Study of Pucotenlimab with Becotatug Vedotin versus Becotatug Vedotin alone for patients with locally advanced head and neck squamous cell carcinoma

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What is this study about?

This study focuses on patients with locally advanced head and neck squamous cell carcinoma, a type of cancer that develops in the tissues of the head and neck region. The study tests two medications: MRG003, a drug that targets a specific protein called EGFR on cancer cells, and pucotenlimab, a medication that helps the immune system fight cancer cells. Both medications are given through intravenous injection, which means they are delivered directly into the bloodstream through a vein.

The purpose of this research is to determine how well patients respond to treatment when receiving MRG003 alone compared to receiving both MRG003 and pucotenlimab together. After receiving these study medications, all patients will proceed to receive chemoradiotherapy, which combines traditional cancer-fighting drugs with radiation treatment.

During the study, patients will receive the study medications over several weeks. MRG003 is given based on body weight, while pucotenlimab is given at a fixed dose. Doctors will monitor patients’ responses to treatment and check for any side effects throughout the study period. The total treatment period may last up to several months, including the initial medication phase and the following chemoradiotherapy.

1 Initial evaluation

You will undergo evaluation to confirm your eligibility for the trial, including head and neck imaging and laboratory tests

Your hearing ability will be assessed to ensure it meets the required criteria

Your general health status will be evaluated using the ECOG performance scale, which measures your ability to perform daily activities

2 Treatment group assignment

You will be randomly assigned to one of two treatment groups:

Group 1: Treatment with both MRG003 and pucotenlimab

Group 2: Treatment with MRG003 alone

3 Induction treatment phase

You will receive medication through intravenous infusion

The treatment will be administered in cycles

After the last cycle, you will wait 21-28 days before undergoing evaluation

4 Treatment response evaluation

Your response to the induction treatment will be evaluated using head and neck imaging

The medical team will assess if the tumor has responded to the treatment

5 Chemoradiotherapy phase

You will receive cisplatin-based chemotherapy combined with radiation therapy

The treatment schedule and total doses will be determined by your medical team

6 Follow-up period

Regular check-ups will monitor your health and treatment response

Side effects will be tracked using standardized criteria (NCI-CTCAE)

Follow-up will continue until one month after the end of adjuvant treatment

Who Can Join the Study?

  • Age between 18 and 75 years
  • Good physical condition with an ECOG performance status of 0 or 1 (able to carry out all normal activities with minimal restrictions)
  • Confirmed diagnosis of previously untreated advanced head and neck cancer that meets specific staging criteria
  • Tumor that can be measured using CT scan (detailed X-ray imaging) or MRI (magnetic resonance imaging)
  • Must be able to receive treatment with cisplatin (a type of chemotherapy medication)
  • No hearing loss or only mild hearing problems (grade 2 or less)
  • Must have acceptable blood test results within 14 days before starting the study, including:
    • Adequate white blood cell count
    • Adequate platelet count
    • Adequate hemoglobin levels
    • Normal liver function tests
    • Normal kidney function
  • No previous treatments for head and neck cancer, including:
    • No prior chemotherapy
    • No prior immunotherapy
    • No prior targeted therapy
    • No prior radiation therapy
    • No prior surgery in the head and neck area

Who Cannot Join the Study?

  • Previous treatment with EGFR antibody therapy (drugs targeting a specific protein involved in cell growth)
  • Active or untreated brain metastases (cancer that has spread to the brain)
  • History of another cancer within the past 5 years, except for successfully treated non-melanoma skin cancer or cervical cancer in situ
  • Serious heart conditions, including:
    • Uncontrolled high blood pressure
    • Heart attack within past 6 months
    • Unstable heart disease
  • Active autoimmune disease (when body’s immune system attacks healthy cells)
  • Active or chronic infections, including:
    • Hepatitis B
    • Hepatitis C
    • HIV
    • Tuberculosis
  • Pregnant or breastfeeding women
  • Known allergies to study medications or their components
  • Participation in another clinical trial within 30 days before starting this study
  • Any condition that, in the opinion of the study doctor, would make participation unsafe

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Centre de Radiothérapie Guillaume le Conquérant Le Havre France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Regional Et Universitaire De Brest Brest France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Centre Antoine Lacassagne Nice France
Institut Sainte Catherine Avignon France
Institut De Cancerologie Strasbourg Europe STRASBOURG, Alsace France
Centre Henri Becquerel Rouen France
Groupe Hospitalier Bretagne Sud Lorient France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Clinique Victor Hugo Le Mans France
Hopital Nord Franche-Comte Belfort France
Institut de Cancérologie de l’Ouest Saint-Herblain France
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
02.06.2025

Trial locations

Investigated drugs:

Pucotenlimab is a medication that belongs to a group called PD-1 inhibitors. It works by helping your immune system fight cancer cells. This medication is designed to boost your body’s natural defenses against head and neck cancer.

MRG003 is an antibody-drug conjugate (ADC) that specifically targets EGFR (Epidermal Growth Factor Receptor) on cancer cells. This medication is designed to deliver cancer-fighting substances directly to tumor cells while minimizing damage to healthy cells.

Chemoradiotherapy is a combination treatment that includes both chemotherapy (cancer-fighting medications) and radiation therapy. This combined approach is used to treat cancer cells from multiple angles.

Head and Neck Squamous Cell Carcinoma (HNSCC) – A cancer that begins in the squamous cells that line the moist surfaces inside the head and neck regions, including the mouth, nose, and throat. The disease typically starts in the thin, flat cells of the epithelium and can spread to nearby tissues and lymph nodes. In locally advanced stages, the cancer has grown larger or spread to nearby tissues or lymph nodes, but has not spread to distant parts of the body. HNSCC commonly develops gradually and may cause symptoms such as persistent sore throat, difficulty swallowing, voice changes, or lumps in the neck area. The condition can affect various areas of the head and neck region, including the oral cavity, pharynx, larynx, and nasal cavity.

Trial ID:
2023-510558-18-00
Protocol code:
GORTEC 2024-03
Trial Phase:
Therapeutic exploratory (Phase II)

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