TransCon (TC) TLR7/8 Agonist, TC IL-2 β/γ, Pembrolizumab Prior to Surgery for Advanced Head and Neck Squamous Cell Carcinoma
Public ClinicalTrials.gov record NCT05980598. 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
BelieveIT-201: Phase 2, Randomized Open-labeled Trial of TransCon (TC) TLR7/8 Agonist in Combination With Pembrolizumab or With TC IL-2 β/γ, or Pembrolizumab Alone as Neoadjuvant Therapy for Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this trial is to evaluate the safety and efficacy of TransCon TLR7/8 Agonist, TransCon IL-2 β/γ, and pembrolizumab given prior to curative intent surgery in treatment of participants with newly diagnosed Stage III/IVA resectable locoregionally advanced head and neck squamous cell carcinoma (LA-HNSCC). After surgery, participants will receive local standard-of-care treatment and will be followed for safety, efficacy, and survival for up to 2 years. This trial contains a safety run-in to evaluate the safety and tolerability of the two treatment arms: Arm A (TransCon TLR7/8 Agonist plus pembrolizumab) and Arm B (TransCon TLR7/8 Agonist plus TransCon IL-2 β/γ). The safety run-in will be followed by the randomized Phase 2, open-label part of the trial comparing the safety, efficacy and survival of treatment Arm A or Arm B compared to treatment Arm C (pembrolizumab monotherapy).
Study identification
- NCT ID
- NCT05980598
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 27 participants
Conditions and interventions
Conditions
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
- Sep 28, 2023
- Primary completion
- Mar 27, 2025
- Completion
- Mar 27, 2025
- Last update posted
- Jul 31, 2025
2023 – 2025
United States locations
- U.S. sites
- 16
- U.S. states
- 12
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Ascendis Investigational Site | Los Angeles | California | 90067 | — |
| Ascendis Investigational Site | San Francisco | California | 94158 | — |
| Ascendis Investigational Site | Chicago | Illinois | 60612 | — |
| Ascendis Investigational Site | Springfield | Illinois | 62702 | — |
| Ascendis Investigational Site | Iowa City | Iowa | 52242 | — |
| Ascendis Investigational Site | Louisville | Kentucky | 40202 | — |
| Ascendis Investigational Site | Boston | Massachusetts | 02114 | — |
| Ascendis Investigational Site | Detroit | Michigan | 48201 | — |
| Ascendis Investigational Site | Rochester | Minnesota | 55905 | — |
| Ascendis Investigational Site | New York | New York | 11794 | — |
| Ascendis Pharma Investigational Site | Canton | Ohio | 44718 | — |
| Ascendis Investigational Site | Cincinnati | Ohio | 45219 | — |
| Ascendis Investigational Site | Columbus | Ohio | 43210 | — |
| Ascendis Investigational Site | Charleston | South Carolina | 29425 | — |
| Ascendis Investigational Site | Knoxville | Tennessee | 37902 | — |
| Ascendis Investigational Site | 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 49 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05980598, 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 Jul 31, 2025 · Synced Sep 14, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05980598 live on ClinicalTrials.gov.