Who is eligible for clinical trial NCT04675294?

Participants must meet protocol criteria for Head and Neck Cancer. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT04675294 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-07-30

Evorpacept (ALX148) in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03) (NCT04675294)

🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: ALX Oncology Inc.

🩺 Plain-English Summary (8th-Grade Level)

A Phase 2 Study of evorpacept (ALX148) in Combination With pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (5 items).

Location: Hoag Hospital — Irvine, California

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (53 Sites)

Hoag Hospital — Irvine, California
University of California San Diego — La Jolla, California
H. Lee Moffitt Cancer Center — Tampa, Florida
Northwest Georgia Oncology Centers — Marietta, Georgia
Rush University Medical Center — Chicago, Illinois
Blessing Cancer Center — Quincy, Illinois
University of Maryland Medical System — Baltimore, Maryland
Massachusetts General Hospital — Boston, Massachusetts
Rutgers Cancer Institute of New Jersey — Newark, New Jersey
Memorial Sloan-Kettering Cancer Center — Long Island City, New York
The Ohio State University — Columbus, Ohio
Oregon Health & Science University — Portland, Oregon
Vanderbilt - Ingram Cancer Center — Nashville, Tennessee
Houston Methodist Cancer Center — Houston, Texas
St. Vincent's — Sydney, New South Wales
Royal Brisbane and Womens Hospital — Brisbane, Queensland
Peter MacCallum Cancer Centre — Melbourne, Victoria
Sir Charles Gairdner Hospital — Perth, Western Australia
Ashford Cancer Centre Research — Windsor Gardens,
Cliniques Universitaires Saint-Luc — Brussels,
AZ Groeninge — Kortrijk,
UZ Leuven — Leuven,
Hamilton Health Sciences - Juravinski Cancer Centre — Hamilton, Ontario
LHSC - Victoria Hospital — London, Ontario
Ottawa Hospital Cancer Centre — Ottawa, Ontario

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗