Actively Recruiting
Study on the Efficacy of Treatment by Radiotherapy and Pembrolizumab in Newly Diagnosed Metastatic Head & Neck Cancers
Led by UNICANCER · Updated on 2024-10-26
102
Participants Needed
26
Research Sites
408 weeks
Total Duration
On this page
Sponsors
U
UNICANCER
Lead Sponsor
G
GORTEC
Collaborating Sponsor
AI-Summary
What this Trial Is About
Study to evaluate the efficacy of treatment by radiotherapy and pembrolizumab in newly diagnosed metastatic head \& neck cancers
CONDITIONS
Official Title
Study on the Efficacy of Treatment by Radiotherapy and Pembrolizumab in Newly Diagnosed Metastatic Head & Neck Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent or consent by a trusted person if the patient is unable
- Histologically confirmed squamous cell carcinoma of head and neck with distant metastases at presentation
- Eligible for pembrolizumab treatment according to European Marketing Authorization
- Age 18 years or older
- Performance status 0-1 (WHO)
- Combined Positive Score (CPS) of 1 or higher for primary tumor
- At least one measurable lesion as per RECIST v1.1
- Adequate hematologic and organ function within 14 days prior to randomization as defined by laboratory tests
- Agreement to use adequate contraception during treatment and up to 4 months after last pembrolizumab dose
- Affiliated with a Social Security System or equivalent
- No disease progression during systemic treatment if randomized after start of pembrolizumab
You will not qualify if you...
- Symptomatic central nervous system metastases or carcinomatous meningitis
- Another malignancy within 2 years prior to inclusion except certain treated skin cancers or in-situ carcinoma
- Prior radiotherapy in the head and neck region
- Any prior or current non-surgical treatment for invasive head and neck cancer except limited pembrolizumab with or without chemotherapy
- Known AIDS
- Active hepatitis B or C infection
- Received live attenuated vaccine within 28 days before enrollment
- Pregnant or breastfeeding women
- Active autoimmune disease except certain stable conditions
- Active immunodeficiency or immunosuppressive therapy
- Active symptomatic interstitial lung disease
- Significant medical or psychiatric conditions making study participation inappropriate
- Social, personal, medical, geographic, or psychological factors interfering with protocol adherence
- Prior organ transplantation including stem-cell transplantation
- Severe acute or chronic medical conditions or laboratory abnormalities increasing study risk
- Person deprived of liberty or under protective custody or guardianship
- Use of investigational medicinal product or device within 30 days prior to inclusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 26 locations
1
Institut Sainte Catherine
Avignon, France, 84000
Actively Recruiting
2
CHU Jean Minjoz
Besançon, France, 25030
Actively Recruiting
3
CHU Bordeaux
Bordeaux, France, 33075
Actively Recruiting
4
Institut Bergonié
Bordeaux, France
Actively Recruiting
5
Centre François Baclesse
Caen, France, 14076
Actively Recruiting
6
CH Carcassonne
Carcassonne, France, 1A810
Actively Recruiting
7
Centre Jean Perrin
Clermont-Ferrand, France, 63011
Actively Recruiting
8
Centre Georges François Leclerc
Dijon, France
Actively Recruiting
9
Centre Guillaume le Conquérant
Le Havre, France
Suspended
10
Centre Jean Bernard - Clinique Victor Hugo
Le Mans, France
Actively Recruiting
11
Centre Oscar Lambret
Lille, France, 59020
Actively Recruiting
12
Groupe Hospitalier Bretagne Sud
Lorient, France
Actively Recruiting
13
Centre Léon Bérard
Lyon, France
Withdrawn
14
Hopital de la Timone
Marseille, France
Actively Recruiting
15
Hopital Nord Franche Comté - Site de Mittan
Montbéliard, France, 25209
Actively Recruiting
16
Centre Antoine Lacassagne
Nice, France
Actively Recruiting
17
Institut Jean Godinot
Reims, France, 51726
Actively Recruiting
18
Centre Henri Becquerel
Rouen, France, 76038
Actively Recruiting
19
CHU de Saint Etienne
Saint-Priest-en-Jarez, France, 42270
Not Yet Recruiting
20
Institut de Cancérologie Strasbourg-Europe
Strasbourg, France
Actively Recruiting
21
Polyclinique de l'Ormeau
Tarbes, France, 65000
Not Yet Recruiting
22
Institut Claudius Regaud
Toulouse, France, 31059
Actively Recruiting
23
Hopital Privé Drome Ardeche
Valence, France, 26000
Not Yet Recruiting
24
CH Valence
Valence, France, 26953
Not Yet Recruiting
25
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France, 54519
Actively Recruiting
26
Gustave Roussy
Villejuif, France
Actively Recruiting
Research Team
N
NICOLAS DE SOUSA CARVALHO
CONTACT
L
LAURE MONARD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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