Evorpacept (ALX148) in Combination With Pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04)

Running, not enrolling · Phase 2

Conditions studied: Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

In brief

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

Key facts

Study ID

NCT04675333

Run by

ALX Oncology Inc.

People needed

172

Starts

2021-05-10

Expected to finish

2026-06-30

Last updated by the study team

2025-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Previously untreated metastatic or unresectable, recurrent head and neck squamous cell carcinoma.
• Adequate bone marrow function.
• Adequate renal and liver function.
• Adequate ECOG performance status.

You may not qualify if…

• Patients with known symptomatic CNS metastases or leptomeningeal disease requiring steroids.
• History of (non-infectious) pneumonitis that required steroids or current pneumonitis.
• Prior treatment with any anti-CD47 or anti-SIRPα agent.
• Prior treatment with anti-PD-1 or PD-L1.

Where it is running

• Hoag Hospital — Irvine, California, United States
• University of California San Diego — La Jolla, California, United States
• Cedar Sinai Medical Center — Los Angeles, California, United States
• University of Miami, Sylvester Comprehensive Cancer Center — Miami, Florida, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Louisville — Louisville, Kentucky, United States
• University of Maryland Medical System — Baltimore, Maryland, United States
• Memorial Sloan Kettering — New York, New York, United States
• The Ohio State University — Columbus, Ohio, United States
• Oregon Health & Science University/ Knight Cancer Institute — Portland, Oregon, United States
• Vanderbilt - Ingram Cancer Center — Nashville, Tennessee, United States
• Houston Methodist Cancer Center — Houston, Texas, United States
• Royal Brisbane and Womens Hospital — Herston, Queensland, Australia
• Ashford Cancer Centre — Adelaide, South Australia, Australia
• Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia
• Sir Charles Gairdner Hospital — Nedlands, Australia
• Cliniques Universitaires Saint-Luc — Brussels, Belgium
• AZ Groeninge — Kortrijk, Belgium
• Amsterdam UMC, Locatie VUMC — Amsterdam, Netherlands
• Universitair Medisch Centrum Groningen — Groningen, Netherlands
• National University Cancer Institute — Singapore, Singapore
• National Cancer Centre Singapore — Singapore, Singapore
• Chungbuk National University Hospital — Cheongju-si, South Korea
• Yeungnam University Medical Center — Daegu, South Korea

Full record on ClinicalTrials.gov

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