MelanomaPhase 3RELATIVITY-098NCT05002569
A Study to Assess Adjuvant Immunotherapy With Nivolumab Plus Relatlimab Versus Nivolumab Alone After Complete Resection of Stage III-IV Melanoma
A Phase 3 study testing Nivolumab and Nivolumab + Relatlimab Fixed Dose Combination in people with Melanoma, run by Bristol-Myers Squibb at 184 sites in 25 countries.
Trial summary
The purpose of this study is to assess nivolumab plus relatlimab fixed-dose combination (FDC) versus nivolumab alone in participants with completely resected stage III-IV melanoma. 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 and Nivolumab + Relatlimab Fixed Dose Combination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,093 participants
- Where
- 184 sitesin 25 countries
- Study dates
- 19 Oct 2021to 2 Apr 2025
- 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
- Must have been diagnosed with either Stage IIIA (> 1 mm tumor in lymph node)/B/C/D or Stage IV melanoma by American Joint Committee on Cancer (AJCC) v8 and have histologically confirmed melanoma that is completely surgically resected (free of disease) with negative margins in order to be eligible
- Participants ≥ 18 years of age must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1. Adolescent participants between 12 and < 18 years of age must have a Lansky/Karnofsky performance score ≥ 80%
- Complete resection must be performed within 90 days prior to randomization
- All participants must have disease-free status documented by a complete physical examination within 14 days prior to randomization and imaging studies within 35 days prior to randomization
- Tumor tissue must be provided for biomarker analyses
Who cannot join
- History of ocular melanoma
- Untreated/unresected CNS metastases or leptomeningeal metastases
- Active, known, or suspected autoimmune disease
- Participants with serious or uncontrolled medical disorder
- Prior immunotherapy treatment for any prior malignancy: No prior immunotherapies are permitted
- Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 4 weeks prior to screening
- History of myocarditis, regardless of etiology.
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
184 sites in 25 countries.
184 sites in 25 countries
United States43 sites
Local Institution - 0267
Allentown, Pennsylvania, 18103
Local Institution - 0258
Ann Arbor, Michigan, 48109
Local Institution - 0191
Atlanta, Georgia, 30322
Local Institution - 0148
Atlanta, Georgia, 30342
Local Institution - 0138
Aurora, Colorado, 80045
Local Institution - 0146
Austin, Texas, 78731
Local Institution - 0176
Birmingham, Alabama, 35249
Dana-Farber Cancer Institute-Melanoma
Boston, Massachusetts, 02215
Local Institution - 0171
Charleston, South Carolina, 29425
Local Institution - 0130
Charlotte, North Carolina, 28204
Local Institution - 0202
Chicago, Illinois, 60611
MetroHealth Medical Center
Cleveland, Ohio, 44109
Local Institution - 0141
Cleveland, Ohio, 44195
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C
Columbus, Ohio, 43210
Local Institution - 0163
Dallas, Texas, 75246
Local Institution - 0145
Durham, North Carolina, 27710
Local Institution - 0137
Fairfax, Virginia, 22031
Local Institution - 0223
Fort Wayne, Indiana, 46804
Local Institution - 0147
Germantown, Tennessee, 38138
Local Institution
Grand Rapids, Michigan, 49503
Local Institution - 0139
Hackensack, New Jersey, 07601
Local Institution - 0172
Houston, Texas, 77030
University of Iowa-Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
Local Institution - 0200
Los Angeles, California, 90025
Local Institution - 0243
Miami, Florida, 33136
Washington University School Of Medicine
Miami, Florida, 33136
Local Institution - 0133
Minneapolis, Minnesota, 55407
Local Institution - 0206
Morristown, New Jersey, 07960
Local Institution - 0183
Nashville, Tennessee, 37232
Local Institution - 0140
New York, New York, 10016
Icahn School Of Medicine At Mount Sinai
New York, New York, 10029
Local Institution - 0210
New York, New York, 10065
Local Institution - 0185
Palo Alto, California, 94304
Local Institution - 0179
Pensacola, Florida, 32504
Local Institution - 0177
Peoria, Illinois, 61615
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Local Institution - 0125
Pittsburgh, Pennsylvania, 15232
Local Institution - 0162
San Francisco, California, 94115
Saint John's Cancer Institute
Santa Monica, California, 90404
Local Institution - 0164
Springdale, Arkansas, 72762
Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center
Tampa, Florida, 33612
Local Institution - 0166
Washington D.C., District of Columbia, 20007
Local Institution - 0178
Westwood, Kansas, 66205
China23 sites
Local Institution - 0259
Beijing, Beijing Municipality, 100034
Local Institution - 0261
Beijing, Beijing Municipality, 100035
Local Institution - 0214
Beijing, Beijing Municipality, 100142
Local Institution - 0219
Changchun, Jilin, 130021
Local Institution - 0234
Changsha Shi, Hunan, 410013
Local Institution - 0230
Chengdu, Sichuan, 610041
Local Institution - 0241
Chongqing, Chongqing Municipality, 400030
Local Institution - 0245
Fuzhou, Fujian, 350014
Local Institution - 0217
Guangzhou, Guangdong, 510060
Local Institution - 0220
Hangzhou, Zhejiang, 310016
Local Institution - 0216
Hangzhou, Zhejiang, 310022
Local Institution - 0221
Hefei, Anhui, 230022
Local Institution - 0222
Kunming, Yunnan, 650106
Local Institution - 0224
Nanchang, Jiangxi, 330006
Local Institution - 0215
Nanjing, Jiangsu, 210000
Local Institution - 0225
Nanjing, Jiangsu, 210029
Local Institution - 0242
Shenyang, Liaoning, 110001
Local Institution - 0244
Taiyuan, 030032
Local Institution - 0263
Tianjin, Tianjin Municipality, 300060
Local Institution - 0228
Ürümqi, Xinjiang, 830000
Local Institution - 0237
Wuhan, Hubei, 430022
Local Institution - 0239
Wuhan, Hubei, 430030
Local Institution - 0226
Zhengzhou, Henan, 450001
Australia12 sites
Local Institution - 0035
Ballarat, Victoria, 3350
Local Institution - 0028
Brisbane, Queensland, 4102
Local Institution - 0253
Heidelberg, Victoria, 3084
Local Institution - 0031
Melbourne, Victoria, 3000
Local Institution - 0251
Murdoch, Western Australia, 6150
Local Institution - 0029
Perth, Western Australia, 6009
Local Institution - 0027
Southport, Queensland, 4215
Local Institution - 0254
Tiwi, Northern Territory, 0810
Local Institution - 0030
Waratah, New South Wales, 2298
Local Institution - 0252
Westmead, New South Wales, 2145
Local Institution - 0032
Wollstonecraft, New South Wales, 2065
Local Institution - 0250
Woodville, South Australia, 5011
Germany12 sites
Local Institution - 0073
Buxtehude, 21614
Local Institution - 0077
Dresden, 01307
Local Institution - 0074
Erlangen, 91054
Local Institution - 0131
Essen, 45147
Local Institution - 0081
Gera, 07548
Local Institution - 0079
Hanover, Lower Saxony, 30625
Local Institution - 0075
Heidelberg, D-69120
Local Institution - 0078
Lübeck, 23538
Local Institution - 0083
Minden, 32429
Local Institution - 0076
Munich, 80337
Local Institution - 0092
Tübingen, Baden-Wurttemberg, 72076
Local Institution - 0080
Würzburg, 97080
Brazil10 sites
Local Institution - 0070
Barretos, São Paulo, 14784400
Local Institution - 0047
Belo Horizonte, Minas Gerais, 30130-090
Local Institution - 0072
Fortaleza, Ceará, 60135237
Local Institution - 0056
Ijuí, Rio Grande do Sul, 98700-000
Local Institution - 0257
Porto Alegre, Rio Grande do Sul, 90035-903
Local Institution - 0049
Porto Alegre, Rio Grande do Sul, 91350-200
Local Institution - 0058
Rio de Janeiro, 20220-410
Local Institution - 0071
Salvador, Estado de Bahia, 40170-070
Local Institution - 0048
Santa Cruz do Sul, Rio Grande do Sul, 96830-180
Local Institution - 0068
Vitória, Espírito Santo, 29055450
Canada7 sites
Local Institution - 0155
Edmonton, Alberta, T6X 1E8
Local Institution - 0197
Halifax, Nova Scotia, B3H 2Y9
Local Institution - 0159
Montreal, Quebec, H2X 1P1
Local Institution - 0158
Montreal, Quebec, H3T 1E2
Local Institution - 0160
Québec, Quebec, G1J 1Z4
Local Institution - 0198
Sherbrooke, Quebec, J1H 5N4
Local Institution - 0175
Vancouver, British Columbia, V5Z 4E6
France7 sites
Local Institution - 0043
Dijon, 21000
Local Institution - 0044
Marseille, 13385
Local Institution - 0039
Nantes, 44093
Local Institution - 0042
Paris, 75010
Local Institution - 0041
Pierre-Bénite, 69310
Local Institution - 0046
Toulouse, 31100
Local Institution - 0040
Villejuif, Val-de-Marne, 94800
Italy7 sites
Local Institution - 0115
Milan, 20133
Local Institution - 0268
Milan, 20133
Local Institution - 0123
Milan, 20141
Local Institution - 0119
Naples, 80131
Local Institution - 0120
Padova, 35128
Local Institution - 0122
Perugia, 06132
Local Institution - 0121
Siena, 53100
Spain6 sites
Local Institution - 0188
Badajoz, 06071
Local Institution - 0201
Barcelona, 08035
Local Institution - 0151
Donostia / San Sebastian, 20014
Local Institution - 0153
Granada, 18012
Local Institution - 0150
Madrid, 28009
Local Institution - 0152
Valencia, 46026
United Kingdom6 sites
Local Institution - 0102
Bristol, BS2 8ED
Local Institution - 0187
Glasgow, G12 0YN
Local Institution - 0154
Newcastle upon Tyne, NE7 7DN
Local Institution - 0101
Nottingham, Nottinghamshire, NG5 1PB
Local Institution - 0232
Oxford, OX3 7LE
Local Institution - 0127
Southampton, SO16 0YD
Argentina5 sites
Local Institution - 0005
Buenos Aires, Distrito Federal, 1426
Local Institution - 0001
CABA, Distrito Federal, C1430
Local Institution - 0003
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ABP
Local Institution - 0002
Ciudad de Buenos Aires, Distrito Federal, C1121ABE
Local Institution - 0004
Córdoba, X5002HWE
Belgium4 sites
Local Institution - 0110
Brussels, 1090
Local Institution - 0105
Brussels, 1200
Local Institution - 0109
Liège, 4000
Local Institution - 0106
Wilrijk, 2610
Czechia4 sites
Local Institution - 0156
Brno, 65653
Local Institution - 0091
Hradec Králové, 50005
Local Institution - 0026
Ostrava, 708 52
Local Institution - 0062
Prague, 12808
Denmark4 sites
Local Institution - 0022
Aalborg, 9100
Local Institution - 0016
Aarhus, Central Jutland, 8200
Local Institution - 0018
Copenhagen, 2730
Local Institution - 0020
Odense, 5000
Israel4 sites
Local Institution - 0116
Afula, 1834111
Local Institution - 0118
Jerusalem, Jerusalem, 9112001
Local Institution - 0199
Petah Tikva, Central District, 4941492
Local Institution - 0117
Ramat Gan, 5262100
Mexico4 sites
Local Institution - 0100
Benito Juárez, Mexico City, 03240
Local Institution - 0093
México, Nuevo León, 64320
Local Institution - 0098
Oaxaca City, 68020
Local Institution - 0021
Zapopan, Jalisco, 45070
Romania4 sites
Local Institution - 0170
Brasov, 500283
Local Institution - 0065
Cluj-Napoca, 400015
Local Institution - 0066
Craiova, 200542
Local Institution - 0064
Floresti/ Cluj, 407280
Austria3 sites
Local Institution - 0082
Graz, Styria, 8036
Local Institution - 0086
Salzburg, 5020
Local Institution - 0084
Vienna, 1090
Chile3 sites
Local Institution - 0013
Santiago, Santiago Metropolitan, 7510032
Local Institution - 0006
Santiago, Santiago Metropolitan, 8420383
Local Institution - 0014
Santiago, Santiago Metropolitan
Finland3 sites
Helsinki University Hospital Adult ICU PPDS
Helsinki, 00290
Local Institution - 0019
Tampere, 33520
Local Institution - 0015
Turku, 20521
Greece3 sites
Local Institution - 0114
Athens, 11527
Local Institution - 0113
Neo Faliro, 185 47
Local Institution - 0112
Thessaloniki, 540 07
Norway3 sites
Local Institution - 0009
Lørenskog, Akershus, 1478
Local Institution - 0017
Oslo, 0310
Local Institution - 0023
Stavanger, Rogaland, 4011
Sweden3 sites
Local Institution - 0010
Gothenburg, 41345
Local Institution - 0011
Lund, 221 85
Local Institution - 0012
Solna, 171 64
Switzerland3 sites
Local Institution - 0085
Basel, 4031
Local Institution - 0087
Chur, 7000
Local Institution - 0090
Zurich, 8091
About this study
Official title: A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy With Nivolumab + Relatlimab Fixed-dose Combination Versus Nivolumab Monotherapy After Complete Resection of Stage III-IV Melanoma
The purpose of this study is to assess nivolumab plus relatlimab fixed-dose combination (FDC) versus nivolumab alone in participants with completely resected stage III-IV melanoma.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabBiological
Also called Opdivo, BMS-936558
Specified dose on specified days
Nivolumab + Relatlimab Fixed Dose CombinationBiological
Also called BMS-986213, Opdualag
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Nivolumab Plus Relatlimab | Experimental | Combination Receives: Biological: Nivolumab + Relatlimab Fixed Dose Combination |
| Arm B: Nivolumab | Experimental | Monotherapy Receives: Biological: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence Free Survival (RFS)
RFS is defined as the time between the date of randomization and the first date of documented recurrence (local, regional, distant, new primary melanoma) or death due to any cause, whichever occurs first.
Measured: Approximately 27.5 Months
Secondary outcomes (8)
Overall Survival (OS)
OS is defined as the time between the date of randomization and the date of death due to any cause.
Measured: Approximately 27.5 Months
Distant Metastasis Free Survival (DMFS)
DMFS is defined as the time between the date of randomization and the date of first distant metastasis or date of death due to any cause, whichever occurs first.
Measured: Approximately 27.5 Months
Progression Free Survival on Next-Line Systemic Therapy (PFS2)
PFS2 defined as time from randomization to second recurrence/objective disease progression on next-line systemic therapy per investigator, or death from any cause, whichever occurs first.
Measured: Approximately 27.5 Months
Number of Participants With Safety Related Events
Safety related events encompass the following measures: Adverse events (AEs), Serious AEs, AEs leading to discontinuation, Drug-Related AEs and Deaths.
An 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 that does not necessarily have a causal relationship with this treatment.
An SAE is an AE which:
- Results in death
- Is life threatening
- Requires hospitalization
- Results in persistent or significant disability/incapacity
- Is a congenital anomaly/birth defect
- Is an important medical event
Measured: Approximately 27.5 Months
Number of Participants With Select AEs
Select AEs will be reported as AEs per organ class.
Organ classes which will be reported:
- Gastrointestinal
- Hepatic
- Pulmonary
- Renal
- Skin
- Hypersensitivity/Infusion reaction
Measured: Approximately 27.5 Months
Number of Participants With Endocrine Related Immune Mediated AEs
Immune-mediated adverse events are AEs consistent with an immune-mediated mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include events with an alternate etiology which were exacerbated by the induction of autoimmunity.
Measured: Approximately 27.5 Months
Number of Participants With Non-endocrine Related Immune Mediated AEs
Immune-mediated adverse events are AEs consistent with an immune-mediated mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include events with an alternate etiology which were exacerbated by the induction of autoimmunity.
Measured: Approximately 27.5 Months
Laboratory Abnormalities for Specific Thyroid Tests
Number of participants with laboratory abnormalities in specific thyroid tests.
Measured: Approximately 27.5 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start19 Oct 2021
- Primary completion16 Dec 2024
- Study completion2 Apr 2025
Why it stopped: Inability to meet protocol objectives
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,093 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05002569
- Sponsor's protocol ID
- CA224-098
- Other IDs
- 2021-001641-13
- Acronym
- RELATIVITY-098
- Status last verified
- Dec 2025
- First submitted
- 4 Aug 2021
- Last updated
- 8 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Expanded access
- Available
Publications
Long GV, Garnett-Benson C, Dolfi S, Ascierto PA, Guo J, Tarhini AA, Chandra S, Munoz-Couselo E, Del Vecchio M, de Melo AC, Callahan M, Gogas H, Dummer R, Schadendorf D, Koelblinger P, Quereux G, Thomas I, Yu JX, Fisher A, Wang B, Djidel P, Chouzy A, Semaan M, Chen B, Cheong AMY, Tawbi HA. Plain language summary of the RELATIVITY-098 study results: nivolumab plus relatlimab given after melanoma is removed by surgery. Future Oncol. 2026 Sep 22:1-10. doi: 10.1080/14796694.2026.2721180. Online ahead of print.
PubMed 42770835Long GV, Garnett-Benson C, Dolfi S, Ascierto PA, Guo J, Tarhini AA, Chandra S, Munoz-Couselo E, Del Vecchio M, de Melo AC, Callahan M, Gogas H, Dummer R, Schadendorf D, Koelblinger P, Quereux G, Thomas I, Yu JX, Fisher A, Wang B, Djidel P, Chouzy A, Semaan M, Chen B, Cheong AMY, Tawbi HA. Adjuvant nivolumab and relatlimab in stage III/IV melanoma: the randomized phase 3 RELATIVITY-098 trial. Nat Med. 2025 Dec;31(12):4301-4309. doi: 10.1038/s41591-025-04032-8. Epub 2025 Oct 18.
PubMed 41109920
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy With Nivolumab + Relatlimab Fixed-dose Combination Versus Nivolumab Monotherapy After Complete Resection of Stage III-IV Melanoma
- ClinicalTrials.gov ID
- NCT05002569
- Acronym / sponsor ID
- RELATIVITY-098 / CA224-098
- Conditions
- Melanoma
- Keywords
- Melanoma, Relatlimab, Nivolumab, Opdivo
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to meet protocol objectives
- Enrolment
- 1,093 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 19 Oct 2021 (actual)
- Primary completion
- 16 Dec 2024 (actual)
- Study completion
- 2 Apr 2025 (actual)
- First posted
- 12 Aug 2021 (actual)
- Results
- Posted 8 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess nivolumab plus relatlimab fixed-dose combination (FDC) versus nivolumab alone in participants with completely resected stage III-IV melanoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Nivolumab Plus Relatlimab | Experimental | Biological: Nivolumab + Relatlimab Fixed Dose CombinationCombination |
| Arm B: Nivolumab | Experimental | Biological: NivolumabMonotherapy |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Must have been diagnosed with either Stage IIIA (> 1 mm tumor in lymph node)/B/C/D or Stage IV melanoma by American Joint Committee on Cancer (AJCC) v8 and have histologically confirmed melanoma that is completely surgically resected (free of disease) with negative margins in order to be eligible
- Participants ≥ 18 years of age must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1. Adolescent participants between 12 and < 18 years of age must have a Lansky/Karnofsky performance score ≥ 80%
- Complete resection must be performed within 90 days prior to randomization
- All participants must have disease-free status documented by a complete physical examination within 14 days prior to randomization and imaging studies within 35 days prior to randomization
- Tumor tissue must be provided for biomarker analyses
Key exclusion criteria (8 listed)
- History of ocular melanoma
- Untreated/unresected CNS metastases or leptomeningeal metastases
- Active, known, or suspected autoimmune disease
- Participants with serious or uncontrolled medical disorder
- Prior immunotherapy treatment for any prior malignancy: No prior immunotherapies are permitted
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivolumabAlso: Opdivo, BMS-936558Specified dose on specified days | Biological | Arm B: Nivolumab |
| Nivolumab + Relatlimab Fixed Dose CombinationAlso: BMS-986213, OpdualagSpecified dose on specified days | Biological | Arm A: Nivolumab Plus Relatlimab |
Primary outcome
Recurrence Free Survival (RFS)
Time frame: Approximately 27.5 Months
RFS is defined as the time between the date of randomization and the first date of documented recurrence (local, regional, distant, new primary melanoma) or death due to any cause, whichever occurs first.
8 secondary outcomes
Overall Survival (OS)
Time frame: Approximately 27.5 Months
Distant Metastasis Free Survival (DMFS)
Time frame: Approximately 27.5 Months
Progression Free Survival on Next-Line Systemic Therapy (PFS2)
Time frame: Approximately 27.5 Months
Number of Participants With Safety Related Events
Time frame: Approximately 27.5 Months
Number of Participants With Select AEs
Time frame: Approximately 27.5 Months
Number of Participants With Endocrine Related Immune Mediated AEs
Time frame: Approximately 27.5 Months
Number of Participants With Non-endocrine Related Immune Mediated AEs
Time frame: Approximately 27.5 Months
Laboratory Abnormalities for Specific Thyroid Tests
Time frame: Approximately 27.5 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42770835Long GV, Garnett-Benson C, Dolfi S, Ascierto PA, Guo J, Tarhini AA, Chandra S, Munoz-Couselo E, Del Vecchio M, de Melo AC, Callahan M, Gogas H, Dummer R, Schadendorf D, Koelblinger P, Quereux G, Thomas I, Yu JX, Fisher A, Wang B, Djidel P, Chouzy A, Semaan M, Chen B, Cheong AMY, Tawbi HA. Plain language summary of the RELATIVITY-098 study results: nivolumab plus relatlimab given after melanoma is removed by surgery. Future Oncol. 2026 Sep 22:1-10. doi: 10.1080/14796694.2026.2721180. Online ahead of print.
- Derived from this study: PubMed 41109920Long GV, Garnett-Benson C, Dolfi S, Ascierto PA, Guo J, Tarhini AA, Chandra S, Munoz-Couselo E, Del Vecchio M, de Melo AC, Callahan M, Gogas H, Dummer R, Schadendorf D, Koelblinger P, Quereux G, Thomas I, Yu JX, Fisher A, Wang B, Djidel P, Chouzy A, Semaan M, Chen B, Cheong AMY, Tawbi HA. Adjuvant nivolumab and relatlimab in stage III/IV melanoma: the randomized phase 3 RELATIVITY-098 trial. Nat Med. 2025 Dec;31(12):4301-4309. doi: 10.1038/s41591-025-04032-8. Epub 2025 Oct 18.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
Related trials for Melanoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
184 sites in 25 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nivolumab and Nivolumab + Relatlimab Fixed Dose Combination in people with Melanoma, run by Bristol-Myers Squibb at 184 sites in 25 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 5 inclusion and 8 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: stopped early, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 184 sites in United States, China, Australia, Germany, Brazil and 20 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. 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 8 Jan 2026). 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: Approximately 27.5 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 NCT05002569, 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 8 Jan 2026.