A Phase 1/2 Study of Relatlimab (anti-LAG-3 Monoclonal Antibody) Administered in Combination with Both Nivolumab (anti-PD-1 Monoclonal Antibody) and BMS-986205 (IDO1 inhibitor) or in Combination with Both Nivolumab and Ipilimumab (anti-CTLA-4 Monoclonal Antibody) in Advanced Malignant Tumors

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508207-21-00

Acronym

CA224-048

Enrollment

130

Registered

2024-03-19

Start date

2019-02-08

Completion date

2025-02-14

Last updated

2025-02-04

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

Conditions

Advanced Malignant Tumors

Brief summary

Number of clinical laboratory test abnormalities, Number of Adverse Events (AEs), Number of Serious Adverse Events (SAEs), Number of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria, Number of AEs leading to discontinuation and deaths, Objective Response Rate (ORR), Disease Control Rate (DCR), Median Duration of Response (mDOR)

Detailed description

Progression Free Survival (PFS)

Interventions

DRUGlinrodostat mesylate; IDO1 inhibitor

DRUGIpilimumab

DRUGRelatlimab intravenous

DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Number of clinical laboratory test abnormalities, Number of Adverse Events (AEs), Number of Serious Adverse Events (SAEs), Number of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria, Number of AEs leading to discontinuation and deaths, Objective Response Rate (ORR), Disease Control Rate (DCR), Median Duration of Response (mDOR)	—

Secondary

Measure	Time frame
Progression Free Survival (PFS)	—

Countries

France, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026