Locally Advanced Head and Neck Squamous Cell Carcinoma
Conditions
Brief summary
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.
Interventions
DRUGPucotenlimab
200mg every 3 weeks (21-day cycles) for a total of 3 cycles.
DRUGMRG003
2.3 mg/kg, every 3 weeks (21-day cycles) for a total of 3 cycles.
Sponsors
Lepu Medical Technology (Beijing) Co., Ltd.
Groupe Oncologie Radiotherapie Tete et Cou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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 * No prior treatment with chemotherapy, immunotherapy and targeted therapy for H&N cancer, radiotherapy or surgery in the head and neck region.
Exclusion criteria
* 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. * Patients with clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (\< 6 months prior to enrollment), myocardial infarction (\< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication, or known persistent reduced left ventricular ejection fraction \< 50%. * Patients with positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). * Patients with positive tests for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating active or chronic infection. Presence of other serious liver diseases, including chronic autoimmune hepatic disorders, primary biliary cirrhosis or sclerosing cholangitis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| objective response rate | around 20 months after the inclusion of the 1st patient | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 1 year from the inclusion of the last patient | 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 |
| Overall survival | 1 year from the inclusion of the last patient | Overall survival (OS) defined as the time between randomization and death from any cause or date of the last follow-up for patients alive |
| Failure-free survival | 1 year from the inclusion of the last patient | 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 |
Contacts
Primary ContactMarceline EMGOUE
Backup ContactLaura SINIGAGLIA
Outcome results
None listed