Evorpacept (ALX148) in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)
Evorpacept (ALX148) in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)
A Phase 2 Study of Evorpacept (ALX148) in Combination With Pembrolizumab in Patients With
Advanced Head and Neck Squamous Cell Carcinoma.
Advanced Head and Neck Squamous Cell Carcinoma.
Head/Neck
Phase II
Adults
Mol. targeted/Immunotherapy/Biologics
ALX148,
MK-3475,
Pembrolizumab (MK-3475)
Choe, Jennifer
International
Vanderbilt University
09-16-2021
Eligibility
18 Years
BOTH
NO
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-SIRP agent.
Prior treatment with anti-PD-1 or PD-L1.
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-SIRP agent.
Prior treatment with anti-PD-1 or PD-L1.
