TransCon (TC) TLR7/8 Agonist, TC IL-2 β/γ, Pembrolizumab Prior to Surgery for Advanced Head and Neck Squamous Cell Carcinoma

Stopped early · Phase 2

Conditions studied: Head and Neck Neoplasms

In brief

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).

Key facts

Study ID

NCT05980598

Run by

Ascendis Pharma A/S

People needed

27

Starts

2023-09-29

Expected to finish

2025-03-28

Last updated by the study team

2025-08-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has local histologically confirmed new diagnosis of resectable, non-metastatic, SCC that is either: Stage III tumor HPV-positive oropharyngeal primary that is tumor size (T) 4, lymph node involvement (N) 0-2, no distant metastases (M) 0; Stage III or IVA oropharyngeal tumor HPV-negative; or Stage III or IVA larynx/hypopharynx/oral cavity primaries regardless of HPV status (per American Joint Committee on Cancer [AJCC] Staging, 8th edition).
• Has available archived or fresh core or excisional biopsy of a tumor lesion. Note: Fine needle aspirations may be allowed after discussion with Medical Monitor.
• Is eligible and plans for primary LA-HNSCC surgery based on investigator decision and per local practice.
• Has results from tumor HPV status by p16 immunohistochemistry (IHC) for oropharyngeal tumors. (HPV DNA analysis for HPV tumor status is acceptable if that is the local standard of care analysis.)
• Has adequate organ function at screening.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• Has at least one lesion that is deemed by the investigator to be easily and safely accessible for IT injection.

You may not qualify if…

• Active autoimmune conditions.
• Has significant cardiac disease.
• Has a known bleeding disorder that is deemed to place the participant at unacceptable risk for bleeding complications from IT injections or biopsies.
• Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (in doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization.

Where it is running

• Ascendis Investigational Site — El Palmar, Spain
• Ascendis Investigational Site — L'Hospitalet de Llobregat, Spain
• Ascendis Investigational Site — Lugo, Spain
• Ascendis Investigational Site — Madrid, Spain
• Ascendis Investigational Site II — Madrid, Spain
• Ascendis Investigational Site — Madrid, Spain
• Ascendis Investigational Site — Madrid, Spain
• Ascendis Investigational Site — Málaga, Spain
• Ascendis Investigational Site — Pamplona, Spain
• Ascendis Investigational Site — Terrassa, Spain
• Ascendis Investigational Site — Valencia, Spain
• Ascendis Investigational Site — Valencia, Spain
• Ascendis Investigational Site — Valencia, Spain
• Ascendis Investigational Site — Zaragoza, Spain
• Ascendis Investigational Site — Los Angeles, California, United States
• Ascendis Investigational Site — San Francisco, California, United States
• Ascendis Investigational Site — Chicago, Illinois, United States
• Ascendis Investigational Site — Springfield, Illinois, United States
• Ascendis Investigational Site — Iowa City, Iowa, United States
• Ascendis Investigational Site — Louisville, Kentucky, United States
• Ascendis Investigational Site — Boston, Massachusetts, United States
• Ascendis Investigational Site — Detroit, Michigan, United States
• Ascendis Investigational Site — Rochester, Minnesota, United States
• Ascendis Investigational Site — New York, New York, United States
• Ascendis Investigational Site — Barcelona, Spain

Full record on ClinicalTrials.gov

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