JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC

Description

This is a global, open-label, randomized, 2-arm, Investigator's choice Phase 3 (Pivotal Stage) study to investigate the efficacy and safety of JNJ-90301900 (NBTXR3) / radiation therapy (RT)±cetuximab versus RT±cetuximab in treatment-naïve, platinum-ineligible, elderly participants with locally advanced head and neck squamous cell carcinoma (LA-HNSCC).

Conditions

Locally Advanced Head and Neck Squamous Cell Carcinoma, Aged

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Study Overview

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Study Details

Study overview

This is a global, open-label, randomized, 2-arm, Investigator's choice Phase 3 (Pivotal Stage) study to investigate the efficacy and safety of JNJ-90301900 (NBTXR3) / radiation therapy (RT)±cetuximab versus RT±cetuximab in treatment-naïve, platinum-ineligible, elderly participants with locally advanced head and neck squamous cell carcinoma (LA-HNSCC).

A Phase 3 Study of NBTXR3 Activated by Investigator's Choice of Radiotherapy Alone or Radiotherapy in Combination With Cetuximab for Platinum-based Chemotherapy-Ineligible Elderly Patients With LA-HNSCC

JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC

Condition
Locally Advanced Head and Neck Squamous Cell Carcinoma
Intervention / Treatment

-

Contacts and Locations

Laguna Hills

Memorial Radiation Oncology Medical Group Laguna Hills, Laguna Hills, California, United States, 92653

Newport Beach

Hoag Memorial Hospital, Newport Beach, California, United States, 92663

San Francisco

University of California San Francisco, San Francisco, California, United States, 94158

Tampa

Moffitt Cancer Center, Tampa, Florida, United States, 33612

Santa Fe

Christus St. Vincent Regional Cancer Center, Santa Fe, New Mexico, United States, 87505

New York

Herbert Irving Comprehensive Cancer Center Columbia University Medical Center, New York, New York, United States, 10032

Staten Island

Richmond University Medical Center, Staten Island, New York, United States, 10310

Chapel Hill

University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States, 27514

Oklahoma City

Stephenson Cancer Center, Oklahoma City, Oklahoma, United States, 73104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age greater than or equal to (\>=) 60 years old
  • * Squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or supraglottic larynx and a candidate for definitive radiation therapy with or without cetuximab
  • * Clinical stage T3-4 NX or T2 N2-3 disease according to the 8th edition of AJCC
  • * One primary tumor lesion amendable for intratumoral injection
  • * Ineligible to receive platinum-based chemotherapy with radiation (at least one of the following):
  • 1. Estimated creatinine clearance \>= 30 and less than (\<) 50 milliliters/minute (mL/min) (per Cockcroft-Gault equation), Grade \>= 2 hearing loss or tinnitus, Grade \>= 2 peripheral neuropathy, Eastern Cooperative Oncology Group (ECOG) Performance Status 2 or New York Heart Association Class 3
  • 2. Age 70-74 years old with Geriatric 8 (G8) score less than or equal to (\<=) 14
  • 3. Age \>= 75 years old
  • * Carcinoma of the nasopharynx, paranasal sinus(es), salivary gland, thyroid gland, or unknown primary
  • * Non-squamous cell histology
  • * Clinical stage T1-2 N0, T2 N1, or M1 disease according to the 8th edition of AJCC
  • * Loco-regionally recurrent head \& neck cancer that has been previously treated with surgery, radiation therapy, and/or chemotherapy
  • * Prior or concurrent primary malignancy (including second synchronous head \& neck cancer) within the last 2 years of informed consent and whose natural history has the potential to interfere with the safety and efficacy assessment of the investigational agent
  • * Ongoing or active infection requiring treatment with antimicrobial therapy within 2 weeks of randomization

Ages Eligible for Study

60 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Johnson & Johnson Enterprise Innovation Inc.,

Johnson & Johnson Enterprise Innovation Inc Clinical trial, STUDY_DIRECTOR, Johnson & Johnson Enterprise Innovation Inc.

Study Record Dates

2027-06-30