New drug cocktail aims to stop head and neck cancer return
NCT ID NCT07535567
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether adding the drug benmelstobart to standard radiotherapy and nimotuzumab can help prevent head and neck cancer from coming back after surgery. About 386 patients with intermediate-risk features will be randomly assigned to one of two groups. The main goal is to see if the combination improves how long patients stay cancer-free.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- nimotuzumab and benmelstobart (drugs)
- What this could lead to
- If successful, this could provide a more effective adjuvant treatment option for head and neck cancer patients with intermediate-risk features, potentially improving disease-free survival.
- What could go wrong
- This is an early-phase trial (Phase II/III) that hasn't started recruiting yet. Adding another drug may increase side effects without clear benefit, and results may not apply to all patients.
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 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 386 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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 * ECOG performance status: 0-2 * Histologically confirmed squamous cell carcinoma of the head and neck (oral cavity, oropharynx, larynx); oropharyngeal cancer must be p16-negative (p16 positivity defined as ≥70% staining) * Completionof curative-intent surgery, with any of the following intermediate-risk factors present postoperatively: ①pT3-4a; ②N2 disease (excluding cases with extranodal extension); ③Closemargin \< 5 mm; ④Lymphovascular and/or perineural invasion; ⑤Invasion depth \> 5mm for T2 oral cavity cancer * Laboratory tests must meet the following criteria: ①Hematologic parameters (within 14 days without transfusion or blood products): a. Hemoglobin (Hb) ≥80 g/L; b.Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹/L; c. Platelet count (PLT) ≥ 80 × 10⁹/L; ②Biochemical parameters: a. Bilirubin (BIL) \< 1.5 × upperlimit of normal (ULN); b.Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; * Expected survival time ≥ 6 months; * Women of child bearing potential must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment and agree to use reliable contraception during the study period; Male subjects must use reliable contraception from before treatment initiation until 120 days after the last dose of study drug * With PD-L1 immunohistochemistry testing * Participant voluntarily agrees to participate in this study and signs the informed consent form Exclusion Criteria: * Pregnancy or lactation, or intention to become pregnant during the study period. * Presence of active autoimmune disease or immunodeficiency, including but not limited to: myasthenia gravis, interstitial pneumonia, enteritis, autoimmune hepatitis, hypophysitis, vasculitis, nephritis, or hyperthyroidism. * Known human immunodeficiency virus (HIV) infection, history of autoimmune diseases, or history of organ transplantation. * Use of systemic immunosuppressive drugs within 2 weeks prior to initiation of study treatment, or anticipated need for systemic immunosuppressive therapy during the study treatment period. * Diagnosis of another malignancy within 3 years prior to enrollment. * History of Grade I or higher myocardial ischemia or myocardial infarction, severe arrhythmia, or ≥ Grade 2 congestive heart failure (New York Heart Association \[NYHA\] classification) within 6 months prior to enrollment. * Participation in another clinical trial or completion of another clinical trial within 4 weeks prior to enrollment. * Prior treatment of immunotherapy (including PD-1/PD-L1/CTLA-4 antibodies) or anti-EGFR agents. * Known or suspected allergy to the investigational product or any drug related to this trial. * Any other severe medical condition that, in the investigator's judgment, may compromise patient safety or interfere with the subject's ability to complete the study.
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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 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.
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Other studies related to the condition(s) this trial covers.
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