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HPV-16 Vaccination and Pembrolizumab Plus Cisplatin for "Intermediate Risk" HPV-16-associated Head and Neck Squamous Cell Carcinoma

NCT04369937 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-05-13

Study results available
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Summary

This clinical trial will evaluate a new combination of pembrolizumab, HPV-16 E6/E7 specific therapeutic vaccination (ISA101b) and cisplatin-based chemoradiotherapy for patients with newly diagnosed, local-regionally advanced, intermediate risk HPV-associated head and neck squamous cell carcinoma.

Conditions

Interventions

RADIATION

IMRT (Intensity Modulated Radiotherapy)

Radiation therapy

DRUG

Pembrolizumab

A potent and highly selective humanized monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between programmed cell death protein 1 (PD-1) and its ligands, PD-L1 and PD-L2.

DRUG

Cisplatin

Chemotherapy

BIOLOGICAL

ISA101b

ISA101b is a therapeutic cancer vaccine that induces specific immune responses to the oncogenic E6 and E7 antigens from HPV16.

Sponsors & Collaborators

Principal Investigators

  • Dan P Zandberg, MD · UPMC Hillman Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-06
Primary Completion
2025-03-12
Completion
2026-03-09
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT04369937 on ClinicalTrials.gov