[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649320":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":40,"centralContacts":45,"locations":54,"responsibleParty":71,"collaborators":73,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":23,"enrollmentInfo":86,"targetDuration":23,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":23,"overallStatus":97,"whyStopped":23,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"University of Illinois at Chicago","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"RiMO-301 combined with radiotherapy and pembrolizumab followed by surgical resection","EXPERIMENTAL","RiMO-301 will be injected intratumorally once prior to radiotherapy at 30% of tumor volume(s). Radiotherapy will start within 1 day after the RiMO-301 injection for 5 fractions of 4-5 Grays per fraction over a period of 5-15 days. Pembrolizumab 200 mg will be administered intravenously every 3 weeks (Q3W) within the first dose given on the same day as the RiMO-301 injection (+\u002F-1 day). Pembrolizumab will continue for 2 cycles (1 cycle = 21 days). Surgical resection of the tumor will occur after the completion of neoadjuvant therapy.",[13,14,15,16],"Drug: RiMO-301","Drug: Pembrolizumab","Radiation: Radiation","Procedure: Surgical resection",[18,24,30,35],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","RiMO-301","RiMO-301 will be dosed at 30% of the tumor volume on Day 0 prior to radiotherapy. The injection point will be as closed to half of the tumor depth as possible.",[9],null,{"type":19,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"Pembrolizumab","Pembrolizumab will be administered at 200 mg once every 3 weeks (Q3W) with the first dose on Day 0 +\u002F- 1 day. Pembrolizumab will be given for a total of two cycles prior to surgery.",[9],[29],"Keytruda",{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":23},"RADIATION","Radiation","Hypofractionated radiation will will be given within 1 day after RiMO-301 injection and will continue over a period of 5-15 days. Participants will be receive 5 fractions of radiation with a dose of 4-5 Gray per fraction.",[9],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":23},"PROCEDURE","Surgical resection","Surgical resection of the tumor will occur following neoadjuvant therapy.",[9],[41],{"name":42,"affiliation":43,"role":44},"Ameen Salahudeen, MD, PhD","Principal Investigator","PRINCIPAL_INVESTIGATOR",[46,50],{"name":42,"role":47,"phone":48,"phoneExt":23,"email":49},"CONTACT","(312) 355-1625","ameen@uic.edu",{"name":51,"role":47,"phone":52,"phoneExt":23,"email":53},"Riley Johnke","(312) 355-1469","johnke@uic.edu",[55],{"facility":5,"status":23,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Chicago","Illinois","60612","United States","US",{"type":62,"coordinates":63},"Point",[64,65],-87.65005,41.85003,{"lat":65,"lon":64},[68,70],{"name":42,"role":47,"phone":69,"phoneExt":23,"email":49},"312-355-1625",{"name":42,"role":44,"phone":23,"phoneExt":23,"email":23},{"type":44,"investigatorFullName":72,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Ameen Salahudeen",[74],{"name":75,"class":76},"Coordination Pharmaceuticals, Inc.","INDUSTRY","100649320","phase-2-rimo-hnc-neo1-phase-2-study-of-rimo-301-and-hypofractionated-radiotherapy-with-pembrolizumab-for-the-neoadjuvant-treatment-of-resectable-locally-advanced-head-neck-cancer-100649320",false,"NCT07732634","RiMO-HNC-NEO1: Phase 2 Study of RiMO-301 and Hypofractionated Radiotherapy With Pembrolizumab for the Neoadjuvant Treatment of Resectable, Locally Advanced Head-Neck Cancer","RiMO-HNC-NEO1","Inclusion Criteria:\n\n* Diagnosis of head and neck cancer that requires surgical resection\n* Must have at least one lesion that is clinically accessible to RiMO-301 injection and amenable to receiving hypofractionated radiotherapy\n* The selected target lesions must be measurable on cross-sectional imaging, and repeated measurements at the same location should be achievable\n* Target tumor not in the previously irradiated field or in the field irradiated at least six months prior to RiMO-301 injection, and with no complications from the prior radiation course\n* Patients must have recovered from acute toxic effects (≤ grade 1 CTCAEv6) of previous cancer treatments prior to enrollment\n* Patients with locally advanced, resectable head and neck cancer:\n\n  * suitable to receive a PD-1 inhibitor (pembrolizumab) as a standard of care in the discretion of the treating physician or Principal Investigator\n  * suitable to receive hypofractionated radiotherapy as a standard of care in the discretion of the treating physician or Principal Investigator\n* Have adequate bone marrow reserve:\n\n  * Absolute neutrophil count ≥1.5x109 cell\u002FL\n  * Platelet count ≥100x109 cell\u002FL\n  * Hemoglobin at least ≥9.0 g\u002FdL unless confirmed by treating physician as not posing any increased harm to patient and approved by Sponsor (transfusion is allowed to achieve hemoglobin of ≥9.0 g\u002FdL 14-days prior to dosing)\n* Have adequate liver function:\n\n  * Total serum bilirubin no more than 1.5x upper limit of normal (ULN)\n  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5x ULN or ≤5.0x ULN in case of documented hepatic metastasis\n  * Alkaline phosphatase ≤5x ULN\n* Have a life expectancy of at least 12 weeks (in the opinion of the investigator)\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Females with childbearing potential should be using adequate contraceptive measures from the time of screening until 6 months after study discontinuation, should not be breastfeeding, and must have a negative pregnancy test prior to start of dosing\n* Patients must sign a study-specific informed consent form prior to study entry.\n\nExclusion Criteria:\n\nDiagnosis other than resectable, locally advanced head and neck cancers\n\n* HPV associated head and neck cancer\n* Nasopharynx head and neck cancer\n* Have signs or symptoms of end-stage failure, major chronic illnesses other than cancer, or any severe concomitant conditions\n* Symptomatic central nervous system metastases and\u002For carcinomatous meningitis\n* Has received any approved or investigational anti-neoplastic agent or immunotherapy other than PD-1 inhibitors, pembrolizumab, within 4 weeks prior to RiMO-301 injection.\n* Patients who are intolerant to pembrolizumab\n* Active autoimmune disease that has required systemic treatment in the past 2 years\n* Ongoing clinically significant infection at or near the incident lesion\n* Major surgery over the target area (excluding placement of vascular access) ≤21 days from the beginning of the study drug or minor surgical procedures ≤7 days. No waiting is required following implantable port, enteral feeding tube, and catheter placement\n* Other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that would make the patient inappropriate for enrollment in this study\n* Has any mental or medical condition that prevents the patient from giving informed consent or participating in the trial\n* Pregnant and nursing women are excluded because of the potential teratogenic effects and potential unknown effects on nursing newborns\n* Patients with a target lesion in the field that had complications from prior radiotherapy that are not amenable to repeat irradiation in the discretion of the treating physician or Principal Investigator\n* Patients with lesions that have significant blood vessel involvement (such as carotid artery encasement) or other major structures","ALL","18 Years",{"count":87,"type":88},20,"ESTIMATED","INTERVENTIONAL",[91],"PHASE2","The primary objective is to evaluate major pathologic response after RiMO-301 with hypofractionated radiotherapy and a PD-1 inhibitor (pembrolizumab), as assessed by clinical response rate using iRECIST criteria; determine event-free survival for up to 12 months; and determine overall survival for up to 24 months. The secondary objectives include determining event-free survival for up to 12 months and overall survival for up to 24 months.",[94,95,96],"Head and Neck Cancer","Head Cancer","Neck Cancer","NOT_YET_RECRUITING","2026-07-23",{"date":100,"type":101},"2026-07-29","ACTUAL",{"date":103,"type":88},"2026-08",{"date":105,"type":88},"2031-08",{"name":5,"class":6},1]