Clinical Trials in the UK / NCT04675294
Active, not recruiting
Phase 2
Evorpacept (ALX148) in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)
NCT04675294 · tracked via the Priya Life Science UK tracker
Condition(s) studied
Head and Neck CancerHead and Neck Squamous Cell Carcinoma
Investigational drug(s) / intervention(s)
evorpacept: IV Q3W
pembrolizumab: IV Q3W
Study summary
A Phase 2 Study of evorpacept (ALX148) in Combination With pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma.
Eligibility
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-SIRPα agent.
* Prior treatment with anti-PD-1 or PD-L1.
Primary outcome measure(s)
- Objective response rate per RECIST 1.1 — Last randomized patient reaching at least 24 weeks of follow-up
Trial sites (53)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 | Australia | |
| Cliniques Universitaires Saint-Luc | Brussels | Belgium | |
| AZ Groeninge | Kortrijk | Belgium | |
| UZ Leuven | Leuven | Belgium | |
| Hamilton Health Sciences - Juravinski Cancer Centre | Hamilton | Ontario | |
| LHSC - Victoria Hospital | London | Ontario | |
| Ottawa Hospital Cancer Centre | Ottawa | Ontario | |
| Princess Margaret Cancer Centre | Toronto | Ontario | |
| VUMC Goederenontvangst | 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 | |
| Chungnam National University Hospital | Daejeon | South Korea | |
| CHA University of Bundang | Gyeonggi-do | South Korea | |
| Gachon University - Gil Medical Center | Incheon | South Korea | |
| Seoul National University Bundang Hospital | Seongnam | South Korea | |
| Korea University Medical Center (KUMC) - Korea University Anam Hospital | Seoul | South Korea | |
| Seoul National University Hospital | Seoul | South Korea | |
| The Catholic University of Korea - Eunpyeong St. Mary's Hospital | Seoul | South Korea | |
| Samsung Medical Center | Seoul | South Korea |
+ 13 more sites — see the full list on the official registry below.
On this site
📄 Keytruda (pembrolizumab) drug profile →More ALX Oncology Inc. trials in the UK
Other trials for the same condition
A Phase 3 Study to Evaluate Petosemtamab Compared With Investigator's Choice Monotherapy in Previously Treated Head and Neck Squamous Cell Carcinoma Patients (LiGeR-HN2)
Active, not recruiting
Study of Zanzalintinib (XL092) + Pembrolizumab vs Pembrolizumab in Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04675294 on ClinicalTrials.gov ↗ ← All trials in the UK