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First received: July 20, 2023

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

Study Status: Completed

Recruit Status: RECRUITING

Condition: Head and Neck Neoplasms

Study Type: INTERVENTIONAL


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 ?/?, or Pembrolizumab Alone as Neoadjuvant Therapy for

Brief Summary: The purpose of this trial is to evaluate the safety and efficacy of TransCon TLR7/8 Agonist, TransCon IL-2 ?/?, 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…

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