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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-522914-22-00 | Registry Identifier | EUCT number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JNJ-90301900 + Concurrent Chemoradiation Therapy (cCRT) | Experimental | Participants will receive JNJ-90301900 administered intratumorally and/or intranodally, in combination with concurrent chemoradiation therapy (cCRT) consisting of platinum based chemotherapy (cisplatin or carboplatin/paclitaxel) and intensity-modulated radiation therapy (IMRT). Post-treatment follow-up will continue until the end of study (EOS), radiographic disease progression, study discontinuation, or study completion, whichever occurs first. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-90301900 | Drug | JNJ-90301900 will administered via intratumoral and/or intranodal injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to approximately 2 years 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response (CR) Rate | Percentage of participants achieving CR according to RECIST v.1.1 will be reported. | Up to approximately 2 years 14 weeks |
| Objective Response Rate (ORR) According to RECIST v.1.1 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Contact | Contact | 844-434-4210 | Participate-In-This-Study1@its.jnj.com |
| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Enterprise Innovation, Inc. Clinical Trial | Johnson & Johnson Enterprise Innovation Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Recruiting | Birmingham | Alabama | 35294 | United States | |
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| Cisplatin | Drug | Cisplatin will be administered intravenously. |
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| Intensity Modulated Radiation Therapy (IMRT) | Radiation | IMRT radiation therapy will be administered. |
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| Carboplatin | Drug | Carboplatin will be administered intravenously. |
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| Paclitaxel | Drug | Paclitaxel will be administered intravenously. |
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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.
| Up to approximately 2 years 14 weeks |
| 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. | Up to approximately 2 years 14 weeks |
| Injected Tumor Response Rate | Response rate will be measured based on total tumor shrinkage compared to baseline among those lesions injected with JNJ-90301900. | Up to approximately 2 years 14 weeks |
| 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. | Up to approximately 2 years 14 weeks |
| 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. | Up to approximately 2 years 14 weeks |
| Progression Free Survival (PFS) | PFS is defined as the time from enrollment to radiographic disease progression, or death from any cause, whichever occurs first. | Up to approximately 2 years 14 weeks |
| 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. | Up to approximately 2 years 14 weeks |
| Number of Participants with Post-Radiation Primary Surgery | Participants with post-radiation primary surgery will be summarized and will continue to be radiographically evaluated for response by RECIST v.1.1. | Up to approximately 2 years 14 weeks |
| City of Hope |
| Recruiting |
| Duarte |
| California |
| 91010 |
| United States |
| Mayo Clinic | Recruiting | Jacksonville | Florida | 32224 | United States |
| Moffit Cancer center | Recruiting | Tampa | Florida | 33612 | United States |
| Emory University | Recruiting | Atlanta | Georgia | 30308 | United States |
| Boston Medical Center | Recruiting | Boston | Massachusetts | 02118 | United States |
| Montefiore Medical Center | Recruiting | The Bronx | New York | 10467 | United States |
| University of North Carolina at Chapel Hill | Recruiting | Chapel Hill | North Carolina | 27514 | United States |
| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| Hopital De La Cavale Blanche | Recruiting | Brest | 29200 | France |
| Centre Oscar Lambret | Recruiting | Lille | 59000 | France |
| Hopital La Timone | Recruiting | Marseille | 13385 | France |
| Centre Henri Becquerel | Recruiting | Rouen | 76038 | France |
| Gustave Roussy | Recruiting | Villejuif | 94805 | France |
| Hiroshima University Hospital | Recruiting | Hiroshima | 734 8551 | Japan |
| Aichi Cancer Center | Recruiting | Nagoya | 464-8681 | Japan |
| Tokyo Medical University Hospital | Recruiting | Tokyo | 160-0023 | Japan |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D050397 | Radiotherapy, Intensity-Modulated |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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