To evaluate the efficacy and safety of Becotatug Vedotin (EGFR-targeted ADC, MRG003) plus Pucotenlimab (PD-1 inhibitor), compared with platinum-based chemotherapy/chemoradiotherapy, as an induction conversion regimen for downstaging primary stage IVB oral squamous cell carcinoma or HPV16-negative oropharyngeal squamous cell carcinoma.
Eastern Cooperative Oncology Group (ECOG) performance status: 0-1;
Histopathologically confirmed oral/oropharyngeal squamous cell carcinoma, including tumors of the tongue, gingiva, buccal mucosa, floor of mouth, hard palate, retromolar trigone, base of tongue, soft palate, or parapharyngeal region;
Clinical stage IVB (cT1-4N3M0 or cT4bN0-3M0, AJCC 8th edition);
At least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1;
Unresolved toxicity of grade 2 or higher due to prior anticancer therapy;
Known grade 3-4 hypersensitivity reaction to any study treatment;
Active severe clinical infection (>grade 2 infection according to NCI-CTCAE version 5.0);
Uncontrolled hypertension or active cardiovascular disease, including cerebrovascular accident within 6 months before randomization, myocardial infarction within 6 months before randomization, unstable angina, congestive heart failure of New York Heart Association (NYHA; Appendix 5) class II or higher, or a serious arrhythmia that cannot be controlled with medication or may potentially affect study treatment;
Parallel
Becotatug Vedotin (MRG003)
Drug2.3 mg/kg by intravenous infusion once every 21 days
Pucotenlimab
Drug200 mg by intravenous infusion once every 21 days
Cisplatin
Drug75mg/m2 by intravenous infusion once every 21 days
Clinical downstaging rate
The ratio of patients could achieve clinical downstaging after two cycles of drug treatment according to the AJCC 8th edition.
Surgical R0 resection rate
The ratio of R0 resection, complete removal of all grossly visible tumor with no residual tumor cells at the microscopic resection margins, i.e., microscopically negative margins.
Rate of 2-year overall survival
Overall survival is calculated from the date of randomization to death. The rate of 2-year overall survival is reported as the percentage of patients who are overall survival for 2 years from the date of randomization.
Rate of 2-year progression free survival
Progression free survival is calculated from the date of randomization to local tumor recurrence or progression, locoregional recurrence or progression, distant metastasis, or death. The rate of 2-year progression free survival is reported as the percentage of patients who are progression free survival for 2 years from the date of randomization.
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