Clinical Trial Comparing Induction Treatment With EGFR-AD... | NCT06959108

NCT06959108

ID	Type	Description	Link
2023-510558-18-00	EU Trial (CTIS) Number

Status Module

Name	Class
Lepu Medical Technology (Beijing) Co., Ltd.	INDUSTRY

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pucotenlimab-MRG003	Experimental	Induction treatment (9 weeks): 3 cycles of the anti-PD-1 Pucotenlimab in combination with the EGFR ADC MRG003 Concurrent chemoradiation (7 weeks). The CRT will start within 28 ± 7 days after the Day 1 of the third cycle of the EGFR ADC MRG003. Adjuvant treatment (24 weeks from one month after the end of CRT).	Drug: Pucotenlimab Drug: MRG003
MRG003 alone	Active Comparator	Induction treatment ( 9 weeks): 3 cycles of the EGFR ADC MRG003 alone Concurrent chemoradiation (7 weeks). The CRT will start within 28 ± 7 days after the Day 1 of the third cycle of the EGFR ADC MRG003.	Drug: MRG003

Name	Type	Description	Arm Group Labels	Other Names
Pucotenlimab	Drug	200mg every 3 weeks (21-day cycles) for a total of 3 cycles.	Pucotenlimab-MRG003

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	around 20 months after the inclusion of the 1st patient

Secondary Outcomes

Measure	Description	Time Frame
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	1 year from the inclusion of the last patient

Eligibility Module

Eligibility Criteria

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.

Name	Role	Phone	Extension	Email
Marceline EMGOUE	Contact	02 42 06 02 56	+33	marceline.emgoue@gortec.fr
Laura SINIGAGLIA	Contact	02 42 06 01 86	+33