Evorpacept (ALX148) in Combination With Pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04)
← catalyst calendarSponsored by ALX Oncology Inc. (industry) · ALXO — their whole pipeline →. With Merck Sharp & Dohme LLC.
Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
172actual
Sites
44
Countries
Australia, Belgium, Netherlands +5
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2021-05-10 | actual | When the study began enrolling |
| Primary completion | 2025-03-03 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-06-30 | estimated | The whole study's end, after follow-up |
| First posted | 2020-12-19 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-08-03 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Head and Neck Cancer
- Head and Neck Squamous Cell Carcinoma
Interventions
- Drug: evorpacept — also filed as ALX148
- Drug: pembrolizumab — also filed as KEYTRUDA®
- Drug: Cisplatin/Carboplatin; 5FU — also filed as Platinol/Paraplatin; Adrucil
Primary outcome
what the primary-completion date above is the date OFObjective response rate per RECIST 1.1
measured Last randomized patient reaching at least 24 weeks of follow-up
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