Nivolumab for Treating Advanced Solid Tumors with ARID1A Mutation and CXCL13 Expression

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04957615

Provider View

This clinical trial is testing the effectiveness of nivolumab, an immunotherapy drug, in treating patients with advanced solid tumors that have a specific genetic mutation (ARID1A) and a protein expression (CXCL13). The study aims to see if nivolumab can help control the disease by boosting the body's immune response against cancer.

Patient Parameters

Program Overview

This study is exploring the use of nivolumab, an immunotherapy drug, to treat patients with solid tumors that have spread or cannot be removed by surgery. These tumors have a specific genetic mutation called ARID1A and express a protein called CXCL13. Nivolumab is a type of monoclonal antibody that may help the immune system attack cancer cells and prevent them from growing and spreading. The trial aims to determine if nivolumab can effectively control the disease in these patients.

Description

The main goals of this study are to determine how well nivolumab works in patients with ARID1A mutations, both with high and low levels of CXCL13 expression, by measuring the response rate and overall survival. The study also aims to assess how long patients live without the disease getting worse and to analyze immune cells in the blood and tumors to find predictors of treatment response.

Participants will receive nivolumab and another drug called relatlimab through an IV infusion every 28 days, as long as the disease does not progress or cause unacceptable side effects. During the trial, patients will undergo CT or MRI scans, tissue biopsies, and blood tests to monitor their condition.

Eligibility Criteria

Inclusion Criteria

  • Have a tumor with an ARID1A genetic mutation.
  • Have cancer that has spread or cannot be removed by surgery, confirmed by lab tests.
  • Have measurable disease as shown by CT or MRI scans.
  • Provide a tumor sample for analysis.
  • Be in good overall health with an ECOG performance status of 0 or 1.
  • Have completed any prior palliative radiotherapy at least 2 weeks before starting the study treatment.
  • Meet specific blood count and organ function criteria.
  • Be 18 years or older.
  • Agree to participate in additional studies related to this trial.

Exclusion Criteria

  • Have previously received certain types of immunotherapy targeting T-cell pathways.
  • Have active brain metastases unless treated and stable for at least 4 weeks.
  • Have serious or uncontrolled medical conditions that could interfere with the study.
  • Have had another active cancer within the past 3 years, except for certain curable cancers.
  • Have an active autoimmune disease, except for specific conditions like vitiligo or type I diabetes.
  • Require systemic treatment with corticosteroids or other immunosuppressive drugs within 14 days of starting the study.
  • Have unresolved side effects from previous cancer treatments, except for certain conditions like neuropathy.
  • Have received any cancer treatment within 28 days before starting the study.
  • Test positive for hepatitis B, hepatitis C, or HIV.
  • Be pregnant or breastfeeding.

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