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

NCT04260126 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2025-10-01

No results posted yet for this study

Summary

VERSATILE-002 is a Phase 2, open-label, multicenter study of the efficacy and safety of PDS0101 administered in combination with pembrolizumab in adults with HPV16 and PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

Conditions

  • 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

IV infusion of pembrolizumab 200 mg + two 0.5mL sub-cutaneous injections of PDS0101 administered on Cycle 1, 2, 3, 4 and 12. IV infusion of Pembrolizumab 200 mg monotherapy will be administered Cycles 5 - 11 and 13 - 35.

Sponsors & Collaborators

Principal Investigators

  • David T Schaaf, MD · PDS Biotechnology Corporation

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-29
Primary Completion
2025-05-14
Completion
2025-05-14
FDA Drug
Yes

Countries

  • United States
  • Ireland
  • Puerto Rico
  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04260126 on ClinicalTrials.gov