Evorpacept (ALX148) in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)
NCT ID: NCT04675294
Last Updated: 2025-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
189 participants
INTERVENTIONAL
2021-04-02
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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evorpacept (ALX148) + pembrolizumab
evorpacept (ALX148) 45 mg/kg IV and pembrolizumab 200 mg IV given every 3 weeks.
evorpacept
IV Q3W
pembrolizumab
IV Q3W
pembrolizumab
pembrolizumab 200 mg IV given every 3 weeks.
pembrolizumab
IV Q3W
Interventions
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evorpacept
IV Q3W
pembrolizumab
IV Q3W
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Adequate bone marrow function.
* Adequate renal and liver function.
* Adequate ECOG performance status.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
ALX Oncology Inc.
INDUSTRY
Responsible Party
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Locations
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Hoag Hospital
Irvine, California, United States
University of California San Diego
La Jolla, California, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, United States
Northwest Georgia Oncology Centers
Marietta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Blessing Cancer Center
Quincy, Illinois, United States
University of Maryland Medical System
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Rutgers Cancer Institute of New Jersey
Newark, New Jersey, United States
Memorial Sloan-Kettering Cancer Center
Long Island City, New York, United States
The Ohio State University
Columbus, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Vanderbilt - Ingram Cancer Center
Nashville, Tennessee, United States
Houston Methodist Cancer Center
Houston, Texas, United States
St. Vincent's
Sydney, New South Wales, Australia
Royal Brisbane and Womens Hospital
Brisbane, Queensland, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Sir Charles Gairdner Hospital
Perth, Western Australia, 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, Canada
LHSC - Victoria Hospital
London, Ontario, Canada
Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
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
SNU Boramae Medical Center
Seoul, , South Korea
Severance Hospital Yonsei University
Seoul, , South Korea
Catholic University of Korea, St. Vincent's Hospital Suwon
Suwon, , South Korea
Yonsei University - Wonju Severance Christian Hospital
Wŏnju, , South Korea
Hospital Universitari Dexeus
Barcelona, Barcelona, Spain
Institud Catala d´Oncologia
Barcelona, , Spain
Hospital Universitario La Paz
Madrid, , Spain
HM Sanchinarro
Madrid, , Spain
Hospital Severo Ochoa
Madrid, , Spain
Hospital Regional Universitario de Malaga
Málaga, , Spain
Hospital Universitario de Navarra
Pamplona, , Spain
Royal Marsden NHS Foundation Trust
London, , United Kingdom
Royal Marsden NHS Foundation Trust
Sutton, , United Kingdom
Countries
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Other Identifiers
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KEYNOTE-B87
Identifier Type: OTHER
Identifier Source: secondary_id
MK-3475-B87
Identifier Type: OTHER
Identifier Source: secondary_id
2020-004093-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-508340-22-00
Identifier Type: CTIS
Identifier Source: secondary_id
AT148003
Identifier Type: -
Identifier Source: org_study_id
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