Nivolumab Combination Shows 65% PFS in HPV-Related Head and Neck Cancer

Trial results for a Phase 2 study (NCT03829722) investigating nivolumab in combination with radiotherapy and carboplatin/paclitaxel for high-risk HPV-related head and neck cancer were posted on ClinicalTrials.gov on 2026-01-22. The study reported a 65% progression-free survival rate in the treatment group.

Background

The study focused on Oropharynx Squamous Cell Carcinoma, specifically high-risk HPV-related cases. This type of cancer affects the oropharynx, which includes the tonsil, base of tongue, oropharyngeal wall, and soft palate.

Trial design

The Phase 2 study (NCT03829722) was a completed trial that enrolled 26 participants with high-risk HPV-related squamous cell carcinoma of the oropharynx. The study investigated the addition of nivolumab to standard fractionated radiation therapy and carboplatin/paclitaxel. Its purpose was to evaluate if this combination could improve 2-year progression-free survival compared to standard of care.

Key results

Results were reported for the group receiving nivolumab, carboplatin/paclitaxel, and radiotherapy. For the outcome of "Progression-free Survival (PFS)", 65% of patients achieved this outcome. The "Proportion of Patients Who Progressed in Any Location" was 15% of patients. The "Overall Survival (OS)" was observed in 26 participants, corresponding to the total study enrollment.

Regarding "Incidence of Acute Toxicity", several incidents were reported with varying counts: 39, 40, 1, 26, 29, 11, 21, 50, and 6 incidents occurred.

What this means

The results from this Phase 2 study provide initial data on the efficacy and safety profile of nivolumab in combination with radiotherapy and chemotherapy for high-risk HPV-related oropharyngeal squamous cell carcinoma. A 65% progression-free survival rate and a 15% progression rate suggest potential activity for this regimen in this patient population. The reported acute toxicity incidents will be important for further safety evaluations.

Source

The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03829722, titled "Radiotherapy, Carboplatin/Paclitaxel and Nivolumab for High Risk HPV-related Head and Neck Cancer," were posted on 2026-01-22 on clinicaltrials.gov.