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    Summary
    EudraCT Number:2021-002163-22
    Sponsor's Protocol Code Number:NANORAY-312
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-11-16
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - PEI
    A.2EudraCT number2021-002163-22
    A.3Full title of the trial
    A Phase 3 (Pivotal Stage) 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 Locally Advanced Head & Neck Squamous Cell Carcinoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    NBTXR3 with or without cetuximab in Locally Advanced Head & Neck Squamous Cell Carcinoma (LA-HNSCC)
    A.4.1Sponsor's protocol code numberNANORAY-312
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04892173
    A.5.4Other Identifiers
    Name:CIV-IDNumber:CIV-21-10-037887
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNanobiotix SA
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNanobiotix SA
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNanobiotix SA
    B.5.2Functional name of contact pointNANORAY-312 CST
    B.5.3 Address:
    B.5.3.1Street Address60 rue de Wattignies
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75012
    B.5.3.4CountryFrance
    B.5.6E-mailnanoray-312@nanobiotix.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Erbitux, 5 mg/mL, 20 mL vials
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCetuximab
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCETUXIMAB
    D.3.9.1CAS number 205923-56-4
    D.3.9.4EV Substance CodeSUB01178MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Locally Advanced Head & Neck Squamous Cell Carcinoma
    E.1.1.1Medical condition in easily understood language
    The most common type of head and neck cancer is called squamous cell carcinoma coming from the membrane lining the mouth, and the parts of the digestive and respiratory tubes of the neck.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10067821
    E.1.2Term Head and neck cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate survival outcomes in subjects treated with intratumorally injected NBTXR3 activated by investigator’s choice of RT alone or RT in combination with cetuximab in comparison to Investigator’s choice alone hereafter referred to as NBTXR3/RT±cetuximab versus RT±cetuximab
    E.2.2Secondary objectives of the trial
    To evaluate long-term survival outcomes of NBTXR3/RT±cetuximab versus RT±cetuximab
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    24-hr ECG evaluation sub-study (at selected sites)
    E.3Principal inclusion criteria
    1. Signed informed consent form (ICF) indicating that the subject understands the purpose of, andprocedures required for the study, and is willing to participate in the study
    2. Age ≥60 years
    3. Biopsy-confirmed SCC of the oral cavity, oropharynx, hypopharynx or supraglottic larynx (archived biopsies are allowed); if no biopsies are available, a new biopsy must be obtained to provideconfirmation of SCC
    4. For subjects with oropharyngeal cancer, HPV status must be known
    5. Tumor categories T3-T4 any N or T2, if ≥N2 according to the 8th edition of the AJCC Cancer Staging Manual
    6. Has one primary tumor lesion that is amenable for intratumoral injection, as determined by the Investigator
    7. Ineligible to receive platinum-based chemotherapy for the treatment of LA HNSCC as defined by having at least 1 of the following:
    a. Estimated creatinine clearance ≥30 and <50 mL/min (calculated by Cockcroft and Gault)
    b. Hearing loss or tinnitus Grade ≥2
    c. Grade ≥2 peripheral neuropathy
    d. ECOG performance status =2
    e. New York Heart Association (NYHA) Class III
    OR
    Aged 70-74 with Geriatric 8 (G8) score ≤14 or aged ≥75 years
    8. Must be able to tolerate RT with curative intent as determined by the study Investigator.
    9. Amenable to definitive treatment with RT. Subjects 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.
    10. ECOG performance status of 0 to ≤2
    11. Life expectancy ≥6 months
    12. Adequate organ and bone marrow function at screening as defined by:
    a. Hemoglobin >9.0 g/dL
    b. Platelet count ≥100,000 cells/mm3
    c. Leukocytes >3000 cells/mm3
    d. Absolute neutrophil count >1500 cells/mm3
    e. Alanine aminotransferase (ALT) ≤3×upper limit of normal (ULN)
    f. Aspartate aminotransferase (AST) ≤3×ULN
    g. Total bilirubin ≤1.5 ULN (in subjects 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 subject may be eligible)
    h. Total serum magnesium within normal ranges if the subject is a candidate for cetuximab treatment as per the Investigator's choice prior to randomization.
    i. Estimated creatinine clearance ≥30 mL/min (calculated by Cockcroft and Gault)
    E.4Principal exclusion criteria
    1. HNSCC category T1, T2N0, T2N1, or M1 according to the 8th Edition of AJCC Cancer Staging Manual
    2. Has received prior antineoplastic systemic therapy or intervention (including pharmacological - both marketed and investigational, RT, or surgery) for the treatment of HNSCC
    3. Subjects with known severe Grade 3 or 4 hypersensitivity reactions to cetuximab and subjects 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 subjects can still be eligible for the study, only if RT alone or NBTXR3+RT alone is chosen and documented from cetuximab treatment by the Investigator before randomization)
    4. Known history of HIV, chronically ongoing active hepatitis B, or chronically ongoing active hepatitis C infection as defined in
    AASLD/EASL guidelines
    5. Loco-regionally recurrent HNSCC that has been previously treated with surgery, chemotherapy and/ or RT are not eligible for the study.
    6. Ulceration or other characteristics (e.g. bleeding diathesis) that may, in the opinion of the Investigator, increase the risk of severe tumor bleeding
    7. SCC originating in the nasopharynx or paranasal sinus, from the salivary gland, or thyroid gland, or on-squamous histology (e.g., melanoma or neuroendocrine carcinoma), or SCC of unknown primary origin
    8. 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 except when:
    - The risk of the prior malignancy interfering with either safety or efficacy endpoints is very low; and if all treatment of that malignancy was completed at least 2 years before randomization and the subject has no clinical evidence of disease recurrence.
    This exception includes completely resected/treated non-melanoma skin cancer, cervical uterine cancer, T1N0M0 invasive hormone sensitive
    breast cancer, hormone sensitive prostate cancer with a Gleason score of 6, and completely resected non muscle invasive bladder cancer.
    9. 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)
    10. Class IV congestive heart failure as defined by the NYHA functional classification system <6 months prior to screening
    11. 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 the time that the ICF is signed through 150 days (18 months for South Korean subjects) after the last cetuximab dose/RT fraction. A woman who is > 1 year postmenopausal or who is surgically sterile is not considered to be of childbearing potential (pregnancy test is not required).
    12. 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 subject's well-being) or that could prevent, limit, or confound the protocol/CIP specified assessments, including subjects under legal protection.
    13. Ongoing or active bacterial or fungal infection (includes infection requiring treatment with antimicrobial therapy for which participants will be required to complete 2 weeks before randomization), symptomatic viral infection, any other clinically significant infection, or use of immune suppressive agents.
    14. Subject participating in another clinical study, except for a non interventional trial/registry at the time of signing the ICF
    E.5 End points
    E.5.1Primary end point(s)
    PFS: time from randomization to loco-regional recurrence, loco-regional progression, distant progression, or death from any cause, whichever occurs first
    E.5.1.1Timepoint(s) of evaluation of this end point
    ITT population.
    E.5.2Secondary end point(s)
    OS: time from randomization to death from any cause
    E.5.2.1Timepoint(s) of evaluation of this end point
    ITT population.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    NBTXR3 (medical device) in addition to investigator's choice of RT (+/-cetuximab)
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA72
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Philippines
    Taiwan
    Brazil
    Canada
    China
    Georgia
    India
    Israel
    Japan
    Korea, Republic of
    United Kingdom
    United States
    Austria
    Belgium
    Czechia
    France
    Germany
    Greece
    Hungary
    Portugal
    Romania
    Spain
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    the date when the required number of PFS (progression-free survival) and OS (overall survival) events have occurred.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days23
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 470
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state27
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 225
    F.4.2.2In the whole clinical trial 500
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Post-RT neck dissection
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation TTCC
    G.4.3.4Network Country Spain
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation GORTEC
    G.4.3.4Network Country France
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation GONO
    G.4.3.4Network Country Italy
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-07-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-25
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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