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

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031250716

Enrollment

Registered

2026-02-09

Start date

2026-03-30

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Experimental: JNJ-90301900 + Concurrent Chemoradiation Therapy (cCRT) Participants will receive JNJ-90301900 administered intratumorally and/or intranodally, in combination with concurrent chemoradiat

Eligibility

Sex/Gender

All

Inclusion 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

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 cisplatin chemotherapy - Suspected or known allergies, hypersensitivity, or intolerance to JNJ-90301900 or its excipients

Design outcomes

Primary

Measure	Time frame
1. 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. [Time Frame: Up to approximately 2 years 14 weeks]	—

Measure

Time frame

1. 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. [Time Frame: Up to approximately 2 years 14 weeks]

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Secondary

Measure	Time frame
2. 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. [Time Frame: Up to approximately 2 years 14 weeks] 3. Complete Response (CR) Rate Percentage of participants achieving CR according to RECIST v.1.1 will be reported. [Time Frame: Up to approximately 2 years 12 weeks] 4. 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. [Time Frame: Up to approximately 2 years 12 weeks] 5. Injected Tumor Response Rate Response rate will be measured based on total tumor shrinkage compared to baseline among those lesions injected with JNJ-90301900. [Time Frame: Up to approximately 2 years 14 weeks] 6. Time to Locoregional Failure (LRF) Time to LRF is defined as time from enrollment to first failure of LRF using investigator RECIST v.1.1 assessments. [Time Frame: Up to approximately 2 years 14 weeks] 7. Time to Distant Failure (DF) Time to DF is defined as time from enrollment to first failure of DF using investigator RECIST v.1.1 assessments. [Time Frame: Up to approximately 2 years 14 weeks] 8. Progression Free Survival (PFS) PFS is defined as the time from enrollment to radiographic disease progression, or death from any cause, whichever occurs first. [Time Frame: Up to approximately 2 years 14 weeks] 9. Number of Participants with Post-Radiation Neck Dissection (PRND) Participants with PRND will be summarized and will continue to be radiographically evaluated for response by RECIST v.1.1. [Time Frame: Up to approximately 2 years 14 weeks] 10. Number of Participants with Post-Radiation Primary Salvage Surgery Participants with post-radiation primary salvage surgery will be summarized and will continue to be radiographically evaluated for response by RECIST v.1.1. [Time Frame:	—

Measure

Time frame

2. 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. [Time Frame: Up to approximately 2 years 14 weeks] 3. Complete Response (CR) Rate Percentage of participants achieving CR according to RECIST v.1.1 will be reported. [Time Frame: Up to approximately 2 years 12 weeks] 4. 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. [Time Frame: Up to approximately 2 years 12 weeks] 5. Injected Tumor Response Rate Response rate will be measured based on total tumor shrinkage compared to baseline among those lesions injected with JNJ-90301900. [Time Frame: Up to approximately 2 years 14 weeks] 6. Time to Locoregional Failure (LRF) Time to LRF is defined as time from enrollment to first failure of LRF using investigator RECIST v.1.1 assessments. [Time Frame: Up to approximately 2 years 14 weeks] 7. Time to Distant Failure (DF) Time to DF is defined as time from enrollment to first failure of DF using investigator RECIST v.1.1 assessments. [Time Frame: Up to approximately 2 years 14 weeks] 8. Progression Free Survival (PFS) PFS is defined as the time from enrollment to radiographic disease progression, or death from any cause, whichever occurs first. [Time Frame: Up to approximately 2 years 14 weeks] 9. Number of Participants with Post-Radiation Neck Dissection (PRND) Participants with PRND will be summarized and will continue to be radiographically evaluated for response by RECIST v.1.1. [Time Frame: Up to approximately 2 years 14 weeks] 10. Number of Participants with Post-Radiation Primary Salvage Surgery Participants with post-radiation primary salvage surgery will be summarized and will continue to be radiographically evaluated for response by RECIST v.1.1. [Time Frame:

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Countries

Japan, United States Of America

Contacts

Public ContactMedical Information Center

Janssen Pharmaceutical K.K.

DL-JANJP-JCO_TL_TSG_EMP@its.jnj.com+81-120-183-275

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026