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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

NCT06959108 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2026-04-07

No results posted yet for this study

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.

Conditions

  • Locally Advanced Head and Neck Squamous Cell Carcinoma

Interventions

DRUG

Pucotenlimab

200mg every 3 weeks (21-day cycles) for a total of 3 cycles.

DRUG

MRG003

2.3 mg/kg, every 3 weeks (21-day cycles) for a total of 3 cycles.

Sponsors & Collaborators

  • Lepu Medical Technology (Beijing) Co., Ltd.

    collaborator INDUSTRY

  • Groupe Oncologie Radiotherapie Tete et Cou

    lead OTHER

Principal Investigators

  • Jean BOURHIS, Medical Director · GORTEC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-13
Primary Completion
2029-06-30
Completion
2029-10-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06959108 on ClinicalTrials.gov