Loading clinical trials...

NOT_YET_RECRUITINGPHASE2

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

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 (LA-SCCHN).

NCT06959108•Groupe Oncologie Radiotherapie Tete et Cou

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.

Key Dates

Start Date

October 1, 2025

Primary Completion Date

June 1, 2029

Completion Date

October 1, 2029

Last Updated

September 2, 2025

Enrollment

106

ESTIMATED participants

Conditions

Locally Advanced Head and Neck Squamous Cell Carcinoma

Interventions

Pucotenlimab

DRUG

MRG003

DRUG

Contacts

Marceline EMGOUE

CONTACT

02 42 06 02 56 marceline.emgoue@gortec.fr

Laura SINIGAGLIA

CONTACT

02 42 06 01 86

Low-Dose Radiotherapy and Anti-PD-1 Immunotherapy as Neoadjuvant Treatment for Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma

NCT07371234

Locally Advanced Head and Neck Squamous Cell Carcinoma

View study

COMPLETEDNA

Group-Mediated Cognitive Behavioral Resistance Exercise Intervention in Head and Neck Cancer Patients Undergoing Chemoradiation Treatment

NCT04733495

Locally Advanced Head and Neck Squamous Cell Carcinoma

View study

COMPLETEDPHASE2

Sodium Thiosulfate in Preventing Ototoxicity for Squamous Cell Cancer Patients Undergoing Chemoradiation With Cisplatin

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 2, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Low-Dose Radiotherapy and Anti-PD-1 Immunotherapy as Neoadjuvant Treatment for Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma

Group-Mediated Cognitive Behavioral Resistance Exercise Intervention in Head and Neck Cancer Patients Undergoing Chemoradiation Treatment

Sodium Thiosulfate in Preventing Ototoxicity for Squamous Cell Cancer Patients Undergoing Chemoradiation With Cisplatin

Home Sleep Apnea Machine in Evaluating Obstructive Sleep Apnea in Patients With Stage III-IV Head and Neck Cancer

A Real-world Study of the Efficacy and Safety of Nimotuzumab in Combination With Chemoradiotherapy for LASCCHN