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Head and Neck CancerPhase 2NCT04675294

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

A Phase 2 study testing evorpacept and pembrolizumab in people with Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, run by ALX Oncology Inc. at 53 sites in 9 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
evorpacept and pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
189 participants
Where
53 sitesin 9 countries
Study dates
2 Apr 2021to 30 Jun 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

53 sites in 9 countries.

53 sites in 9 countries

United States14 sites

  • University of Maryland Medical System

    Baltimore, Maryland, 21201

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • The Ohio State University

    Columbus, Ohio, 43210

  • Houston Methodist Cancer Center

    Houston, Texas, 77030

  • Hoag Hospital

    Irvine, California, 92618

  • University of California San Diego

    La Jolla, California, 92037

  • Memorial Sloan-Kettering Cancer Center

    Long Island City, New York, 11101

  • Northwest Georgia Oncology Centers

    Marietta, Georgia, 30060

  • Vanderbilt - Ingram Cancer Center

    Nashville, Tennessee, 37232

  • Rutgers Cancer Institute of New Jersey

    Newark, New Jersey, 07103

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Blessing Cancer Center

    Quincy, Illinois, 62301

  • H. Lee Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

South Korea14 sites

  • Chungbuk National University Hospital

    Cheongju-si, 28644

  • Yeungnam University Medical Center

    Daegu, 42415

  • Chungnam National University Hospital

    Daejeon, 35015

  • CHA University of Bundang

    Gyeonggi-do, 13496

  • Gachon University - Gil Medical Center

    Incheon, 21565

  • Seoul National University Bundang Hospital

    Seongnam, 13620

  • Korea University Medical Center (KUMC) - Korea University Anam Hospital

    Seoul, 02841

  • Seoul National University Hospital

    Seoul, 03080

  • The Catholic University of Korea - Eunpyeong St. Mary's Hospital

    Seoul, 03312

  • Samsung Medical Center

    Seoul, 06351

  • SNU Boramae Medical Center

    Seoul, 07061

  • Severance Hospital Yonsei University

    Seoul, 3722

  • Catholic University of Korea, St. Vincent's Hospital Suwon

    Suwon, 16247

  • Yonsei University - Wonju Severance Christian Hospital

    Wŏnju, 26426

Other trials in South Korea

Spain7 sites

  • Hospital Universitari Dexeus

    Barcelona, Barcelona, 08028

  • Institud Catala d´Oncologia

    Barcelona, 08908

  • Hospital Universitario La Paz

    Madrid, 28046

  • HM Sanchinarro

    Madrid, 28050

  • Hospital Severo Ochoa

    Madrid, 28911

  • Hospital Regional Universitario de Malaga

    Málaga, 29010

  • Hospital Universitario de Navarra

    Pamplona, 31008

Other trials in Spain

Australia5 sites

  • Royal Brisbane and Womens Hospital

    Brisbane, Queensland, 4029

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3051

  • Sir Charles Gairdner Hospital

    Perth, Western Australia, 6009

  • St. Vincent's

    Sydney, New South Wales, 2146

  • Ashford Cancer Centre Research

    Windsor Gardens, 5087

Other trials in Australia

Canada4 sites

  • Hamilton Health Sciences - Juravinski Cancer Centre

    Hamilton, Ontario, L9G2X1

  • LHSC - Victoria Hospital

    London, Ontario, N6A5W9

  • Ottawa Hospital Cancer Centre

    Ottawa, Ontario, K1H 8L6

  • Princess Margaret Cancer Centre

    Toronto, Ontario

Other trials in Canada

Belgium3 sites

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • AZ Groeninge

    Kortrijk, 8500

  • UZ Leuven

    Leuven, B - 3000

Other trials in Belgium

Netherlands2 sites

  • VUMC Goederenontvangst

    Amsterdam, 1081

  • Universitair Medisch Centrum Groningen

    Groningen, 9713

Other trials in Netherlands

Singapore2 sites

  • National University Cancer Institute

    Singapore, 119074

  • National Cancer Centre Singapore

    Singapore, 169610

Other trials in Singapore

United Kingdom2 sites

  • Royal Marsden NHS Foundation Trust

    London, SW3 6JJ

  • Royal Marsden NHS Foundation Trust

    Sutton, SM2 5PT

Other trials in United Kingdom

About this study

Official title: 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.

Read the 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.

Being tested
evorpacept, pembrolizumab
Keywords
ALX148, CD47, SIRPα, HNSCC, pembrolizumab, evorpacept
Medical subject headings
Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • evorpaceptDrug

    Also called ALX148

    IV Q3W

  • pembrolizumabDrug

    Also called KEYTRUDA®

    IV Q3W

Study groups in NCT04675294
Study groupRoleWhat they receive
evorpacept (ALX148) + pembrolizumabExperimentalevorpacept (ALX148) 45 mg/kg IV and pembrolizumab 200 mg IV given every 3 weeks.
Receives: Drug: evorpacept; Drug: pembrolizumab
pembrolizumabActive comparatorpembrolizumab 200 mg IV given every 3 weeks.
Receives: Drug: pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate per RECIST 1.1

    Measured: Last randomized patient reaching at least 24 weeks of follow-up

Secondary outcomes (4)

  1. Duration of response

    Measured: Up to 36 months

  2. Progression-free survival

    Measured: Up to 36 months

  3. Overall survival

    Measured: Up to 36 months

  4. Adverse events

    Measured: Up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2020
  2. Study start2 Apr 2021
  3. Primary completion3 Mar 2025
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
189 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04675294
Sponsor's protocol ID
AT148003
Other IDs
KEYNOTE-B87, MK-3475-B87, 2020-004093-21, 2023-508340-22-00, 2023
Status last verified
Jul 2025
First submitted
15 Dec 2020
Last updated
1 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing evorpacept and pembrolizumab in people with Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, run by ALX Oncology Inc. at 53 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United States, South Korea, Spain, Australia, Canada and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate per RECIST 1.1 (time frame: Last randomized patient reaching at least 24 weeks of follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04675294.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.

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