançon, 25030

  • Local Institution - 0112

    Bordeaux, 33075

  • Local Institution - 0113

    Brest, Finistère, 29200

  • Local Institution - 0111

    Lille, 59037

  • Local Institution - 0033

    Marseille, 13011

  • Local Institution - 0035

    Nantes, 44000

  • Local Institution - 0130

    Nice, 06200

  • Local Institution - 0036

    Paris, 75475

  • Local Institution - 0032

    Pierre-Bénite, 69495

  • Local Institution - 0034

    Villejuif, 94800

Other trials in France

Canada8 sites

  • Local Institution - 0134

    Calgary, Alberta, T2N 4N2

  • Local Institution - 0131

    Halifax, Nova Scotia, B3H 2Y9

  • Local Institution - 0142

    Hamilton, Ontario, L8V 5C2

  • Local Institution - 0124

    Kingston, Ontario, K7L 2V7

  • Local Institution - 0116

    Montreal, Quebec, H2X 3E4

  • Local Institution - 0123

    Sherbrooke, Quebec, J1H 5N4

  • Local Institution - 0140

    Toronto, Ontario, M5G 2M9

  • Local Institution - 0133

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Italy8 sites

  • Local Institution - 0040

    Bergamo, 24127

  • Local Institution - 0037

    Milan, 20133

  • Local Institution - 0146

    Milan, 20141

  • Local Institution - 0101

    Naples, 80131

  • Local Institution - 0039

    Padova, 35128

  • Local Institution - 0046

    Palermo, Sicily, 90127

  • Local Institution - 0145

    Perugia, 06132

  • Local Institution - 0038

    Siena, 53100

Other trials in Italy

Spain8 sites

  • Local Institution - 0067

    A Coruña, 15006

  • Local Institution - 0065

    Badalona, 08916

  • Local Institution - 0071

    Barcelona, Barcelona [Barcelona], 08028

  • Local Institution - 0066

    Madrid, 28034

  • Local Institution - 0070

    Madrid, 28046

  • Local Institution - 0068

    Málaga, 29010

  • Local Institution - 0064

    Santander, 39008

  • Local Institution - 0069

    Valencia, 46009

Other trials in Spain

Austria4 sites

  • Local Institution - 0049

    Graz, 8036

  • Local Institution - 0051

    Innsbruck, 6020

  • Local Institution - 0050

    Salzburg, 5020

  • Local Institution - 0048

    Vienna, 1090

Other trials in Austria

Belgium4 sites

  • Local Institution - 0028

    Charleroi, 6000

  • Local Institution - 0011

    Ghent, 9000

  • Local Institution - 0008

    Kortrijk, 8500

  • Local Institution - 0010

    Liège, 4000

Other trials in Belgium

Netherlands4 sites

  • Local Institution - 0107

    Breda, 4819 EV

  • Local Institution - 0001

    Groningen, 9700RB

  • Local Institution - 0030

    Rotterdam, 3015 AA

  • Local Institution - 0002

    Utrecht, 3584 CX

Other trials in Netherlands

Czechia3 sites

  • Local Institution - 0075

    Ostrava-Poruba, 708 52

  • Local Institution - 0074

    Prague, Praha 2, 12808

  • Local Institution - 0073

    Prague, 100 34

Other trials in Czechia

Denmark3 sites

  • Local Institution - 0007

    Aarhus N, 8200

  • Local Institution - 0012

    Herlev, 2730

  • Local Institution - 0013

    Odense, 5000

Other trials in Denmark

Finland3 sites

  • Local Institution - 0014

    Helsinki, Etelä-Suomen Lääni, 00290

  • Local Institution - 0015

    Tampere, Pirkanmaa, 33520

  • Local Institution - 0110

    Turku, 20251

Other trials in Finland

Greece3 sites

  • Local Institution - 0084

    Athens, Attikí, 185 47

  • Local Institution - 0082

    Athens, 115 27

  • Local Institution - 0083

    Thessaloniki, 57100

Other trials in Greece

Norway3 sites

  • Local Institution - 0063

    Bergen, 5021

  • Local Institution - 0027

    Grålum, 1714

  • Local Institution - 0005

    Oslo, 0310

Other trials in Norway

Poland3 sites

  • Local Institution - 0023

    Gdansk, 80-214

  • Local Institution - 0103

    Poznan, Greater Poland Voivodeship, 60-569

  • Local Institution - 0022

    Warsaw, 02-781

Other trials in Poland

Romania3 sites

  • Local Institution - 0047

    Cluj-Napoca, 400015

  • Local Institution - 0020

    Craiova, 200542

  • Local Institution - 0021

    Sector 2, 022328

Other trials in Romania

Sweden2 sites

  • Local Institution - 0003

    Linköping, Östergötlands Län [se-05], 581 85

  • Local Institution - 0026

    Örebro, 701 85

Other trials in Sweden

Switzerland2 sites

  • Local Institution - 0053

    Lausanne, 1011

  • Local Institution - 0052

    Zurich, 8091

Other trials in Switzerland

United Kingdom2 sites

  • Local Institution - 0044

    Cardiff, CF14 2TL

  • Local Institution - 0095

    Southampton, SO16 6YD

Other trials in United Kingdom

About this study

Official title: 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.

Conditions
Melanoma
Being tested
Nivolumab, Placebo
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NivolumabBiological

    Also called Opdivo

    Specified dose on specified days

  • PlaceboOther

    Specified dose on specified days

Study groups in NCT04099251
Study groupRoleWhat they receive
NivolumabExperimentalNot described
Receives: Biological: Nivolumab
PlaceboPlacebo comparatorNot described
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recurrence Free Survival (RFS)

    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.

    Measured: 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 outcomes (11)

  1. Distant Metastasis-Free Survival (DMFS)

    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.

    Measured: 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)

  2. Duration of Treatment on Next Line Therapy Per Investigator Assessment

    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.

    Measured: From first dose date of next-line therapy to last dose date of next-line therapy (up to approximately 32 months)

  3. Progression-Free Survival Through Next-Line Therapy

    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.

    Measured: 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)

  4. Number of Participants Experiencing Adverse Events (AEs)

    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.

    Measured: From first dose up to 30 days post last dose of the blinded phase (up to 13 months)

  5. Number of Participants Experiencing Adverse Events Leading to Discontinuation

    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.

    Measured: From first dose up to 30 days post last dose of the blinded phase (up to 13 months)

  6. Number of Participants Experiencing Select Adverse Events

    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.

    Measured: From first dose up to 30 days post last dose of the blinded phase (up to 13 months)

  7. Number of Participants Experiencing Serious Adverse Events (SAEs)

    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.

    Measured: From first dose up to 30 days post last dose of the blinded phase (up to 13 months)

  8. Number of Participants Experiencing Death

    All study participants who died during the blinded phase of the study following treatment.

    Measured: From first dose up to 30 days post last dose of the blinded phase (up to 13 months)

  9. Number of Participants Experiencing Grade 3 or 4 Laboratory Abnormalities in Selected Hematology Parameters

    The number of participants experiencing Grade 3 or 4 laboratory abnormalities in the specific pre-determined hematology tests.

    Measured: From first dose up to 30 days post last dose of the blinded phase (up to 13 months)

  10. Number of Participants Experiencing Laboratory Abnormalities in Selected Liver Parameters

    The number of participants experiencing laboratory abnormalities in the specific pre-determined liver tests.

    Measured: From first dose up to 30 days post last dose of the blinded phase (up to 13 months)

  11. Overall Survival (OS)

    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.

    Measured: From randomization up to the date of death or the last date the participant was known to be alive

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2019
  2. Study start28 Oct 2019
  3. Primary completion28 Jun 2022
  4. Study completion30 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
790 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04099251
Sponsor's protocol ID
CA209-76K
Other IDs
2022-502354-14
Acronym
CheckMate76K
Status last verified
Aug 2026
First submitted
20 Sep 2019
Last updated
7 Aug 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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
Expanded access
Available

Publications

  • Kirkwood JM, Mohr P, Hoeller C, Grob JJ, Del Vecchio M, Lord-Bessen J, Srinivasan S, Nassar A, Campigotto F, Fairbanks H, Taylor F, Lawrance R, Long GV, Weber J. Patient-reported outcomes with adjuvant nivolumab versus placebo after complete resection of stage IIB/C melanoma in the randomized phase 3 CheckMate 76 K trial. Eur J Cancer. 2025 May 2;220:115371. doi: 10.1016/j.ejca.2025.115371. Epub 2025 Mar 19.

    PubMed 40139004

  • Kirkwood JM, Del Vecchio M, Weber J, Hoeller C, Grob JJ, Mohr P, Loquai C, Dutriaux C, Chiarion-Sileni V, Mackiewicz J, Rutkowski P, Arenberger P, Quereux G, Meniawy TM, Ascierto PA, Menzies AM, Durani P, Lobo M, Campigotto F, Gastman B, Long GV. Adjuvant nivolumab in resected stage IIB/C melanoma: primary results from the randomized, phase 3 CheckMate 76K trial. Nat Med. 2023 Nov;29(11):2835-2843. doi: 10.1038/s41591-023-02583-2. Epub 2023 Oct 16.

    PubMed 37845511

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nivolumab in people with Melanoma, run by Bristol-Myers Squibb at 130 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 130 sites in United States, Germany, Australia, France, Canada and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04099251, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.

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