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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03459222
Other study ID # CA224-048
Secondary ID 2018-000058-22
Status Active, not recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date May 30, 2018
Est. completion date November 10, 2026

Study information

Verified date September 2023
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to demonstrate the safety and preliminary activity with triple combinations of relatlimab in combination with nivolumab and BMS-986205, or in combination with nivolumab and ipilimumab in immunotherapy-naive and pretreated populations across select advanced tumor types.


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Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Relatlimab
Specified dose on specified days
Nivolumab
Specified dose on specified days
Drug:
BMS-986205
Specified dose on specified days
Biological:
Ipilimumab
Specified dose on specified days

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Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  France,  Italy,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of clinical laboratory test abnormalities Approximately 4 years
Primary Number of Adverse Events (AEs) Approximately 4 years
Primary Number of Serious Adverse Events (SAEs) Approximately 4 years
Primary Number of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria Up to 6 weeks
Primary Number of AEs leading to discontinuation Approximately 4 years
Primary Number of AEs leading to death Approximately 4 years
Primary Objective Response Rate (ORR) Approximately 4 years
Primary Disease Control Rate (DCR) Approximately 4 years
Primary Median Duration of Response (mDOR) Approximately 4 years
Secondary Progression-Free Survival (PFS) Up to 4 years
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