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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 is a Phase 2 study that was terminated before completion, run by Ascendis Pharma A/S. The registered enrollment target is 27 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05980598
The ClinicalTrials.gov registry entry for NCT05980598 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ascendis Pharma A/S, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT05980598 reports 0 study locations.
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.
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