A Phase 2 Study of ALX148 in Combination with Pembrolizumab in Patients with Advanced Head and Neck Squamous Cell Carcinoma.
Primary Objective;
To assess the effect of ALX148 plus pembrolizumab on 12-month overall survival (OS) rate and objective response rate (ORR) in patients with metastatic or with unresectable, recurrent HNSCC that is PD-L1 positive (CPS ≥1) and who have not yet been treated for their advanced disease.
Secondary Objectives:
1. To assess secondary measures of efficacy for ALX148 administered in combination with
pembrolizumab and for pembrolizumab alone.
2. To assess the safety and tolerability of ALX148 administered in combination with pembrolizumab and for pembrolizumab alone (including for patients in the safety lead-in cohort).
Exploratory Objective:
To explore the pharmacodynamic effect of ALX148 administered in combination with pembrolizumab and pembrolizumab alone in patients.
Pembrolizumab (MK-3475)
Chemotherapy multiple agents systemic
- Rutgers Cancer Institute of New Jersey-University Hospital
Inclusion Criteria
- Patients with metastatic or unresectable, recurrent head and neck squamous cell
carcinoma (HNSCC) that is PD-L1 positive (CPS > 1) and who have not received prior
systemic therapy for their advanced disease.
- Adequate bone marrow function.
- Adequate renal and liver function.
- Adequate ECOG performance status.
Exclusion Criteria
- Patients with known symptomatic CNS metastases or leptomeningeal disease requiring
steroids.
- History of (non-infectious) pneumonitis that required steroids or has current
pneumonitis.
- Prior treatment with any anti-CD47 or anti-SIRPα agent.
- Prior treatment with anti-PD-1 or PD-L1.
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356.