Intratumoral JNJ-90301900 combined with chemoradiation for locally advanced head and neck squamous cell carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, single-arm phase 1b trial giving intratumoral injections of JNJ-90301900 together with standard cisplatin-based chemotherapy and intensity-modulated radiation therapy (IMRT) to participants with locally advanced head and neck squamous cell carcinoma. The study enrolls patients with Stage III–IVB disease in specified primary sites who are candidates for definitive concurrent chemoradiation and have at least one measurable lesion. Primary goals are to characterize safety and tolerability and to obtain preliminary signals of anti-tumor activity using standard response criteria, with procedures conducted at multiple cancer centers. Participants will receive the investigational injections at the treating center alongside the planned chemoradiation schedule and will undergo regular follow-up for adverse events and tumor response.

Why it matters

Who can join: the full rules

Inclusion criteria:

* Pathologically (histologically or cytologically) proven diagnosis of HNSCC of the oral cavity, oropharynx (p16 negative), hypopharynx, or supraglottic larynx
* 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

Exclusion criteria:

* 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

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• City of Hope
  Duarte, California, United States Recruiting
• Mayo Clinic
  Jacksonville, Florida, United States Recruiting
• Moffit Cancer center
  Tampa, Florida, United States Recruiting
• Emory University
  Atlanta, Georgia, United States Recruiting
• Boston Medical Center
  Boston, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.