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)
Sponsor: ISA Pharmaceuticals
A PHASE2 clinical study on HPV16 Positive and Squamous Cell Carcinoma of the Oropharynx, this trial is ongoing. The trial is conducted by ISA Pharmaceuticals and has accumulated 29 data snapshots since 2018. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.
Study Description(click to expand)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 .
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 .
Status Flow
Change History
29 versions recorded-
Feb 2026 — Present [monthly]
Unknown PHASE2
Status: Active Not Recruiting → Unknown
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Sep 2025 — Feb 2026 [monthly]
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▶ Show 24 earlier versions
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May 2023 — Jan 2024 [monthly]
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Status: Recruiting → Active Not Recruiting
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Jan 2019 — Feb 2019 [monthly]
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Status: Not Yet Recruiting → Recruiting
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Oct 2018 — Jan 2019 [monthly]
Not Yet Recruiting PHASE2
First recorded
Eligibility Summary
No eligibility information available.
Contact Information
- ISA Pharmaceuticals
- Regeneron Pharmaceuticals
For direct contact, visit the study record on ClinicalTrials.gov .