RECRUITING

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

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Conditions

Locally Advanced Head and Neck Squamous Cell CarcinomaAgedLA-HNSCCNBTXR3hafnium oxideradioenhancerRadiotherapyRTHNSCCradiation therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2021-12-10
Study Completion:2027-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04892173

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.

Ages Eligible for Study:60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age greater than or equal to (\>=) 60 years old
  2. * Squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or supraglottic larynx and a candidate for definitive radiation therapy with or without cetuximab
  3. * Clinical stage T3-4 NX or T2 N2-3 disease according to the 8th edition of AJCC
  4. * One primary tumor lesion amendable for intratumoral injection
  5. * Ineligible to receive platinum-based chemotherapy with radiation (at least one of the following):
  6. 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
  7. 2. Age 70-74 years old with Geriatric 8 (G8) score less than or equal to (\<=) 14
  8. 3. Age \>= 75 years old
  1. * Carcinoma of the nasopharynx, paranasal sinus(es), salivary gland, thyroid gland, or unknown primary
  2. * Non-squamous cell histology
  3. * Clinical stage T1-2 N0, T2 N1, or M1 disease according to the 8th edition of AJCC
  4. * Loco-regionally recurrent head \& neck cancer that has been previously treated with surgery, radiation therapy, and/or chemotherapy
  5. * 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
  6. * Ongoing or active infection requiring treatment with antimicrobial therapy within 2 weeks of randomization

Contacts and Locations

Study Contact

Study Contact
CONTACT
844-434-4210
Participate-In-This-Study@its.jnj.com

Principal Investigator

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

Study Locations (Sites)

Memorial Radiation Oncology Medical Group Laguna Hills
Laguna Hills, California, 92653
United States
Hoag Memorial Hospital
Newport Beach, California, 92663
United States
University of California San Francisco
San Francisco, California, 94158
United States
Moffitt Cancer Center
Tampa, Florida, 33612
United States
Christus St. Vincent Regional Cancer Center
Santa Fe, New Mexico, 87505
United States
Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
New York, New York, 10032
United States
Richmond University Medical Center
Staten Island, New York, 10310
United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
United States

Collaborators and Investigators

Sponsor: Johnson & Johnson Enterprise Innovation Inc.

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-10
Study Completion Date2027-06-30

Study Record Updates

Study Start Date2021-12-10
Study Completion Date2027-06-30

Terms related to this study

Keywords Provided by Researchers

  • LA-HNSCC
  • NBTXR3
  • hafnium oxide
  • radioenhancer
  • Radiotherapy
  • RT
  • HNSCC
  • radiation therapy

Additional Relevant MeSH Terms

  • Locally Advanced Head and Neck Squamous Cell Carcinoma
  • Aged