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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

July 6, 2020

Primary Completion Date

March 12, 2025

Study Completion Date

January 15, 2026

Conditions
HPV-Related Squamous Cell CarcinomaHead and Neck Squamous Cell Carcinoma
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.

Trial Locations (1)

15232

UPMC Hillman Cancer Center, Pittsburgh

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

collaborator

ISA Pharmaceuticals

INDUSTRY

lead

Dan Zandberg

OTHER