[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07219212":3,"trial-entities:NCT07219212":265,"trial-summary:NCT07219212":269},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":55,"secondary_outcomes":60,"sex":88,"minimum_age":89,"maximum_age":90,"healthy_volunteers":15,"eligibility_criteria":91,"std_ages":105,"locations":108,"central_contacts":253,"overall_officials":259,"references":263,"see_also_links":264},"NCT07219212","90301900HNC1001","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","RECRUITING","2028-07-14","2026-08","2026-08-28","2026-01-26","Johnson & Johnson Enterprise Innovation Inc.","INDUSTRY",false,"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).",null,[19],"Squamous Cell Carcinoma of Head and Neck",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE1",{"count":26,"type":27},45,"ESTIMATED",[29,38,42,47,51],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":35},"DRUG","JNJ-90301900","JNJ-90301900 will administered via intratumoral and\u002For intranodal injection.",[34],"JNJ-90301900 + Concurrent Chemoradiation Therapy (cCRT)",[36,37],"NBTXR3","Functionalized hafnium oxide nanoparticles",{"type":30,"name":39,"description":40,"armGroupLabels":41},"Cisplatin","Cisplatin will be administered intravenously.",[34],{"type":43,"name":44,"description":45,"armGroupLabels":46},"RADIATION","Intensity Modulated Radiation Therapy (IMRT)","IMRT radiation therapy will be administered.",[34],{"type":30,"name":48,"description":49,"armGroupLabels":50},"Carboplatin","Carboplatin will be administered intravenously.",[34],{"type":30,"name":52,"description":53,"armGroupLabels":54},"Paclitaxel","Paclitaxel will be administered intravenously.",[34],[56],{"measure":57,"description":58,"timeFrame":59},"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",[61,64,67,70,73,76,79,82,85],{"measure":62,"description":63,"timeFrame":59},"Complete Response (CR) Rate","Percentage of participants achieving CR according to RECIST v.1.1 will be reported.",{"measure":65,"description":66,"timeFrame":59},"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.",{"measure":68,"description":69,"timeFrame":59},"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.",{"measure":71,"description":72,"timeFrame":59},"Injected Tumor Response Rate","Response rate will be measured based on total tumor shrinkage compared to baseline among those lesions injected with JNJ-90301900.",{"measure":74,"description":75,"timeFrame":59},"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.",{"measure":77,"description":78,"timeFrame":59},"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.",{"measure":80,"description":81,"timeFrame":59},"Progression Free Survival (PFS)","PFS is defined as the time from enrollment to radiographic disease progression, or death from any cause, whichever occurs first.",{"measure":83,"description":84,"timeFrame":59},"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.",{"measure":86,"description":87,"timeFrame":59},"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.","ALL","18 Years","74 Years",{"inclusion":92,"exclusion":98,"raw_text":104},[93,94,95,96,97],"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",[99,100,101,102,103],"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","Inclusion criteria:\n\n* Pathologically (histologically or cytologically) proven diagnosis of HNSCC of the oral cavity, oropharynx (p16 negative), hypopharynx, or supraglottic larynx\n* Stage III, IVA or IVB according to the 8th Edition of the American Joint Committee on Cancer (AJCC) guidelines\n* A candidate for definitive concurrent chemoradiation therapy treatment as determined by investigator and per local guidelines\n* Participants must have at least 1 target lesion (primary tumor or involved lymph node) per RECIST v.1.1\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1\n\nExclusion criteria:\n\n* Primary tumor originating in the nasopharynx, paranasal sinuses, salivary glands, thyroid gland, parathyroid gland, skin, or unknown primary site\n* Non-squamous histology\n* Stages 0, I, II, and IVC HNSCC, loco-regionally recurrent HNSCC, or synchronous second primary HNSCC (within 2 months)\n* Ineligible to receive platinum-based chemotherapy\n* Suspected or known allergies, hypersensitivity, or intolerance to JNJ-90301900 or its excipients",[106,107],"ADULT","OLDER_ADULT",[109,118,126,133,141,148,156,164,172,180,188,196,203,210,217,224,232,239,246],{"facility":110,"status":8,"city":111,"state":112,"zip":113,"country":114,"geoPoint":115},"University of Alabama at Birmingham","Birmingham","Alabama","35294","United States",{"lat":116,"lon":117},33.52066,-86.80249,{"facility":119,"status":8,"city":120,"state":121,"zip":122,"country":114,"geoPoint":123},"City of Hope","Duarte","California","91010",{"lat":124,"lon":125},34.13945,-117.97729,{"facility":127,"status":8,"city":128,"state":121,"zip":129,"country":114,"geoPoint":130},"University of California at San Diego Moores Cancer Center","La Jolla","92093",{"lat":131,"lon":132},32.84727,-117.2742,{"facility":134,"status":8,"city":135,"state":136,"zip":137,"country":114,"geoPoint":138},"Mayo Clinic","Jacksonville","Florida","32224",{"lat":139,"lon":140},30.33218,-81.65565,{"facility":142,"status":8,"city":143,"state":136,"zip":144,"country":114,"geoPoint":145},"Moffit Cancer center","Tampa","33612",{"lat":146,"lon":147},27.94752,-82.45843,{"facility":149,"status":8,"city":150,"state":151,"zip":152,"country":114,"geoPoint":153},"Emory University","Atlanta","Georgia","30308",{"lat":154,"lon":155},33.749,-84.38798,{"facility":157,"status":8,"city":158,"state":159,"zip":160,"country":114,"geoPoint":161},"Boston Medical Center","Boston","Massachusetts","02118",{"lat":162,"lon":163},42.35843,-71.05977,{"facility":165,"status":8,"city":166,"state":167,"zip":168,"country":114,"geoPoint":169},"Montefiore Medical Center","The Bronx","New York","10467",{"lat":170,"lon":171},40.84985,-73.86641,{"facility":173,"status":8,"city":174,"state":175,"zip":176,"country":114,"geoPoint":177},"University of North Carolina at Chapel Hill","Chapel Hill","North Carolina","27514",{"lat":178,"lon":179},35.9132,-79.05584,{"facility":181,"status":8,"city":182,"state":183,"zip":184,"country":114,"geoPoint":185},"University of Pennsylvania","Philadelphia","Pennsylvania","19104",{"lat":186,"lon":187},39.95238,-75.16362,{"facility":189,"status":8,"city":190,"zip":191,"country":192,"geoPoint":193},"Hopital De La Cavale Blanche","Brest","29200","France",{"lat":194,"lon":195},48.39029,-4.48628,{"facility":197,"status":8,"city":198,"zip":199,"country":192,"geoPoint":200},"Centre Oscar Lambret","Lille","59000",{"lat":201,"lon":202},50.63391,3.05512,{"facility":204,"status":8,"city":205,"zip":206,"country":192,"geoPoint":207},"Hopital La Timone","Marseille","13385",{"lat":208,"lon":209},43.29695,5.38107,{"facility":211,"status":8,"city":212,"zip":213,"country":192,"geoPoint":214},"Centre Henri Becquerel","Rouen","76038",{"lat":215,"lon":216},49.44313,1.09932,{"facility":218,"status":8,"city":219,"zip":220,"country":192,"geoPoint":221},"Gustave Roussy","Villejuif","94805",{"lat":222,"lon":223},48.7939,2.35992,{"facility":225,"status":8,"city":226,"zip":227,"country":228,"geoPoint":229},"Hiroshima University Hospital","Hiroshima","734 8551","Japan",{"lat":230,"lon":231},34.4,132.45,{"facility":233,"status":8,"city":234,"zip":235,"country":228,"geoPoint":236},"Aichi Cancer Center","Nagoya","464-8681",{"lat":237,"lon":238},35.18147,136.90641,{"facility":240,"status":8,"city":241,"zip":242,"country":228,"geoPoint":243},"Shizuoka Cancer Center","Shizuoka","411 8777",{"lat":244,"lon":245},34.98333,138.38333,{"facility":247,"status":8,"city":248,"zip":249,"country":228,"geoPoint":250},"Tokyo Medical University Hospital","Tokyo","160-0023",{"lat":251,"lon":252},35.6895,139.69171,[254],{"name":255,"role":256,"phone":257,"email":258},"Study Contact","CONTACT","844-434-4210","Participate-In-This-Study1@its.jnj.com",[260],{"name":261,"affiliation":13,"role":262},"Johnson & Johnson Enterprise Innovation, Inc. Clinical Trial","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":266,"biomarkers":268},[267],"Head and Neck Squamous Cell Carcinoma",[],{"nct_id":4,"found":270,"summary":271,"prompt_version":281},true,{"design":272,"status":273,"heading":274,"summary":275,"follow_up":276,"word_count":277,"commitments":278,"compensation":279,"drugs_mentioned":280},"This is a Phase 1b, global, open-label, single-arm study, meaning all 45 participants will receive the same treatments, and everyone involved will know what treatments are being given.","completed","JNJ-90301900 with Chemoradiation for Head and Neck Cancer","This study is looking at a treatment called JNJ-90301900, which is injected directly into tumors, alongside standard chemotherapy (Cisplatin, Carboplatin, Paclitaxel) and radiation therapy (IMRT). It's for people with locally advanced head and neck squamous cell carcinoma (HNSCC), a type of cancer that starts in the mouth or throat. The main goal is to see how safe JNJ-90301900 is and what side effects it might cause. The study plans to enroll about 45 participants between 18 and 74 years old who have Stage III, IVA, or IVB HNSCC and are able to receive standard chemoradiation. The study's current status is unclear.","Participants will be monitored for adverse events for up to approximately 2 years and 14 weeks.",101,"Not specified in the trial record.","Not stated in the trial record.",[31,39,48,52],"v2"]