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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-74
SponsorJohnson & Johnson Enterprise Innovation Inc.

About this trial

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).

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • JNJ-90301900
  • Cisplatin
  • Intensity Modulated Radiation Therapy (IMRT)
  • Carboplatin
  • Paclitaxel

Treatment groups

45 Participants
are divided into 1 treatment group