Evorpacept (ALX148) in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)

July 30, 2025 updated by: ALX Oncology Inc.

A Phase 2 Study of ALX148 in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)

A Phase 2 Study of evorpacept (ALX148) in Combination With pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a open-label, randomized phase 2 multi-center study of the anti-tumor efficacy of evorpacept (ALX148) + pembrolizumab and of pembrolizumab alone in patients with metastatic or unresectable, recurrent HNSCC that is PD-L1 positive (CPS ≥1 by an FDA-approved test) and who have not yet been treated for their advanced disease. The study comprises an initial safety lead-in cohort followed by a randomized portion.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
189

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
      • Windsor Gardens, Australia, 5087
        • Ashford Cancer Centre Research
    • New South Wales
      • Sydney, New South Wales, Australia, 2146
        • St. Vincent's
    • Queensland
      • Brisbane, Queensland, Australia, 4029
        • Royal Brisbane and Womens Hospital
    • Victoria
      • Melbourne, Victoria, Australia, 3051
        • Peter MacCallum Cancer Centre
    • Western Australia
      • Perth, Western Australia, Australia, 6009
        • Sir Charles Gairdner Hospital
  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint-Luc
      • Kortrijk, Belgium, 8500
        • AZ Groeninge
      • Leuven, Belgium, B - 3000
        • UZ Leuven
  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L9G2X1
        • Hamilton Health Sciences - Juravinski Cancer Centre
      • London, Ontario, Canada, N6A5W9
        • LHSC - Victoria Hospital
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa Hospital Cancer Centre
      • Toronto, Ontario, Canada
        • Princess Margaret Cancer Centre
  • Korea, Republic of
      • Cheongju, Korea, Republic of, 28644
        • Chungbuk National University Hospital
      • Daegu, Korea, Republic of, 42415
        • Yeungnam University Medical Center
      • Daejeon, Korea, Republic of, 35015
        • Chungnam national university hospital
      • Gyeonggi-do, Korea, Republic of, 13496
        • CHA University of Bundang
      • Incheon, Korea, Republic of, 21565
        • Gachon University - Gil Medical Center
      • Seongnam, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 03312
        • The Catholic University of Korea - Eunpyeong St. Mary's Hospital
      • Seoul, Korea, Republic of, 02841
        • Korea University Medical Center (KUMC) - Korea University Anam Hospital
      • Seoul, Korea, Republic of, 07061
        • SNU Boramae Medical Center
      • Seoul, Korea, Republic of, 3722
        • Severance Hospital Yonsei University
      • Suwon, Korea, Republic of, 16247
        • Catholic University of Korea, St. Vincent's Hospital Suwon
      • Wŏnju, Korea, Republic of, 26426
        • Yonsei University - Wonju Severance Christian Hospital
  • Netherlands
      • Amsterdam, Netherlands, 1081
        • VUMC Goederenontvangst
      • Groningen, Netherlands, 9713
        • Universitair Medisch Centrum Groningen
  • Singapore
      • Singapore, Singapore, 169610
        • National Cancer Centre Singapore
      • Singapore, Singapore, 119074
        • National University Cancer Institute
  • Spain
      • Barcelona, Spain, 08028
        • Hospital Universitari Dexeus
      • Barcelona, Spain, 08908
        • Institud Catala d´Oncologia
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28911
        • Hospital Severo Ochoa
      • Madrid, Spain, 28050
        • HM Sanchinarro
      • Málaga, Spain, 29010
        • Hospital Regional Universitario de Málaga
      • Pamplona, Spain, 31008
        • Hospital Universitario de Navarra
  • United Kingdom
      • London, United Kingdom, SW3 6JJ
        • Royal Marsden NHS Foundation Trust
      • Sutton, United Kingdom, SM2 5PT
        • Royal Marsden NHS Foundation Trust
  • United States
    • California
      • Irvine, California, United States, 92618
        • Hoag Hospital
      • La Jolla, California, United States, 92037
        • University of California San Diego
    • Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Northwest Georgia Oncology Centers
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Quincy, Illinois, United States, 62301
        • Blessing Cancer Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical System
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • Rutgers Cancer Institute of New Jersey
    • New York
      • Long Island City, New York, United States, 11101
        • Memorial Sloan-Kettering Cancer Center
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt - Ingram Cancer Center
    • Texas
      • Houston, Texas, United States, 77030
        • Houston Methodist Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: evorpacept (ALX148) + pembrolizumab
evorpacept (ALX148) 45 mg/kg IV and pembrolizumab 200 mg IV given every 3 weeks.
Drug: evorpacept
IV Q3W
Other Names:
  • ALX148
Drug: pembrolizumab
IV Q3W
Other Names:
  • KEYTRUDA®
Active Comparator: pembrolizumab
pembrolizumab 200 mg IV given every 3 weeks.
Drug: pembrolizumab
IV Q3W
Other Names:
  • KEYTRUDA®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Objective response rate per RECIST 1.1
Time Frame: Last randomized patient reaching at least 24 weeks of follow-up
Last randomized patient reaching at least 24 weeks of follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Duration of response
Time Frame: Up to 36 months
Up to 36 months
Progression-free survival
Time Frame: Up to 36 months
Up to 36 months
Overall survival
Time Frame: Up to 36 months
Up to 36 months
Adverse events
Time Frame: Up to 36 months
Up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ALX Oncology Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 2, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 3, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 15, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 1, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AT148003
  • KEYNOTE-B87 (Other Identifier: Merck Sharp & Dohme LLC)
  • MK-3475-B87 (Other Identifier: Merck Sharp & Dohme LLC)
  • 2020-004093-21 (EudraCT Number)
  • 2023-508340-22-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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