Not currently recruiting at University of California Health

A Study of JNJ-90301900 in Combination With Chemoradiation Therapy in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma

a study on Head and Neck Cancer Head and Neck Squamous Cell Carcinoma Squamous Cell Carcinoma

Summary

Eligibility
for people ages 18-74 (full criteria)
Location
at UCSD
Dates
study started
study ends around

Description

Summary

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).

Official Title

A Study of JNJ-90301900 in Combination With Concurrent Chemoradiation Therapy in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma

Keywords

Squamous Cell Carcinoma of Head and Neck, Cisplatin, Intensity-Modulated Radiotherapy, Carboplatin, Paclitaxel, JNJ-90301900, Intensity Modulated Radiation Therapy (IMRT), JNJ-90301900 + Concurrent Chemoradiation Therapy (cCRT)

Eligibility

You can join if…

Open to people ages 18-74

  • 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

You 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

Locations

  • University of California at San Diego Moores Cancer Center currently not accepting new patients, but might later
    La Jolla California 92093 United States
  • City of Hope accepting new patients
    Duarte California 91010 United States
  • University of Alabama at Birmingham accepting new patients
    Birmingham Alabama 35294 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Johnson & Johnson Enterprise Innovation Inc.
ID
NCT07219212
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 45 study participants
Last Updated
Contact us about this trial