New triple therapy aims to wipe out head and neck tumors before surgery
NCT ID NCT07393477
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a combination of three drugs (becotatug vedotin, pucotenlimab, and cisplatin) given before surgery can shrink or eliminate tumors in people with advanced head and neck cancer. About 30 adults aged 18-70 with stage III/IVA disease who have not had prior treatment will receive the therapy for 6-12 weeks. Researchers will check how many patients have no cancer cells left after treatment and how long they stay cancer-free.
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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 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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May 2029
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 to 70 years
- 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: 1. Aged 18-70 years (inclusive). 2. Histopathologically confirmed Stage III/IVA head and neck squamous cell carcinoma (HNSCC) of the oropharynx, oral cavity, hypopharynx, or larynx (per 8th edition AJCC Cancer Staging Manual). 3. Measurable primary lesions per RECIST v1.1. 4. Treatment-naive (no prior anti-tumor therapy for current disease). 5. ECOG performance status 0-1. 6. Eligible for elective standard surgery plus adjuvant chemoradiotherapy/radiotherapy (investigator-assessed). 7. No active autoimmune diseases. 8. No concurrent malignant tumors. 9. Estimated life expectancy \>= 6 months. 10. Available tumor tissue for PD-L1 IHC testing (22C3 DAKO assay). 11. Adequate hematological function (screening): ANC \>= 1.5×10⁹/L, platelets \>= 100×10⁹/L, Hb \>= 100 g/L, WBC \>= 3.5×10⁹/L; no blood transfusion or bleeding tendency within 7 days. 12. Normal liver function: ALT, AST, ALP, serum bilirubin \<= 1.5×ULN. 13. Normal renal function: Serum Cr \<= 1.5×ULN or creatinine clearance \> 60 mL/min. 14. HPV status confirmed by p16 IHC and in situ hybridization (ISH). 15. Voluntary participation with signed informed consent; legal guardian-signed consent for incompetent subjects, and witness-supervised consent for illiterate subjects. Exclusion Criteria: 1. Cachexia or multiple organ failure. 2. Active autoimmune disease of any type. 3. Concomitant second primary malignancy (e.g., esophageal cancer). 4. Severe active infection requiring systemic therapy. 5. Uncontrolled serious medical conditions interfering with study treatment (e.g., severe heart/cerebrovascular disease, uncontrolled diabetes/hypertension, active peptic ulcer). 6. Dementia, altered mental status, or other conditions impairing informed consent or questionnaire completion. 7. Peripheral neuropathy \>= Grade 2 per CTCAE v5.0. 8. Hearing impairment \>= Grade 2 per CTCAE v5.0. 9. History of malignancy within 5 years prior to screening. 10. Known HIV-positive status or diagnosed AIDS. 11. Nasopharyngeal carcinoma or HNSCC at sites other than oral cavity, oropharynx, larynx, hypopharynx (e.g., paranasal sinuses, unknown primary). 12. Receipt of investigational drugs or participation in other interventional trials within 30 days prior to screening. 13. Systemic glucocorticoids (\>10 mg prednisone equivalent/day) or other immunosuppressants within 14 days prior to randomization (inhaled/topical steroids and adrenal hormone replacement are permitted without active autoimmune disease). 14. Pregnant/lactating women; subjects of childbearing potential refusing contraception. 15. Active infection requiring treatment or systemic anti-infective use within 1 week prior to first dose. 16. Live vaccine administration within 30 days prior to first dose. 17. Vulnerable populations (e.g., mental illness, cognitive impairment, critically ill status). 18. Other conditions deemed unsuitable for enrollment by the investigator.
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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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Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a glowing dye show surgeons where head and neck tumors end?
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- Can a Four-Part combo before surgery wipe out head and neck tumors?
- Can a new drug shrink advanced solid tumors?