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TransCon TLR7 · BelieveIT-201

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

Ensayo de Ascendis Pharma A/S en Neoplasias de cabeza y cuello.

Más ensayos de: Cáncer de cabeza y cuello.

Fase

Fase 2

Estado

Interrumpido

Participantes

27

previstos

Centros

65

Fin del objetivo primario

mar 2025

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en sep 2023.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «The Sponsor made the decision to close enrollment as part of a strategic portfolio review.».

Qué mide

Respuesta patologica mayor (Up to 6 weeks after Cycle 2 (each cycle is 21 days)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe 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).

Más ensayos de ASND

Todos los de ASND, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT05980598), actualizada en jul 2025.