Can a new drug combo slow advanced head and neck cancer?
NCT ID NCT07807163
First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time
Summary
This phase 2 trial tests an experimental drug called ficerafusp alfa, which targets two proteins that help tumors grow, when given with the immunotherapy pembrolizumab. The study enrolls adults with recurrent or metastatic head and neck squamous cell carcinoma that has not been treated with systemic therapy. Researchers compare a weekly dosing schedule of ficerafusp alfa to an alternative schedule to see if the alternative is as effective at keeping cancer from progressing.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ficerafusp alfa (an investigational drug targeting EGFR and TGF-beta) combined with pembrolizumab (an immunotherapy)
- What this could lead to
- If successful, this could support a more convenient dosing schedule for ficerafusp alfa plus pembrolizumab, potentially improving treatment options for people with advanced head and neck cancer.
- What could go wrong
- This is a phase 2 trial, so the results are preliminary. The alternative dosing may not be as effective as the weekly regimen, and side effects from the drug combination could be significant.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 160 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥18 years on the day the Informed Consent Form is signed. * Histologically or cytologically confirmed R or M HNSCC. Eligible primary tumor locations are oral cavity, hypopharynx, larynx or oropharynx (with documented HPV-negative disease if presenting with OPSCC). Note: primary tumor location of paranasal sinuses and nasopharynx, any histology are excluded. * No prior systemic therapy administered in the R or M setting; and completed systemic therapy \>6 months prior if given as part of multimodal treatment for locoregionally advanced disease in the adjuvant or definitive setting. * Archival tumor tissue or willing to undergo pretreatment biopsy at Screening if archival tissue is insufficient or unavailable. * PD-L1 CPS ≥1. * Measurable disease based on RECIST 1.1. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Adequate organ function, as defined in the protocol. Exclusion Criteria: * Disease suitable for local therapy administered with curative intent. * Prior treatment with anti-TGFβ therapy. * Prior therapy with an anti-EGFR antibody (exception: radio sensitizing agents and multimodal treatment for locoregionally advanced disease). * Prior history of Grade ≥2 intolerance or hypersensitivity reaction to anti-EGFR therapy or other murine proteins. * Prior therapy with an immune checkpoint inhibitor completed within 6 months prior to study treatment initiation. * Progressive disease \<6 months from completion of curative intent systemic therapy for locoregionally advanced HNSCC. * Life expectancy less than 3 months. * Known active central nervous system metastases, history of spinal cord compression from tumor involvement, a history of carcinomatous meningitis, or leptomeningeal disease are excluded. * Current active major bleeding, or a recent major bleeding episode within 4 weeks prior to enrollment. * Subject participated in another clinical study or received treatment with another investigational drug must wait at least 5 half-lives of the treatment received or 4 weeks (whichever is shorter) following prior therapy. * Active autoimmune disease requiring systemic treatment in the past 2 years. * Subjects with chronic hepatitis B virus (HBV) infection with active disease who meet the criteria for anti-HBV therapy and are not on a suppressive antiviral therapy prior to initiation of study treatment. * Subjects with a known history of hepatitis C virus (HCV) who have not completed curative antiviral treatment or have an HCV viral load above the limit of quantification at Screening. * Known history of human immunodeficiency virus (HIV). * Receipt of any organ transplantation, including autologous and allogeneic stem cell transplantation, with the exception of transplants that do not require immunosuppression. * Known to be diagnosed and/or treated for any other additional malignancy within 2 years prior to randomization with the exception of the following: curatively treated basal cell carcinoma or squamous cell carcinoma of the skin, and curatively resected in situ cervical cancer, and curatively resected in situ breast cancer, and low-risk early stage prostate cancer. * Any condition requiring systemic treatment with either corticosteroids (\>10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 7 days prior to the first dose of study treatment, except for topical, intranasal, intrabronchial, or ocular steroids. * Use of a live or live attenuated vaccine within 4 weeks prior to Screening.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Site US074
RECRUITINGTyler, Texas, 75702, United States
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- Leftover immunotherapy may boost chemo: new study investigates timing
- New drug cocktail shows promise for tough head and neck cancers