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

Squamous Cell Carcinoma of the Oropharynx Clinical Trial

Official title:
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)

Clinical Trial 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.

Clinical Trial 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 . ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03669718
Study type Interventional
Source ISA Pharmaceuticals
Contact
Status Active, not recruiting
Phase Phase 2
Start date November 30, 2018
Completion date June 2025
View Details
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