Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT07172256
Brief Summary:
This is a phase 2, pilot, randomized, open-label 3-arm study to assess the safety, tolerability, and efficacy of CUE-101 monotherapy, and CUE-101 in combination with pembrolizumab as neoadjuvant therapy in HLA-A\*0201-positive treatment naive participants with locally advanced, unresectable HPV-16 associated head and neck squamous cell carcinoma (HNSCC).
Detailed Description:
This is a phase 2, pilot, randomized, open-label 3-arm study to assess the safety, tolerability, and efficacy of CUE-101 monotherapy, and CUE-101 in combination with pembrolizumab as neoadjuvant therapy in HLA-A\*0201-positive treatment naive participants with locally advanced, unresectable HPV-16 associated head and neck squamous cell carcinoma (HNSCC). CUE-101 monotherapy will be administered at 4 mg/kg IV on Days 1 and 21. Pembrolizumab monotherapy will be administered at 200 mg IV on Days 1 and 21. CUE-101 and pembrolizumab combination therapy will be administered by sequential infusion. Pembrolizumab will be administered at 200 mg IV followed by CUE-101 will be administered at 4 mg/kg IV on Days 1 and 21.
Study:
NCT07172256
Study Brief:
Protocol Section:
NCT07172256