About this trial
This study is a randomized, open-label, multi-center phase II trial evaluating the efficacy and safety of the becotatug vedotin in combination with pucotenlimab regimen in patients with advanced head and neck squamous cell carcinoma who are intolerant to platinum-based therapy.
Eligibility criteria
Qualifiers
Histologically or cytologically diagnosed as squamous cell carcinoma, with the lesion site located in the oral cavity, oropharynx, hypopharynx, larynx, etc.;
Recurrence and metastasis occurred after previous local treatment (surgery, radiotherapy, or concurrent chemoradiotherapy), with no possibility of cure, and no systemic treatment had been received previously, or previous induction or adjuvant treatment had been received, but the time from the end of the above treatment was ≥ 6 months;
Existence of distant metastasis at the time of initial treatment, or extensive local lesion range, and not curable after MDT assessment;
Patients who cannot tolerate platinum-based chemotherapy or do not accept cisplatin-based chemotherapy; Definition of cisplatin intolerance: Any of the following criteria met: age ≥ 70 years; mild or above hearing impairment; creatinine clearance rate < 50 ml/min (calculated according to the Cockcroft and Gault formula);
Disqualifiers
None
Trial design
Treatments tested in this trial
- Becotatug Vedotin (recombinant humanized anti-EGFR mAb-MMAE conjugate) combined with Pucotenlimab (recombinant humanized anti-PD-1 mAb)
Treatment groups
Locations
Sponsors and collaborators
Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
Lead sponsor
Affiliated Cancer Hospital of Shantou University Medical College
Collaborator
The University of HongKong-Shenzhen Hospital
Collaborator