Informations générales (source: ClinicalTrials.gov)
Randomized Trial of Loco-regional Radiotherapy Added to Pembrolizumab Alone or With Chemotherapy Versus Systemic Treatment Alone for Patients With Newly Diagnosed Head and Neck Squamous Cell Carcinoma With Synchronous Metastases
Interventional
Phase 3
UNICANCER (Voir sur ClinicalTrials)
décembre 2021
octobre 2029
12 septembre 2025
Study to evaluate the efficacy of treatment by radiotherapy and pembrolizumab in newly
diagnosed metastatic head & neck cancers
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Yun Gan TAO | 10/06/2026 06:20:05 | Contact (sur clinicalTrials) | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Antoine Lacassagne - Nice - France | Contact (sur clinicalTrials) | ||||
| Centre François Baclesse - 14076 - Caen - France | Contact (sur clinicalTrials) | ||||
| Centre Georges François Leclerc - Dijon - France | Contact (sur clinicalTrials) | ||||
| Centre Guillaume le Conquérant - Le Havre - France | Contact (sur clinicalTrials) | ||||
| Centre Henri Becquerel - 76038 - Rouen - France | Contact (sur clinicalTrials) | ||||
| Centre Jean Bernard - Clinique Victor Hugo - Le Mans - France | Contact (sur clinicalTrials) | ||||
| Centre Jean Perrin - 63011 - Clermont-Ferrand - France | Contact (sur clinicalTrials) | ||||
| Centre Léon Bérard - Lyon - France | Contact (sur clinicalTrials) | ||||
| Centre Oscar Lambret - 59020 - Lille - France | Contact (sur clinicalTrials) | ||||
| CH Carcassonne - 1A810 - Carcassonne - France | Contact (sur clinicalTrials) | ||||
| CH Valence - 26953 - Valence - France | Contact (sur clinicalTrials) | ||||
| CHU Bordeaux - 33075 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| CHU de Saint Etienne - 42270 - Saint-Priest-en-Jarez - France | Contact (sur clinicalTrials) | ||||
| CHU Jean Minjoz - 25030 - Besançon - France | Contact (sur clinicalTrials) | ||||
| Groupe Hospitalier Bretagne Sud - Lorient - France | Contact (sur clinicalTrials) | ||||
| Gustave Roussy - Villejuif - France | Contact (sur clinicalTrials) | ||||
| Hopital de la Timone - Marseille - France | Contact (sur clinicalTrials) | ||||
| Hopital Nord Franche Comté - Site de Mittan - 25209 - Montbéliard - France | Contact (sur clinicalTrials) | ||||
| Hopital Privé Drome Ardeche - 26000 - Valence - France | Contact (sur clinicalTrials) | ||||
| Institut Bergonié - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Institut Claudius Regaud - 31059 - Toulouse - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancérologie de Lorraine - 54519 - Vandoeuvre les nancy - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancérologie Strasbourg-Europe - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| Institut Jean Godinot - 51726 - Reims - France | Contact (sur clinicalTrials) | ||||
| Institut Sainte Catherine - 84000 - Avignon - France | Contact (sur clinicalTrials) | ||||
| Polyclinique de l'Ormeau - 65000 - Tarbes - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
1. Patient must have signed a written informed consent form prior to any study specific
procedures. When the patient is physically unable to give their written consent, a
trusted person of their choice, independent from the investigator or the sponsor,
can confirm in writing the patient's consent.
2. Histologically confirmed squamous cell carcinoma of head and neck (oral cavity,
oropharynx, hypopharynx, and larynx) including unknown primary head and neck lymph
nodes with distant metastases at presentation (T1-4 N0-3 M1). Histological
confirmation is required in case of a single metastatic lesion.
3. Eligible for treatment by pembrolizumab according to the European Marketing
Authorization
4. Patient ≥18 years old
5. Performance status: 0-1 (WHO)
6. Combined Positive Score (CPS) ≥1 for primary tumor (as determined per local
practice)
7. Subjects must have at least one measurable lesion as per RECIST v1.1 to assess
efficacy
8. Adequate hematologic and end-organ function, defined by the following laboratory
test results, obtained within 14 days prior to randomization:
a. If randomization is done before treatment start: i. Absolute neutrophil count
≥1.5 × 10⁹/L ii. Platelet ≥100 × 10⁹/L iii. Hemoglobin ≥90 g/L iv. Aspartate
aminotransferase (AST) and alanine aminotransferase (ALT), ≤3 × upper limit of
normal (ULN), (unless documented liver metastases where ≤5 x ULN is permitted) v.
Bilirubin ≤1.5 × ULN. vi. Serum albumin ≥25 g/L vii. Creatinine clearance ≥30 mL/min
(calculated per institutional guidelines or by Cockcroft-Gault or Modification of
Diet in Renal Disease (MDRD) formula) viii. Corrected serum calcium of ≤11.5 mg/dL
or ≤2.6 mmol/L. b. If randomization if done after treatment start i. Absolute
neutrophil count ≥1.0 × 10⁹/L ii. Platelet ≥75 × 10⁹/L iii. Hemoglobin ≥85 g/L
9. Patient must agree to use adequate contraception methods for the duration of the
study treatment and up to 4 months after the last dose of pembrolizumab
administration
10. Patients must be affiliated to a Social Security System (or equivalent)
11. No disease progression during systemic treatment if the randomization is done after
the start of pembrolizumab for the current disease
1. Patient must have signed a written informed consent form prior to any study specific
procedures. When the patient is physically unable to give their written consent, a
trusted person of their choice, independent from the investigator or the sponsor,
can confirm in writing the patient's consent.
2. Histologically confirmed squamous cell carcinoma of head and neck (oral cavity,
oropharynx, hypopharynx, and larynx) including unknown primary head and neck lymph
nodes with distant metastases at presentation (T1-4 N0-3 M1). Histological
confirmation is required in case of a single metastatic lesion.
3. Eligible for treatment by pembrolizumab according to the European Marketing
Authorization
4. Patient ≥18 years old
5. Performance status: 0-1 (WHO)
6. Combined Positive Score (CPS) ≥1 for primary tumor (as determined per local
practice)
7. Subjects must have at least one measurable lesion as per RECIST v1.1 to assess
efficacy
8. Adequate hematologic and end-organ function, defined by the following laboratory
test results, obtained within 14 days prior to randomization:
a. If randomization is done before treatment start: i. Absolute neutrophil count
≥1.5 × 10⁹/L ii. Platelet ≥100 × 10⁹/L iii. Hemoglobin ≥90 g/L iv. Aspartate
aminotransferase (AST) and alanine aminotransferase (ALT), ≤3 × upper limit of
normal (ULN), (unless documented liver metastases where ≤5 x ULN is permitted) v.
Bilirubin ≤1.5 × ULN. vi. Serum albumin ≥25 g/L vii. Creatinine clearance ≥30 mL/min
(calculated per institutional guidelines or by Cockcroft-Gault or Modification of
Diet in Renal Disease (MDRD) formula) viii. Corrected serum calcium of ≤11.5 mg/dL
or ≤2.6 mmol/L. b. If randomization if done after treatment start i. Absolute
neutrophil count ≥1.0 × 10⁹/L ii. Platelet ≥75 × 10⁹/L iii. Hemoglobin ≥85 g/L
9. Patient must agree to use adequate contraception methods for the duration of the
study treatment and up to 4 months after the last dose of pembrolizumab
administration
10. Patients must be affiliated to a Social Security System (or equivalent)
11. No disease progression during systemic treatment if the randomization is done after
the start of pembrolizumab for the current disease
1. Symptomatic central nervous system (CNS) metastases and / or carcinomatous
meningitis
2. History of another malignancy within 2 years prior to study inclusion, with the
exception of completely resected basal or squamous cell skin cancer, or successfully
treated in-situ carcinoma
3. Prior radiotherapy in the head and neck region
4. Any prior or current non-surgical treatment for invasive head and neck cancer.
(except for pembrolizumab +/- chemotherapy for the current cancer for a maximum of 6
cycles). This will include but is not limited to: prior tyrosine kinase inhibitors,
any monoclonal antibody, chemotherapy, anti-PD-1/PD-L1 and CTLA-4, prior
radiotherapy (RT), or use of any investigational agent. Loco-regional recurrent or
second primary head and neck cancer after prior surgical treatment alone in the head
and neck region could be eligible.
5. Known Acquired Immune Deficiency Syndrome (AIDS)
6. Known currently active infection including hepatitis B or hepatitis C
7. Patient having received live attenuated vaccine within 28 days prior to enrolment
8. Pregnant or breast feeding woman
9. Active autoimmune disease except vitiligo, type-1 diabetes, hypothyroid stabilized
with hormonal substitution, or psoriasis which do not require systemic treatment
10. Active immunodeficiency or ongoing immunosuppressive therapy
11. Active symptomatic interstitial lung disease
12. 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
13. Any social, personal, medical, geographic 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
14. Prior organ transplantation including allogenic stem-cell transplantation
15. 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
16. Person deprived of their liberty or under protective custody or guardianship
17. Patient who have taken any investigational medicinal product or have used an
investigational device within 30 days prior to study inclusion