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Randomized open-label phase II clinical trial of the TLR7/8 agonist TransCon in combination with pembrolizumab or pembrolizumab alone as neoadjuvant treatment in participants with head and neck squamous cell carcinoma.

THE AIM OF THIS STUDY IS TO LEARN WHAT EFFECTS, GOOD AND BAD, THE STUDY DRUGS HAVE AND TO SEE IF THEY WORK SAFELY TO SHRINK LOCALLY ADVANCED RESECTABLE HEAD AND NECK CANCERS, AS WELL AS TO IMPROVE SURVIVAL.

Dr. Gonzalo Fernández Hinojal [SP] Curriculum
Specialist Medical Oncology Department
Madrid headquarters
Cancer Center
Head and Neck Cancer Area
Status
In recruitment
headquarters
Pamplona/Madrid
Early phase

Technical Summary

  • PHASE II OPEN-LABEL RANDOMIZED TRIAL OF TLR7/8 AGONIST TRANSCON IN COMBINATION WITH PEMBROLIZUMAB, TLR7/8 AGONIST TRANSCON IN COMBINATION WITH IL-2 SS/? TRANSCON, OR PEMBROLIZUMAB ALONE AS NEOADJUVANT TREATMENT IN PARTICIPANTS WITH STAGE III-IVA RESECTABLE LOCOREGIONALLY ADVANCED HEAD AND NECK SQUAMOUS CELL CARCINOMA (HNSCC-LA).
  • Code EudraCT: 2023-506092-10-00
  • Protocol number: ASND0038
  • Promoter: Ascendis Pharma Oncology Division S/A
  • Molecule/Drug: Agonista TransCon TLR7/8 / pembrolizumab /TransCon IL-2 ß/?

* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.

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