NCT04957615

Nivolumab for the Treatment of Metastatic or Unresectable Solid Tumors With ARID1A Mutation and CXCL13 Expression

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: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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 body's 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.

Conditions

• Metastatic Malignant Solid Neoplasm
• Unresectable Solid Neoplasm

Interventions

Type	Name	Description
BIOLOGICAL	Nivolumab	Given IV

Timeline

• Start date: 2021-09-21
• Primary completion: 2027-05-31
• Completion: 2027-05-31
• First posted: 2021-07-12
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study