IRX-2 Regimen and Durvalumab, for Incurable H&N Squamous Cell Carcinoma

Phase 1 Completed 19 enrolled H. Lee Moffitt Cancer Center and Research Institute AstraZeneca · collab Brooklyn ImmunoTherapeutics, LLC · collab

Non-randomizedSequentialOpen-labelTreatment

Summary

The purpose of this study is to see if the IRX-2 regimen and Durvalumab, will have a tolerable safety profile and will increase the intratumoral immune profile compared with the pretreatment tumors.

Timeline

Start: 2019-08-21
Primary completion: 2022-05-12
Completion: 2023-06-30

Outcome

Met primary endpoint

paper Primary endpoints were safety and biomarkers to assess the immune response in the tumor microenvironment including significant increases in PD-L1 expression and CD8 + tumor infiltrating lymphocytes (TIL) comparing pre- and on-treatment tumor biopsies. PMID 38820888 ↗

paper On-treatment biopsies showed significantly increased PD-L1 (p = 0.005), CD3+ (p = 0.020), CD4+ (p = 0.022), and CD8 + T cells (p = 0.017) compared to pre-treatment. PMID 38820888 ↗

Publications

Park R, Li J, Slebos RJC, Chaudhary R, Poole MI, Ferraris C, Farinhas J, Hernandez-Prera J, Kirtane K, Teer JK, Song X, Hall MS, Tasoulas J, Amelio AL, Chung CH. Phase Ib trial of IRX-2 plus durvalumab in patients with recurrent and/or metastatic head and neck squamous cell carcinoma. Oral Oncol. 2024 Jul;154:106866. doi: 10.1016/j.oraloncology.2024.106866. Epub 2024 May 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Durvalumab	Monoclonal antibody	1500 mg	—
Subject	IRX-2	Protein / enzyme biologic	230 unknown	—
Subject	IRX-2	Protein / enzyme biologic	460 unknown	—
Background	Cyclophosphamide	Other / unclassified	300 mg/m2	Intravenous