Advanced Solid TumorsPhase 1RELATIVITY-111NCT05498480
Study of Relatlimab in Combination With Nivolumab in Chinese Participants
A Phase 1 study testing Relatlimab and Nivolumab in people with Advanced Solid Tumors, run by Bristol-Myers Squibb at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and drug levels of relatlimab combined with nivolumab 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?
- Relatlimab and Nivolumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 27 Jul 2022to 18 Jan 2024
- Phase
- Phase 1
- 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
- Participants must have histologic or cytological confirmation of an incurable solid malignancy that is advanced (metastatic and/or unresectable) except for participants with primary central nervous system (CNS) tumors.
- Participants must have received, and then progressed or been intolerant to at least 1 standard treatment regimen in the advanced or metastatic setting (immune check inhibitor-experienced or non-experienced population may be included), if such a therapy exists. Participants who refuse or are ineligible for standard therapy will be allowed to enroll provided their refusal/ineligibility is documented in medical records.
- Eastern Cooperative Oncology Group (ECOG) 0 to 1.
Who cannot join
- Participants with history of severe and/or life-threatening toxicity related to prior immune therapy (eg, anti-cytotoxic T-lymphocyte-associated protein 4 [anti-CTLA-4] or anti-programmed cell death protein 1 [anti-PD-1]/programmed death-ligand 1 [PD-L1] treatment or any other antibody or drug specifically targeting T cell co-stimulation or immune checkpoint pathways) except those that are unlikely to re-occur with standard countermeasures (eg, hormone replacement after endocrinopathy).
- Participants with an active, known, or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- Prior treatment with LAG-3 targeted agents.
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 201315
About this study
Official title: A Phase 1 Study of Relatlimab (Anti-LAG-3 Monoclonal Antibody) in Combination With Nivolumab (Anti-PD-1 Monoclonal Antibody) in Chinese Participants With Advanced Solid Tumors
The purpose of this study is to evaluate the safety and drug levels of relatlimab combined with nivolumab in Chinese participants with advanced solid tumors.
- Conditions
- Advanced Solid Tumors
- Being tested
- Relatlimab, Nivolumab
- Keywords
- Advanced Solid Tumors, Relatlimab, Nivolumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RelatlimabBiological
Also called BMS-986016
Specified dose on specified days
NivolumabBiological
Also called BMS-936558, Opdivo
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Relatlimab Dose 1 + Nivolumab | Experimental | Not described Receives: Biological: Relatlimab; Biological: Nivolumab |
| Cohort 2: Relatlimab Dose 2 + Nivolumab | Experimental | Not described Receives: Biological: Relatlimab; Biological: Nivolumab |
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: Up to 123 Weeks
Number of Participants with Immune-mediated Adverse Events (IMAEs)
Measured: Up to 123 Weeks
Number of Participants with Serious Adverse Events (SAEs)
Measured: Up to 123 Weeks
Number of Deaths
Measured: Up to 123 Weeks
Number of Participants with AEs Leading to Discontinuation
Measured: Up to 123 Weeks
Number of Participants with Dose-Limiting Toxicities (DLTs)
Measured: Up to 123 Weeks
Number of Participants with Clinical Laboratory Abnormalities
Measured: Up to 123 Weeks
Maximum Observed Plasma Concentration (Cmax) of Relatlimab
Measured: Up to 123 Weeks
Time of Maximum Observed Plasma Concentration (Tmax) of Relatlimab
Measured: Up to 123 Weeks
Trough-observed serum concentration (Ctrough) of Relatlimab
Measured: Up to 123 Weeks
Secondary outcomes (8)
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator
Measured: Up to 123 Weeks
Disease Control Rate (DCR) per RECIST v1.1 by Investigator
Measured: Up to 123 Weeks
Duration of Response (DOR) per RECIST v1.1 by Investigator
Measured: Up to 123 Weeks
Best Overall Response (BOR) per RECIST v1.1 by Investigator
Measured: Up to 123 Weeks
Ctrough of Nivolumab
Measured: Up to 123 Weeks
Observed Serum Concentration at End of Infusion (Ceoi) of Nivolumab
Measured: Up to 123 Weeks
Percentage of Participants Positive for Anti-drug Antibodies (ADAs) to Relatlimab
Measured: Up to 123 Weeks
Percentage of Participants Positive for ADAs to Nivolumab
Measured: Up to 123 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start27 Jul 2022
- Primary completion18 Jan 2024
- Study completion18 Jan 2024
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 6 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
- NCT05498480
- Sponsor's protocol ID
- CA224-111
- Acronym
- RELATIVITY-111
- Status last verified
- Feb 2024
- First submitted
- 10 Aug 2022
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of Relatlimab (Anti-LAG-3 Monoclonal Antibody) in Combination With Nivolumab (Anti-PD-1 Monoclonal Antibody) in Chinese Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05498480
- Acronym / sponsor ID
- RELATIVITY-111 / CA224-111
- Conditions
- Advanced Solid Tumors
- Keywords
- Advanced Solid Tumors, Relatlimab, Nivolumab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 27 Jul 2022 (actual)
- Primary completion
- 18 Jan 2024 (actual)
- Study completion
- 18 Jan 2024 (actual)
- First posted
- 12 Aug 2022 (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 evaluate the safety and drug levels of relatlimab combined with nivolumab 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 1: Relatlimab Dose 1 + Nivolumab | Experimental | Biological: Relatlimab, Biological: Nivolumab |
| Cohort 2: Relatlimab Dose 2 + Nivolumab | Experimental | Biological: Relatlimab, Biological: Nivolumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants must have histologic or cytological confirmation of an incurable solid malignancy that is advanced (metastatic and/or unresectable) except for participants with primary central nervous system (CNS) tumors.
- Participants must have received, and then progressed or been intolerant to at least 1 standard treatment regimen in the advanced or metastatic setting (immune check inhibitor-experienced or non-experienced population may be included), if such a therapy exists. Participants who refuse or are ineligible for standard therapy will be allowed to enroll provided their refusal/ineligibility is documented in medical records.
- Eastern Cooperative Oncology Group (ECOG) 0 to 1.
Key exclusion criteria (4 listed)
- Participants with history of severe and/or life-threatening toxicity related to prior immune therapy (eg, anti-cytotoxic T-lymphocyte-associated protein 4 [anti-CTLA-4] or anti-programmed cell death protein 1 [anti-PD-1]/programmed death-ligand 1 [PD-L1] treatment or any other antibody or drug specifically targeting T cell co-stimulation or immune checkpoint pathways) except those that are unlikely to re-occur with standard countermeasures (eg, hormone replacement after endocrinopathy).
- Participants with an active, known, or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- Prior treatment with LAG-3 targeted agents.
- 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 |
|---|---|---|
| RelatlimabAlso: BMS-986016Specified dose on specified days | Biological | Cohort 1: Relatlimab Dose 1 + Nivolumab, Cohort 2: Relatlimab Dose 2 + Nivolumab |
| NivolumabAlso: BMS-936558, OpdivoSpecified dose on specified days | Biological | Cohort 1: Relatlimab Dose 1 + Nivolumab, Cohort 2: Relatlimab Dose 2 + Nivolumab |
Primary outcome
Number of Participants with Adverse Events (AEs)
Time frame: Up to 123 Weeks
Number of Participants with Immune-mediated Adverse Events (IMAEs)
Time frame: Up to 123 Weeks
Number of Participants with Serious Adverse Events (SAEs)
Time frame: Up to 123 Weeks
Number of Deaths
Time frame: Up to 123 Weeks
Number of Participants with AEs Leading to Discontinuation
Time frame: Up to 123 Weeks
Number of Participants with Dose-Limiting Toxicities (DLTs)
Time frame: Up to 123 Weeks
Number of Participants with Clinical Laboratory Abnormalities
Time frame: Up to 123 Weeks
Maximum Observed Plasma Concentration (Cmax) of Relatlimab
Time frame: Up to 123 Weeks
Time of Maximum Observed Plasma Concentration (Tmax) of Relatlimab
Time frame: Up to 123 Weeks
Trough-observed serum concentration (Ctrough) of Relatlimab
Time frame: Up to 123 Weeks
8 secondary outcomes
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator
Time frame: Up to 123 Weeks
Disease Control Rate (DCR) per RECIST v1.1 by Investigator
Time frame: Up to 123 Weeks
Duration of Response (DOR) per RECIST v1.1 by Investigator
Time frame: Up to 123 Weeks
Best Overall Response (BOR) per RECIST v1.1 by Investigator
Time frame: Up to 123 Weeks
Ctrough of Nivolumab
Time frame: Up to 123 Weeks
Observed Serum Concentration at End of Infusion (Ceoi) of Nivolumab
Time frame: Up to 123 Weeks
Percentage of Participants Positive for Anti-drug Antibodies (ADAs) to Relatlimab
Time frame: Up to 123 Weeks
Percentage of Participants Positive for ADAs to Nivolumab
Time frame: Up to 123 Weeks
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 20 Feb 2024.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: No. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
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Active, not recruitingPhase 2
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Relatlimab and Nivolumab in people with Advanced Solid Tumors, run by Bristol-Myers Squibb at 1 site 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 3 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 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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.
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: Up to 123 Weeks). The study lists 10 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 20 Feb 2024.