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NCT05980598 · ClinicalTrials.gov registry record · Phase 2
TransCon (TC) TLR7/8 Agonist, TC IL-2 β/γ, Pembrolizumab Prior to Surgery for Advanced Head and Neck Squamous Cell Carcinoma
A Phase 2 study, sponsored by Ascendis Pharma A/S.
- Terminated
- Registry status
- Phase 2
- Development phase
- 27
- Enrollment target
NCT05980598: Clinical Trial Phase 2 study, sponsored by Ascendis Pharma A/S.
NCT05980598 is a Phase 2 study that was terminated before completion, run by Ascendis Pharma A/S. The registered enrollment target is 27 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05980598, a Phase 2 study, was terminated before completion, sponsored by Ascendis Pharma A/S.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 27 participants
- Enrollment target
Study Summary
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).
Primary Outcome
The proportion of participants with a major pathological response (mPR) as assessed by the Central Pathologist at the time of definitive surgery. mPR is defined as ≤10% invasive squamous cell carcinoma within the resected primary tumor specimen and all the sampled regional lymph nodes.
Interventions
- DRUG Pembrolizumab
- DRUG TransCon IL-2 β/γ
- DRUG TransCon TLR7/8 Agonist
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2023-09-29 |
| Est. Completion | 2025-03-28 |
| Phase | Phase 2 |
Why NCT05980598 stopped before completion
NCT05980598 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT05980598 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05980598 about?
NCT05980598 is a clinical study titled "TransCon (TC) TLR7/8 Agonist, TC IL-2 β/γ, Pembrolizumab Prior to Surgery for Advanced Head and Neck Squamous Cell Carcinoma". 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 carc...
What is the current status of trial NCT05980598?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2023-09-29. Estimated completion is 2025-03-28.
What interventions are being tested in trial NCT05980598?
The interventions under investigation include: Pembrolizumab (DRUG), TransCon IL-2 β/γ (DRUG), TransCon TLR7/8 Agonist (DRUG).
Who is sponsoring clinical trial NCT05980598?
This trial is sponsored by Ascendis Pharma A/S, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05980598's enrollment target sits among peer trials
27 1697th of 2000 higher than 293 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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