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).
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
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
Single group
JNJ-90301900
DrugJNJ-90301900 will administered via intratumoral and/or intranodal injection.
Cisplatin
DrugCisplatin will be administered intravenously.
Intensity Modulated Radiation Therapy (IMRT)
RadiationIMRT radiation therapy will be administered.
Carboplatin
DrugCarboplatin will be administered intravenously.
Paclitaxel
DrugPaclitaxel will be administered intravenously.
Number of Participants with Adverse Events (AEs) by Severity
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.
Complete Response (CR) Rate
Percentage of participants achieving CR according to RECIST v.1.1 will be reported.
Objective Response Rate (ORR) According to RECIST v.1.1
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)
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
Response rate will be measured based on total tumor shrinkage compared to baseline among those lesions injected with JNJ-90301900.
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