# Study of PDS0101 and Pembrolizumab Combination I/O in Subjects With HPV16 + Recurrent and/or Metastatic HNSCC

> **NCT04260126** · PHASE2 · COMPLETED · sponsor: **PDS Biotechnology Corp.** · enrollment: 95 (actual)

## Conditions studied

- Metastatic Head and Neck Cancer
- Recurrent Head and Neck Cancer
- HPV Positive Oropharyngeal Squamous Cell Carcinoma
- Neoplasms, Head and Neck

## Interventions

- **COMBINATION_PRODUCT:** Pembrolizumab (KEYTRUDA®) and PDS0101

## Key facts

- **NCT ID:** NCT04260126
- **Lead sponsor:** PDS Biotechnology Corp.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2021-03-29
- **Primary completion:** 2025-05-14
- **Final completion:** 2025-05-14
- **Target enrollment:** 95 (ACTUAL)
- **Last updated:** 2025-10-01

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04260126

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04260126, "Study of PDS0101 and Pembrolizumab Combination I/O in Subjects With HPV16 + Recurrent and/or Metastatic HNSCC". Retrieved via AI Analytics 2026-06-25 from https://api.ai-analytics.org/clinical/NCT04260126. Licensed CC0.

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