A Phase 3 study of NBTXR3 with or without cetuximab in LA-HNSCC
EU CTIS ID: 2024-520386-31-00
What this study is testing
To evaluate progression-free survival (PFS) outcomes in participants treated with intratumorally injected JNJ-90301900 (NBTXR3) activated by Investigator’s choice of radiotherapy (RT) alone or RT in combination with cetuximab in comparison to Investigator’s choice alone hereafter referred to as JNJ-90301900 (NBTXR3) /RT±cetuximab versus RT±cetuximab
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Age ≥ 60 years old
- 2. Biopsy-confirmed SCC of the oral cavity, oropharynx, hypopharynx, or supraglottic larynx (archived biopsies within 3 months are allowed); if no biopsies are available, a new biopsy must be obtained to provide confirmation of SCC
- 3. Tumor categories T3-T4 any N or T2 if ≥N2 according to the 8th edition of AJCC
- 4. One primary tumor lesion amendable for intratumoral injection
- 5. Ineligible to receive platinum-based chemotherapy for the treatment of LA-HNSCC as defined by having at least one of the following: a.Estimated creatinine clearance ≥30 and <50 mL/min (per Cockcroft-Gault equation), b.Grade ≥2 hearing loss or tinnitus c.Grade ≥2 peripheral neuropathy d.New York Heart Association Class 3 OR Age 70-74 years old with Geriatric 8 (G8) score ≤ 14 or Age ≥ 75 years old
You likely can't join if
- 1. SCC originating in the nasopharynx, paranasal sinus, salivary gland, or thyroid gland; or non-squamous histology (eg, melanoma or neuroendocrine carcinoma), or SCC of unknown primary origin
- 2. Non-squamous cell histology
- 3. Clinical stage T1-2 N0, T2 N1, or M1 disease according to the 8th edition of AJCC
- 4. Loco-regionally recurrent head & neck cancer that has been previously treated with surgery, radiation therapy, and/or chemotherapy
- 5. Prior or concurrent primary malignancy (including second synchronous head & neck cancer) within the last 2 years of informed consent and whose natural history has the potential to interfere with the safety and efficacy assessment of the investigational agent
- 6. Ongoing or active infection requiring treatment with antimicrobial therapy within 2 weeks of randomization
The study team makes the final eligibility decision.
Where it's taking place
- Greece
- Portugal
- Belgium
- France
- Spain
- Germany
- Hungary
- Romania
- Austria
- Japan
- United States
- Israel
- Taiwan
- Brazil
- United Kingdom
- Korea, Republic of
- Philippines
- China
- India
- Canada
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Greece; Portugal; Belgium; France; Spain; Germany and 15 more locations. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from EU CTIS. The study team decides eligibility, and your own doctor gives medical advice.