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Nanoparticle

NBTXR3 +/− Cetuximab for Head and Neck Cancer

Phase 3

Recruiting

Led By Sue Yom, MD, PhD

Research Sponsored by Nanobiotix

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

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)

Must not have

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)

Local regionally recurrent HNSCC that has been previously treated with chemotherapy and/or RT are not eligible for the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 months following first randomized participant

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a new cancer treatment against the current standard of care to see if it is more effective and has fewer side effects.

Who is the study for?

This trial is for people aged 65 or older with a specific type of throat cancer (SCC) that hasn't been treated before. They must be able to handle radiation therapy, not have certain other health issues like severe allergies to cetuximab, HIV, active hepatitis B or C, heart problems, or lung disease. Women who are pregnant or nursing and those not using birth control can't join.

What is being tested?

The study tests NBTXR3 combined with radiation therapy (RT), with or without the drug cetuximab. It's an open-label Phase 3 trial where patients are randomly assigned to one of two groups: one receiving NBTXR3/RT±cetuximab and the other receiving RT±cetuximab alone.

What are the potential side effects?

Possible side effects include reactions related to cetuximab such as skin rash and infusion reactions; typical radiation therapy side effects like skin irritation and fatigue; plus any potential unknown effects from the new treatment NBTXR3.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is confirmed as squamous cell carcinoma in specific areas of the head or neck.

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My cancer is classified as T3-T4 or T2 with significant lymph node involvement.

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I am 65 years old or older.

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My magnesium levels are normal and I might receive cetuximab treatment.

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My doctor can inject medicine directly into my tumor.

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My oropharyngeal cancer's HPV status is known.

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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have serious heart rhythm problems.

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My head or neck cancer has returned but I haven't had chemo or radiation for it.

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My head or neck cancer is in an early or specific advanced stage.

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I have had treatment for head and neck cancer before.

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I don't have another cancer that could affect this treatment's safety or results.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 months following first randomized participant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 months following first randomized participant

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 months following first randomized participant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free Survival (PFS)

Secondary study objectives

Distant control

Duration of Overall Response

Local-regional control

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm AExperimental Treatment2 Interventions

NBTXR3, as an intratumoral/intranodal injection, activated by investigator's choice of RT alone or RT in combination with cetuximab. NBTXR3 is given as a single intratumoral injection as a dose of 33% of the Gross Tumor Volume

Group II: Arm BActive Control2 Interventions

Investigator's choice of RT alone or RT in combination with cetuximab

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

NBTXR3

2011

Completed Phase 3

~210

Radiation Therapy

2017