NCT04398524

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: ISA Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This study will assess the ability of ISA101b plus cemiplimab to improve Overall Response Rate in subjects who have progressed on prior anti-PD-1 therapy.

Conditions

• Squamous Cell Carcinoma of the Oropharynx

Interventions

Type	Name	Description
DRUG	ISA101b	ISA101b 4 times plus cemiplimab every 3 weeks for up to 24 months

Timeline

• Start date: 2021-07-01
• Primary completion: 2024-06-30
• Completion: 2024-12-30
• First posted: 2020-05-21
• Last updated: 2024-01-16

Locations

41 sites across 9 countries: United States, Belgium, Czechia, France, Germany, Israel, Italy, Spain, United Kingdom

Regulatory

• FDA-regulated drug study