Nivolumab: Phase 1 Head and Neck Cancer Trial Safety Data Posted

Trial results for a Phase 1 study (NCT03727061) investigating nivolumab in combination with porfimer sodium interstitial photodynamic therapy for locally advanced or recurrent head and neck cancer were posted on ClinicalTrials.gov on 2025-03-11. The trial, which enrolled 5 participants, was terminated and focused on evaluating safety.

Background

This Phase 1 trial investigated the use of nivolumab in combination with porfimer sodium interstitial photodynamic therapy (I-PDT). The study focused on patients with locally advanced or recurrent head and neck carcinoma. Porfimer sodium is a light-sensitive drug activated by laser light delivered through special fibers into the tumor.

Trial design

The study (NCT03727061) was a Phase 1 trial that enrolled 5 participants with locally advanced or recurrent head and neck carcinoma. The trial was terminated. Interventions included nivolumab and porfimer sodium. The trial aimed to evaluate the safety of interstitial photodynamic therapy (I-PDT) and determine potentially effective light settings.

Key results

The trial's key measurements focused on the frequency of adverse events per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 in the Arm A (Porfimer Sodium, I-PDT) group. The reported counts of participants for adverse events were 0 participants, 1 participant, 4 participants, and 0 participants.

What this means

This Phase 1 trial was terminated, and the reported results provide initial safety data for the combination of nivolumab and porfimer sodium interstitial photodynamic therapy in a small cohort of 5 participants with locally advanced or recurrent head and neck cancer. The data on adverse event frequencies contributes to the understanding of the safety profile of this experimental treatment approach.

Source

The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03727061, titled 'Porfimer Sodium Interstitial Photodynamic Therapy With or Without Standard of Care Chemotherapy in Treating Patients With Locally Advanced or Recurrent Head and Neck Cancer,' were posted on 2025-03-11 on clinicaltrials.gov.