NCT03669718

A Randomized Phase 2 Study of Cemiplimab ± ISA101b in HPV16-Positive OPC

A Randomized, Double-blind, Placebo-Controlled, Phase 2 Study of Cemiplimab Versus the Combination of Cemiplimab With ISA101b in the Treatment of Subjects With HPV16-Positive Oropharyngeal Cancer (OPC)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 194 (estimated)
• Sponsor: ISA Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This will be a blinded, placebo-controlled, randomized, phase 2 study in which subjects will be randomly assigned 1:1 to cemiplimab plus placebo or cemiplimab plus ISA101b.

Detailed description

This study will assess the ability of ISA101b to improve Overall Response Rate in subjects with HPV16 positive OPC, when combined with cemiplimab, an investigational anti-PD-1 antibody being developed by Regeneron Pharmaceuticals. ISA101b is a therapeutic cancer vaccine that induces specific immune responses to the oncogenic E6 and E7 antigens from HPV16. Trials in HPV16 driven malignancies indicate it has activity in HPV16 driven malignancies including oropharyngeal and cervical cancers. Cemiplimab, also known as REGN2810, is in late stage trials and appears to have similar activity to approved anti PD-1 antibodies in a number of malignancies .

Conditions

• Squamous Cell Carcinoma of the Oropharynx
• HPV16 Positive

Interventions

Type	Name	Description
BIOLOGICAL	ISA101b	Every 3 weeks for a total of 3 times
DRUG	Cemiplimab	Every 3 weeks for up to 24 months
OTHER	Placebo	Every 3 weeks for a total of 3 times

Timeline

• Start date: 2018-11-30
• Primary completion: 2024-09-01
• Completion: 2025-06-01
• First posted: 2018-09-13
• Last updated: 2023-12-29

Locations

44 sites across 13 countries: United States, Belgium, Brazil, Czechia, France, Germany, Hungary, Italy, Mexico, Netherlands, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study