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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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

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

Other trials in United States

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

Other trials in China

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

Other trials in Australia

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

Other trials in Germany

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

Other trials in Brazil

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

Other trials in Canada

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

Other trials in France

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

Other trials in Italy

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

Other trials in Spain

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

Other trials in United Kingdom

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

Other trials in Argentina

Belgium4 sites
  • Local Institution - 0110

    Brussels, 1090

  • Local Institution - 0105

    Brussels, 1200

  • Local Institution - 0109

    Liège, 4000

  • Local Institution - 0106

    Wilrijk, 2610

Other trials in Belgium

Czechia4 sites
  • Local Institution - 0156

    Brno, 65653

  • Local Institution - 0091

    Hradec Králové, 50005

  • Local Institution - 0026

    Ostrava, 708 52

  • Local Institution - 0062

    Prague, 12808

Other trials in Czechia

Denmark4 sites
  • Local Institution - 0022

    Aalborg, 9100

  • Local Institution - 0016

    Aarhus, Central Jutland, 8200

  • Local Institution - 0018

    Copenhagen, 2730

  • Local Institution - 0020

    Odense, 5000

Other trials in Denmark

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

Other trials in Israel

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

Other trials in Mexico

Romania4 sites
  • Local Institution - 0170

    Brasov, 500283

  • Local Institution - 0065

    Cluj-Napoca, 400015

  • Local Institution - 0066

    Craiova, 200542

  • Local Institution - 0064

    Floresti/ Cluj, 407280

Other trials in Romania

Austria3 sites
  • Local Institution - 0082

    Graz, Styria, 8036

  • Local Institution - 0086

    Salzburg, 5020

  • Local Institution - 0084

    Vienna, 1090

Other trials in Austria

Chile3 sites
  • Local Institution - 0013

    Santiago, Santiago Metropolitan, 7510032

  • Local Institution - 0006

    Santiago, Santiago Metropolitan, 8420383

  • Local Institution - 0014

    Santiago, Santiago Metropolitan

Other trials in Chile

Finland3 sites
  • Helsinki University Hospital Adult ICU PPDS

    Helsinki, 00290

  • Local Institution - 0019

    Tampere, 33520

  • Local Institution - 0015

    Turku, 20521

Other trials in Finland

Greece3 sites
  • Local Institution - 0114

    Athens, 11527

  • Local Institution - 0113

    Neo Faliro, 185 47

  • Local Institution - 0112

    Thessaloniki, 540 07

Other trials in Greece

Norway3 sites
  • Local Institution - 0009

    Lørenskog, Akershus, 1478

  • Local Institution - 0017

    Oslo, 0310

  • Local Institution - 0023

    Stavanger, Rogaland, 4011

Other trials in Norway

Sweden3 sites
  • Local Institution - 0010

    Gothenburg, 41345

  • Local Institution - 0011

    Lund, 221 85

  • Local Institution - 0012

    Solna, 171 64

Other trials in Sweden

Switzerland3 sites
  • Local Institution - 0085

    Basel, 4031

  • Local Institution - 0087

    Chur, 7000

  • Local Institution - 0090

    Zurich, 8091

Other trials in Switzerland

Portugal1 site
  • Local Institution - 0249

    Coimbra, 3000-075

Other trials in Portugal

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.

Conditions
Melanoma
Being tested
Nivolumab, Nivolumab + Relatlimab Fixed Dose Combination
Keywords
Melanoma, Relatlimab, Nivolumab, Opdivo
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, BMS-936558

    Specified dose on specified days

  • Nivolumab + Relatlimab Fixed Dose CombinationBiological

    Also called BMS-986213, Opdualag

    Specified dose on specified days

Study groups in NCT05002569
Study groupRoleWhat they receive
Arm A: Nivolumab Plus RelatlimabExperimentalCombination
Receives: Biological: Nivolumab + Relatlimab Fixed Dose Combination
Arm B: NivolumabExperimentalMonotherapy
Receives: Biological: Nivolumab

What is being measured

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

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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.

  1. First posted12 Aug 2021
  2. Study start19 Oct 2021
  3. Primary completion16 Dec 2024
  4. Study completion2 Apr 2025

Why it stopped: Inability to meet protocol objectives

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,093 participants (actual)
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
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 42770835
  • 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. 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

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.

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