Zusammenfassende Beschreibung der Studie (Datenquelle: BASEC)
La présente étude a pour objectif d'évaluer l'efficacité de l'ajout de nivolumab (immunothérapie) au traitement standard de référence pour un cancer de la bouche ou de la gorge précédemment traité par chirurgie qui présente un risque élevé de rechute.
Le traitement standard combine la radiothérapie (traitement par les rayons X) et la chimiothérapie par cisplatine.
Le nivolumab est un anticorps monoclonal anti-PD-1, capable de stimuler la réponse immunitaire contre les cellules tumorales. Cette efficacité a été observée pour des cancers de la bouche ou de la gorge à un stade très avancé. Cette étude a pour but d’évaluer si un bénéfice peut aussi être observé dans une situation nettement moins évoluée.
Ainsi, l'étude comparera les données de deux groupes de patients. Le premier groupe recevra le traitement standard (radiothérapie+cisplatine) et le deuxièeme groupe recevra le traitement standard + le nivolumab. Les participants seront distribués au hasard dans l'un de ces deux groupes et en seront informés avant le début du traitement.
Untersuchte Krankheiten(Datenquelle: BASEC)
cancer épidermoïde localement avancé de la tête et du cou
Health conditions
(Datenquelle: WHO)
Squamous Cell Carcinoma of Head and Neck
Seltene Krankheit
(Datenquelle: BASEC)
Nein
Untersuchte Intervention (z.B. Medikament, Therapie, Kampagne)
(Datenquelle: BASEC)
Traitement combinant le nivolumab (immunothérapie) au traitement standard cisplatine (chimiothérapie) + radiothérapie
- Bras A: radiothérapie+cisplatine
- Bras B: nivolumab+radiothérapie+cisplatine
Interventions
(Datenquelle: WHO)
Drug: Cisplatin
Drug: Nivolumab
Radiation: RT
Kriterien zur Teilnahme an der Studie
(Datenquelle: BASEC)
- Agé de 18 à 75 ans
- Statut de performance ECOG de 0 ou 1
- Cancer épidermoïde de la tête et du cou histologiquement confirmé (cavité orale, oropharynx ou larynx)
Ausschlusskriterien
(Datenquelle: BASEC)
- Cancer du nasopharynx, des sinus paranasaux, tumeurs de la cavité nasale ou cancer de la tyroïde
- Cancer incluant des ganglions lymphatiques du cou avec un site primaire inconnu
- Cancer métastatique
Inclusion/Exclusion Criteria
(Datenquelle: WHO)
Inclusion Criteria:
1. Age > 18 and < 75 years
2. Performance Status (PS) ECOG 0-1 (Appendix 2)
3. Written informed consent
4. Recording of alcohol consumption and smoking history
5. Stage III, stage IV (American Joint Committee on Cancer 7th edition) 38
6. Oral cavity, oropharynx, hypopharynx or larynx
7. Squamous cell carcinoma treated by primary surgery
8. Recovery from the surgical procedure allowing for cisplatin-RT
9. RT planned within 4 to 8 weeks after surgery
10. Patient/tumor carrying a high risk of relapse with:
- extra-capsular extension (ECE),
- and/or positive margins (R1 or close margin = 1 mm)
11. Availability of surgical tumour specimen (PD-L1, TILs and immune landscape ...)
12. For oropharyngeal tumor, known p16 status (by IHC)
13. Determination of patient ability to receive cisplatin 100 mg/m2 for 3 cycles:
- Calculated creatinine clearance = 60 mL/min as determined by CKD-EPI method
(Cockcroft and Gault or MDRD method allowed)
- Absolute neutrophil count =1 500/µL, platelets =100 000/µL, haemoglobin = 10
g/dL, aspartate (AST) and alanine transaminase (ALT) less than 2 times the upper
limit of the normal range (ULN), total bilirubin = 1.5 mg/dL, serum albumin >35
g/L
- Peripheral neuropathy = grade 1
- Sensorineural hearing loss (confirmed by audiogram)
- Cardiac function compatible with hyperhydration
- No administration of prophylactic phenytoin
- For ppatients aged 71-74 years, PS must be 0 and fit according to geriatric
evaluation
Exclusion Criteria:
1. Nasopharyngeal, paranasal sinuses, nasal cavity tumours or thyroid cancers
2. Squamous cell carcinoma involving cervical neck nodes with unknown primary site
3. Metastatic disease (stage IVc)
4. Active viral infection (HIV, Hepatitis B/C) or known history of positive test for HIV
5. Active autoimmune disease
6. Active immunodeficiency or ongoing immunosuppressive therapy
7. Active CNS disease
8. Interstitial lung disease
9. Active infection
10. 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,
induction chemotherapy, prior RT, or use of any investigational agent
11. Concurrent treatment with any other systemic anti-cancer therapy that is not specified
in the protocol
12. Concomitant treatment with any drug on the prohibited medication list such as live
vaccines. Live vaccines administered more than 30 days before study entry are
permitted
13. History of other malignancy within the last 3 years (exception of in situ carcinoma,
thyroid papillary carcinoma, skin carcinomas, localized prostate carcinoma Gleason 6
and in situ breast carcinoma)
14. Pregnant, breastfeeding patients, and female patients of childbearing potential who
are unwilling or unable to use 2 highly effective methods of contraception as outlined
in the protocol for the duration of the study and for at least 6 months after the last
dose of cisplatin and 7 months after the last dose of nivolumab
15. 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
16. Known hypersensitivity reaction to study drugs
17. 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
18. Prior organ transplantation including allogenic stem-cell transplantation
19. 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
20. Persisting toxicity related to prior therapy or pre-existing conditions (NCI CTCAE v.
4.03 Grade > 1) 39
21. Other severe acute or chronic medical conditions including colitis, pneumonitis,
pulmonary fibrosis or psychiatric conditions including active suicidal ideation; or
laboratory abnormalities that may increase the risk associated with study
participation and, in the judgment of the investigator, would make the patient
inappropriate for entry into this study
22. Concurrent enrolment in another clinical trial using an investigational anti-cancer
treatment within 28 days prior to the first dose of study treatment
Minimum age: 18 Years
Maximum age: 74 Years
Sex: All
-
Weitere Informationen zur Studie
Datum der Studienregistrierung
01.06.2018
Einschluss der ersten teilnehmenden Person
10.10.2018
Rekrutierungsstatus
Recruiting
Wissenschaftlicher Titel
(Datenquelle: WHO)
A Phase III Randomized Trial of Post-operative Adjuvant Nivolumab and Concomitant Chemo-radiotherapy in High-risk Patients With Resected Squamous Cell Carcinoma of Head and Neck
Studientyp
(Datenquelle: WHO)
Interventional
Design der Studie
(Datenquelle: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase
(Datenquelle: WHO)
Phase 3
Primäre Endpunkte
(Datenquelle: WHO)
Disease free survival
Sekundäre Endpunkte
(Datenquelle: WHO)
Acute toxicity
Late toxicity
Overall survival
Kontakt für Auskünfte
(Datenquelle: WHO)
Please refer to primary and secondary sponsors
Ergebnisse der Studie
(Datenquelle: WHO)
Zusammenfassung der Ergebnisse
noch keine Angaben verfügbar
Link zu den Ergebnissen im Primärregister
noch keine Angaben verfügbar
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
noch keine Angaben verfügbar
Studiendurchführungsorte
Durchführungsorte in der Schweiz
(Datenquelle: BASEC)
Lausanne
Durchführungsländer
(Datenquelle: WHO)
Möglicherweise erscheint hier die Schweiz noch nicht als Durchführungsland, weil sie im WHO-Primärregister noch nicht eingetragen wurde.
France
Kontakt für weitere Auskünfte zur Studie
Angaben zur Kontaktperson in der Schweiz
(Datenquelle: BASEC)
Dr Petr Szturz
+41795567667
petr.szturz@chuv.ch
Kontakt für allgemeine Auskünfte
(Datenquelle: WHO)
Jean BOURHIS, Pr
(0)21 314 46 66
jean.bourhis@chuv.ch
Kontakt für wissenschaftliche Auskünfte
(Datenquelle: WHO)
Joël GUIGAY, MD
04 92 03 15 01
Joel.Guigay@nice.unicancer.fr
Bewilligung durch Ethikkommission (Datenquelle: BASEC)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Commission
cantonale d’Éthique de la Recherche sur l’être humain Vaud (CER-VD)
Datum der Bewilligung durch die Ethikkommission
10.03.2020
Weitere Studienidentifikationsnummern
Studienidentifikationsnummer der Ethikkommission (BASEC-ID)
(Datenquelle: BASEC)
2019-02292
Secondary ID (Datenquelle: WHO)
GORTEC 2018-01
Zurück zur Übersicht