NCT05134948

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2021

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 26, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

November 30, 2021

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2025

Completed
Last Updated

December 3, 2025

Status Verified

November 1, 2025

Enrollment Period

3.8 years

First QC Date

November 16, 2021

Last Update Submit

November 26, 2025

Conditions

Advanced Solid Tumors

Keywords

BMS-986213

Outcome Measures

Primary Outcomes (14)

  • Number of Participants with Adverse Events (AEs)

    Approximately 3 years

  • Number of Participants with Immune-mediated Adverse Events (IMAEs)

    Approximately 3 years

  • Number of Participants with Serious Adverse Events (SAEs)

    Approximately 3 years

  • Number of Deaths

    Approximately 3 years

  • Number of Participants with AEs Leading to Discontinuation

    Approximately 3 years

  • Number of Participants with Laboratory Abnormalities

    Approximately 3 years

  • Maximum Observed Plasma Concentration (Cmax) of Relatlimab

    Approximately 3 years

  • Time of Maximum Observed Plasma Concentration (Tmax) of Relatlimab

    Approximately 3 years

  • Trough Observed Plasma Concentration (Ctrough) of Relatlimab

    Approximately 3 years

  • Concentration of Relatlimab at the end of a dosing interval (Ctau)

    Approximately 3 years

  • Average concentration of Relatlimab over a dosing interval (Cavg(TAU))

    Approximately 3 years

  • Area under the concentration-time curve in one dosing interval (AUC(TAU)) of Relatlimab

    Approximately 3 years

  • Total Body Clearance (CLT) of Relatlimab

    Approximately 3 years

  • Observed Concentration of Relatlimab at End of Infusion (Ceoi)

    Approximately 3 years

Secondary Outcomes (8)

  • Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator

    Approximately 3 years

  • Disease Control Rate (DCR) by RECIST v1.1 by Investigator

    Approximately 3 years

  • Duration of Response (DOR) by RECIST v1.1 by Investigator

    Approximately 3 years

  • Best Overall Response (BOR) by RECIST v1.1 by Investigator

    Approximately 3 years

  • Ctrough of Nivolumab

    Approximately 3 years

  • +3 more secondary outcomes

Study Arms (2)

Cohort A: BMS-986213 Fixed Dose Combination

EXPERIMENTAL
Drug: BMS-986213

Cohort B: BMS-986213 Fixed Dose Combination

EXPERIMENTAL
Drug: BMS-986213

Interventions

BMS-986213DRUG

Specified dose on specified days

Cohort A: BMS-986213 Fixed Dose CombinationCohort B: BMS-986213 Fixed Dose Combination

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Local Institution - 0001

Beijing, Beijing Municipality, 100142, China

Location

Local Institution - 0002

Fuzhou, Fujian, 350014, China

Location

Related Links

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2021

First Posted

November 26, 2021

Study Start

November 30, 2021

Primary Completion

September 1, 2025

Study Completion

October 24, 2025

Last Updated

December 3, 2025

Record last verified: 2025-11

Locations

CN(2)