Trials / Active Not Recruiting

Active Not RecruitingNCT04953104

ARID1A and/or KDM6A Mutation and CXCL13 Expression

A Phase II Clinical Trial to Investigate ARID1A and/or KDM6A Mutation and CXCL13 Expression in the Pre-treatment Tumor Samples as a Combinatorial Predictive Biomarker for Immune Checkpoint Therapy in Metastatic Urothelial Cancer

Status: Active Not Recruiting
Phase: Phase 2
Study type: Interventional
Enrollment: 6 (actual)

Sponsor: M.D. Anderson Cancer Center · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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 body's 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 and/or KDM6A mutations receiving nivolumab and relatlimab combination therapy. II. To estimate objective response rate (ORR) and overall survival (OS) in participants with ARID1A and/or KDM6A mutations plus CXCL13-high expression and ARID1A and/or 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 and/or KDM6A mutation treated with nivolumab and relatlimab combination therapy. II. To estimate progression free survival (PFS) in subjects with ARID1A and/or KDM6A mutations plus CXCL13-high expression and ARID1A and/or 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 and/or 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.

Conditions

Interventions

Type	Name	Description
OTHER	Diagnostic Laboratory Biomarker Analysis	Correlative studies
BIOLOGICAL	Nivolumab	Given IV
DRUG	Relatlimab	Given IV

Timeline

Start date: 2021-09-21
Primary completion: 2026-12-31
Completion: 2026-12-31
First posted: 2021-07-07
Last updated: 2026-04-15

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT04953104. Inclusion in this directory is not an endorsement.