OncoMatch/Clinical Trials/NCT07814287
Becotatug Vedotin Plus Pucotenlimab and Platinum Chemotherapy in Locally Advanced Epidermal Growth Factor Receptor (EGFR)-Positive Head and Neck Squamous Cell Carcinoma
Official title: Becotatug Vedotin Plus Pucotenlimab and Platinum Chemotherapy in Locally Advanced Epidermal Growth Factor Receptor (EGFR)-Positive Head and Neck Squamous Cell Carcinoma: A Phase II Prospective Single-Arm Multicenter Trial
Is NCT07814287 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies Becotatug Vedotin, Pucotenlimab, and Cisplatin for head and neck squamous cell carcinoma, hnscc.
Treatment: Becotatug Vedotin, Pucotenlimab, and Cisplatin — This prospective, single-arm, multicenter phase II trial aims to evaluate the efficacy and safety of neoadjuvant beccotatug vedotin combined with pucotenlimab and cisplatin in patients with locally advanced epidermal growth factor receptor (EGFR)-positive head and neck squamous cell carcinoma (HNSCC). A total of 40 treatment-naive patients aged 18-70 years with stage III-IV (AJCC 8th edition) EGFR-positive HNSCC will be enrolled. Participants will receive three 3-week cycles of the triple-drug regimen. Tumor response will be reassessed after cycle 3 using RECIST v1.1. Patients achieving a complete or partial response (CR/PR) may proceed to de-escalation surgery followed by definitive chemoradiotherapy, or to definitive chemoradiotherapy alone; non-responders will undergo radical surgery with or without radiotherapy/chemoradiotherapy, or definitive chemoradiotherapy, as determined by multidisciplinary team (MDT) discussion. The primary endpoint is objective response rate (ORR). Secondary endpoints include major pathological response (MPR), pathological complete response (pCR), disease control rate (DCR), 2-year progression-free survival (PFS), 2-year overall survival (OS), quality of life, and safety. This study aims to provide preliminary evidence on the feasibility and activity of this novel triple combination in the neoadjuvant setting, potentially offering a new treatment paradigm to improve long-term outcomes and reduce recurrence.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) any tested (testing required; no eligibility threshold specified)
Required: EGFR expression
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: anti-PD-1 therapy
Prior therapy with anti-PD-1 ... antibodies (or any other agents targeting T-cell co-stimulation or checkpoint pathways)
Cannot have received: anti-PD-L1 therapy
Prior therapy with ... anti-PD-L1 ... antibodies (or any other agents targeting T-cell co-stimulation or checkpoint pathways)
Cannot have received: anti-PD-L2 therapy
Prior therapy with ... anti-PD-L2 ... antibodies (or any other agents targeting T-cell co-stimulation or checkpoint pathways)
Cannot have received: anti-CTLA-4 therapy
Prior therapy with ... anti-CTLA-4 antibodies (or any other agents targeting T-cell co-stimulation or checkpoint pathways)
Lab requirements
Blood counts
wbc ≥4,000/μl, anc ≥2,000/μl, hemoglobin ≥9 g/dl, platelets ≥100,000/μl
Kidney function
serum creatinine ≤1.5×uln or calculated creatinine clearance ≥60 ml/min (cockcroft-gault)
Liver function
bilirubin ≤1.5×uln (or ≤3×uln if known gilbert's syndrome), ast and alt ≤3×uln, alkaline phosphatase ≤3×uln, albumin ≥3 g/dl
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07814287 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require CD274?
Yes, CD274 any tested is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR expression is a required biomarker for enrollment.
What disease stage is eligible?
Stage III or IV is required.
Is there an age limit?
Yes. Patients must be 70 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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