Nivolumab for Treating Metastatic Urothelial Cancer with ARID1A Mutation and Response Based on CXCL13 Levels

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04953104

Provider View

This study is testing the drug nivolumab for patients with urothelial cancer that has spread and has a specific genetic mutation. The trial aims to see if nivolumab can help control the cancer by boosting the immune system.

Patient Parameters

Program Overview

This phase II study is exploring the effects of nivolumab, an immunotherapy drug, in patients with urothelial cancer that has spread to other parts of the body. The focus is on patients with a specific genetic mutation in the ARID1A gene and how it relates to the levels of a protein called CXCL13. Nivolumab is a type of immunotherapy that may help the immune system attack cancer cells and prevent them from growing and spreading. The study aims to select patients based on the genetic and immune characteristics of their tumors to see if nivolumab can effectively control the disease.

Description

The main goal of this study is to see how well nivolumab, combined with another drug called relatlimab, works in patients with specific genetic mutations (ARID1A and/or KDM6A) in their cancer. Researchers will look at how many patients respond to the treatment and how long they live after starting it. They will also study how the levels of a protein called CXCL13 affect the treatment's success.

Secondary goals include understanding how long patients live without the cancer getting worse and examining the immune cells in the tumors to find out what might predict a good or bad response to the treatment.

Patients in the study will receive nivolumab through an IV every four weeks for up to two years, as long as the cancer does not worsen and there are no severe side effects. After finishing the treatment, patients will be monitored for 100 days and then every 3-6 months.

Eligibility Criteria

Inclusion Criteria

  • Have a tumor with a genetic mutation in the ARID1A and/or KDM6A genes.
  • Have urothelial cancer that has spread or cannot be removed by surgery, affecting the bladder, urethra, ureter, or kidney area.
  • The cancer must have worsened after at least one round of chemotherapy or the patient must be unable or unwilling to receive standard chemotherapy.
  • Have measurable cancer that can be seen on a CT or MRI scan.
  • Provide a sample of the tumor for analysis.
  • Be in good overall health with an ECOG performance status of 0 or 1.
  • Have completed any prior radiation therapy at least two weeks before starting the study treatment.
  • Meet specific blood test requirements for neutrophils, platelets, hemoglobin, liver enzymes, bilirubin, and kidney function.
  • Agree to participate in additional studies related to the trial.
  • Women of childbearing potential must use effective birth control during the study and for five months after.
  • Men must use effective birth control during the study and avoid donating sperm.
  • Women must have a negative pregnancy test before starting the treatment.

Exclusion Criteria

  • Have previously received treatment with certain immune-targeting drugs.
  • Have active cancer in the brain or spinal fluid unless treated and stable.
  • Have serious or uncontrolled medical conditions that could increase risks or interfere with the study.
  • Have had another active cancer within the past three years, except for certain skin or prostate cancers.
  • Have an active autoimmune disease, except for certain stable conditions.
  • Require treatment with high-dose steroids or other immune-suppressing drugs.
  • Have unresolved side effects from previous cancer treatments, except for certain conditions like neuropathy.
  • Have received recent cancer treatments within 14 days or five half-lives of the study drug.
  • Test positive for hepatitis B or C, or have HIV/AIDS.

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