Clinical Trial 23898

• Overview

  Study Title:

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

  Summary:

  The purpose of this study is to help researchers understand more about the possible effectiveness and safety of JNJ-90301900 (formerly NBTXR3) injected directly into tumor and used together with chemoradiation in participants suffering from the head & neck squamous cell cancer.

  Objective:

  Primary * To evaluate safety and tolerability of JNJ-90301900 in combination with concurrent cisplatin/IMRT in study participants Secondary * To determine tumor responses of JNJ-90301900 in combination with cisplatin/IMRT in study participants * To evaluate loco‑regional and distant control of JNJ-90301900 in combination with cisplatin/IMRT in study participants * To evaluate PFS outcomes of JNJ-90301900 in combination with cisplatin/IMRT in study participants * To evaluate the need for HNSCC cancer salvage surgery

• Treatments

  Therapies:

  Chemotherapy (NOS); Radiotherapy

  Medications:

  JNJ-90301900 (NBTXR3) (); cisplatin ()

• Inclusion Criteria

  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
  • Other criteria may apply

• Exclusion Criteria

  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 cisplatin chemotherapy
  • Suspected or known allergies, hypersensitivity, or intolerance to JNJ-90301900 or its excipients
  • Other exclusions apply

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