Head and Neck CancerPhase 2NCT04675333
Evorpacept (ALX148) in Combination With Pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04)
A Phase 2 study testing evorpacept, pembrolizumab and Cisplatin/Carboplatin; 5FU in people with Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, run by ALX Oncology Inc. at 44 sites in 8 countries.
Trial summary
A Phase 2 Study of evorpacept (ALX148) in Combination With pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
- What is being tested?
- evorpacept, pembrolizumab and Cisplatin/Carboplatin; 5FU
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 44 sitesin 8 countries
- Study dates
- 10 May 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
- Previously untreated metastatic or unresectable, recurrent head and neck squamous cell carcinoma.
- 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 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
44 sites in 8 countries.
44 sites in 8 countries
United States13 sites
University of Maryland Medical System
Baltimore, Maryland, 21201
Rush University Medical Center
Chicago, Illinois, 60612
The Ohio State University
Columbus, Ohio, 43235
Houston Methodist Cancer Center
Houston, Texas, 77030
Hoag Hospital
Irvine, California, 92618
University of California San Diego
La Jolla, California, 92037
Cedar Sinai Medical Center
Los Angeles, California, 90048
University of Louisville
Louisville, Kentucky, 40202
University of Miami, Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Vanderbilt - Ingram Cancer Center
Nashville, Tennessee, 37232
Memorial Sloan Kettering
New York, New York, 10021
Oregon Health & Science University/ Knight Cancer Institute
Portland, Oregon, 97239
Moffitt Cancer Center
Tampa, Florida, 33612
South Korea10 sites
Chungbuk National University Hospital
Cheongju-si, 28644
Yeungnam University Medical Center
Daegu, 42415
Gachon University (GCU) - Gil Medical Center (Gil Hospital)
Incheon, 21565
Seoul National University, Bundang Hospital
Seongnam, 13620
CHA University - Bundang CHA General Hospital (CHA Bundang Medical Center)
Seongnam-si, 13496
The Catholic University of Korea - Eunpyeong St. Mary's Hospital
Seoul, 03312
Seoul National University Hospital (SNUH) - SMG-SNU Boramae Medical Center
Seoul, 07061
Seoul National University Hospital
Seoul, 3080
Severance Hospital, Yonsei University Health System
Seoul, 3722
Samsung Medical Center
Seoul, 6351
Spain8 sites
Institut Catala d Oncologia (ICO)
Badalona, 08916
Hospital Universitari Dexeus
Barcelona, Barcelona, 08028
Institut Catala dOncologia
L'Hospitalet de Llobregat, 08908
Hospital Universitario Severo Ochoa
Leganés, 28911
Grupo Hospital de Madrid (HM) - Hospital Universitario Madrid Sanchinarro - Cent
Madrid, 2850
Hospital Universitario La Paz
Madrid
Hospital Regional Universitario de Malaga
Málaga, 29011
Hospital Universitario de Navarra
Pamplona, 31008
Australia4 sites
Ashford Cancer Centre
Adelaide, South Australia, 5037
Royal Brisbane and Womens Hospital
Herston, Queensland, 4029
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Sir Charles Gairdner Hospital
Nedlands, 6009
United Kingdom3 sites
The Royal Marsden Hospital - Surrey
London, 5PT
University College London Hospital
London, 5PT
The Royal Marsden Hospital- London
London, 6JJ
Belgium2 sites
Cliniques Universitaires Saint-Luc
Brussels
AZ Groeninge
Kortrijk, 8500
Netherlands2 sites
Amsterdam UMC, Locatie VUMC
Amsterdam, 1081
Universitair Medisch Centrum Groningen
Groningen, 9713
Singapore2 sites
National University Cancer Institute
Singapore, 119074
National Cancer Centre Singapore
Singapore, 168583
About this study
Official title: A Phase 2 Study of ALX148 in Combination With Pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04)
A Phase 2 Study of evorpacept (ALX148) in Combination With pembrolizumab and Chemotherapy 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 + 5FU + platinum and of pembrolizumab + 5FU + platinum in patients with metastatic or unresectable, recurrent HNSCC who have not yet been treated for their advanced disease. The study comprises of an initial safety lead-in followed by a randomized portion.
- Being tested
- evorpacept, pembrolizumab, Cisplatin/Carboplatin; 5FU
- 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
Cisplatin/Carboplatin; 5FUDrug
Also called Platinol/Paraplatin; Adrucil
IV Q3W
| Study group | Role | What they receive |
|---|---|---|
| evorpacept (ALX148) + pembrolizumab + Chemotherapy | Experimental | evorpacept (ALX148) 45 mg/kg IV, pembrolizumab 200 mg IV, and chemotherapy given every 3 weeks. Receives: Drug: evorpacept; Drug: pembrolizumab; Drug: Cisplatin/Carboplatin; 5FU |
| pembrolizumab + Chemotherapy | Active comparator | pembrolizumab 200 mg IV and chemotherapy given every 3 weeks. Receives: Drug: pembrolizumab; Drug: Cisplatin/Carboplatin; 5FU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate per RECIST 1.1
Measured: Last randomized patient reaching at least 24 weeks of follow-up
Secondary outcomes (4)
Duration of response
Measured: Up to 36 months
Progression-free survival
Measured: Up to 36 months
Overall survival
Measured: Up to 36 months
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.
- First posted19 Dec 2020
- Study start10 May 2021
- Primary completion3 Mar 2025
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- ALX Oncology Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04675333
- Sponsor's protocol ID
- AT148004
- Other IDs
- KEYNOTE-B88, MK-3475-B88, 2020-004662-19, 2023-508342-17-00, 2023
- Status last verified
- Jul 2025
- First submitted
- 15 Dec 2020
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of ALX148 in Combination With Pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04)
- ClinicalTrials.gov ID
- NCT04675333
- Acronym / sponsor ID
- AT148004
- Keywords
- ALX148, CD47, SIRPα, HNSCC, pembrolizumab, evorpacept
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 172 participants (actual)
- Lead sponsor
- ALX Oncology Inc.Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 10 May 2021 (actual)
- Primary completion
- 3 Mar 2025 (actual)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 19 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 2 Study of evorpacept (ALX148) in Combination With pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma.
Detailed description
This is a open-label, randomized phase 2 multi-center study of the anti-tumor efficacy of evorpacept (ALX148) + pembrolizumab + 5FU + platinum and of pembrolizumab + 5FU + platinum in patients with metastatic or unresectable, recurrent HNSCC who have not yet been treated for their advanced disease. The study comprises of an initial safety lead-in followed by a randomized portion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| evorpacept (ALX148) + pembrolizumab + Chemotherapy | Experimental | Drug: evorpacept, Drug: pembrolizumab, Drug: Cisplatin/Carboplatin; 5FUevorpacept (ALX148) 45 mg/kg IV, pembrolizumab 200 mg IV, and chemotherapy given every 3 weeks. |
| pembrolizumab + Chemotherapy | Active comparator | Drug: pembrolizumab, Drug: Cisplatin/Carboplatin; 5FUpembrolizumab 200 mg IV and chemotherapy given every 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Previously untreated metastatic or unresectable, recurrent head and neck squamous cell carcinoma.
- Adequate bone marrow function.
- Adequate renal and liver function.
- Adequate ECOG performance status.
Key exclusion criteria (4 listed)
- Patients with known symptomatic CNS metastases or leptomeningeal disease requiring steroids.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| evorpaceptAlso: ALX148IV Q3W | Drug | evorpacept (ALX148) + pembrolizumab + Chemotherapy |
| pembrolizumabAlso: KEYTRUDA®IV Q3W | Drug | evorpacept (ALX148) + pembrolizumab + Chemotherapy, pembrolizumab + Chemotherapy |
| Cisplatin/Carboplatin; 5FUAlso: Platinol/Paraplatin; AdrucilIV Q3W | Drug | evorpacept (ALX148) + pembrolizumab + Chemotherapy, pembrolizumab + Chemotherapy |
Primary outcome
Objective response rate per RECIST 1.1
Time frame: Last randomized patient reaching at least 24 weeks of follow-up
4 secondary outcomes
Duration of response
Time frame: Up to 36 months
Progression-free survival
Time frame: Up to 36 months
Overall survival
Time frame: Up to 36 months
Adverse events
Time frame: Up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
44 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing evorpacept, pembrolizumab and Cisplatin/Carboplatin; 5FU in people with Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, run by ALX Oncology Inc. at 44 sites in 8 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 3 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 44 sites in United States, South Korea, Spain, Australia, United Kingdom and 3 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?
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 3 Aug 2025.