Evorpacept (ALX148) in Combination With Pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04)
A Phase 2 Study of ALX148 in Combination With Pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04)
5 other identifiers
interventional
172
8 countries
44
Brief Summary
A Phase 2 Study of evorpacept (ALX148) in Combination With pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 head-and-neck-cancer
Started May 2021
Typical duration for phase_2 head-and-neck-cancer
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 15, 2020
CompletedFirst Posted
Study publicly available on registry
December 19, 2020
CompletedStudy Start
First participant enrolled
May 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 3, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
ExpectedAugust 3, 2025
July 1, 2025
3.8 years
December 15, 2020
July 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective response rate per RECIST 1.1
Last randomized patient reaching at least 24 weeks of follow-up
Secondary Outcomes (4)
Duration of response
Up to 36 months
Progression-free survival
Up to 36 months
Overall survival
Up to 36 months
Adverse events
Up to 36 months
Study Arms (2)
evorpacept (ALX148) + pembrolizumab + Chemotherapy
EXPERIMENTALevorpacept (ALX148) 45 mg/kg IV, pembrolizumab 200 mg IV, and chemotherapy given every 3 weeks.
pembrolizumab + Chemotherapy
ACTIVE COMPARATORpembrolizumab 200 mg IV and chemotherapy given every 3 weeks.
Interventions
IV Q3W
IV Q3W
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ALX Oncology Inc.lead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (44)
Hoag Hospital
Irvine, California, 92618, United States
University of California San Diego
La Jolla, California, 92037, United States
Cedar Sinai Medical Center
Los Angeles, California, 90048, United States
University of Miami, Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Louisville
Louisville, Kentucky, 40202, United States
University of Maryland Medical System
Baltimore, Maryland, 21201, United States
Memorial Sloan Kettering
New York, New York, 10021, United States
The Ohio State University
Columbus, Ohio, 43235, United States
Oregon Health & Science University/ Knight Cancer Institute
Portland, Oregon, 97239, United States
Vanderbilt - Ingram Cancer Center
Nashville, Tennessee, 37232, United States
Houston Methodist Cancer Center
Houston, Texas, 77030, United States
Royal Brisbane and Womens Hospital
Herston, Queensland, 4029, Australia
Ashford Cancer Centre
Adelaide, South Australia, 5037, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000, Australia
Sir Charles Gairdner Hospital
Nedlands, 6009, Australia
Cliniques Universitaires Saint-Luc
Brussels, Belgium
AZ Groeninge
Kortrijk, 8500, Belgium
Amsterdam UMC, Locatie VUMC
Amsterdam, 1081, Netherlands
Universitair Medisch Centrum Groningen
Groningen, 9713, Netherlands
National University Cancer Institute
Singapore, 119074, Singapore
National Cancer Centre Singapore
Singapore, 168583, Singapore
Chungbuk National University Hospital
Cheongju-si, 28644, South Korea
Yeungnam University Medical Center
Daegu, 42415, South Korea
Gachon University (GCU) - Gil Medical Center (Gil Hospital)
Incheon, 21565, South Korea
Seoul National University, Bundang Hospital
Seongnam, 13620, South Korea
CHA University - Bundang CHA General Hospital (CHA Bundang Medical Center)
Seongnam-si, 13496, South Korea
The Catholic University of Korea - Eunpyeong St. Mary's Hospital
Seoul, 03312, South Korea
Seoul National University Hospital (SNUH) - SMG-SNU Boramae Medical Center
Seoul, 07061, South Korea
Seoul National University Hospital
Seoul, 3080, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 3722, South Korea
Samsung Medical Center
Seoul, 6351, South Korea
Hospital Universitari Dexeus
Barcelona, Barcelona, 08028, Spain
Institut Catala d Oncologia (ICO)
Badalona, 08916, Spain
Institut Catala dOncologia
L'Hospitalet de Llobregat, 08908, Spain
Hospital Universitario Severo Ochoa
Leganés, 28911, Spain
Grupo Hospital de Madrid (HM) - Hospital Universitario Madrid Sanchinarro - Cent
Madrid, 2850, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Regional Universitario de Malaga
Málaga, 29011, Spain
Hospital Universitario de Navarra
Pamplona, 31008, Spain
The Royal Marsden Hospital - Surrey
London, 5PT, United Kingdom
University College London Hospital
London, 5PT, United Kingdom
The Royal Marsden Hospital- London
London, 6JJ, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2020
First Posted
December 19, 2020
Study Start
May 10, 2021
Primary Completion
March 3, 2025
Study Completion (Estimated)
June 30, 2026
Last Updated
August 3, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share