Clinical trial for Carcinoma, Squamous Cell
Official title JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC
ClinicalTrials.gov ID: NCT04892173
What this study is testing
What is JNJ-90301900 (NBTXR3)?
An investigational suspension of hafnium oxide particles being studied as a potential treatment for locally advanced head and neck squamous cell carcinoma. It is designed to generate oxygen free radicals when activated by ionizing radiation.
Also referred to as Functionalized hafnium oxide nanoparticles.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if adding NBTXR3 to standard radiation treatment improves safety and effectiveness compared to radiation alone or with cetuximab.
- Who it's for
- Older adults who have not had treatment before, cannot take platinum drugs, and have locally advanced squamous cell cancer of the head or neck.
- What's involved
- Participants will receive radiation therapy, may get the drug cetuximab, and will receive an injection of NBTXR3 directly into the tumor. They will have regular clinic visits for treatment and monitoring.
- Time commitment
- The study lasts for the course of radiation treatment and follow‑up visits, typically several months, with scheduled appointments for injections, scans, and health checks.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older
You may be able to join if
- Age greater than or equal to (\>=) 60 years old
- Biopsy-confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or supraglottic larynx and a candidate for definitive radiation...
- Clinical stage T3-4 NX or T2 N2-3 disease according to the 8th edition of AJCC
- One primary tumor lesion amendable for intratumoral injection
- Estimated creatinine clearance \>= 30 and less than (\<) 50 milliliters/minute (mL/min) (per Cockcroft-Gault equation),
You likely can't join if
- Carcinoma of the nasopharynx, paranasal sinus, salivary gland, or thyroid gland; or non-squamous histology or SCC of unknown primary origin
- Clinical stage T1-2 N0, T2 N1, or M1 disease according to the 8th edition of AJCC
- Loco-regionally recurrent head \& neck cancer that has been previously treated with surgery, radiation therapy, and/or chemotherapy
- Prior or concurrent primary malignancy (including second synchronous head \& neck cancer) within the last 2 years of informed consent and whose...
- Ongoing or active infection requiring treatment with antimicrobial therapy within 2 weeks of randomization
See the full eligibility criteria
- Age greater than or equal to (\>=) 60 years old
- Biopsy-confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or supraglottic larynx and a candidate for definitive radiation therapy with or without cetuximab
- Clinical stage T3-4 NX or T2 N2-3 disease according to the 8th edition of AJCC
- One primary tumor lesion amendable for intratumoral injection
- Estimated creatinine clearance \>= 30 and less than (\<) 50 milliliters/minute (mL/min) (per Cockcroft-Gault equation),
- Grade \>= 2 hearing loss or tinnitus,
- Grade \>= 2 peripheral neuropathy,
- New York Heart Association Class 3
- Aged 70-74 years old with Geriatric 8 (G8) score less than or equal to (\ = 75 years old
- Eastern cooperative oncology group (ECOG) performance status 0 to 1
- Life expectancy \>= 6 months
- Carcinoma of the nasopharynx, paranasal sinus, salivary gland, or thyroid gland; or non-squamous histology or SCC of unknown primary origin
- Clinical stage T1-2 N0, T2 N1, or M1 disease according to the 8th edition of AJCC
- Loco-regionally recurrent head \& neck cancer that has been previously treated with surgery, radiation therapy, and/or chemotherapy
- 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 how well...
- Ongoing or active infection requiring treatment with antimicrobial therapy within 2 weeks of randomization
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Duarte, California, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- San Francisco, California, United States
- Washington D.C., District of Columbia, United States
- Jacksonville, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Lexington, Kentucky, United States
- Boston, Massachusetts, United States
- Staten Island, New York, United States
- The Bronx, New York, United States
- Chapel Hill, North Carolina, United States
- Charlotte, North Carolina, United States
- Cincinnati, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
+ 99 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, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Duarte, California, United States; La Jolla, California, United States; Los Angeles, California, United States; San Francisco, California, United States; Washington D.C., District of Columbia, United States and 113 more locations. Enter your location above to see the nearest enrolling 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 ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.