Neoadjuvant Becotatug Vedotin Plus Pucotenlimab in Locally Advanced Oral and Oropharyngeal Squamo… (NCT07545083) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Neoadjuvant Becotatug Vedotin Plus Pucotenlimab in Locally Advanced Oral and Oropharyngeal Squamous Cell Carcinoma (OSCC)
26 participantsStarted 2026-04
Plain-language summary
The purpose of this study is to evaluate the effectiveness and safety of the combination therapy of Becotatug Vedotin with Pucotenlimab as a possible neoadjuvant therapyand for locally advanced oral/pharyngeal squamous cell carcinoma.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Participants must have histologically or cytologically confirmed oral/oropharyngeal squamous cell carcinoma (including tongue, lips, gums, cheeks, floor of mouth, hard palate, soft palate, posterior molar area, lateral pharyngeal wall, posterior pharyngeal wall, tonsils). PD-L1 expression score (CPS score) \>1, EGFR expression score (IHC) \>90%+.
* Participants must diagnosed with clinical staging III or IVa (AJCC, 8th edition), without evidence of distant metastasis (M0) based on PET/CT or chest, abdominal and pelvic CT scans, and standard treatment is recommended, including surgical resection and adjuvant radiotherapy+/- chemotherapy.
* Age ranges from 18 to 75 years old.
* ECOG performance status 0 or 1.
* Expected survival ≥ 3 months.
* Participants must have not received treatment for before.
* There must be at least one clinically assessable lesion according to the RECIST V1.1 criteria prior to treatment.
* The participants may have any human papillomavirus (HPV) status of the tumor. Patients with oropharyngeal cancer need to undergo HPV testing, including p16 immunohistochemistry and/or confirmatory HPV polymerase chain reaction (PCR) or in situ hybridization (ISH) testing.
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation, and continue contraception for 12 months after the end of treatment. …