Nasopharyngeal cancer recurrent Trials in Disease

Study of nivolumab treatment for patients with nasopharyngeal cancer who did not respond to or worsened after platinum chemotherapy

This clinical trial is designed for patients with nasopharyngeal cancer that has either returned or spread after treatment with platinum-based chemotherapy. The study focuses on testing nivolumab, an immunotherapy medication that helps the body's immune system recognize and fight cancer cells more effectively.

Main inclusion criteria:

• You must be at least 18 years old
• You must have a confirmed diagnosis of squamous cell carcinoma that started in the nasopharynx, verified through tissue or cell examination
• Your cancer must have progressed during or after platinum-based chemotherapy, or returned within 6 months of completing this treatment
• The cancer must have either come back in the original location or lymph nodes, or spread to other parts of the body
• Your ECOG performance status must be 0-1, meaning you are able to care for yourself and are up and about more than half of your waking hours
• You must be willing and able to provide written consent, attend all follow-up visits, and undergo all planned study procedures

Main exclusion criteria:

• Being under 18 years old
• Pregnancy or breastfeeding
• Previous treatment with immunotherapy medications
• Active or untreated cancer that has spread to the brain
• Active autoimmune disease requiring systemic treatment
• Uncontrolled or severe heart disease
• Active infections such as hepatitis B or C, tuberculosis, HIV, or AIDS
• Other active cancers requiring treatment, with some exceptions for certain skin cancers
• Major surgery within 4 weeks before starting the study
• Treatment with other experimental drugs within 4 weeks before starting the study
• History of severe allergic reactions to similar medications

Focus and goals of the trial:

The study aims to evaluate how effective nivolumab is in treating nasopharyngeal cancer that has not responded to standard platinum-based chemotherapy. The medication is given as a solution through an intravenous infusion directly into a vein. Each patient may receive treatment for up to 6 months, with regular monitoring throughout the study period.

During the trial, patients will undergo regular assessments to track how the cancer responds to treatment. At 12 weeks, an MRI scan will be performed to measure whether the tumor has decreased in size by at least 30% or disappeared completely. Additional MRI scans and health evaluations will be conducted at 6 months, and follow-up visits will continue for up to 18 months. Throughout the study, patients will also complete quality of life questionnaires and undergo safety evaluations to monitor any side effects from the treatment.

Investigational drug:

Nivolumab is an immunotherapy medication that works by blocking a protein called PD-1 on immune cells. Normally, this protein prevents T-cells, which are part of your immune system, from attacking cancer cells. By blocking PD-1, nivolumab allows your immune system to better recognize and destroy cancer cells. The medication is administered through an intravenous infusion at a concentration of 10 mg/mL.

The trial also references platinum-based chemotherapy, which refers to traditional cancer treatment medications containing platinum. These medications work by damaging the DNA of cancer cells to prevent them from dividing and growing. However, in this study, platinum-based chemotherapy is mentioned as a previous treatment that patients would have already received before becoming eligible for the nivolumab trial.