Actively Recruiting
Randomized Phase 2 Trial of Induction Treatment of Anti-PD-1 Pucotenlimab and EGFR-ADC MRG003 Versus EGFR-ADC Alone Followed by Chemoradiotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma
Led by Groupe Oncologie Radiotherapie Tete et Cou · Updated on 2026-04-07
106
Participants Needed
1
Research Sites
17 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
Researchers are evaluating treatments for patients with locally advanced squamous cell carcinoma of the head and neck (LA-HNSCC) who require chemoradiotherapy. This Phase 2 trial compares the effects of an induction treatment using EGFR-ADC MRG003 alone versus a combination of EGFR-ADC MRG003 with the anti-PD-1 drug Pucotenlimab before chemoradiotherapy. The study aims to assess the objective response rate of these treatments to better understand their impact on this condition. Participants are assigned to one of two groups. One group receives three cycles of EGFR-ADC MRG003 alone as induction treatment over 9 weeks, followed by chemoradiotherapy lasting 7 weeks. The other group receives three cycles of both Pucotenlimab and MRG003 combined during the induction period, then chemoradiotherapy, followed by adjuvant Pucotenlimab treatment for 24 weeks starting about one month after chemoradiotherapy ends. Chemoradiotherapy begins within 28 days after completing the induction cycles. During the study, participants undergo imaging assessments to evaluate their tumor response. Researchers will measure the primary outcome, which is the objective response rate approximately 20 months after the first patient is included. Secondary outcomes include progression-free survival, failure-free survival, and overall survival, all assessed one year after the last patient is included. The total participation duration includes induction, chemoradiotherapy, and follow-up for outcome measurement, with safety and response closely monitored throughout.
CONDITIONS
Brief 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 of grade 2 or less according to NCICTCAE v.5
- 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 drugs targeting T-cell co-stimulation or checkpoint pathways
- Treatment with investigational agents or devices within 4 weeks before study treatment
- History of another malignancy within the last 3 years except certain fully resected cancers
- Active cardiovascular disease including recent stroke, myocardial infarction, unstable angina, heart failure class II or higher, or serious arrhythmia requiring medication
- Positive HIV or AIDS diagnosis
- Active or chronic hepatitis B or C infection or other serious liver diseases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 9 weeks
Participants receive 3 cycles of induction treatment with either the combination of anti-PD-1 Pucotenlimab and EGFR ADC MRG003 or EGFR ADC MRG003 alone.
3 treatment visits every 3 weeks
Duration - 7 weeks
Participants undergo chemoradiotherapy starting within 28 ± 7 days after the first day of the third induction cycle.
Weekly treatment visits during chemoradiation
Duration - 24 weeks
Participants receive adjuvant treatment for up to 24 weeks starting one month after the end of chemoradiotherapy (only for those in the combination treatment arm).
Regular visits during adjuvant treatment
Trial Site Locations
Total: 1 location
1
Gustave Roussy
Villejuif, France, 94800
Actively Recruiting
Research Team
M
Marceline EMGOUE
L
Laura SINIGAGLIA
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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