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.
Patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Evaluable tumor burden assessed by H&N-computed tomography scan (CT-scan) or magnetic resonance imaging (MRI), based on RECIST v 1.1
Patients eligible to cisplatin-based chemotherapy
No hearing loss by clinical assessment or ≤ grade 2 hearing impairment (according to NCICTCAE v.5
Metastatic disease (stage IVC as per AJCC/TNM, 8th Ed.).
Patients having received prior therapy with anti-PD1, anti-PD-L1, anti-PD-L2, anti- CD137, or anti-CTLA-4 antibody (or any other antibody or drug specifically targeting Tcell co-stimulation or checkpoint pathways).
Treatment for other diseases with an investigational agent or use of an investigational device within 4 weeks of the first dose of study treatment
History of another malignancy within the last 3 years prior to randomization, with the exception of completely resected non-melanoma cell skin cancer outside the head and neck area or completely resected stage I breast cancer, or completely resected in-situ nonmuscular invasive bladder, cervix, uterine and/or prostate (Gleason 6) carcinomas, or T1a squamous cell carcinoma of the esophagus or rectum/anus.
Parallel
Pucotenlimab
Drug200mg every 3 weeks (21-day cycles) for a total of 3 cycles.
MRG003
Drug2.3 mg/kg, every 3 weeks (21-day cycles) for a total of 3 cycles.
objective 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
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
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
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
Click on the lead sponsor to view all of their trials.
Groupe Oncologie Radiotherapie Tete et Cou
Lead sponsor
Lepu Medical Technology (Beijing) Co., Ltd.
Collaborator
