Informations générales (source: ClinicalTrials.gov)
A Phase 3 Study of NBTXR3 Activated by Investigator's Choice of Radiotherapy Alone or Radiotherapy in Combination With Cetuximab for Platinum-based Chemotherapy-Ineligible Elderly Patients With LA-HNSCC
Interventional
Phase 3
Nanobiotix (Voir sur ClinicalTrials)
janvier 2022
juin 2027
19 novembre 2024
This is a global, open-label, randomized, 2-arm, Investigator's choice Phase 3 (Pivotal
Stage) study to investigate the efficacy/performance and safety of NBTXR3/RT±cetuximab
versus RT±cetuximab in treatment-naïve, platinum-ineligible, elderly participants with
LA-HNSCC.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 04/12/2024 12:44:17 | Contact (sur clinicalTrials) | |||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Europeen Georges Pompidou | Sarah KREPS, MD, PhD | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Tenon | Florence Huguet, MD, PhD | 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 | |||||
| Ambroise Paré Clinic Group - Hartmann Clinic - Paris - France | Jean-Michel Vannetzel, MD | Contact (sur clinicalTrials) | |||
| Centre de Lutte Contre le Cancer - Centre Henri-Becquerel - Rouen - France | Sébastien Thureau, MD, PhD | Contact (sur clinicalTrials) | |||
| Centre de Lutte contre le Cancer - Centre Oscar Lambret - Lille - France | Xavier Liem, MD | Contact (sur clinicalTrials) | |||
| Centre François Baclesse - Caen - France | Juliette THARIAT | Contact (sur clinicalTrials) | |||
| Centre Hospitalier de Valenciennes - Valenciennes - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Regional Universitaire Brest - Brest - France | Ulrike Schick, MD, PhD | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire Amiens-Picardie - Site Sud - Amiens - France | Etienne Fessart, MD | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire de Saint-Étienne - Saint-Étienne - France | Eric Jadaud, MD | Contact (sur clinicalTrials) | |||
| Centre Léon Bérard - Lyon - France | Contact (sur clinicalTrials) | ||||
| Hôpital de la Timone - Marseille - France | Sebastien Salas, MD, PhD | Contact (sur clinicalTrials) | |||
| Hôpital Haut-Lévêque - Pessac - France | Charles Dupin, MD | Contact (sur clinicalTrials) | |||
| Hôpital Pontchaillou - Rennes - France | Franck JEGOUX | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de Lorraine - Vandœuvre-lès-Nancy - France | Sophie Renard, MD | Contact (sur clinicalTrials) | |||
| Institut Gustave Roussy - Villejuif - France | Thanh-Van Nguyen, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Signed informed consent form (ICF) indicating that the participant understands the
purpose of, and procedures required for the study, and is willing to participate in
the study
- Age ≥60 years
- Biopsy-confirmed squamous cell carcinoma (SCC) of the oral cavity, oropharynx,
supraglottic larynx, or hypopharynx (archived biopsies are allowed); if no biopsies
are available, a new biopsy must be obtained to provide confirmation of SCC
- For participants with oropharyngeal cancer, human papilloma virus (HPV) p16 status
must be known
- Tumor categories T3-T4 any N or T2, if ≥N2 according to the 8th edition of the
American Joint Committee on Cancer Staging Manual (AJCC v8)
- Has one primary tumor lesion that is amenable for intratumoral injection, as
determined by the Investigator
- Ineligible to receive platinum-based chemotherapy for the treatment of LA HNSCC as
defined by having at least one of the following:
1. Estimated creatinine clearance ≥30 and <50 mL/min (calculated by Cockcroft and
Gault)
2. Hearing loss or tinnitus Grade ≥2
3. Grade ≥2 peripheral neuropathy
4. ECOG performance status=2
5. New York Heart Association (NYHA) Class III OR Aged 70-74 with Geriatric 8 (G8)
score ≤14 or aged ≥75 years
- Must be able to tolerate RT with curative intent as determined by the study
Investigator.
- Amenable to definitive treatment with RT. Participants with an oral cavity cancer,
should not be eligible to the primary standard treatment, which is surgery, and the
decision for definitive treatment with RT requires consultation with the head and
neck surgeon and the site's multidisciplinary tumor board.
- ECOG performance status of 0 to 2
- Life expectancy ≥6 months
- Adequate organ and bone marrow function at screening as defined by:
1. Hemoglobin >9.0 g/dL
2. Platelet count >100,000 cells/mm3
3. Leukocytes >3000 cells/mm3
4. Absolute neutrophil count >1500 cells/mm3
5. Alanine aminotransferase (ALT) ≤3 x upper limit of normal (ULN)
6. Aspartate aminotransferase (AST) ≤3×ULN
7. Total bilirubin ≤1.5 ULN (in participants with Gilbert's syndrome, if total
bilirubin is >1.5×ULN, measure direct and indirect bilirubin and if direct
bilirubin is ≤1.5×ULN, the participant may be eligible)
8. Total serum magnesium within normal ranges if the participant is a candidate
for cetuximab treatment as per the Investigator's choice prior to randomization
9. Estimated creatinine clearance ≥30 mL/min (calculated by Cockcroft and Gault)
- Signed informed consent form (ICF) indicating that the participant understands the
purpose of, and procedures required for the study, and is willing to participate in
the study
- Age ≥60 years
- Biopsy-confirmed squamous cell carcinoma (SCC) of the oral cavity, oropharynx,
supraglottic larynx, or hypopharynx (archived biopsies are allowed); if no biopsies
are available, a new biopsy must be obtained to provide confirmation of SCC
- For participants with oropharyngeal cancer, human papilloma virus (HPV) p16 status
must be known
- Tumor categories T3-T4 any N or T2, if ≥N2 according to the 8th edition of the
American Joint Committee on Cancer Staging Manual (AJCC v8)
- Has one primary tumor lesion that is amenable for intratumoral injection, as
determined by the Investigator
- Ineligible to receive platinum-based chemotherapy for the treatment of LA HNSCC as
defined by having at least one of the following:
1. Estimated creatinine clearance ≥30 and <50 mL/min (calculated by Cockcroft and
Gault)
2. Hearing loss or tinnitus Grade ≥2
3. Grade ≥2 peripheral neuropathy
4. ECOG performance status=2
5. New York Heart Association (NYHA) Class III OR Aged 70-74 with Geriatric 8 (G8)
score ≤14 or aged ≥75 years
- Must be able to tolerate RT with curative intent as determined by the study
Investigator.
- Amenable to definitive treatment with RT. Participants with an oral cavity cancer,
should not be eligible to the primary standard treatment, which is surgery, and the
decision for definitive treatment with RT requires consultation with the head and
neck surgeon and the site's multidisciplinary tumor board.
- ECOG performance status of 0 to 2
- Life expectancy ≥6 months
- Adequate organ and bone marrow function at screening as defined by:
1. Hemoglobin >9.0 g/dL
2. Platelet count >100,000 cells/mm3
3. Leukocytes >3000 cells/mm3
4. Absolute neutrophil count >1500 cells/mm3
5. Alanine aminotransferase (ALT) ≤3 x upper limit of normal (ULN)
6. Aspartate aminotransferase (AST) ≤3×ULN
7. Total bilirubin ≤1.5 ULN (in participants with Gilbert's syndrome, if total
bilirubin is >1.5×ULN, measure direct and indirect bilirubin and if direct
bilirubin is ≤1.5×ULN, the participant may be eligible)
8. Total serum magnesium within normal ranges if the participant is a candidate
for cetuximab treatment as per the Investigator's choice prior to randomization
9. Estimated creatinine clearance ≥30 mL/min (calculated by Cockcroft and Gault)
- HNSCC category T1, T2N0, T2N1 or M1 according to the 8th edition of the American
Joint Committee on Cancer Staging Manual (AJCC v8)
- Has received prior antineoplastic systemic therapy or intervention (including
pharmacological - both marketed and investigational, RT, or surgery) for the
treatment of HNSCC
- Participants with known severe Grade 3 or 4 hypersensitivity reactions to cetuximab
and participants with known prior or ongoing interstitial lung disease must be
excluded as a candidate for cetuximab treatment as per the Investigator's choice
before randomization (these participants can still be eligible for the study, only
if RT alone is chosen by the Investigator before randomization)
- Known history of human immunodeficiency virus (HIV) Chronically ongoing active
hepatitis B, or chronically ongoing active hepatitis C infection as defined in AASLD
(American Association for the Study of Liver Diseases)/EASL (European Association
for the Study of the Liver) guidelines
- Local regionally recurrent HNSCC that has been previously treated with surgery,
chemotherapy and/or RT are not eligible for the study
- Ulceration or other characteristics that may, in the opinion of the Investigator,
increase the risk of severe tumor bleeding
- SCC originating in the nasopharynx or paranasal sinus, from the salivary gland, or
thyroid gland, or non-squamous histology (e.g., melanoma or neuroendocrine
carcinoma), or SCC of unknown primary origin
- Prior or concurrent malignancy (including a second synchronous HNSCC) whose natural
history or treatment has the potential to interfere with the safety or efficacy
assessment of the investigational regimen
- Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia,
ventricular fibrillation, torsades de pointes, second- or third-degree
atrioventricular heart block without a permanent pacemaker in place)
- Class IV congestive heart failure as defined by the New York Heart Association
functional classification system <6 months prior to screening
- A pregnant or nursing woman, or women of childbearing potential and men who are
sexually active and not willing/able to use medically acceptable forms of
contraception starting from signed ICF through 150 days after the last cetuximab
dose/RT fraction. A woman who is ≥1 year postmenopausal or surgically sterile is not
considered to be of childbearing potential.
- Any condition for that, in the opinion of the Investigator, participation would not
be in the best interest of the individual (e.g., compromises the participant's
well-being) or that could prevent, limit, or confound the protocol/CIP specified
assessments, including subjects under legal protection
- Subject participating in another clinical study at the time of signature of the
informed consent form
- Ongoing or active bacterial or fungal infection, symptomatic viral infection, any
other clinically significant infection, or use of immune suppressive agents