Trial results for a Phase 2 study evaluating pembrolizumab in combination with cisplatin and ISA101b for HPV-16-associated head and neck squamous cell carcinoma were posted on ClinicalTrials.gov on 2026-05-13. The study reported a 75.5% 2-year progression-free survival rate for patients treated with the combination therapy.
Background
The study investigated a new combination of pembrolizumab, HPV-16 E6/E7 specific therapeutic vaccination (ISA101b), and cisplatin-based chemoradiotherapy. This regimen was evaluated for patients with newly diagnosed, local-regionally advanced, intermediate risk HPV-associated head and neck squamous cell carcinoma.
Trial design
The Phase 2 study (NCT04369937) enrolled 18 participants with HPV-Related Squamous Cell Carcinoma and Head and Neck Squamous Cell Carcinoma. The trial evaluated the combination of pembrolizumab, cisplatin, and ISA101b alongside IMRT.
Key results
The trial reported the following key measurements for the IMRT + Pembrolizumab + Cisplatin + ISA101b group:
- Progression-free Survival (PFS) at 2 Years was 75.5 percentage of patients.
- Serious Adverse Events Related to Study Treatment were reported in 1 participant, 3 participants, 1 participant, 1 participant, 16 participants, 11 participants, 1 participant, 4 participants, 1 participant, 1 participant, and 1 participant across different events.
What this means
The results from this Phase 2 study indicate that the combination of pembrolizumab, cisplatin, and ISA101b, along with IMRT, achieved a 75.5% 2-year progression-free survival rate in patients with intermediate risk HPV-16-associated head and neck squamous cell carcinoma. This specific outcome suggests potential efficacy for this regimen in the studied population. The trial also reported various serious adverse events related to study treatment, with individual events affecting between 1 and 16 participants. Further context on the nature and severity of these events would be needed for a complete safety profile assessment.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04369937, titled "HPV-16 Vaccination and Pembrolizumab Plus Cisplatin for "Intermediate Risk" HPV-16-associated Head and Neck Squamous Cell Carcinoma", were posted on 2026-05-13 on clinicaltrials.gov.