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New treatment option for Squamous Cell Carcinoma of Head and Neck
Official title A Study of JNJ-90301900 in Combination With Chemoradiation Therapy in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma
ClinicalTrials.gov ID: NCT07219212
What this study is testing
What is JNJ-90301900?
JNJ-90301900 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for squamous cell carcinoma of head and neck.
Also referred to as NBTXR3, 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
- This global, open-label, single arm, phase 1b study aims to learn more about whether a treatment called JNJ-90301900 is safe and effective when injected directly into tumors, along with standard chemotherapy and radiation therapy, for participants with head and neck squamous cell cancer (HNSCC; a type of solid tumor that begins in outer tissue layer of the mouth \& throat).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 74
You may be able to join if
- Pathologically (histologically or cytologically) proven diagnosis of HNSCC of the oral cavity, oropharynx (p16 negative), hypopharynx, or...
- Stage III, IVA or IVB according to the 8th Edition of the American Joint Committee on Cancer (AJCC) guidelines
- A candidate for definitive concurrent chemoradiation therapy treatment as determined by investigator and per local guidelines
- Participants must have at least 1 target lesion (primary tumor or involved lymph node) per RECIST v.1.1
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1
You likely can't join if
- Primary tumor originating in the nasopharynx, paranasal sinuses, salivary glands, thyroid gland, parathyroid gland, skin, or unknown primary site
- Non-squamous histology
- Stages 0, I, II, and IVC HNSCC, loco-regionally recurrent HNSCC, or synchronous second primary HNSCC (within 2 months)
- Ineligible to receive platinum-based chemotherapy
- Suspected or known allergies, hypersensitivity, or intolerance to JNJ-90301900 or its excipients
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Duarte, California, United States
- Jacksonville, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Boston, Massachusetts, United States
- The Bronx, New York, United States
- Chapel Hill, North Carolina, United States
- Philadelphia, Pennsylvania, United States
- Brest, France
- Lille, France
- Marseille, France
- Rouen, France
- Villejuif, France
- Hiroshima, Japan
- Nagoya, Japan
- Tokyo, Japan
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 - 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, 18 years to 74 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Duarte, California, United States; Jacksonville, Florida, United States; Tampa, Florida, United States; Atlanta, Georgia, United States; Boston, Massachusetts, United States and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.