Advanced Solid TumorsPhase 1/2RELATIVITY 059NCT05134948
A Study to Assess Relatlimab and Nivolumab Fixed-dose Combination in Chinese Participants With Advanced Solid Tumors
A Phase 1/2 study testing BMS-986213 in people with Advanced Solid Tumors, run by Bristol-Myers Squibb at 2 sites in China.
Trial summary
The purpose of this study is to assess the safety, drug levels, immunogenicity and preliminary efficacy of BMS-986213 (nivolumab-relatlimab fixed-dose combination) in Chinese participants with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- BMS-986213
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesChina
- Study dates
- 30 Nov 2021to 24 Oct 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of at least one lesion with measurable disease as defined by RECIST v1.1 criteria for response assessment
- Participants must have received, and then progressed, or been intolerant to at least one standard treatment regimen in the advanced or metastatic setting, if such a therapy exists
- ECOG status of 0 or 1
- Life expectancy of ≥ 12 weeks at the time of informed consent per Investigator assessment
Who cannot join
- Participants with history of severe and/or life-threatening toxicity related to prior immune therapy (eg, anti-CTLA-4 or anti-PD-1/PD-L1 treatment or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways)
- Participants with an active, known or suspected autoimmune disease
- Participants with primary CNS tumors
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
2 sites in 1 country.
China2 sites
Local Institution - 0001
Beijing, Beijing Municipality, 100142
Local Institution - 0002
Fuzhou, Fujian, 350014
About this study
Official title: A Phase 1/2 Study of Relatlimab (Anti-LAG-3 Monoclonal Antibody) and Nivolumab (Anti-PD-1 Monoclonal Antibody) Fixed-dose Combination in Chinese Participants With Advanced Solid Tumors (RELATIVITY 059)
The purpose of this study is to assess the safety, drug levels, immunogenicity and preliminary efficacy of BMS-986213 (nivolumab-relatlimab fixed-dose combination) in Chinese participants with advanced solid tumors.
- Conditions
- Advanced Solid Tumors
- Being tested
- BMS-986213
- Keywords
- BMS-986213
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986213Drug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: BMS-986213 Fixed Dose Combination | Experimental | Not described Receives: Drug: BMS-986213 |
| Cohort B: BMS-986213 Fixed Dose Combination | Experimental | Not described Receives: Drug: BMS-986213 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events (AEs)
Measured: Approximately 3 years
Number of Participants with Immune-mediated Adverse Events (IMAEs)
Measured: Approximately 3 years
Number of Participants with Serious Adverse Events (SAEs)
Measured: Approximately 3 years
Number of Deaths
Measured: Approximately 3 years
Number of Participants with AEs Leading to Discontinuation
Measured: Approximately 3 years
Number of Participants with Laboratory Abnormalities
Measured: Approximately 3 years
Maximum Observed Plasma Concentration (Cmax) of Relatlimab
Measured: Approximately 3 years
Time of Maximum Observed Plasma Concentration (Tmax) of Relatlimab
Measured: Approximately 3 years
Trough Observed Plasma Concentration (Ctrough) of Relatlimab
Measured: Approximately 3 years
Concentration of Relatlimab at the end of a dosing interval (Ctau)
Measured: Approximately 3 years
Average concentration of Relatlimab over a dosing interval (Cavg(TAU))
Measured: Approximately 3 years
Area under the concentration-time curve in one dosing interval (AUC(TAU)) of Relatlimab
Measured: Approximately 3 years
Total Body Clearance (CLT) of Relatlimab
Measured: Approximately 3 years
Observed Concentration of Relatlimab at End of Infusion (Ceoi)
Measured: Approximately 3 years
Secondary outcomes (8)
Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator
Measured: Approximately 3 years
Disease Control Rate (DCR) by RECIST v1.1 by Investigator
Measured: Approximately 3 years
Duration of Response (DOR) by RECIST v1.1 by Investigator
Measured: Approximately 3 years
Best Overall Response (BOR) by RECIST v1.1 by Investigator
Measured: Approximately 3 years
Ctrough of Nivolumab
Measured: Approximately 3 years
Ceoi of Nivolumab
Measured: Approximately 3 years
Number of Anti-drug Antibodies (ADAs) to Relatlimab
Measured: Approximately 3 years
Number of ADAs to Nivolumab
Measured: Approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start30 Nov 2021
- Primary completion1 Sep 2025
- Study completion24 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT05134948
- Sponsor's protocol ID
- CA224-059
- Acronym
- RELATIVITY 059
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2021
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study of Relatlimab (Anti-LAG-3 Monoclonal Antibody) and Nivolumab (Anti-PD-1 Monoclonal Antibody) Fixed-dose Combination in Chinese Participants With Advanced Solid Tumors (RELATIVITY 059)
- ClinicalTrials.gov ID
- NCT05134948
- Acronym / sponsor ID
- RELATIVITY 059 / CA224-059
- Conditions
- Advanced Solid Tumors
- Keywords
- BMS-986213
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 24 Oct 2025 (actual)
- First posted
- 26 Nov 2021 (actual)
- Results
- Not posted in the source record
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 the safety, drug levels, immunogenicity and preliminary efficacy of BMS-986213 (nivolumab-relatlimab fixed-dose combination) in Chinese participants with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A: BMS-986213 Fixed Dose Combination | Experimental | Drug: BMS-986213 |
| Cohort B: BMS-986213 Fixed Dose Combination | Experimental | Drug: BMS-986213 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Presence of at least one lesion with measurable disease as defined by RECIST v1.1 criteria for response assessment
- Participants must have received, and then progressed, or been intolerant to at least one standard treatment regimen in the advanced or metastatic setting, if such a therapy exists
- ECOG status of 0 or 1
- Life expectancy of ≥ 12 weeks at the time of informed consent per Investigator assessment
Key exclusion criteria (4 listed)
- Participants with history of severe and/or life-threatening toxicity related to prior immune therapy (eg, anti-CTLA-4 or anti-PD-1/PD-L1 treatment or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways)
- Participants with an active, known or suspected autoimmune disease
- Participants with primary CNS tumors
- 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 |
|---|---|---|
| BMS-986213Specified dose on specified days | Drug | Cohort A: BMS-986213 Fixed Dose Combination, Cohort B: BMS-986213 Fixed Dose Combination |
Primary outcome
Number of Participants with Adverse Events (AEs)
Time frame: Approximately 3 years
Number of Participants with Immune-mediated Adverse Events (IMAEs)
Time frame: Approximately 3 years
Number of Participants with Serious Adverse Events (SAEs)
Time frame: Approximately 3 years
Number of Deaths
Time frame: Approximately 3 years
Number of Participants with AEs Leading to Discontinuation
Time frame: Approximately 3 years
Number of Participants with Laboratory Abnormalities
Time frame: Approximately 3 years
Maximum Observed Plasma Concentration (Cmax) of Relatlimab
Time frame: Approximately 3 years
Time of Maximum Observed Plasma Concentration (Tmax) of Relatlimab
Time frame: Approximately 3 years
Trough Observed Plasma Concentration (Ctrough) of Relatlimab
Time frame: Approximately 3 years
Concentration of Relatlimab at the end of a dosing interval (Ctau)
Time frame: Approximately 3 years
Average concentration of Relatlimab over a dosing interval (Cavg(TAU))
Time frame: Approximately 3 years
Area under the concentration-time curve in one dosing interval (AUC(TAU)) of Relatlimab
Time frame: Approximately 3 years
Total Body Clearance (CLT) of Relatlimab
Time frame: Approximately 3 years
Observed Concentration of Relatlimab at End of Infusion (Ceoi)
Time frame: Approximately 3 years
8 secondary outcomes
Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator
Time frame: Approximately 3 years
Disease Control Rate (DCR) by RECIST v1.1 by Investigator
Time frame: Approximately 3 years
Duration of Response (DOR) by RECIST v1.1 by Investigator
Time frame: Approximately 3 years
Best Overall Response (BOR) by RECIST v1.1 by Investigator
Time frame: Approximately 3 years
Ctrough of Nivolumab
Time frame: Approximately 3 years
Ceoi of Nivolumab
Time frame: Approximately 3 years
Number of Anti-drug Antibodies (ADAs) to Relatlimab
Time frame: Approximately 3 years
Number of ADAs to Nivolumab
Time frame: Approximately 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
Related trials for Advanced Solid Tumors
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Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
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RecruitingPhase 1/2
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Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BMS-986213 in people with Advanced Solid Tumors, run by Bristol-Myers Squibb at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 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: finished, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Participants with Adverse Events (AEs) (time frame: Approximately 3 years). The study lists 14 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 3 Dec 2025.