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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
229
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Local Institution - 0006
Duarte, California, United States
Local Institution - 0003
Aurora, Colorado, United States
Number of Participants With Grade 3/Grade 4 Laboratory Test Results
Laboratory test results are graded using the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0. Grade 3 = Severe or medically significant but not immediately life-threatening. Grade 4 = Life-threatening or disabling.
Time frame: From first dose (Day 1) and within 30 days of last dose of study therapy (up to approximately 69 months)
Number of Participants With Adverse Events and Deaths
Adverse events are any unfavorable or unintended signs, symptoms, or diseases occurring in study participants during a clinical trial, regardless of whether they are related to the intervention. They include all-cause mortality, serious adverse events, and other events exceeding a set frequency threshold. Serious adverse events are a subset that result in significant outcomes such as death, life-threatening conditions, hospitalization or its prolongation, persistent or significant disability/incapacity, or other medically important conditions.
Time frame: From first dose (Day 1) and within 30 days of last dose of study therapy (up to approximately 69 months)
Number of Participants With Dose Limiting Toxicities
Dose-Limiting Toxicities (DLTs) are treatment-related adverse events occurring during the first cycle (typically Days 1-28) that meet predefined severity criteria per NCI CTCAE v4.03. Hematologic DLTs include Grade 4 neutropenia \>5 days, Grade 3 neutropenia with fever, Grade 4 thrombocytopenia or Grade 3 with bleeding, and Grade 4 anemia. Non-hematologic DLTs include any toxicity ≥Grade 3 (except alopecia or controlled nausea) or treatment interruption ≥2 weeks due to adverse events.
Time frame: From first dose (Day 1) and up to 42 days post first dose
Objective Response Rate (ORR)
Objective Response Rate (ORR) is the percentage of participants whose best overall response is Complete Response (CR) or Partial Response (PR) per RECIST v1.1. CR is the disappearance of all target lesions and reduction of pathological lymph nodes to \<10 mm. PR is at least a 30% decrease in the sum of diameters of target lesions from baseline. ORR is calculated as: (Number of participants with CR or PR ÷ Total participants) × 100. Confidence intervals are typically estimated using the Clopper-Pearson method.
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Specified dose on specified days
Local Institution - 0004
Baltimore, Maryland, United States
Local Institution - 0005
St Louis, Missouri, United States
Local Institution - 0001
Germantown, Tennessee, United States
Local Institution - 0012
Wollstonecraft, New South Wales, Australia
Local Institution - 0011
Nedlands, Western Australia, Australia
Local Institution - 0017
Marseille, France
Local Institution - 0016
Toulouse, France
Local Institution - 0015
Villejuif, France
...and 12 more locations
Time frame: From the date of first dose (Day 1) to up to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (up to 80 months)
Disease Control Rate (DCR)
Disease Control Rate (DCR) is the percentage of participants whose Best Overall Response (BOR) is Complete Response (CR), Partial Response (PR), or Stable Disease (SD) per RECIST v1.1. CR is the disappearance of all target lesions and reduction of any pathological lymph nodes to \<10 mm. PR is at least a 30% decrease in the sum of diameters of target lesions from baseline. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease, taking as reference the smallest sum diameters while on study. DCR is calculated as: (Number of participants with CR, PR, or SD ÷ Total participants) × 100.
Time frame: From the date of first dose (Day 1) to up to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (up to 80 months)
Duration of Response (DoR)
Duration of Response (mDOR) is the median time from the first documented occurrence of Complete Response (CR) or Partial Response (PR) until disease progression or death, assessed per RECIST v1.1. CR is the disappearance of all target lesions and reduction of pathological lymph nodes to \<10 mm. PR is at least a 30% decrease in the sum of diameters of target lesions from baseline. Progression is defined as at least a 20% increase in the sum of diameters of target lesions or appearance of new lesions.
Time frame: From the date of first dose (Day 1) to up to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (up to 80 months)
Progression Free Survival (PFS)
Progression-Free Survival (PFS) is the time from randomization or treatment start until the first documented disease progression or death from any cause, whichever occurs first, assessed per RECIST v1.1. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions (minimum 5 mm absolute increase) or appearance of new lesions. Participants without progression or death are censored at the date of last adequate tumor assessment. PFS is typically analyzed using Kaplan-Meier estimates and reported in months.
Time frame: From the date of first dose (Day 1) to up to the date of the first documented disease progression or death (up to approximately 80 months)
Progression Free Survival Rate at 6 and 12 Months
Progression-Free Survival Rate (PFSR) is the percentage of participants who remain alive without disease progression, assessed per RECIST v1.1. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions (minimum 5 mm absolute increase) or appearance of new lesions. Participants without progression or death by the time point are considered event-free
Time frame: Month 6 and 12