Ignite Creation Date:
2024-05-06 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05704647
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2023-01-19
Brief Title:
Phase II Study of Nivolumab in Combination With Relatlimab in Patients With Active Melanoma Brain Metastases
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Study of Nivolumab in Combination With Relatlimab in Patients With Active Melanoma Brain Metastases
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To learn if giving nivolumab in combination with relatlimab can help to control melanoma that has spread to the brain melanoma with brain metastases The safety and side effects of the study drug combination will also be studied
Detailed Description:
Primary Objectives
To assess the intracranial objective response rate iORR defined as intracranial CR PR per modified RECIST 11 criteria of nivolumab relatlimab nivorela in subjects with MBM and treatment naïve to anti-PD-1 agents in the metastatic setting
Secondary Objectives
To determine the safety of the combination of nivorela
To assess the clinical benefit rate CBR defined as CR PR SD 6 months of the combination
To determine overall response rates intracranial extracranial DoR PFS and using a modified version of iRANO and compared to modified RECIST v11 and Response Assessment in Neuro-oncology - Brain Metastases RANO-BM for patients treated with nivorela
To determine the 1-year intracranial progression-free survival rate for the combination of nivorela
To determine overall survival
Advanced MRI imaging to assess for edema tumor response and predictors of response and radiation necrosis
To evaluate the brain-specific safety and tolerability of the combination regimen in subjects with or without SRT received prior to study entry or on study
To evaluate changes in neurocognitive function and health-related quality of life
To assess available tumor tissue - intracranial andor extra cranial - in specimens obtained at baseline archival andor fresh tissue on treatment and at time of progression
To assess immune cell subsets by flow cytometry TCR NGS for diversity and clonality cytokine expression cfDNA from peripheral blood
Exploratory Endpoints
Radiotherapy-assisted PFS defined as time from study treatment initiation to the first occurrence of disease progression or death from any cause whichever occurs first as determined by the investigator according to RECIST v11 modified by excluding 5 lesions that can be treated by SRT from the sum of largest diameters from baseline onwards
To explore the association between baseline and on-treatment gut microbiome features with response and toxicity
To understand the association between habitual diet and gut microbiome features in this study population
To explore predictors of biological response through the change in metabolic parameters
To assess the intracranial objective response rate iORR defined as intracranial CR PR per modified RECIST 11 criteria of nivolumab relatlimab nivorela in subjects with MBM and treatment naïve to anti-PD-1 agents in the metastatic setting
Secondary Objectives
To determine the safety of the combination of nivorela
To assess the clinical benefit rate CBR defined as CR PR SD 6 months of the combination
To determine overall response rates intracranial extracranial DoR PFS and using a modified version of iRANO and compared to modified RECIST v11 and Response Assessment in Neuro-oncology - Brain Metastases RANO-BM for patients treated with nivorela
To determine the 1-year intracranial progression-free survival rate for the combination of nivorela
To determine overall survival
Advanced MRI imaging to assess for edema tumor response and predictors of response and radiation necrosis
To evaluate the brain-specific safety and tolerability of the combination regimen in subjects with or without SRT received prior to study entry or on study
To evaluate changes in neurocognitive function and health-related quality of life
To assess available tumor tissue - intracranial andor extra cranial - in specimens obtained at baseline archival andor fresh tissue on treatment and at time of progression
To assess immune cell subsets by flow cytometry TCR NGS for diversity and clonality cytokine expression cfDNA from peripheral blood
Exploratory Endpoints
Radiotherapy-assisted PFS defined as time from study treatment initiation to the first occurrence of disease progression or death from any cause whichever occurs first as determined by the investigator according to RECIST v11 modified by excluding 5 lesions that can be treated by SRT from the sum of largest diameters from baseline onwards
To explore the association between baseline and on-treatment gut microbiome features with response and toxicity
To understand the association between habitual diet and gut microbiome features in this study population
To explore predictors of biological response through the change in metabolic parameters
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-00571 | OTHER | NCI-CTRP Clinical Trials Registry | None |