CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 18 enrolled
Drug / intervention
Pembrolizumab +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04369937
NCT04369937Phase 2Completed
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Phase II Study Evaluating HPV-16 Vaccination (ISA101b) and Pembrolizumab Plus Cisplatin Chemoradiotherapy for "Intermediate Risk" HPV-16 Associated Head and Neck Squamous Cell Carcinoma (HNSCC)

Dan Zandberg·interventional·Posted Apr 30, 2020·Updated May 13, 2026

In Brief

A Phase 2 clinical trial evaluating IMRT (Intensity Modulated Radiotherapy), Pembrolizumab, and 2 other interventions for HPV-Related Squamous Cell Carcinoma and Head and Neck Squamous Cell Carcinoma. Completed, enrolled 18 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHPV-Related Squamous Cell Carcinoma, Head and Neck Squamous Cell Carcinoma
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC, ISA Pharmaceuticals

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedApr 30, 2020
Enrollment StartJul 6, 2020
Primary CompletionMar 12, 2025
Study CompletionMar 9, 2026
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 6.2 years ago

Interventions

IMRT (Intensity Modulated Radiotherapy)radiation

Radiation therapy

Pembrolizumabdrug

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.

Cisplatindrug

Chemotherapy

ISA101bbiological

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