The primary objective of this study is to compare the objective response rate (ORR) of patients with LA-HNSCC, treated with induction of EGFR-ADC MRG003 and anti PD-1 Pucotenlimab versus EGFR-ADC MRG003 alone before chemoradiotherapy. People eligible to participate in this study must be between the ages of 18 and 75 and have locally advanced squamous cell carcinoma of the head and neck requiring treatment with chemoradiotherapy (cisplatin combined with radiotherapy). Half of the research participants will receive MRG003 alone as induction before radiochemotherapy and the other half will receive MRG003 combined with pucotenlimab as induction before radiochemotherapy, then pucotenlimab as adjuvant\* after radiochemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
106
200mg every 3 weeks (21-day cycles) for a total of 3 cycles.
2.3 mg/kg, every 3 weeks (21-day cycles) for a total of 3 cycles.
Gustave Roussy
Villejuif, France
RECRUITINGobjective response rate
objective response rate evaluated by the investigators with head and neck radiological imaging according to RECIST version 1.1 criteria at the end of induction phase of EGFR-ADC MRG003 + anti-PD-1 Pucotenlimab or EGFR-ADC MRG003 alone
Time frame: around 20 months after the inclusion of the 1st patient
Progression-free survival
Progression-free survival (PFS) as the time from randomization to the first progression (locoregional/metastatic progression after induction, CRT or adjuvant treatment) or death from any cause, or the date of the last follow-up for patients who did not have progression or death
Time frame: 1 year from the inclusion of the last patient
Failure-free survival
Failure-free survival (FFS) as the time from randomization to the first of the following events: locoregional /metastatic progression after the completion of CRT or failure to receive CRT; or death from any case or the date of the last follow-up for patients who did not have these events
Time frame: 1 year from the inclusion of the last patient
Overall survival
Overall survival (OS) defined as the time between randomization and death from any cause or date of the last follow-up for patients alive
Time frame: 1 year from the inclusion of the last patient
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