Evorpacept (ALX148) in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)
A Phase 2 Study of ALX148 in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)
5 other identifiers
interventional
189
9 countries
53
Brief Summary
A Phase 2 Study of evorpacept (ALX148) in Combination With pembrolizumab 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 Apr 2021
Typical duration for phase_2 head-and-neck-cancer
53 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
April 2, 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 1, 2025
July 1, 2025
3.9 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
EXPERIMENTALevorpacept (ALX148) 45 mg/kg IV and pembrolizumab 200 mg IV given every 3 weeks.
pembrolizumab
ACTIVE COMPARATORpembrolizumab 200 mg IV given every 3 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
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 has 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 (53)
Hoag Hospital
Irvine, California, 92618, United States
University of California San Diego
La Jolla, California, 92037, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612, United States
Northwest Georgia Oncology Centers
Marietta, Georgia, 30060, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Blessing Cancer Center
Quincy, Illinois, 62301, United States
University of Maryland Medical System
Baltimore, Maryland, 21201, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Rutgers Cancer Institute of New Jersey
Newark, New Jersey, 07103, United States
Memorial Sloan-Kettering Cancer Center
Long Island City, New York, 11101, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Vanderbilt - Ingram Cancer Center
Nashville, Tennessee, 37232, United States
Houston Methodist Cancer Center
Houston, Texas, 77030, United States
St. Vincent's
Sydney, New South Wales, 2146, Australia
Royal Brisbane and Womens Hospital
Brisbane, Queensland, 4029, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3051, Australia
Sir Charles Gairdner Hospital
Perth, Western Australia, 6009, Australia
Ashford Cancer Centre Research
Windsor Gardens, 5087, Australia
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
AZ Groeninge
Kortrijk, 8500, Belgium
UZ Leuven
Leuven, B - 3000, Belgium
Hamilton Health Sciences - Juravinski Cancer Centre
Hamilton, Ontario, L9G2X1, Canada
LHSC - Victoria Hospital
London, Ontario, N6A5W9, Canada
Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
VUMC Goederenontvangst
Amsterdam, 1081, Netherlands
Universitair Medisch Centrum Groningen
Groningen, 9713, Netherlands
National University Cancer Institute
Singapore, 119074, Singapore
National Cancer Centre Singapore
Singapore, 169610, Singapore
Chungbuk National University Hospital
Cheongju-si, 28644, South Korea
Yeungnam University Medical Center
Daegu, 42415, South Korea
Chungnam National University Hospital
Daejeon, 35015, South Korea
CHA University of Bundang
Gyeonggi-do, 13496, South Korea
Gachon University - Gil Medical Center
Incheon, 21565, South Korea
Seoul National University Bundang Hospital
Seongnam, 13620, South Korea
Korea University Medical Center (KUMC) - Korea University Anam Hospital
Seoul, 02841, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
The Catholic University of Korea - Eunpyeong St. Mary's Hospital
Seoul, 03312, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
SNU Boramae Medical Center
Seoul, 07061, South Korea
Severance Hospital Yonsei University
Seoul, 3722, South Korea
Catholic University of Korea, St. Vincent's Hospital Suwon
Suwon, 16247, South Korea
Yonsei University - Wonju Severance Christian Hospital
Wŏnju, 26426, South Korea
Hospital Universitari Dexeus
Barcelona, Barcelona, 08028, Spain
Institud Catala d´Oncologia
Barcelona, 08908, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
HM Sanchinarro
Madrid, 28050, Spain
Hospital Severo Ochoa
Madrid, 28911, Spain
Hospital Regional Universitario de Malaga
Málaga, 29010, Spain
Hospital Universitario de Navarra
Pamplona, 31008, Spain
Royal Marsden NHS Foundation Trust
London, SW3 6JJ, United Kingdom
Royal Marsden NHS Foundation Trust
Sutton, SM2 5PT, United Kingdom
MeSH Terms
Conditions
Interventions
Condition 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
April 2, 2021
Primary Completion
March 3, 2025
Study Completion (Estimated)
June 30, 2026
Last Updated
August 1, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share