Brief description of trial (Data source: BASEC)
La radiothérapie associée au Cétuximab est l’un des traitements de référence du cancer de la sphère ORL. Cependant, l’efficacité du Cétuximab en combinaison avec la radiothérapie est insuffisante, ou transitoire, chez une proportion non négligeable de patients. L’objectif de cette étude est de comparer le bénéfice éventuel en termes d’efficacité et de toxicité entre la radiothérapie associée au Pembrolizumab et la radiothérapie associée au Cétuximab.
Le Pembrolizumab est un anticorps monoclonal humanisé conçu pour se fixer à un récepteur appelé PD-1 (Programmed Death-1 c’est-à-dire mort programmée de la cellule -1). En effet, la fixation de PD-L1 (Programmed Death Ligand -1) sur son récepteur PD-1 entraîne la désactivation de certaines cellules de défense naturelle du corps, appelées cellules T, ce qui permet aux cellules cancéreuses d’échapper à l’attaque du système immunitaire. En bloquant le récepteur PD-1, le Pembrolizumab empêche l'inactivation de ces cellules immunitaires et augmente ainsi la capacité du système immunitaire à tuer les cellules cancéreuses.
Le Pembrolizumab est un traitement prometteur. Son efficacité anti-tumorale a été démontrée dans le traitement des cancers. Son utilisation dans le traitement du cancer de la peau (les mélanomes) a été approuvée en Suisse, en Europe et aux Etats-Unis et également dans le traitement du cancer bronchique non à petites cellules (uniquement aux USA).
Utilisé tout seul chez des patients porteurs d’un cancer ORL, il a montré une activité anti-tumorale encourageante, conduisant à poursuivre l’évaluation de son efficacité en combinaison avec la radiothérapie. Cependant, il n’est pas encore approuvé dans le traitement des cancers de la tête et du cou en Suisse.
Health conditions investigated(Data source: BASEC)
Carcinome épidermoïde localement avancé de la tête et du cou
Health conditions
(Data source: WHO)
Squamous Cell Carcinoma of the Head and Neck
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
La moitié des patients recevra le traitement de référence (radiothérapie associée au Cétuximab) et l’autre moitié, le traitement à l’étude (radiothérapie associée au Pembrolizumab).
Interventions
(Data source: WHO)
Drug: Cetuximab
Drug: Pembrolizumab
Radiation: Radiotherapy
Criteria for participation in trial
(Data source: BASEC)
- Age: ≥18 et ≤ 80 ans
- Carcinome épidermoïde localement avancé de la tête et du cou, confirmé histologiquement et non-traité (Stade III, IVa et IVb selon American Joint Committee on Cancer Staging System) d'un ou plusieurs des sites suivants: cavité orale, oropharynx, hypopharynx et larynx.
- Disponibilité de tissu tumoral et de sang avant le traitement (pour l'analyse des biomarqueurs, PD-L1, TILs, analyse de la réponse immunitaire)
Exclusion criteria
(Data source: BASEC)
- Cancer du nasopharynx, des sinus maxillaires ou de la thyroïde
- Cancer épidermoïde impliquant des adénopathies cervicales sans porte d'entrée
- Maladie métastatique
Inclusion/Exclusion Criteria
(Data source: WHO)
Inclusion Criteria:
1. Written informed consent
2. Age =18 = 80 years.
3. Performance Status ECOG 0-1
4. Histologically confirmed diagnosis of previously untreated locally advanced HNSCC
(Stage III, IVa and IVb according to the American Joint Committee on Cancer Staging
System) of one or more of the following sites: oral cavity, oropharynx, hypopharynx
and larynx
5. Availability of pre-treatment tumour tissue (for biomarker analysis, PD -L1, TILs and
immune-monitoring)
6. p16 expression from tumor sample (immunohistochemistry)
7. Recording of the smoking history
8. No viral infection (HIV, Hepatitis B/C)
9. No autoimmune disease
10. No immunodeficiency or immunosuppressive therapy
11. No active CNS disease
12. No interstitial lung disease
13. No active infection
14. Women of child-bearing potential: negative serum pregnancy test at screening and use
of appropriate contraception methods from study entry
15. Patients not proposed cisplatin-based chemotherapy because of age, general condition,
if medically unfit or patient refusal.
16. Adequate organ laboratory values
17. Health insurance coverage
Exclusion Criteria:
1. Nasopharyngeal, paranasal sinuses, nasal cavity tumours or thyroid cancers;
2. Squamous cell cancer involving cervical neck nodes with unknown primary site;
3. Metastatic disease;
4. Any prior or current treatment for invasive head and neck cancer. This will include
but is not limited to: prior tyrosine kinase inhibitors, any monoclonal antibody,
prior neoadjuvant therapy, prior surgical resection, or use of any investigational
agent;
5. Weight loss of >10% during the last 3 weeks prior the screening visit;
6. Concurrent treatment with any other systemic anti-cancer therapy that is not specified
in the protocol;
7. Concomitant treatment with any drug on the prohibited medication list such as live
vaccines (for details, see the protocol);
8. History of another malignancy within the last 3 years (exception of in situ carcinoma
and skin carcinomas);
9. If female, pregnant or lactating;
10. Significant disease which, in the judgment of the investigator, as a result of the
medical interview, physical examinations, or screening investigations would make the
patient inappropriate for entry into the trial.
11. Known hypersensitivity reaction to study medication;
12. Any social, personal, medical and/or psychologic factor(s) that could interfere with
the observance of the patient to the protocol and/or the follow-up and/or the
signature of the informed consent.
Minimum age: 18 Years
Maximum age: 80 Years
Sex: All
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Further information on trial
Date trial registered
Feb 29, 2016
Incorporation of the first participant
May 18, 2016
Recruitment status
Not recruiting
Academic title
(Data source: WHO)
A Phase II Randomized Study to Determine the Tolerance and Efficacy of Pembrolizumab or Cetuximab Combined With Radiation Therapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase
(Data source: WHO)
Phase 2
Primary end point
(Data source: WHO)
Locoregional Control
Secundary end point
(Data source: WHO)
Acute adverse events
Compliance to Pembrolizumab and Cetuximab
Delayed toxicity According to RTOG late toxicity scale
Duration of the feeding tube dependence
Health related quality of life (QL)
Impact of p16 / HPV tumor status on the efficacy of the 2 regimens in patients with oropharyngeal initial tumor
Locoregional progression and distant metastasis
Overall survival
Progression free survival
Contact information
(Data source: WHO)
Please refer to primary and secondary sponsors
Trial results
(Data source: WHO)
Results summary
no information available yet
Link to the results in the primary register
no information available yet
Information on the availability of individual participant data
no information available yet
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Lausanne
Countries
(Data source: WHO)
Switzerland might not appear as site of trial if it has not yet been entered as such in the WHO primary registry.
France
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
E. Mahmut Ozsahin
+41 21 314 46 03
mahmut.ozsahin@chuv.ch
Contact for general information
(Data source: WHO)
Jean Pr BOURHIS, MD
CHU Vaudois, Rue du Bugnon 46, CH-1011 Lausanne, Suisse
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Commission
cantonale d’Éthique de la Recherche sur l’être humain Vaud (CER-VD)
Date of authorisation by the ethics committee
09.12.2016
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2016-01552
Secondary ID (Data source: WHO)
GORTEC 2015-01
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