Study on Adding Nivolumab to Cisplatin and Radiotherapy for High-Risk Patients with Head and Neck Squamous Cell Carcinoma

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What is this study about?

This clinical trial is focused on studying a type of cancer called squamous cell carcinoma of the head and neck. This cancer affects areas such as the mouth, throat, and voice box. The study is testing a treatment that combines two medications: nivolumab and cisplatin, along with radiotherapy. Nivolumab is a medication that helps the immune system fight cancer, while cisplatin is a chemotherapy drug that kills cancer cells. The purpose of the study is to see if adding nivolumab to the standard treatment of cisplatin and radiotherapy can improve outcomes for patients.

Participants in the study will receive treatment through an infusion, which means the medication is given directly into the bloodstream through a vein. The study will compare the effects of the combination of nivolumab and cisplatin with radiotherapy to the effects of cisplatin and radiotherapy alone. Some participants will receive a placebo instead of nivolumab to help researchers understand the true effects of the medication. The study will last for several months, and participants will have regular check-ups and imaging tests to monitor their health and the progress of the cancer.

The main goal is to determine if the combination treatment can help patients live longer without the cancer coming back. Researchers will also look at overall survival rates and any side effects that may occur. This study is important because it could lead to better treatment options for people with high-risk squamous cell carcinoma of the head and neck who have already had surgery to remove the cancer.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, medical history, and recovery from surgery.

The study focuses on patients with squamous cell carcinoma of the head and neck who have undergone surgery.

2 treatment preparation

Radiotherapy is planned to start within 4 to 9 weeks after surgery. An additional week may be allowed if necessary due to healing or logistical issues.

The treatment involves a combination of medications and radiotherapy.

3 medication administration

The treatment includes cisplatin and nivolumab, both administered through intravenous infusion.

Cisplatin is provided as a 1 mg/ml solution for infusion.

Nivolumab is provided as a 10 mg/ml concentrate for infusion.

4 treatment process

The main objective is to evaluate the effectiveness of adding nivolumab to the standard treatment of cisplatin and radiotherapy.

The primary goal is to assess disease-free survival, which is the time from the start of the study until any recurrence of cancer or death.

5 monitoring and follow-up

Regular monitoring is conducted to assess overall survival and any side effects.

Secondary objectives include evaluating the incidence of new cancers and the safety of the treatment.

6 study duration

The study is expected to continue until December 2029.

Participants are monitored throughout the study to ensure safety and effectiveness of the treatment.

Who Can Join the Study?

  • Must be between 18 and 75 years old.
  • Must have a type of cancer called squamous cell carcinoma in the head and neck area, which has been treated with surgery.
  • Cancer must be classified as stage III or IV, or stage II for a specific type of throat cancer with certain conditions, according to a cancer classification system.
  • Must have had a complete removal of the visible tumor during surgery.
  • Must currently be free of any disease.
  • Must have recovered from surgery enough to start treatment with a combination of chemotherapy and radiotherapy.
  • Radiotherapy should be planned to start 4 to 9 weeks after surgery, with a possible extension of 1 week if needed.
  • Must have a high risk of cancer coming back, based on specific criteria like tumor spread beyond its capsule, nerve invasion, multiple lymph node involvement, or close surgical margins.
  • Must have a suitable tumor sample available for testing certain markers related to the immune system.
  • Must have a Performance Status of 0-1, which means being fully active or having some symptoms but still able to carry out light work.
  • Must provide written consent to participate in the study.
  • Must provide information about alcohol use and smoking history.
  • Cancer must be confirmed through a tissue examination and originate from specific areas like the mouth, throat, or voice box.

Who Cannot Join the Study?

  • Patients who have not had surgery to remove the squamous cell carcinoma in the head and neck area. Squamous cell carcinoma is a type of skin cancer that can also occur in the lining of certain organs.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.

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
Hospital Universitario De Navarra Pamplona Spain
Centre Jean Perrin Clermont Ferrand France
Institut De Cancerologie De Lorraine Vandoeuvre Les Nancy France
Centre de Radiothérapie Guillaume le Conquérant Le Havre France
Centre Radiothérapie de Blois La Chaussée Saint Victor France
Centre Hospitalier Intercommunal Creteil Creteil France
Comite Entreprise Paul Papin Angers France
Hospital Clinico San Carlos Madrid Spain
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Oncopole Claudius Regaud Toulouse France
Aix Marseille University Marseille France

Other Sites

Site Name City Country Status
Centre Antoine Lacassagne Nice France
Centre Hospitalier Victor Dupouy Argenteuil France
Hopital Tenon Paris France
Centre Hospitalier Universitaire De Nimes Nimes France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital Universitario 12 De Octubre Madrid Spain
Wielkopolskie Centrum Onkologii Im. Marii Sklodowskiej-Curie Poznan Poland
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
Institut Sainte Catherine Avignon France
Hospital Universitario Virgen De Las Nieves Granada Spain
Centre Hospitalier Prive Saint-Gregoire Saint-Gregoire France
Clinique Pasteur Lanroze Brest France
Institut Godinot Reims France
CHP Sainte Marie Osny Osny France
Centre Hospitalier Bethune Beuvry Beuvry France
Centre Hospitalier Du Pays D Aix Centre Hospitalier Intercommunal Aix-Pertuis Aix En Provence France
Polyclinique De Limoges Limoges France
Institut De Cancerologie Strasbourg Europe STRASBOURG, Alsace France
Centre Henri Becquerel Rouen France
Centre Hospitalier Blois Simone Veil Blois France
Hospital Clinic De Barcelona Barcelona Spain
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy Warsaw Poland
Hospital Universitario De Cruces Barakaldo Spain
Centre Hospitalier Metropole Savoie Chambery France
Hospital Universitario Lucus Augusti Lugo Spain
Centre Hospitalier Universitaire De Nantes Nantes France
Groupe Hospitalier Bretagne Sud Lorient France
Centre Hospitalier De Saint-Quentin Saint Quentin France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Hopital Prive Clairval Marseille France
Centre Hospitalier Simone Veil De Beauvais Beauvais France
Polyclinique Bordeaux Nord Aquitaine Bordeaux France
Societe De Recherche Oncologique Clinique 37 Chambray Les Tours France
Clinique Victor Hugo Le Mans France
Hopital Nord Franche-Comte Belfort France
Institut de Cancérologie de l’Ouest Saint-Herblain France
Centre Francois Baclesse Caen France
L’Hopital Prive Du Confluent Nantes France
Cldmjxykz Uidedyqsiskypg Szvhmoctf Woluwe-Saint-Lambert Belgium
Causbxtfr Sshlb Bezannes France
Coigvu Lxpv Boatai Lyon France
Hduzysbg Ugvndvsoameln Mjmiduy Dm Vcgybveosf Santander Spain
Iosweavq Ckafxs Dnfahszvfispgdjuu L'hospitalet De Llobregat Spain
Hvpjxxnl Uygfjyryzhajm Dg Burdlbx Badajoz Spain
Casimy Hejtnpbgevm Vlolxlu Valence France
Cge Dr Cxvwmlywu Htpwman Aigwl Vrvpmo Montigny-Le-Tilleul Belgium
Cwa dwvgvzdmqkwnag Epagny Metz Tessy France
Crpipt Mkpll Cmjts Valence France
Chvfeh Hwslxnyapel dq Bdjusgyp sbz Mzp Boulogne sur Mer France
Cymucn Ailraoy dy Cccktxwpohqo Mougins France
Cnctwh do Rogguzdhdmlel &jyblox Ctmhdxxb Szrllg Aefq STRASBOURG, Alsace France
Cijcpr Haastnjqzvo Rsayxarf Ufxxptaquhrbx Dn Tmsmn Tours France
Upjvmbumve Giiunmx Hiigcsiz Avonxup Chaidari Greece
Ivhaxnab do Cmbkjaxasoms Haxnvuyynep Ujrpdfzuwczoj db Silos Epwkxcq (qsighlr Saint Priest En Jarez France
Hmzlojib Vktb dramofbt Barcelona Spain
Cfcjji Oapoo Ldvrspb Lille France
Ipazxmkx Cxroy Paris France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
13.06.2024
France France
Not recruiting
13.06.2024
Greece Greece
Not recruiting
13.06.2024
Poland Poland
Not recruiting
13.06.2024
Spain Spain
Not recruiting
13.06.2024

Trial locations

Investigated drugs:

Nivolumab is a medication used in this trial to help the body’s immune system attack cancer cells. It is an immunotherapy drug that works by blocking a protein called PD-1, which can prevent the immune system from effectively fighting cancer. In this trial, it is used after surgery in patients with high-risk squamous cell carcinoma of the head and neck to see if it can improve outcomes when combined with other treatments.

Cisplatin is a chemotherapy drug used in this trial to kill cancer cells. It works by damaging the DNA of the cancer cells, which prevents them from dividing and growing. In this study, cisplatin is used in combination with radiation therapy to enhance the treatment’s effectiveness against squamous cell carcinoma of the head and neck.

Radiation Therapy (RT) is a treatment that uses high-energy rays to target and destroy cancer cells. In this trial, radiation therapy is used alongside cisplatin to treat patients who have had surgery for squamous cell carcinoma of the head and neck. The goal is to eliminate any remaining cancer cells and reduce the risk of the cancer returning.

Squamous Cell Carcinoma of the Head and Neck – This is a type of cancer that originates in the squamous cells lining the moist surfaces inside the head and neck, such as the mouth, nose, and throat. It typically begins as a small, localized growth that can gradually expand and invade nearby tissues. Over time, it may spread to lymph nodes in the neck and potentially to other parts of the body. The progression of this cancer can vary, with some cases remaining localized while others become more aggressive. Symptoms often include a persistent sore throat, difficulty swallowing, and changes in voice. Early detection and monitoring are crucial for managing its progression.

Trial ID:
2024-513206-65-00
Protocol code:
GORTEC 2018-01
Trial Phase:
Therapeutic confirmatory (Phase III)

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