Ignite Creation Date:
2024-05-06 @ 4:21 PM
Last Modification Date:
2024-10-26 @ 2:08 PM
Study NCT ID:
NCT04957615
Status:
RECRUITING
Last Update Posted:
2024-02-09
First Post:
2021-07-01
Brief Title:
Nivolumab for the Treatment of Metastatic or Unresectable Solid Tumors With ARID1A Mutation and 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 Solid Tumors
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:
This phase II trial studies the effect of nivolumab in treating patients with solid tumors that have spread to other places in the body metastatic or cannot be removed by surgery unresectable with RID1A mutation and CXCL13 expression 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 to control the disease
Detailed Description:
PRIMARY OBJECTIVES
I To estimate objective response rate ORR and overall survival OS in patients with ARID1A mutations receiving nivolumab therapy
II To estimate objective response rate ORR and overall survival OS in patients with ARID1A mutations plus CXCL13-high expression and ARID1A mutations plus CXCL13-low expression receiving nivolumab therapy
SECONDARY OBJECTIVES
I To estimate progression free survival PFS in subjects with harboring ARID1A mutation treated with nivolumab monotherapy
II To estimate progression free survival PFS in subjects with ARID1A mutations plus CXCL13-high expression and ARID1A mutations plus CXCL13-low expression treated with nivolumab monotherapy
III To assess peripheral and tumor infiltrating immune cell sub-populations in patients with ARID1A mutations ARID1A plus CXCL13-high and ARID1A plus CXCL13-low expression to determine predictors of response and resistance
IV To determine expression pattern of CXCL13 in ARID1A mutant tumors
OUTLINE
Patients receive nivolumab and relatlimab IV over 30 minutes on day 1 of each cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients undergo computed tomography CT or magnetic resonance imaging MRI tissue biopsy and blood sample collection during screening and on the trial
I To estimate objective response rate ORR and overall survival OS in patients with ARID1A mutations receiving nivolumab therapy
II To estimate objective response rate ORR and overall survival OS in patients with ARID1A mutations plus CXCL13-high expression and ARID1A mutations plus CXCL13-low expression receiving nivolumab therapy
SECONDARY OBJECTIVES
I To estimate progression free survival PFS in subjects with harboring ARID1A mutation treated with nivolumab monotherapy
II To estimate progression free survival PFS in subjects with ARID1A mutations plus CXCL13-high expression and ARID1A mutations plus CXCL13-low expression treated with nivolumab monotherapy
III To assess peripheral and tumor infiltrating immune cell sub-populations in patients with ARID1A mutations ARID1A plus CXCL13-high and ARID1A plus CXCL13-low expression to determine predictors of response and resistance
IV To determine expression pattern of CXCL13 in ARID1A mutant tumors
OUTLINE
Patients receive nivolumab and relatlimab IV over 30 minutes on day 1 of each cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients undergo computed tomography CT or magnetic resonance imaging MRI tissue biopsy and blood sample collection during screening and on the trial
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 |
|---|---|---|---|
| 2021-0207 | OTHER | M D Anderson Cancer Center | None |
| NCI-2021-06371 | REGISTRY | None | None |