A Randomized Phase 2 Study of Cemiplimab ± ISA101b in HPV16-Positive OPC
Public ClinicalTrials.gov record NCT03669718. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03669718
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 194 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 30, 2018 (Actual)
- Primary completion
- Sep 2024 (Estimated)
- Completion
- Jun 2025 (Estimated)
- Last update posted
- Dec 29, 2023
2018 – 2025
United States locations
- U.S. sites
- 10
- U.S. states
- 8
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | — |
| Moores Cancer Center at the UC San Diego Health | San Diego | California | 92093 | — |
| University of California San Francisco | San Francisco | California | 94115 | — |
| Robert H. Lurie Comprehensive Cancer Center | Chicago | Illinois | 60208 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| ICAHN School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| University of Cincinnati Cancer Institute | Cincinnati | Ohio | 45069 | — |
| Providence Portland Medical Center | Portland | Oregon | 97213 | — |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | — |
| M. D. Anderson Cancer Center | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 34 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03669718, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 29, 2023 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03669718 live on ClinicalTrials.gov.