Actively Recruiting
Clinical Trial Comparing Induction Treatment With EGFR-ADC MRG003 Alone or in Combination With the Anti PD1 Pucotenlimab, Followed by Radiochemotherapy in Locally Advanced Squamous Cell Cancers of the Head and Neck
Led by Groupe Oncologie Radiotherapie Tete et Cou · Updated on 2026-04-07
106
Participants Needed
1
Research Sites
207 weeks
Total Duration
On this page
Sponsors
G
Groupe Oncologie Radiotherapie Tete et Cou
Lead Sponsor
L
Lepu Medical Technology (Beijing) Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Trial Comparing Induction Treatment With EGFR-ADC MRG003 Alone or in Combination With the Anti PD1 Pucotenlimab, Followed by Radiochemotherapy in Locally Advanced Squamous Cell Cancers of the Head and Neck
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 75 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Evaluable tumor burden assessed by head and neck CT scan or MRI based on RECIST v1.1
- Eligible for cisplatin-based chemotherapy
- No hearing loss or hearing impairment grade 2 or less (NCICTCAE v5)
- No prior chemotherapy, immunotherapy, targeted therapy, radiotherapy, or surgery for head and neck cancer
You will not qualify if you...
- Metastatic disease (stage IVC as per AJCC/TNM, 8th Edition)
- Prior therapy with anti-PD1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibodies or similar agents
- Treatment with investigational agents or devices within 4 weeks before first study dose
- History of malignancy within 3 years except certain resected cancers outside head and neck
- Active cardiovascular disease including stroke, myocardial infarction, unstable angina, congestive heart failure (NYHA Class II or higher), serious arrhythmia requiring medication, or reduced left ventricular ejection fraction below 50%
- Positive test for HIV or AIDS
- Positive test for hepatitis B surface antigen or hepatitis C RNA indicating active or chronic infection
- Serious liver diseases including chronic autoimmune hepatic disorders, primary biliary cirrhosis, or sclerosing cholangitis
AI-Screening
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Trial Site Locations
Total: 1 location
1
Gustave Roussy
Villejuif, France, 94800
Actively Recruiting
Research Team
M
Marceline EMGOUE
CONTACT
L
Laura SINIGAGLIA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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