Found 1 Presentation For Request "976TiP"
976TiP - SPEARHEAD-2 trial design: A phase II pilot trial of ADP-A2M4 in combination with pembrolizumab in patients with recurrent or metastatic head and neck cancer
- Ezra E. Cohen (San Diego, CA, United States of America)
Abstract
Background
ADP-A2M4 SPEAR T-cells are genetically engineered to target MAGE-A4+ tumors in HLA-A*02 positive patients (pts). Safety and efficacy for ADP-A2M4 cells have been demonstrated in a phase I trial (NCT03132922). MAGE-A4 is frequently expressed in recurrent/metastatic head and neck squamous cell carcinoma (r/m HNSCC). Pembrolizumab (pembro), an anti-PD-1 checkpoint inhibitor, monotherapy is approved as 1st-line treatment of r/m HNSCC that expresses PD-L1. The combination of ADP-A2M4 and pembro may result in a synergistic effect due to the inhibition of PD-1 on ADP-A2M4 cells potentially leading to deeper and more durable anti-tumor responses.
Trial design
This single-arm trial will enroll up to 10 pts to evaluate efficacy, safety, and tolerability of ADP-A2M4 with pembro. Checkpoint inhibitor naïve r/m HNSCC pts who are HLA-A*02, MAGE-A4+, and PD-L1 positive (≥1%) will be eligible. Part A is a run-in-phase with pembro as standard-of-care monotherapy followed by Part B, an interventional phase, during which ADP-A2M4 will be administered with pembro post-ADP-A2M4 infusion in patients without response or following progressive disease (PD) with pembro in Part A.
Clinical trial identification
NCT03132922.
Legal entity responsible for the study
Adaptimmune.
Funding
Adaptimmune.
Disclosure
E.E. Cohen: Advisory/Consultancy: ALX Oncology; Advisory/Consultancy: Ascendis; Advisory/Consultancy: Bayer; Advisory/Consultancy: Bioline Rx; Advisory/Consultancy: BMS; Advisory/Consultancy: Debio; Advisory/Consultancy: Dynavax; Advisory/Consultancy: MSD; Advisory/Consultancy: Merck; Advisory/Consultancy: Regeneron. R. Leidner: Advisory/Consultancy: Merck; Advisory/Consultancy: Oncolys; Advisory/Consultancy: Sanofi; Research grant/Funding (institution): Bristol-Myers Squibb. N. Hyland, T. Trivedi, M. Dudley, S. Biswas, D. Williams, E. Norry: Shareholder/Stockholder/Stock options, Full/Part-time employment: Adaptimmune. All other authors have declared no conflicts of interest.