Status:
ACTIVE_NOT_RECRUITING
Evorpacept (ALX148) in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)
Lead Sponsor:
ALX Oncology Inc.
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A Phase 2 Study of evorpacept (ALX148) in Combination With pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma.
Detailed Description
This is a open-label, randomized phase 2 multi-center study of the anti-tumor efficacy of evorpacept (ALX148) + pembrolizumab and of pembrolizumab alone in patients with metastatic or unresectable, re...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2026
Estimated Enrollment :
189 Patients enrolled
Trial Details
Trial ID
NCT04675294
Start Date
April 2 2021
End Date
June 30 2026
Last Update
August 1 2025
Active Locations (53)
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1
Hoag Hospital
Irvine, California, United States, 92618
2
University of California San Diego
La Jolla, California, United States, 92037
3
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
4
Northwest Georgia Oncology Centers
Marietta, Georgia, United States, 30060