MelanomaPhase 3RELATIVITY-127NCT05625399
A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma
A Phase 3 study testing Nivolumab + Relatlimab and rHuPH20 in people with Melanoma, run by Bristol-Myers Squibb at 149 sites in 19 countries.
Trial summary
The purpose of this study is to demonstrate that the study drug exposure level of the nivolumab + relatlimab FDC subcutaneous (SC) formulation is not worse than nivolumab + relatlimab FDC intravenous (IV) administration in participants with previously untreated metastatic or unresectable 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 + Relatlimab and rHuPH20
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 579 participants
- Where
- 149 sitesin 19 countries
- Study dates
- 6 Mar 2023to 18 Nov 2027
- 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
- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1/Lansky Performance Score ≥ 80% for adolescents (≥ 12 to < 18 years of age).
- Participants must have histologically confirmed Stage III (unresectable) or Stage IV (metastatic) melanoma, per the American Joint Committee for Cancer (AJCC) staging system.
- Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
- Participants must be ≥ 12 years of age. Participants who are ≥ 12 years of age and < 18 years of age (adolescents) must weigh ≥ 40 kg at the time of signing the informed consent (assent).
- Participants must have histologically confirmed Stage III (unresectable) or Stage IV (metastatic) melanoma, per the AJCC staging system (8th edition).
Who cannot join
- Participants must not have ocular melanoma.
- Participants must not have a history of myocarditis, regardless of etiology.
- Participants must not have a condition requiring systemic treatment with either corticosteroids (>10 milligrams [mg] daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses >10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
149 sites in 19 countries.
149 sites in 19 countries
Germany19 sites
Local Institution - 0060
Berlin, 10117
Local Institution - 0038
Buxtehude, 21614
Local Institution - 0136
Dortmund, 44137
Local Institution - 0039
Erfurt, 99089
Local Institution - 0049
Essen, 45147
Local Institution - 0166
Frankfurt am Main, 60590
Local Institution - 0065
Giessen, 35385
Local Institution - 0135
Göttingen, 37075
Local Institution - 0138
Hamburg, 20251
Local Institution - 0101
Heidelberg, Baden-Wurttemberg, 69120
Local Institution - 0003
Lübeck, Schleswig-Holstein, 23538
Local Institution - 0137
Ludwigshafen, 67063
Local Institution - 0165
Marburg, 35043
Local Institution - 0044
Minden, 32429
Local Institution - 0112
Nuremberg, 90419
Local Institution - 0011
Regensburg, Bavaria, 93042
Local Institution - 0053
Rostock, 18057
Local Institution - 0081
Tübingen, 72076
Local Institution - 0079
Ulm, Baden-Wurttemberg, 89081
United States15 sites
Local Institution - 0146
Baltimore, Maryland, 21201
Local Institution - 0169
Cleveland, Ohio, 44195
Local Institution - 0139
Easton, Pennsylvania, 18045
Local Institution - 0113
Englewood, Colorado, 80113
Local Institution - 0115
Fairfax, Virginia, 22031
Local Institution - 0114
Jacksonville, Florida, 32224
Local Institution - 0098
Los Angeles, California, 90025
Local Institution - 0122
Murray, Utah, 84107
Local Institution - 0013
Omaha, Nebraska, 68130
Local Institution - 0093
Orange, California, 92868-3201
Local Institution - 0124
Philadelphia, Pennsylvania, 19107
Local Institution - 0125
Phoenix, Arizona, 85013
Local Institution - 0071
Rochester, Minnesota, 55905
Local Institution - 0189
Springdale, Arkansas, 72762
Local Institution - 0123
Stanford, California, 94305
Australia15 sites
Local Institution - 0008
Bendigo, Victoria, 3550
Local Institution - 0090
Birtinya, Queensland, 4575
Local Institution - 0059
Box Hill, Victoria, 3128
Local Institution - 0050
Coffs Harbour, New South Wales, 2450
Local Institution - 0154
Heidelberg, Victoria, 3084
Local Institution - 0030
Melbourne, Victoria, 3004
Local Institution - 0106
Nedlands, Western Australia, 6009
Local Institution - 0161
Nedlands, Western Australia, 6009
Local Institution - 0175
Orange, New South Wales, 2800
Local Institution - 0172
Port Macquarie, New South Wales, 2444
Local Institution - 0109
Traralgon, Victoria, 3844
Local Institution - 0118
Wagga Wagga, New South Wales, 2650
Local Institution - 0184
Waratah, New South Wales, 2298
Local Institution - 0033
Westmead, New South Wales, 2145
Local Institution - 0055
Wollstonecraft, New South Wales, 2065
France15 sites
Local Institution - 0007
Amiens, 80054
Local Institution - 0128
Bayonne, 64100
Local Institution - 0022
Bordeaux, 33000
Local Institution - 0127
Chambray-lès-Tours, Indre-Et-Loire, 37044
Local Institution - 0129
Clermont-Ferrand, 63003
Local Institution - 0046
Dijon, 21079
Local Institution - 0111
Lille, Nord, 59000
Local Institution - 0117
Marseille, 13385
Local Institution - 0063
Nantes, OH, 44093
Local Institution - 0034
Paris, Île-de-France Region, 75475
Local Institution - 0052
Pierre-Bénite, 69310
Local Institution - 0089
Rennes, 35042
Local Institution - 0099
Rouen, 76031
Local Institution - 0108
Toulouse, Cedex 9, 31059
Local Institution - 0061
Villejuif, Val-De-Marne, 94805
Spain15 sites
Local Institution - 0086
A Coruña, A Coruna, 15006
Local Institution - 0134
Badalona, 08916
Local Institution - 0047
Barcelona, Barcelona, 08035
Local Institution - 0024
Barcelona, 08036
Local Institution - 0012
Donostia / San Sebastian, Gipuzkoa, 20014
Local Institution - 0153
Jaén, Jaen, 23007
Local Institution - 0045
Las Palmas de Gran Canaria, 35016
Local Institution - 0126
Madrid, Madrid, 28009
Local Institution - 0004
Madrid, Madrid, 28041
Local Institution - 0040
Madrid, 28007
Local Institution - 0056
Madrid, 28050
Local Institution - 0006
Seville, 41009
Local Institution - 0041
Valencia, Valencia, 46009
Local Institution - 0043
Valencia, 46009
Local Institution - 0151
Valencia, 46014
Brazil12 sites
Local Institution - 0009
Barretos, São Paulo, 14784-400
Local Institution - 0107
Belo Horizonte, Minas Gerais, 30130-090
Local Institution - 0159
Blumenau, Santa Catarina, 89010-340
Local Institution - 0177
Fortaleza, Ceará, 60135237
Local Institution - 0025
Ijuí, Rio Grande do Sul, 98700-000
Local Institution - 0031
Porto Alegre, Rio Grande do Sul, 90035-903
Local Institution - 0058
Porto Alegre, Rio Grande do Sul, 90610-000
Local Institution - 0002
Porto Alegrelegre, Rio Grande do Sul, 91350-250
Local Institution - 0110
Rio de Janeiro, Rio de Janeiro, 20220-410
Local Institution - 0018
São José do Rio Preto, São Paulo, 15090-000
Local Institution - 0130
São Paulo, São Paulo, 01321-001
Local Institution - 0180
Vitória, Espírito Santo, 29043-260
Chile9 sites
Local Institution - 0178
Port Montt, Los Lagos Region, 5507642
Local Institution - 0140
Recoleta, Santiago Metropolitan, 8380455
Local Institution - 0119
Santiago, Providencia, 7500653
Local Institution - 0144
Santiago, Santiago Metropolitan, 0101010
Local Institution - 0010
Santiago, Santiago Metropolitan, 7510032
Local Institution - 0074
Santiago, Santiago Metropolitan, 8150513
Local Institution - 0017
Santiago, 7500921
Local Institution - 0143
Temuco, Araucania, 4800827
Local Institution - 0028
Viña del Mar, Valparaiso, 2520598
Italy7 sites
Local Institution - 0051
Bari, 70124
Local Institution - 0077
Genova, Genova, 16132
Local Institution - 0170
Milan, 20133
Local Institution - 0084
Naples, 80131
Local Institution - 0032
Perugia, 06132
Local Institution - 0064
Roma, 00168
Local Institution - 0014
Siena, Siena, 53100
Canada5 sites
Local Institution - 0141
Calgary, Alberta, T2N 5G2
Local Institution - 0121
Hamilton, Ontario, L8V 5C2
Local Institution - 0096
Ottawa, Ontario, K1H 8L6
Local Institution - 0103
Québec, Quebec, G1J 1Z4
Local Institution - 0116
Toronto, Ontario, M4N 3M5
Czechia5 sites
Local Institution - 0094
Hradec Králové, 500 05
Local Institution - 0091
Olomouc, 77900
Local Institution - 0082
Ostrava Poruba, 708 52
Local Institution - 0083
Prague, NY, 128 00
Local Institution - 0095
Prague, 182 00
Israel5 sites
Local Institution - 0026
Afula, 1834111
Local Institution - 0054
Jerusalem, Israel, 9112001
Local Institution - 0102
Petah-Tikvah, 4941492
Local Institution - 0173
Tel Aviv, 6423906
Local Institution - 0035
Tel HaShomer, 5262100
Poland5 sites
Local Institution - 0171
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796
Local Institution - 0021
Krakow, Lesser Poland Voivodeship, 30727
Local Institution - 0005
Opole, Opole Voivodeship, 45-061
Local Institution - 0015
Poznan, Wiekopolskie, 60-780
Local Institution - 0066
Warsaw, 02-781
Austria4 sites
Local Institution - 0027
Graz, 8036
Local Institution - 0029
Salzburg, 5020
Local Institution - 0168
Sankt Pölten, 3100
Local Institution - 0037
Vienna, 1090
Norway4 sites
Local Institution - 0163
Bodø, 8005
Local Institution - 0156
Grålum, 1714
Local Institution - 0158
Lørenskog, 1474
Local Institution - 0155
Oslo, 0379
Belgium3 sites
Local Institution - 0072
Brussels, 1200
Local Institution - 0078
Charleroi, 6000
Local Institution - 0016
Liège, 4000
Finland3 sites
Local Institution - 0164
Helsinki, 00029
Local Institution - 0167
Tampere, 33521
Local Institution - 0162
Turku, 20520
Switzerland3 sites
Local Institution - 0092
Bern, 3010
Local Institution - 0080
Chur, 7000
Local Institution - 0105
Lausanne, 1011
United Kingdom3 sites
Local Institution - 0068
Headington, Oxford, Oxfordshire, OX3 7LE
Local Institution - 0088
London, Greater London, SW3 6JJ
Local Institution - 0120
Newcastle upon Tyne, Tyne and Wear, NE7 7DN
Sweden2 sites
Local Institution - 0097
Lund, 222 42
Local Institution - 0062
Solna, Stockholm County, 171 64
About this study
Official title: A Phase 3, Randomized, Open-label, Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination Versus Intravenous Nivolumab + Relatlimab Fixed-dose Combination in Participants With Previously Untreated Metastatic or Unresectable Melanoma
The purpose of this study is to demonstrate that the study drug exposure level of the nivolumab + relatlimab FDC subcutaneous (SC) formulation is not worse than nivolumab + relatlimab FDC intravenous (IV) administration in participants with previously untreated metastatic or unresectable melanoma.
- Conditions
- Melanoma
- Being tested
- Nivolumab + Relatlimab, rHuPH20
- Keywords
- Nivolumab, Relatlimab, FDC, Melanoma, rHuPH20, OPDUALAG
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nivolumab + RelatlimabDrug
Also called BMS-986213, Opdualag
Specified dose on specified days
rHuPH20Drug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Nivolumab + Relatlimab FDC SC | Experimental | Not described Receives: Drug: Nivolumab + Relatlimab; Drug: rHuPH20 |
| Nivolumab + Relatlimab FDC IV | Active comparator | Not described Receives: Drug: Nivolumab + Relatlimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adjusted Time-Averaged Nivolumab Serum Concentration Over the First 28 Days (Cavgd28-Nivo) on Natural Logarithmic Scale
Blood samples were collected to assess serum concentration.
Measured: Pre-dose (Day 1 to Day 28)
Adjusted Time-Averaged Relatlimab Serum Concentration Over the First 28 Days (Cavgd28-Rela) on Natural Logarithmic Scale
Blood samples were collected to assess serum concentration.
Measured: Pre-dose (Day 1 to Day 28)
Adjusted Trough Nivolumab Serum Concentration at Steady-State (Cminss-Nivo) on Natural Logarithmic Scale
Blood samples were collected to assess serum concentration.
Measured: Pre-dose (Day 1 to Day 28)
Adjusted Trough Relatlimab Serum Concentration at Steady-State (Cminss-Rela) on Natural Logarithmic Scale
Blood samples were collected to assess serum concentration.
Measured: Pre-dose (Day 1 to Day 28)
Secondary outcomes (20)
Objective Response Rate (ORR) by BICR
Objective response rate (ORR) is defined as the percentage of participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on blinded independent central review (BICR) assessments using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), divided by the number of all randomized participants. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)
Disease Control Rate (ORR) Per BICR
Disease control rate (DCR) is defined as the percentage of participants who achieve a BOR of confirmed Complete Response (CR), confirmed Partial Response (PR), or stable disease (SD), based on BICR assessments (using RECIST 1.1) divided by the number of all randomized participants. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of target lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.
Measured: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)
Time to Response (TTR) Per BICR
Time to response (TTR) assessed by BICR is defined as the time between the date of randomization and the first confirmed documented response (CR or PR) per RECIST 1.1 criteria.
CR: Disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)
Duration of Response (DoR) Per BICR
Duration of Response (DOR) in months is defined as the time from date of the first documentation of objective response (CR or PR) to the first documentation of PD or to death due to any cause in the absence of documented PD. CR is complete disappearance of all target lesions except nodal disease; all target nodes must decrease to normal size (short axis < 10 mm). PR is ≥30% decrease under baseline of the sum of diameters of all target measurable lesions. Disease progression is defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm.
Measured: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)
Progression Free Survival Per BICR
Progression free survival (PFS) is defined as time from on treatment to disease progression or death (whichever comes first). At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Measured: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)
Objective Response Rate (ORR) Per Investigator
Objective response rate (ORR) is defined as the percentage of participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on Investigator assessments using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), divided by the number of all randomized participants. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)
Disease Control Rate (ORR) Per Investigator
Disease control rate (DCR) is defined as the percentage of participants who achieve a BOR of confirmed Complete Response (CR), confirmed Partial Response (PR), or stable disease (SD), based on Investigator assessments (using RECIST 1.1) divided by the number of all randomized participants. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of target lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.
Measured: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)
Time to Response (TTR) Per Investigator
Time to response (TTR) assessed by Investigator is defined as the time between the date of randomization and the first confirmed documented response (CR or PR) per RECIST 1.1 criteria.
CR: Disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)
Duration of Response (DoR) Per Investigator
Duration of Response (DOR) in months is defined as the time from date of the first documentation of objective response (CR or PR) to the first documentation of PD or to death due to any cause in the absence of documented PD. CR is complete disappearance of all target lesions except nodal disease; all target nodes must decrease to normal size (short axis < 10 mm). PR is ≥30% decrease under baseline of the sum of diameters of all target measurable lesions. Disease progression is defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm.
Measured: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)
Progression Free Survival Per Investigator
Progression free survival (PFS) is defined as time from on treatment to disease progression or death (whichever comes first). At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Measured: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)
Overall Survival (OS)
Overall survival is defined as the time from the first dosing date (or from randomization/on treatment) to the date of death from any cause. Median computed using Kaplan-Meier method.
Measured: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)
Trough Serum Concentration of Nivolumab and Relatlimab (Cmind28) at Day 28
Blood samples were collected to assess serum concentration.
Measured: Pre-dose at Day 28
Peak Serum Concentration (Cmax1) After the First Dose of Nivolumab and Relatlimab
Blood samples were collected to assess serum concentration.
Measured: Post-dose Day 1
Maximum Observed Concentration at Steady State (Cmaxss) Nivolumab and Relatlimab
Blood samples were collected to assess serum concentration.
Measured: Post-dose Day 1
Average Observed Concentration at Steady State (Cavgss) of Nivolumab and Relatlimab
Blood samples were collected to assess serum concentration.
Measured: Post-dose Day 1
Number of Participants With Adverse Events, SAEs, AEs Leading to Discontinuation and Deaths
AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any untoward medical occurrence at any dose that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life functions, results in a congenital abnormality or birth defect, or is an important medical event that may not result in death, be life-threatening, or require hospitalization, but may require medical or surgical intervention to prevent any of the outcomes listed above.
Measured: First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 26 months)
Number of Participants With Immune-mediate Adverse Events (IMAEs)
AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment.
Measured: First dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months)
Number of Participants With Other Event of Special Interest (OESI)
AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment.
Measured: First dose (Day 1) and 100 days after last dose of study therapy (up to approximately 28 months)
Number of Participants With On-Treatment Worst CTCAE Grade 3-4 Laboratory Parameters
AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment.
Measured: First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 26 months)
Change From Baseline Functional Assessment of Cancer Therapy -Melanoma (FACT-M) Total Score
The FACT-M questionnaire was used to assess the effects of disease symptoms on functioning and well-being. As a generic cancer-related core, the FACT-M includes the 27-item FACT General (FACT-G) to assess physical well-being (PWB; 7 items), social/family well-being (SWB; 7 items), emotional well-being (EWB; 6 items), and functional well-being (FWB; 7 items). In addition, the FACT-M includes a 16-item disease-specific Melanoma Subscale (MS). Each FACT-M item is rated on a 5-point scale ranging from 0 (not at all) to 4 (very much). Scores for the PWB, FWB, SWB, and EWB subscales can be combined to produce a FACT-G total score, which provides an overall indicant of generic quality of life, while the FACT-G and MS scores can be combined to produce a total score for the FACT-M, which provides a composite measure of general and targeted quality of life. Overall scale ranges from 0 to 172, higher values indicate better functioning as well as lower symptom burden.
Measured: Baseline (Day 1) and Week 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2022
- Study start6 Mar 2023
- Primary completion4 Aug 2025
- Study completion18 Nov 2027 (estimated)
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.
- 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
- None (open label)
- Enrolment
- 579 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Halozyme Therapeutics
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05625399
- Sponsor's protocol ID
- CA224-127
- Other IDs
- U1111-1274-0193, 2022-500967-11-00
- Acronym
- RELATIVITY-127
- Status last verified
- Aug 2026
- First submitted
- 15 Nov 2022
- Last updated
- 26 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Open-label, Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination Versus Intravenous Nivolumab + Relatlimab Fixed-dose Combination in Participants With Previously Untreated Metastatic or Unresectable Melanoma
- ClinicalTrials.gov ID
- NCT05625399
- Acronym / sponsor ID
- RELATIVITY-127 / CA224-127
- Conditions
- Melanoma
- Keywords
- Nivolumab, Relatlimab, FDC, Melanoma, rHuPH20, OPDUALAG
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 579 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Halozyme Therapeutics
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 4 Aug 2025 (actual)
- Study completion
- 18 Nov 2027 (estimated)
- First posted
- 22 Nov 2022 (actual)
- Results
- Posted 26 Aug 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 demonstrate that the study drug exposure level of the nivolumab + relatlimab FDC subcutaneous (SC) formulation is not worse than nivolumab + relatlimab FDC intravenous (IV) administration in participants with previously untreated metastatic or unresectable melanoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nivolumab + Relatlimab FDC SC | Experimental | Drug: Nivolumab + Relatlimab, Drug: rHuPH20 |
| Nivolumab + Relatlimab FDC IV | Active comparator | Drug: Nivolumab + Relatlimab |
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)
- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1/Lansky Performance Score ≥ 80% for adolescents (≥ 12 to < 18 years of age).
- Participants must have histologically confirmed Stage III (unresectable) or Stage IV (metastatic) melanoma, per the American Joint Committee for Cancer (AJCC) staging system.
- Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
- Participants must be ≥ 12 years of age. Participants who are ≥ 12 years of age and < 18 years of age (adolescents) must weigh ≥ 40 kg at the time of signing the informed consent (assent).
- Participants must have histologically confirmed Stage III (unresectable) or Stage IV (metastatic) melanoma, per the AJCC staging system (8th edition).
Key exclusion criteria (4 listed)
- Participants must not have ocular melanoma.
- Participants must not have a history of myocarditis, regardless of etiology.
- Participants must not have a condition requiring systemic treatment with either corticosteroids (>10 milligrams [mg] daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses >10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
- Other protocol-defined Inclusion/Exclusion criteria apply.
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 |
|---|---|---|
| Nivolumab + RelatlimabAlso: BMS-986213, OpdualagSpecified dose on specified days | Drug | Nivolumab + Relatlimab FDC IV, Nivolumab + Relatlimab FDC SC |
| rHuPH20Specified dose on specified days | Drug | Nivolumab + Relatlimab FDC SC |
Primary outcome
Adjusted Time-Averaged Nivolumab Serum Concentration Over the First 28 Days (Cavgd28-Nivo) on Natural Logarithmic Scale
Time frame: Pre-dose (Day 1 to Day 28)
Blood samples were collected to assess serum concentration.
Adjusted Time-Averaged Relatlimab Serum Concentration Over the First 28 Days (Cavgd28-Rela) on Natural Logarithmic Scale
Time frame: Pre-dose (Day 1 to Day 28)
Blood samples were collected to assess serum concentration.
Adjusted Trough Nivolumab Serum Concentration at Steady-State (Cminss-Nivo) on Natural Logarithmic Scale
Time frame: Pre-dose (Day 1 to Day 28)
Blood samples were collected to assess serum concentration.
Adjusted Trough Relatlimab Serum Concentration at Steady-State (Cminss-Rela) on Natural Logarithmic Scale
Time frame: Pre-dose (Day 1 to Day 28)
Blood samples were collected to assess serum concentration.
20 secondary outcomes
Objective Response Rate (ORR) by BICR
Time frame: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)
Disease Control Rate (ORR) Per BICR
Time frame: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)
Time to Response (TTR) Per BICR
Time frame: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)
Duration of Response (DoR) Per BICR
Time frame: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)
Progression Free Survival Per BICR
Time frame: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)
Objective Response Rate (ORR) Per Investigator
Time frame: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)
Disease Control Rate (ORR) Per Investigator
Time frame: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)
Time to Response (TTR) Per Investigator
Time frame: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)
Duration of Response (DoR) Per Investigator
Time frame: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)
Progression Free Survival Per Investigator
Time frame: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)
Overall Survival (OS)
Time frame: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)
Trough Serum Concentration of Nivolumab and Relatlimab (Cmind28) at Day 28
Time frame: Pre-dose at Day 28
Peak Serum Concentration (Cmax1) After the First Dose of Nivolumab and Relatlimab
Time frame: Post-dose Day 1
Maximum Observed Concentration at Steady State (Cmaxss) Nivolumab and Relatlimab
Time frame: Post-dose Day 1
Average Observed Concentration at Steady State (Cavgss) of Nivolumab and Relatlimab
Time frame: Post-dose Day 1
Number of Participants With Adverse Events, SAEs, AEs Leading to Discontinuation and Deaths
Time frame: First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 26 months)
Number of Participants With Immune-mediate Adverse Events (IMAEs)
Time frame: First dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months)
Number of Participants With Other Event of Special Interest (OESI)
Time frame: First dose (Day 1) and 100 days after last dose of study therapy (up to approximately 28 months)
Number of Participants With On-Treatment Worst CTCAE Grade 3-4 Laboratory Parameters
Time frame: First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 26 months)
Change From Baseline Functional Assessment of Cancer Therapy -Melanoma (FACT-M) Total Score
Time frame: Baseline (Day 1) and Week 85
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: 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
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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
149 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nivolumab + Relatlimab and rHuPH20 in people with Melanoma, run by Bristol-Myers Squibb at 149 sites in 19 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 4 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 26 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 149 sites in Germany, United States, Australia, France, Spain and 14 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 26 Aug 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?
Adjusted Time-Averaged Nivolumab Serum Concentration Over the First 28 Days (Cavgd28-Nivo) on Natural Logarithmic Scale (time frame: Pre-dose (Day 1 to Day 28)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2026.