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

NCT04398524 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2024-01-16

No results posted yet for this study

Summary

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

Conditions

  • Squamous Cell Carcinoma of the Oropharynx

Interventions

DRUG

ISA101b

ISA101b 4 times plus cemiplimab every 3 weeks for up to 24 months

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2024-06-30
Completion
2024-12-30
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Czechia
  • France
  • Germany
  • Israel
  • Italy
  • Spain
  • United Kingdom

Study Locations

More Related Trials

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 NCT04398524 on ClinicalTrials.gov