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Nanoparticle

NBTXR3 +/− Cetuximab for Head and Neck Cancer

Phase 3
Recruiting
Led By Christophe Le Tourneau, 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
Must be able to tolerate RT with curative intent as determined by the study Investigator.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 months following first randomized participant
Awards & highlights

Study 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.Check my eligibility
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.See study design
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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I can undergo radiation therapy with the goal of curing my condition.
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My cancer is classified as T3-T4 or T2 with significant lymph node involvement.
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I am a candidate for radiation therapy as my main treatment.
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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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My organs and bone marrow are working well.
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I can take care of myself and am up and about more than half of my waking hours.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free Survival (PFS)
Secondary outcome measures
Distant control
Duration of Overall Response
Local-regional control
+5 more

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
Completed Phase 3
~7250

Find a Location

Who is running the clinical trial?

NanobiotixLead Sponsor
6 Previous Clinical Trials
450 Total Patients Enrolled
Christophe Le Tourneau, MD, PhDPrincipal InvestigatorInstitute Curie
Sue Yom, MD, PhDPrincipal InvestigatorUniversity of San Francisco
2 Previous Clinical Trials
116 Total Patients Enrolled

Media Library

NBTXR3 (Nanoparticle) Clinical Trial Eligibility Overview. Trial Name: NCT04892173 — Phase 3
Head and Neck Cancers Research Study Groups: Arm A, Arm B
Head and Neck Cancers Clinical Trial 2023: NBTXR3 Highlights & Side Effects. Trial Name: NCT04892173 — Phase 3
NBTXR3 (Nanoparticle) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04892173 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are some similar studies that have been done using NBTXR3?

"There are 137 ongoing studies and 32 trials in Phase 3 for NBTXR3. Most of these trials are based in Dresden, Arizona, but there are 6111 locations running clinical trials for NBTXR3 globally."

Answered by AI

How is NBTXR3 used to improve patients' conditions?

"NBTXR3 is the most common form of pharmacotherapy, but it can also be used to treat other conditions such as metastatic squamous cell carcinoma of the head and neck (hnscc), regionally advanced squamous cell carcinoma of the head and neck, and squamous cell carcinoma."

Answered by AI

Can patients sign up for this test currently?

"That is accurate, the website provides updated information that this clinical trial is still enrolling patients. The original posting date was 1/5/2022, with the most recent update on 3/22/2022. They are expecting to have 500 patients total at the one site."

Answered by AI

What are some possible side effects of NBTXR3?

"NBTXR3 is a Phase 3 trial medication, so it has some efficacy data and multiple rounds of safety data, giving it a score of 3."

Answered by AI
~52 spots leftby Jul 2024