Evorpacept (ALX148) in Combination With Pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04)
NCT ID: NCT04675333
Last Updated: 2025-08-03
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
172 participants
INTERVENTIONAL
2021-05-10
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 + Chemotherapy
evorpacept (ALX148) 45 mg/kg IV, pembrolizumab 200 mg IV, and chemotherapy given every 3 weeks.
evorpacept
IV Q3W
pembrolizumab
IV Q3W
Cisplatin/Carboplatin; 5FU
IV Q3W
pembrolizumab + Chemotherapy
pembrolizumab 200 mg IV and chemotherapy given every 3 weeks.
pembrolizumab
IV Q3W
Cisplatin/Carboplatin; 5FU
IV Q3W
Interventions
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evorpacept
IV Q3W
pembrolizumab
IV Q3W
Cisplatin/Carboplatin; 5FU
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 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
Cedar Sinai Medical Center
Los Angeles, California, United States
University of Miami, Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Louisville
Louisville, Kentucky, United States
University of Maryland Medical System
Baltimore, Maryland, United States
Memorial Sloan Kettering
New York, New York, United States
The Ohio State University
Columbus, Ohio, United States
Oregon Health & Science University/ Knight Cancer Institute
Portland, Oregon, United States
Vanderbilt - Ingram Cancer Center
Nashville, Tennessee, United States
Houston Methodist Cancer Center
Houston, Texas, United States
Royal Brisbane and Womens Hospital
Herston, Queensland, Australia
Ashford Cancer Centre
Adelaide, South Australia, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Sir Charles Gairdner Hospital
Nedlands, , Australia
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
AZ Groeninge
Kortrijk, , Belgium
Amsterdam UMC, Locatie VUMC
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
Gachon University (GCU) - Gil Medical Center (Gil Hospital)
Incheon, , South Korea
Seoul National University, Bundang Hospital
Seongnam, , South Korea
CHA University - Bundang CHA General Hospital (CHA Bundang Medical Center)
Seongnam-si, , South Korea
The Catholic University of Korea - Eunpyeong St. Mary's Hospital
Seoul, , South Korea
Seoul National University Hospital (SNUH) - SMG-SNU Boramae Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital Universitari Dexeus
Barcelona, Barcelona, Spain
Institut Catala d Oncologia (ICO)
Badalona, , Spain
Institut Catala dOncologia
L'Hospitalet de Llobregat, , Spain
Hospital Universitario Severo Ochoa
Leganés, , Spain
Grupo Hospital de Madrid (HM) - Hospital Universitario Madrid Sanchinarro - Cent
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Regional Universitario de Malaga
Málaga, , Spain
Hospital Universitario de Navarra
Pamplona, , Spain
The Royal Marsden Hospital - Surrey
London, , United Kingdom
University College London Hospital
London, , United Kingdom
The Royal Marsden Hospital- London
London, , United Kingdom
Countries
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Other Identifiers
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KEYNOTE-B88
Identifier Type: OTHER
Identifier Source: secondary_id
MK-3475-B88
Identifier Type: OTHER
Identifier Source: secondary_id
2020-004662-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-508342-17-00
Identifier Type: CTIS
Identifier Source: secondary_id
AT148004
Identifier Type: -
Identifier Source: org_study_id
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