An Investigational Immuno-therapy Study to Assess the Safety, Tolerability and Effectiveness of Anti-LAG-3 With and Without Anti-PD-1 in the Treatment of Solid Tumors

A Phase I/2a Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination With Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) in Advanced Solid Tumors

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223834

Enrollment

1000

Registered

2018-03-06

Start date

2018-03-07

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms by Site

Interventions

investigational material(s) Generic name etc : Relatlimab (BMS-986016) INN of investigational material : - Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investig

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: For Dose escalation: subjects with cervical, ovarian, bladder and colorectal cancer (CRC), head and neck, gastric and hepatocellular cancer naive to immuno-oncology agents; 1st line melanoma and 1st line/2nd line NSCLC; Renal Cell Carcinoma naive to IO; NSCLC progressing while on or after therapy with anti-PD1/anti-PDL-1 and melanoma subjects progressed while-on or after treatment with anti-PD1 or anti-PDL1 with or without anti-CTLA-4. For Dose Expansion: all of the above in escalation except for cervical, ovarian, and CRC Progressed, or been intolerant to, at least one standard treatment regimen, except for subjects in 1st line cohorts. ECOG performance status of 0 or 1 At least 1 lesion with measurable disease at baseline Availability of an existing tumor biopsy sample (and consent to allow pre-treatment tumor biopsy)

Exclusion criteria

Exclusion criteria: Primary central nervous system (CNS) tumors or solid tumors with CNS metastases as the only site of active disease Autoimmune disease Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent Uncontrolled CNS metastases

Design outcomes

Primary

Measure	Time frame
safety Proportion of subjects with Adverse Events (AEs) Grade 3 or higher per CTCAE v4 Proportion of subjects with Serious Adverse Events (SAEs) Grade 3 or higher per CTCAE v4 Proportion of Deaths Proportion of subjects with laboratory abnormalities Objective response rate (ORR) Disease control rate (DCR) Duration of response (DOR) Proportion of participants with AEs meeting acute safety criteria	—

Secondary

Measure	Time frame
safety efficacy pharmacokinetics Maximum observed serum concentration (Cmax) of BMS-986016 administered both alone and in combination with nivolumab Time of maximum observed serum concentration (Tmax) of BMS-986016 administered both alone and in combination with nivolumab Trough observed serum concentration (Ctrough) of BMS-986016 administered both alone and in combination with nivolumab Concentration at the end of a dosing interval (Ctau) [Eg: concentration at 336 hours] of BMS-986016 administered both alone and in combination with nivolumab Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-986016 administered both alone and in combination with nivolumab Total body clearance (CLT) of BMS-986016 administered both alone and in combination with nivolumab Volume of distribution at steady state (Vss) of BMS-986016 administered both alone and in combination with nivolumab Effective elimination half-life that explains the degree of area under the concentration-time curve (AUC) accumulation observed (T-HALFeff AUC) of BMS-986016 administered both alone and in combination with nivolumab Effective elimination half-life that explains the degree of Cmax accumulation observed (T-HALFeff Cmax) of BMS-986016 administered both alone and in combination with nivolumab Accumulation index; ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose (AI_AUC) of BMS-986016 administered both alone and in combination with nivolumab Cmax accumulation index; ratio of Cmax at steady state to Cmax after the first dose (AI_Cmax) of BMS-986016 administered both alone and in combination with nivolumab Ctau accumulation index; ratio of Ctau at steady state to Ctau after the first dose (AI_Ctau) of BMS-986016 administered both alone and in combination with nivolumab Degree of fluctuation (DF) or fluctuation index ([Cmax - Ctau]/Css,avg]) of BMS-986016 administered both alone and in combination with nivolumab Immunogenicity measured by anti-drug antibody (	—

Measure

Time frame

safety efficacy pharmacokinetics Maximum observed serum concentration (Cmax) of BMS-986016 administered both alone and in combination with nivolumab Time of maximum observed serum concentration (Tmax) of BMS-986016 administered both alone and in combination with nivolumab Trough observed serum concentration (Ctrough) of BMS-986016 administered both alone and in combination with nivolumab Concentration at the end of a dosing interval (Ctau) [Eg: concentration at 336 hours] of BMS-986016 administered both alone and in combination with nivolumab Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-986016 administered both alone and in combination with nivolumab Total body clearance (CLT) of BMS-986016 administered both alone and in combination with nivolumab Volume of distribution at steady state (Vss) of BMS-986016 administered both alone and in combination with nivolumab Effective elimination half-life that explains the degree of area under the concentration-time curve (AUC) accumulation observed (T-HALFeff AUC) of BMS-986016 administered both alone and in combination with nivolumab Effective elimination half-life that explains the degree of Cmax accumulation observed (T-HALFeff Cmax) of BMS-986016 administered both alone and in combination with nivolumab Accumulation index; ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose (AI_AUC) of BMS-986016 administered both alone and in combination with nivolumab Cmax accumulation index; ratio of Cmax at steady state to Cmax after the first dose (AI_Cmax) of BMS-986016 administered both alone and in combination with nivolumab Ctau accumulation index; ratio of Ctau at steady state to Ctau after the first dose (AI_Ctau) of BMS-986016 administered both alone and in combination with nivolumab Degree of fluctuation (DF) or fluctuation index ([Cmax - Ctau]/Css,avg]) of BMS-986016 administered both alone and in combination with nivolumab Immunogenicity measured by anti-drug antibody (

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Countries

Asia except Japan, Europe, Japan, North America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026