Squamous Cell Carcinoma of Head and Neck
Conditions
Brief summary
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
DRUGJNJ-90301900
JNJ-90301900 will administered via intratumoral and/or intranodal injection.
DRUGCisplatin
Cisplatin will be administered intravenously.
RADIATIONIntensity Modulated Radiation Therapy (IMRT)
IMRT radiation therapy will be administered.
DRUGCarboplatin
Carboplatin will be administered intravenously.
DRUGPaclitaxel
Paclitaxel will be administered intravenously.
Sponsors
Johnson & Johnson Enterprise Innovation Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events (AEs) by Severity | Up to approximately 2 years 14 weeks | An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version (v) 5.0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete Response (CR) Rate | Up to approximately 2 years 14 weeks | Percentage of participants achieving CR according to RECIST v.1.1 will be reported. |
| Objective Response Rate (ORR) According to RECIST v.1.1 | Up to approximately 2 years 14 weeks | ORR defined as percentage of participants achieving complete response (CR) or partial response (PR) by investigator assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1. |
| Disease Control Rate (DCR) | Up to approximately 2 years 14 weeks | DCR is defined as the percentage of participants achieving CR, PR, or stable disease (SD) as per RECIST v.1.1 criteria. |
| Injected Tumor Response Rate | Up to approximately 2 years 14 weeks | Response rate will be measured based on total tumor shrinkage compared to baseline among those lesions injected with JNJ-90301900. |
| Time to Locoregional Failure (LRF) | Up to approximately 2 years 14 weeks | Time to LRF is defined as time from enrollment to first failure of LRF using investigator RECIST v.1.1 assessments. |
| Time to Distant Failure (DF) | Up to approximately 2 years 14 weeks | Time to DF is defined as time from enrollment to first failure of DF using investigator RECIST v.1.1 assessments. |
| Progression Free Survival (PFS) | Up to approximately 2 years 14 weeks | PFS is defined as the time from enrollment to radiographic disease progression, or death from any cause, whichever occurs first. |
| Number of Participants with Post-Radiation Neck Dissection (PRND) | Up to approximately 2 years 14 weeks | Participants with PRND will be summarized and will continue to be radiographically evaluated for response by RECIST v.1.1. |
| Number of Participants with Post-Radiation Primary Surgery | Up to approximately 2 years 14 weeks | Participants with post-radiation primary surgery will be summarized and will continue to be radiographically evaluated for response by RECIST v.1.1. |
Countries
France, Japan, United States
Contacts
CONTACTStudy Contact
STUDY_DIRECTORJohnson & Johnson Enterprise Innovation, Inc. Clinical Trial
Johnson & Johnson Enterprise Innovation Inc.
Outcome results
None listed