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Recruiting NCT07219212

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

Phase I Interventional Squamous Cell Carcinoma of Head and Neck

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: JNJ-90301900, Cisplatin, Intensity Modulated Radiation Therapy (IMRT), Carboplatin.
Who it may be relevant to
Registry conditions: Squamous Cell Carcinoma of Head and Neck. Basic parameters: 18 years — 74 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, France, Japan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

  • Drug JNJ-90301900
    JNJ-90301900 will administered via intratumoral and/or intranodal injection.
  • Drug Cisplatin
    Cisplatin will be administered intravenously.
  • Radiation Intensity Modulated Radiation Therapy (IMRT)
    IMRT radiation therapy will be administered.
  • Drug Carboplatin
    Carboplatin will be administered intravenously.
  • Drug Paclitaxel
    Paclitaxel will be administered intravenously.

Primary outcome measures

  • Number of Participants with Adverse Events (AEs) by Severity [Time frame: Up to approximately 2 years 14 weeks]
Secondary outcome measures (9)
  • Complete Response (CR) Rate [Time frame: Up to approximately 2 years 14 weeks]
  • Objective Response Rate (ORR) According to RECIST v.1.1 [Time frame: Up to approximately 2 years 14 weeks]
  • Disease Control Rate (DCR) [Time frame: Up to approximately 2 years 14 weeks]
  • Injected Tumor Response Rate [Time frame: Up to approximately 2 years 14 weeks]
  • Time to Locoregional Failure (LRF) [Time frame: Up to approximately 2 years 14 weeks]
  • Time to Distant Failure (DF) [Time frame: Up to approximately 2 years 14 weeks]
  • Progression Free Survival (PFS) [Time frame: Up to approximately 2 years 14 weeks]
  • Number of Participants with Post-Radiation Neck Dissection (PRND) [Time frame: Up to approximately 2 years 14 weeks]
  • Number of Participants with Post-Radiation Primary Surgery [Time frame: Up to approximately 2 years 14 weeks]

Eligibility 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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 10 centers
  • University of Alabama at Birmingham — Birmingham
  • City of Hope — Duarte
  • University of California at San Diego Moores Cancer Center — La Jolla
  • Mayo Clinic — Jacksonville
  • Moffit Cancer center — Tampa
  • Emory University — Atlanta
  • Boston Medical Center — Boston
  • Montefiore Medical Center — The Bronx
  • … and 2 more centers
France · 5 centers
  • Hopital De La Cavale Blanche — Brest
  • Centre Oscar Lambret — Lille
  • Hopital La Timone — Marseille
  • Centre Henri Becquerel — Rouen
  • Gustave Roussy — Villejuif
Japan · 4 centers
  • Hiroshima University Hospital — Hiroshima
  • Aichi Cancer Center — Nagoya
  • Shizuoka Cancer Center — Shizuoka
  • Tokyo Medical University Hospital — Tokyo

Identifiers

NCT: NCT07219212 · 90301900HNC1001 · 2025-522914-22-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗