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Not listed Phase 2 Interventional

A Phase II Study of Cemiplimab and ISA101b in Patients With Recurrent/Metastatic HPV16 Positive OPC

ClinicalTrials.gov ID: NCT04398524

Public ClinicalTrials.gov record NCT04398524. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 2:30 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase II Study of Cemiplimab, an Anti-PD-1 Monoclonal Antibody, and ISA101b Vaccine in Patients With Recurrent/Metastatic HPV16 Positive Oropharyngeal Cancer Who Have Experienced Disease Progression With Prior Anti-PD-1 Therapy

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This will be an open-label, phase 2 study in which subjects will receive ISA101b and cemiplimab.

Study identification

NCT ID
NCT04398524
Recruitment status
Not listed
Study type
Interventional
Phase
Phase 2
Lead sponsor
ISA Pharmaceuticals
Industry
Enrollment
65 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 1, 2021 (Actual)
Primary completion
Jun 30, 2024 (Estimated)
Completion
Dec 30, 2024 (Estimated)
Last update posted
Jan 16, 2024

2021 – 2024

United States locations

U.S. sites
8
U.S. states
7
U.S. cities
8
Facility City State ZIP Site status
City of Hope National Medical Center Duarte California 91010 —
UCSF Helen Diller Family Comprehensive Cancer Center San Francisco California 94115 —
Anschutz Cancer Pavilion Aurora Colorado 80045 —
H. Lee Moffitt Cancer Center & Research Institute Tampa Florida 33612 —
Massachusetts General Hospital Boston Massachusetts 02114 —
Washington University St Louis Missouri 63110 —
Roswell Park Cancer Institute Buffalo New York 14263 —
Providence Portland Medical Center Portland Oregon 97213 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 33 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04398524, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 16, 2024 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04398524 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →