OncoMatch/Clinical Trials/NCT07632339
Becotatug Vedotin Combined With Pucotenlimab for Locally Recurrent Resectable Head and Neck Squamous Cell Carcinoma
Is NCT07632339 recruiting? Yes, currently enrolling (Jul 2026). This Phase 2 trial studies Becotatug Vedotin combined with Pucotenlimab for head and neck cancer.
Treatment: Becotatug Vedotin combined with Pucotenlimab — This is a multicenter, randomized, controlled, Phase II clinical study designed to evaluate the efficacy and safety of neoadjuvant and adjuvant therapy with vebikotamab combined with Pucotenlimab compared to standard treatment in patients with locally recurrent resectable head and neck squamous cell carcinoma (HNSCC). Investigational Arm: The dosing regimen for the investigational arm is as follows: Pucotenlimab: 200 mg per dose, administered intravenously (IV) every 3 weeks (Q3W). No dose adjustments are permitted; however, dosing delays are allowed up to a maximum of 12 weeks from the date of the previous dose. This is administered for two preoperative cycles. Becotatug Vedotin: 2.3 mg/kg, administered IV Q3W for two preoperative cycles. Following neoadjuvant therapy, patients will undergo surgery at 4 weeks ± 7 days. Postoperatively (at 6 weeks ± 3 weeks), patients will be stratified for adjuvant therapy based on pathological response: Patients who achieve a major pathological response (MPR) and have no high-risk factors will receive 6 cycles of single-agent adjuvant Pucotenlimab (200 mg/dose, Q3W). Patients who do not achieve MPR or who present with high-risk factors will receive standard postoperative adjuvant therapy. Control Arm: Patients in the control arm will undergo upfront surgery followed by standard adjuvant therapy.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) expression (testing required; no eligibility threshold specified)
Availability of tumor tissue for PD-L1 testing (paraffin-embedded specimens collected within 2 years or fresh tumor tissue)
Disease stage
Excluded: Stage IVB, IVC
Performance status
ECOG 0–1(Restricted strenuous activity)
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Demographics
Prior therapy
Cannot have received: systemic antineoplastic therapy for recurrent disease
Patients must not have received any prior systemic antineoplastic therapy for the recurrent disease
Cannot have received: PD-1/PD-L1/PD-L2/CTLA-4 antibody or agent targeting T-cell activating/inhibitory receptors
Prior treatment with PD-1/PD-L1/PD-L2/CTLA-4 antibodies, or agents targeting activating or inhibitory receptors on T cells (e.g., OX40, CD137)
Cannot have received: antibody-drug conjugate with MMAE payload
Prior treatment with antibody-drug conjugates (ADCs) bearing an MMAE payload
Cannot have received: systemic therapy for locally advanced disease
Exception: permitted if ≥6 months have elapsed from completion to consent
Prior systemic therapy as part of a multimodality treatment for locally advanced disease is permitted, provided that ≥6 months have elapsed from the completion of such therapy to the signing of the informed consent form
Cannot have received: re-irradiation to head and neck region
Exception: within 6 months prior to enrollment
Re-irradiation to the head and neck region (including cervical, supraclavicular, and infraclavicular lymph nodes) within 6 months prior to enrollment
Cannot have received: concurrent antineoplastic therapy
concurrent receipt of any other antineoplastic therapy
Lab requirements
Blood counts
ANC ≥1.5×10⁹/L, platelets ≥100×10⁹/L, hemoglobin ≥9 g/dL (no transfusions within 14 days prior to screening)
Kidney function
Serum creatinine ≤1.5 × ULN and calculated creatinine clearance ≥50 mL/min (Cockcroft-Gault formula)
Liver function
Serum total bilirubin (TBIL) ≤1.5 × ULN, AST and ALT ≤2.5 × ULN (≤5 × ULN if hepatic metastasis present)
Cardiac function
Normal ECG or ECG abnormalities with no clinical significance; LVEF >50% by echocardiography
Adequate organ function, defined as follows (assessed within 14 days prior to the first dose of the investigational product): Bone Marrow: ANC ≥1.5×10⁹/L, platelets ≥100×10⁹/L, hemoglobin ≥9 g/dL (no blood transfusions or blood component therapy within 14 days prior to screening); Liver & Kidney: Serum total bilirubin (TBIL) ≤1.5 × ULN, AST and ALT ≤2.5 × ULN (if hepatic metastasis is present, AST and ALT ≤5 × ULN are allowed). Serum creatinine ≤1.5 × ULN and calculated creatinine clearance ≥50 mL/min (using the Cockcroft-Gault formula); Cardiac Function: Normal cardiac function, defined as a normal electrocardiogram (ECG) or ECG abnormalities with no clinical significance, and left ventricular ejection fraction (LVEF) >50% as determined by echocardiography.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07632339 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic antineoplastic therapy for recurrent disease, PD-1/PD-L1/PD-L2/CTLA-4 antibody or agent targeting T-cell activating/inhibitory receptors, antibody-drug conjugate with MMAE payload disqualifies patients from enrollment.
Does this trial require CD274?
Yes, CD274 expression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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