Testing the Addition of Relatlimab to Usual Immunotherapy for Recurrent or Metastatic Nasopharyngeal Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06029270

Provider View

This study is exploring whether adding a new drug, relatlimab, to the usual immunotherapy can help control nasopharyngeal cancer that has returned or spread. The goal is to see if this combination can extend the time before the cancer grows or spreads again.

Patient Parameters

Program Overview

This phase II clinical trial is testing if adding a new drug called relatlimab to the usual immunotherapy can help treat nasopharyngeal cancer that has come back or spread to other parts of the body. Relatlimab is a type of medication known as a monoclonal antibody, which may help stop cancer cells from growing and spreading. The usual treatment includes chemotherapy drugs like cisplatin or carboplatin and gemcitabine, along with an immunotherapy drug called nivolumab. This study aims to find out if adding relatlimab can help keep the cancer from growing or spreading longer than the usual treatment alone.

Description

Primary Objective:

  • To find out if adding relatlimab to nivolumab maintenance therapy can improve the time patients live without their cancer getting worse.

Secondary Objectives:

  • To see if adding relatlimab improves overall survival compared to nivolumab alone.
  • To compare how often the cancer returns or spreads between the two treatment groups.
  • To evaluate if adding relatlimab improves the response to treatment and how long the response lasts.
  • To assess the safety and side effects of the combination treatment.
  • To study the role of Epstein-Barr virus (EBV) DNA levels as a marker for predicting outcomes.

Exploratory Objectives:

  • To collect blood and tissue samples for future research.
  • To further study EBV DNA levels as a predictive marker.

Treatment Plan:

  • Induction Therapy: Patients receive nivolumab, cisplatin or carboplatin, and gemcitabine in cycles every 21 days for up to 6 cycles, unless the disease progresses or side effects are unacceptable. Imaging tests and blood samples are collected during this phase.

  • Maintenance Therapy: Patients whose cancer does not progress are randomly assigned to one of two groups:

    • Group 1: Receives nivolumab every 4 weeks for up to 2 years.
    • Group 2: Receives nivolumab and relatlimab every 4 weeks for up to 2 years.

After treatment, patients are monitored regularly for several years to track their health and any changes in their cancer.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with nasopharyngeal cancer that has returned or spread and cannot be treated with surgery or radiation.
  • Cancer must show signs of Epstein-Barr virus (EBV) or have a history of detectable EBV DNA.
  • Must have measurable disease based on specific medical criteria.
  • Be 18 years or older.
  • Have a good performance status, meaning able to carry out daily activities with minimal restrictions.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
  • Must have adequate blood cell counts and organ function.
  • No prior systemic treatment for recurrent or metastatic nasopharyngeal cancer.
  • No prior treatment with certain immune therapies, except in specific cases.
  • Must have completed any previous cancer treatments at least 6 months before joining the study.
  • No major health issues that could interfere with the study, such as recent heart problems or active infections.
  • No history of severe allergic reactions to study drugs.
  • Must provide blood samples for EBV DNA testing before and after initial treatment.

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