NBTXR3 and Radiation Therapy in Treating Patients With Locally Advanced SCC of the Oral Cavity or Oropharynx

December 26, 2022 updated by: Nanobiotix

A Phase I Dose-Escalation/Dose Expansion Study Of NBTXR3 Activated By Intensity Modulated Radiation Therapy In Patients With Locally Advanced Squamous Cell Carcinoma Of The Oral Cavity Or Oropharynx

RATIONALE: Cancers of the oral cavity represent 30% of head and neck carcinomas in the western world. The oropharynx is the posterior continuation of the oral cavity and connects with the nasopharynx (above) and laryngopharynx (below). It is also a frequent site of primary head and neck cancers. These structures play a crucial role in swallowing, breath and speech. Locally advanced oropharyngeal cancers can obstruct the air flow or infiltrate muscles or nerves, which significantly disturb local functions. The incidence of Head and Neck Squamous Cell Cancer in patients older 65 years is high, 47% occurred in this population as recorded by the Surveillance, Epidemiology, and End Results registries in the United States. Regarding the therapeutic strategies, the association of radiotherapy with chemotherapy or biologics has demonstrated significant improvement of outcomes with the drawback of higher toxicity, or as demonstrated by 2 meta-analyses, without survival improvement in older patients. NBTXR3 and radiation therapy may increase the cancer cell killing and complete tumor shrinkage allowing a definitive treatment and preservation of local structures and functions in patients older 65 years, who cannot receive cisplatin.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients will receive a single administration of NBTXR3 on day 1,as an intratumor injection, followed by Intensity Modulated Radiation Therapy starting 24 hours later (Day 2), and up to completion of 7 weeks, i.e. 70 Grays, 2Grays/fraction. Patients whose tumor has completely shrunk will be followed for the post-radiotherapy evaluation up to the End of Treatment visit. Those patients whose tumor has not shrunk more than 50% of the baseline size, will stop the radiotherapy and may have a salvage tumor surgery. Then, all patients will be followed every 8 weeks, for the safety evaluation and cancer disease status until the end of the study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France, 14076
        • Centre François Baclesse
      • Lille, France, 59000
        • Centre Oscar Lambret
      • Marseille, France, 13385
        • Hôpital La Timone
      • Nice, France, 06189
        • Centre Antoine Lacassagne
      • Paris, France, 75005
        • Institut Curie
      • Rennes, France, 35033
        • CHU Pontchaillou
      • Saint-Priest-en-Jarez, France, 42270
        • Institut de Cancérologie de la Loire Lucien Neuwirth
      • Villejuif, France, 94800
        • Institut Gustave Roussy
  • Hungary
      • Budapest, Hungary
        • Hungarian Defense Forces Hospital
      • Budapest, Hungary
        • National Institute of Oncology
  • Poland
      • Gliwice, Poland
        • Centrum Onkologii - Instytut im. M. Skłodowskiej- Curie, Oddział w Gliwicach
      • Kielce, Poland
        • Świętokrzyskie Centrum Onkologii Samodzielny Publiczny Zakład Opieki Zdrowotnej W Kielcach
      • Lublin, Poland
        • Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli
      • Tomaszów Mazowiecki, Poland
        • NU-MED, Provita Prolife
      • Zamość, Poland
        • Nu-Med Centrum Diagnostyki I Terapii Onkologicznej Zamość Spółka Z Ograniczoną Odpowiedzialnością
  • Spain
      • Barcelona, Spain
        • Vall d'Hebron Hospital
      • Barcelona, Spain
        • Institut Catala d'Oncologia Hospital
      • Madrid, Spain
        • Hospital Universitario Madrid Sanchinarro
      • Madrid, Spain
        • Hospital Fundacion Jimenez Diaz
      • Málaga, Spain, 29010
        • Hospital Universitario Regional de Málaga

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Patients aged ≥ 70 years old, or
  • Patients aged ≥ 65 years old and < 70 years old who are unable to receive cisplatin, or
  • Patients who have contraindication to cisplatin or that are intolerant to cisplatin or cetuximab or that cannot receive the combination of chemoradiation, regardless the age
  • Histologically or cytologically confirmed squamous cell carcinoma (SCC) of the oral cavity or oropharynx
  • T3 or T4 primary tumor or Stage III or IVA according to AJCC guidelines (8th Edition, 2018)
  • No evidence of distant metastatic disease, as determined by a negative PET scan or CT scan
  • Clinically eligible for intratumor implantation by injection
  • Karnofsky Performance Status ≥ 70

  • Adequate function of Bone marrow:

    • White Blood Cell (WBC) > 3.0 x 10^9/L
    • Absolute neutrophil count (ANC) > or = 1.0 x 10^9/L
    • Platelet count > or = 100 x 10^9/L
    • Hemoglobin > or = 9.0 g/dL

  • Adequate function of Kidney:

    o Creatinine < or = 3.0 x ULN or creatinine clearance > or = 30 mL/min/1.73m²

  • Adequate function of the liver:

    • AST < or = 5 x ULN
    • ALT < or = 5 x ULN
    • Bilirubin < or = 1.5 x ULN
  • Negative pregnancy test ≤ 7 days of NBTXR3 injection in all females of child-bearing potential

Exclusion Criteria:

  • Written Informed Consent not obtained, signed and dated
  • Prior radiotherapy to any area within the planned radiotherapy field
  • Tumor-related dyspnea
  • Tumor ulceration which implies vascular risk
  • Non measurable disease as defined by RECIST criteria
  • History of stroke, CABG, or significant blockage of carotid arteries or coronary arteries or current blockage of coronary or carotid arteries equal to or in excess of 50% blockage
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active severe infection, symptomatic congestive heart failure, acute coronary syndrome, etc.
  • Medical history of life-threatening ventricular arrhythmia
  • Prior or concurrent non-head and neck malignancies, excluding adequately treated basal or squamous cell cancer of the skin, and in situ cervical cancer, and any other cancer from which the subject has been cancer free for 5 years
  • Concurrent treatment with any other anticancer therapy, including chemotherapy, immunotherapy, targeted therapy, gene therapy, or patients planning to receive these treatments during the study
  • Patients unable to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures or those with severe psychiatric illness/social situations that would limit compliance with study requirements
  • Patients participating in another clinical investigation at the time of signature of the informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: NBTXR3 IntraTumoral injection (IT)
Single intratumor injection
Device: NBTXR3 activated by IMRT

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dose Escalation: Incidence of DLTs and determination of the Recommended Phase 2 Dose
Time Frame: 12 months
The incidence of early DLTs (early adverse effects related to NBTXR3, as an intratumor injection, activated by IMRT)
12 months
Dose Escalation: Determination of the Recommended Phase 2 Dose
Time Frame: 12 months
The recommended Phase II dose (RD) of NBTXR3 administered as intratumor injection, activated by Intensity Modulated Radiation Therapy (IMRT)
12 months
Dose Expansion: Overall Response Rate
Time Frame: 12-24 months
The Objective Response Rate (ORR) of the primary tumor, by imaging according to RECIST 1.1
12-24 months
Dose Expansion: Complete Response Rate
Time Frame: 12-24 months
The Complete Response Rate (CRR) of the primary tumor, by imaging according to RECIST 1.1
12-24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Dose Escalation: Objective Response Rate (ORR) of the primary tumor
Time Frame: 12-24 months
The Objective Response Rate (ORR) of the primary tumor, by imaging according to RECIST 1.1
12-24 months
Dose Escalation: Complete Response Rate
Time Frame: 12 months
The Complete Response Rate (CRR) of the primary tumor, by imaging according to RECIST 1.1
12 months
Dose Expansion: Local Progression Free Survival
Time Frame: 12-24 months
Local Progression Free Survival (LPFS) defined as any recurrence at the site of the primary tumor
12-24 months
Dose Expansion: Progression Free Survival
Time Frame: 12-24 months
Progression Free Survival (PFS) defined as the time to any progression at the site of the primary tumor, in regional lymph nodes and/or distant metastasis
12-24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nanobiotix

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christophe LE TOURNEAU, MD-PhD, Institut Curie Paris France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 3, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 10, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 20, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 29, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 26, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NBTXR3-102
  • ID RCB: 2013-A00706-39 (Other Identifier: Other)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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