Ignite Creation Date:
2024-05-06 @ 4:20 PM
Last Modification Date:
2024-10-26 @ 2:08 PM
Study NCT ID:
NCT04953104
Status:
RECRUITING
Last Update Posted:
2024-02-08
First Post:
2021-06-28
Brief Title:
Nivolumab for the Treatment of Patients With Metastatic Urothelial Cancer With ARID1A Mutation and Stratify Response Based on CXCL13 Expression
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase II Clinical Trial to Investigate ARID1A Mutation and CXCL13 Expression in the Pre-Treatment Tumor Samples as a Combinatorial Predictive Biomarker for Immune Checkpoint Therapy in Metastatic Urothelial Cancer
Status:
RECRUITING
Status Verified Date:
2024-09
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:
This phase II trial studies the effect of nivolumab in urothelial cancer that has spread to other places in the body metastatic specifically in patients with aberrations in ARID1A gene ARID1A mutation and correlate with expression level of CXCL13 an immune cytokine Immunotherapy with monoclonal antibodies such as nivolumab may help the bodys immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread Giving nivolumab may help control the disease in patients with urothelial cancer or solid tumors This trial aims at enriching patient selection based on genomic and immunological attributes of the tumor
Detailed Description:
PRIMARY OBJECTIVE
I To estimate objective response rate ORR and overall survival OS in participants with ARID1A andor KDM6A mutations receiving nivolumab and relatlimab combination therapy II To estimate objective response rate ORR and overall survival OS in participants with ARID1A andor KDM6A mutations plus CXCL13-high expression and ARID1A andor KDM6A mutations plus CXCL13-low expression receiving nivolumab and relatlimab therapy
SECONDARY OBJECTIVES
I To estimate progression free survival PFS in subjects with harboring ARID1A andor KDM6A mutation treated with nivolumab and relatlimab combination therapy
II To estimate progression free survival PFS in subjects with ARID1A andor KDM6A mutations plus CXCL13-high expression and ARID1A andor KDM6A mutations plus CXCL13-low expression treated with nivolumab and relatlimab combination therapy
III To assess peripheral and tumor infiltrating immune cell sub-populations in patients with ARID1A mutations KDM6A mutations ARID1A plus CXCL13-high and ARID1A plus CXCL13-low expression KDM6A plus CXCL13-high and KDM6A plus CXCL13-low expression to determine predictors of response and resistance
IV To determine the expression pattern of CXCL13 in ARID1A andor KDM6A mutant tumors
OUTLINE
Patients receive nivolumab intravenously IV over 30 minutes on day 1 Cycles repeats 28 days 4 weeks for up to 2 years in the absence of disease or unacceptable toxicity
After the completion of study treatment patients are followed up for 100 days then every 3-6 months thereafter
I To estimate objective response rate ORR and overall survival OS in participants with ARID1A andor KDM6A mutations receiving nivolumab and relatlimab combination therapy II To estimate objective response rate ORR and overall survival OS in participants with ARID1A andor KDM6A mutations plus CXCL13-high expression and ARID1A andor KDM6A mutations plus CXCL13-low expression receiving nivolumab and relatlimab therapy
SECONDARY OBJECTIVES
I To estimate progression free survival PFS in subjects with harboring ARID1A andor KDM6A mutation treated with nivolumab and relatlimab combination therapy
II To estimate progression free survival PFS in subjects with ARID1A andor KDM6A mutations plus CXCL13-high expression and ARID1A andor KDM6A mutations plus CXCL13-low expression treated with nivolumab and relatlimab combination therapy
III To assess peripheral and tumor infiltrating immune cell sub-populations in patients with ARID1A mutations KDM6A mutations ARID1A plus CXCL13-high and ARID1A plus CXCL13-low expression KDM6A plus CXCL13-high and KDM6A plus CXCL13-low expression to determine predictors of response and resistance
IV To determine the expression pattern of CXCL13 in ARID1A andor KDM6A mutant tumors
OUTLINE
Patients receive nivolumab intravenously IV over 30 minutes on day 1 Cycles repeats 28 days 4 weeks for up to 2 years in the absence of disease or unacceptable toxicity
After the completion of study treatment patients are followed up for 100 days then every 3-6 months thereafter
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 |
|---|---|---|---|
| 2021-0104 | OTHER | M D Anderson Cancer Center | None |
| NCI-2021-05785 | REGISTRY | None | None |