Phase II Trial Adding Relatlimab to Nivolumab Maintenance After Platinum-Gemcitabine-Nivolumab for Recurrent or Metastatic Nasopharyngeal Cancer

What this Trial Is About

Researchers are evaluating whether adding BMS-986016 relatlimab, a monoclonal antibody, to the standard immunotherapy treatment with nivolumab can improve outcomes for adults with recurrent or metastatic nasopharyngeal cancer. This phase II trial focuses on patients whose cancer has returned or spread after initial treatment, aiming to see if this combination can extend the time without disease progression. The study also explores survival rates, response patterns, and biomarkers related to Epstein-Barr virus in these patients. Participants first receive induction therapy with nivolumab, combined with chemotherapy drugs cisplatin or carboplatin, and gemcitabine in cycles repeated every 21 days for up to six cycles. Those whose cancer does not progress are then randomly assigned to one of two maintenance therapy groups one group receives nivolumab alone every four weeks, and the other group receives both nivolumab and relatlimab every four weeks, continuing for up to two years or until disease progression or unacceptable side effects. Imaging scans such as CT, MRI, PETCT, and bone scans are performed during the study to monitor disease status. Throughout the study, participants undergo regular imaging and blood sample collections to assess disease progression, response to treatment, and levels of Epstein-Barr virus DNA as biomarkers. After completing the treatment phase, patients are followed with periodic visits every four months for two years, then every six months up to five years, and annually thereafter. The main outcome measured is progression-free survival, with additional assessments including overall survival, tumor response, patterns of relapse, adverse events, and biomarker evaluations over a period of up to six years.

Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer