A Phase 2 interventional study of evorpacept and pembrolizumab in Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, sponsored by ALX Oncology Inc.. Active, not recruiting at 53 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-01.
Sponsored by ALX Oncology Inc. · Phase 2, Interventional, and Treatment
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Among 1,099 studies in Squamous Cell Carcinoma of Head and Neck with a site in United States — 217 open to participants now, 347 under way, 28 of them phase 3. Squamous Cell Carcinoma of Head and Neck · United States.
Among the 1,099 studies in Squamous Cell Carcinoma of Head and Neck with a site in United States, this one is the 143rd largest by enrollment of the 993 interventional ones that give a count, is one of 76 that started in 2021, is one of 359 in phase 2, reaches primary completion later than 27 of the 346 other live ones, and was the 729th registered.
2,019 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 573 are open to participants now.
Browse Squamous Cell Carcinoma of Head and Neck studies →217 of the 1,099 studies in Squamous Cell Carcinoma of Head and Neck with a site in United States are open now. Recruiting first, the newest first:
National Cancer Institute (NCI) · Sites in United States
Ages 18+
University of Miami · Sites in United States
Ages 18+
National Cancer Institute (NCI) · Sites in United States
Ages 18–120
Mayo Clinic · Sites in United States
Ages 18+
West Virginia University · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 435 Squamous Cell Carcinoma of Head and Neck studies recruiting now, 311 (71%) set no upper age limit and 87 (20%) stop at 75 or younger; 5 take children under 18; 13 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,099 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 519 · Phase 2 528 · Phase 3 83 · Phase 4 4
First in 1988; this study’s year is marked. 76 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 189 is above the median of 48 across 1,653 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.
Median enrollment 41 across the 993 interventional studies, 130 across the 63 observational. Of the 690 that completed or were terminated, 288 (42%) have results posted.
This tab as a report to print or save as PDF → With an account.
420 of 1,099 have an industry lead sponsor. The 10 most frequent:
ALX Oncology Inc. is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
ALX Oncology Inc. has 3 studies filed under Squamous Cell Carcinoma of Head and Neck — fewer than ten, so there is no comparison to draw.
107 of the studies in Squamous Cell Carcinoma of Head and Neck with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06998069Phase 3Brown UniversityHead and Neck Cancer Study Project in the Geriatric Population | 2026-12-01 |
| NCT06064877Phase 3AVEO Pharmaceuticals, Inc.A Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R/M) HPV Negative Head and Neck Squamous Cell Carcinoma | 2027-08 |
| NCT04965792Dana-Farber Cancer InstitutePost-treatment Surveillance in HPV+ Oropharyngeal SCC | 2026-11 |
| NCT05600842University of California, IrvineDe-escalated Radiation for Human Papillomavirus-Positive Squamous Cell Carcinoma of the Oropharynx | 2026-11 |
| NCT02955290Roswell Park Cancer InstituteCIMAvax Vaccine, Nivolumab, and Pembrolizumab in Treating Patients With Advanced Non-small Cell Lung Cancer or Squamous Head and Neck Cancer | 2026-11-25 |
Add all 107 to your calendar (.ics) → With an account.
Among the 1,099 studies in Squamous Cell Carcinoma of Head and Neck with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
A Phase 2 Study of evorpacept (ALX148) in Combination With pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma.
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.
2,019 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 573 are open to participants now.
This study's enrollment of 189 is above the median of 48 across 1,653 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.
Browse Squamous Cell Carcinoma of Head and Neck studies →ALX Oncology Inc. is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Compared within Squamous Cell Carcinoma of Head and Neck, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Head and Neck Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumor sample. Some scores count stained tumor cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumor sample. Some scores count stained tumor cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
evorpacept (ALX148) 45 mg/kg IV and pembrolizumab 200 mg IV given every 3 weeks.
Drug: evorpacept · Drug: pembrolizumab
pembrolizumab 200 mg IV given every 3 weeks.
Drug: pembrolizumab
IV Q3W
Also known as: ALX148
IV Q3W
Also known as: KEYTRUDA®
Objective response rate per RECIST 1.1
Time frame: Last randomized patient reaching at least 24 weeks of follow-up
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
Plan to share: No
No publications or documents are linked to this record.
Ran from Apr 2021 to primary completion in Mar 2025, 47 months.
Of 68 industry-sponsored phase 2 interventional studies under Squamous Cell Carcinoma of Head and Neck, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 60. This study's 47 months is close to that.
Counting every sponsor, half of 366 studies reached it within 53 months; a quarter within 35 and three quarters within 82.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: ALX148
Squamous Cell Carcinoma of Head and Neck →
ALX Oncology Inc.