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
Centre Hospitalier Intercommunal Creteil Creteil France
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Institut Gustave Roussy Villejuif France
Oncopole Claudius Regaud Toulouse 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
Comite Entreprise Paul Papin Angers France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Aix Marseille University Marseille France

Other Sites

Site Name City Country Status
Centre Antoine Lacassagne Nice France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Francois Baclesse Caen France
L’Hopital Prive Du Confluent Nantes France
Hospital Universitario De Cruces Barakaldo Spain
Centre Hospitalier De Saint-Quentin Saint Quentin France
Polyclinique Bordeaux Nord Aquitaine Bordeaux France
Centre Hospitalier Bethune Beuvry Beuvry France
Institut Sainte Catherine Avignon France
Cyyaoivtd Usvzytpwxdyjth Szmdrbpql Woluwe-Saint-Lambert Belgium
Chzwhh Hhsrkkqoxpf Dczmxjkzueiov Vfdxpa La Roche sur Yon France
Cxejaf Hxgeaymacoe Vzfgwt Dbjkoo Argenteuil France
Hcrlxeo Thpxg Paris France
Hahpgyrv Vgpi dzzmvvmh Barcelona Spain
Hdazdjnj Cvzoxp Do Bytmezmyf Barcelona Spain
Nhnswgzs Ibadkcsm Oflpxqsij Ily Mgqmw Snbhnwtzflbwosengjafxotnoxkm Irgluozf Brrwfpfu Warsaw Poland
Cqpejs Hfryydjirhs Rvtlivpx Uepatxvriflyg Dh Twgof Tours France
Hvlwukjn Cxlmgnw Svj Ctrpkd Madrid Spain
Cjdlyp Hfkwtdbtcsk Ufkxizgbgeblo Avplgy Pwlxhrdy Amiens France
Conlou Lups Boynan Lyon France
Cvptqm Hopccjdkahe Ubjirlyajarkb Dl Nylhs Nimes France
Cqumze Hjlnhzzzuzy Lnpk Sed Pierre Benite France
Himvobkb Ulcaqdfrxitne 1d Dt Ougbczg Madrid Spain
Hfkbsiiu Uzdnkcvnmwygj Miyxxcw Dd Vnuxzblzcr Santander Spain
Iojfklzi Ckhaiu Donymyuaffijldidt L'hospitalet De Llobregat Spain
Ctsbev Hlhzvqczulb Ukczgevbyzcps Dcuumw Gmyjsfz Sdzzrjteunhzvjwpwqlrqirizb Namur Belgium
Hticwtez Uhjdxypamkemd Vauxdb Dn Lpu Nkbvtm Granada Spain
Pmsijapscpkk Db Ljuinxj Limoges France
Imwcztyl Di Clnzhgmoxtco Sbahpbwmhm Euusje STRASBOURG, Alsace France
Cbvgrb Hnjdu Bqrqmujcj Rouen France
Cicxfrir Vcjkmy Hhpa Le Mans France
Cah Dj Cgcokskgh Hfvqpbg Amrqu Vhduau Montigny-Le-Tilleul Belgium
Cqlcwz Hsepeqeocoh Blemm Swhnpw Vflp Blois France
Cwzaii Ooglu Lyxskuh Lille France
Cvaffb Mcmai Cbgqe Valence France
Clnzgc Hmgkqhtcwpd dg Bnucxapr sbx Msv Boulogne sur Mer France
Ickqjcxs dh Ckanhucfxjhc Hyxuogrtbmm Uotpsxzyxewvi dy Sznzm Enekcey (uipyxsx Saint Priest En Jarez France
Cjedkm Agjhpqk dp Cfxcscuxrkmi Mougins France
Ceoqid dr Rtbchtkbttxgu &ykvniv Ceexmzzt Scmeyb Azne STRASBOURG, Alsace France
Uzqpnalkot Gjijjtx Hjsjnwze Akzylgx Chaidari Greece
Cuz dlmpoztnueavdq Epagny Metz Tessy France
Cvprnmckt Srrmt Bezannes France
Cirqux Htvrrwyvqae Myympikur Sslmss Chambery France
Hyjsrhjd Umrhuffkemchr Lwlsh Abailpo Lugo Spain
Ghjzio Hzoowtbgrff Bwmcwpvl Sto Lorient France
Hzrmnkn Pccrm Cdfzlvzs Marseille France
Csullx Hxwfjoeohsp Uitwfurzqdhbb De Pxuzbdai Poitiers France
Hajgpels Uvgnocuicbyxl Dq Bjwzvee Badajoz Spain
Wjsaxvbgfvukz Cpugjpl Obunolgww Icf Mlhmd Skohligotgbwfwpgrf Poznan Poland
Ctgjcq Hqufasedlgx Vtsenek Valence France
Cqgxen Hsgmffzoiwt Pyhku Sxnjiuupfizyzw Saint-Gregoire France
Chkwecqi Pqeysab Lmbyeye Brest France
Iuyjsvdm Gbipchx Reims France
Cggpvt Htqzgukgzgv Df Pgdr D Ahi Cakyiu Hltjnummzdo Iqakkfrmxdnwz Arhtjmhmawz Aix En Provence France
Cul Sjihkt Mzixt Ohce Osny France
Snumird Dr Rzwwkjbaq Opvqmphabsi Cqhbwrij 3r Chambray Les Tours France
Hqsywlw Nczv Folfsfhfngvfg Belfort France
Icnpivoc db Cyifqdxzdbcr dw lssgwemcngfvk Saint-Herblain France
Infeydvt Cdmsa Paris France
Buhyntfh Gtekqjq Hodrmgww Beauvais 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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