[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100507937":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":45,"centralContacts":45,"locations":46,"responsibleParty":112,"collaborators":114,"id":118,"slug":119,"hasResults":120,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":45,"eligibilityCriteria":124,"healthyVolunteers":120,"sex":125,"minAge":126,"maxAge":127,"enrollmentInfo":128,"targetDuration":45,"studyType":131,"phases":132,"briefSummary":135,"conditions":136,"keywords":45,"overallStatus":49,"whyStopped":45,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},{"fullName":5,"class":6},"Privo Technologies","INDUSTRY",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1: Pathologically proven and clinically confirmed Tis\u002FCIS of the lip or oral cavity","EXPERIMENTAL","PRV111 Topical Locoregional Delivery Placed Over the Tumor Region Primary Endpoint: Overall Response Rate (ORR) Primary Objective: Demonstrate the safety and efficacy of PRV111 in patients with Carcinoma in Situ (CIS) (WHO 2017)",[13],"Drug: PRV111 (Cisplatin Transmucosal System)",{"label":15,"type":10,"description":16,"interventionNames":17},"Arm 2: Pathologically proven and clinically confirmed T1-T3, Nx, M0 of the lip or oral cavity","Arm 2 PRV211 Intraoperative Locoregional Delivery Placed into the Resected Tumor Bed Primary Endpoint: Safety Primary Objective: Determine Safety of PRV211 in intraoperative setting",[18],"Drug: PRV211 (Intraoperative Cisplatin System)",{"label":20,"type":10,"description":21,"interventionNames":22},"Arm 3a: Histologically confirmed squamous cell carcinoma (SCC) of the oral cavity, classified as cli","Intratumoral Injectable for Tumors of the Oral Cavity Primary Endpoint: Safety and Objective Response Rate (ORR) Primary objective: Determine a safe and effective dose for PRV131 intratumoral injectable.",[23],"Drug: PRV131 (Cisplatin Intratumoral Injectable)",{"label":25,"type":10,"description":26,"interventionNames":27},"Arm 3b: Histologically confirmed malignant tumor in the lungs (primary or secondary), classified as","Intratumoral Injectable for Tumors of the Lung Primary Endpoint: Safety and Objective Response Rate (ORR) Primary objective: Determine a safe and effective dose for PRV131 intratumoral injectable.",[23],[29,36,41],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","PRV211 (Intraoperative Cisplatin System)","PRV211 system is comprised of two parts, a liquid permeation enhancer (PE) and cisplatin patch. The permeation is brushed onto the resected tumor bed and after 5 minutes the patch can be applied directly over the same area. Apply up to 2 layers of the PRV211 system to the tumor bed post-resection. The duration of the PRV211 treatment takes approximately 10-20 minutes and then the surgeon can continue as planned with the rest of the standard of care procedure. The proposed starting dose is 0.5 mg\u002Fcm2 of cisplatin on the tumor bed. This approach can be safe and effective in preventing locoregional recurrence after surgery and eliminating high-risk factors for local recurrence, such as dysplasia at the margins.",[15],[35],"Cisplatin",{"type":30,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"PRV111 (Cisplatin Transmucosal System)","PRV111 (Cisplatin Transmucosal System) is a thin, 2-layer, matrix-type, transmucosal patch consisting of a chitosan matrix layer embedded with cisplatin loaded chitosan particles (CLPs) and a non-woven fabric adhesive unidirectional backing, which is applied to the matrix layer during manufacturing. The patch is self-adhesive. In addition to the PRV111 patch, a separately packaged Permeation Enhancer (PE) Powder for Reconstitution used in conjunction with PRV111. The reconstituted PE Solution is intended to improve the absorption of the cisplatin active ingredient and will be applied prior to patch application.",[9],[35],{"type":30,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"PRV131 (Cisplatin Intratumoral Injectable)","PRV131 is a nanoparticle-based cisplatin formulation designed for intratumoral administration. The product is supplied as a lyophilized powder and reconstituted with a separately packaged diluent to form a suspension for injection. The reconstituted suspension is administered directly into the tumor, with dosing customized based on tumor size and injection site distribution. Upon intratumoral administration, the nanoparticles facilitate deep tumor penetration and localized drug release, enabling high local cisplatin concentrations while minimizing systemic exposure.",[20,25],null,[47,67,82,97],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"City of Hope National Medical Center","RECRUITING","Duarte","California","91010","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-117.97729,34.13945,{"lat":59,"lon":58},[62],{"name":63,"role":64,"phone":65,"phoneExt":45,"email":66},"Krupal Patel, MD Assistant Clinical ProfessorDivision of Head and Neck Surgery","CONTACT","6262187100","kruppatel@coh.org",{"facility":68,"status":49,"city":69,"state":70,"zip":71,"country":53,"countryCode":54,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Miami Cancer Institute","Miami","Florida","33176",{"type":56,"coordinates":73},[74,75],-80.19366,25.77427,{"lat":75,"lon":74},[78],{"name":79,"role":64,"phone":80,"phoneExt":45,"email":81},"Alessandra Villa, DDS Chief of oral medicine, oral oncology and dentistry at Miami C","786-527-8151","alessandro.villa@baptisthealth.net",{"facility":83,"status":49,"city":84,"state":85,"zip":86,"country":53,"countryCode":54,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"The University of Chicago","Chicago","Illinois","60637",{"type":56,"coordinates":88},[89,90],-87.65005,41.85003,{"lat":90,"lon":89},[93],{"name":94,"role":64,"phone":95,"phoneExt":45,"email":96},"Alexander Pearson, MD","(773) 834-1604","apearson5@medicine.bsd.uchicago.edu",{"facility":98,"status":49,"city":99,"state":100,"zip":101,"country":53,"countryCode":54,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"The Cleveland Clinic Foundation","Cleveland","Ohio","44195",{"type":56,"coordinates":103},[104,105],-81.69541,41.4995,{"lat":105,"lon":104},[108],{"name":109,"role":64,"phone":110,"phoneExt":45,"email":111},"Kyunghee Burkitt, MD Department of Hematology and Medical Oncology","216-339-6492","burkitk@ccf.org",{"type":113,"investigatorFullName":45,"investigatorTitle":45,"investigatorAffiliation":45,"oldNameTitle":45,"oldOrganization":45},"SPONSOR",[115],{"name":116,"class":117},"National Cancer Institute (NCI)","NIH","100507937","phase-2-a-study-evaluating-the-safety-and-efficacy-of-prv111-prv211-and-prv131-in-subjects-with-oral-and-lung-cancers-100507937",false,"NCT05893888","A Study Evaluating the Safety and Efficacy of PRV111, PRV211, and PRV131 in Subjects With Oral and Lung Cancers","A Phase 1\u002F2\u002F3 Multicenter Study Evaluating the PRV Platform of Localized Nanoengineered Therapies for Oral Cavity and Lung Cancers","Different diagnosis for ARM 1 \\& ARM 2, however the rest of inclusion criteria are the same for both arms:\n\nIn order to be eligible to participate in the study, an individual must meet all of the following criteria:\n\n• Diagnosis Arm 1: Pathologically proven and clinically confirmed Tis\u002FCIS of the lip or oral cavity Arm 2: Pathologically proven and clinically confirmed T1-T3, Nx,M0 of the lip or oral cavity\n\nCriteria for Inclusion for both ARM 1 \\& ARM 2:\n\n1. Tumors for which the cytological and architectural changes upon histopathological assessment warrant surgical intervention\n2. Adult subjects, men and women, defined by age ≥18 years at the time of screening.\n3. Tumor must be accessible, with no evidence of infection or active bleeding.\n4. Tumor is amenable to surgical resection within 8 weeks of screening visit (Visit 0).\n5. Clinically and\u002For radiologically measurable tumor.\n6. Eastern Collaborative Oncology Group Performance Status of ≤2.\n7. Male and female subjects of childbearing potential must agree to use 2 methods of effective contraception from screening and for at least 30 days after the final dose of investigational product. Appropriate birth control is defined as barrier methods with spermicides, oral or parenteral contraceptives and\u002For intrauterine devices, or naturally or surgically sterile (with documentation in the subject's medical records). Postmenopausal women are defined as presenting at least 12 months' natural spontaneous amenorrhea, or at least 6 weeks following surgical menopause (bilateral oophorectomy). Females of childbearing potential must be non-lactating and have a negative serum hCG within 14 days of treatment initiation.\n8. Absence of any serious underlying medical conditions which could impair the ability of the subject to participate in the study.\n9. Have a life expectancy of ≥3 months.\n10. Willing and able to provide written informed consent.\n11. Able to return to study site for treatment and follow-up visits as defined in the Protocol.\n\nCriteria for Exclusion for both ARM 1 and ARM 2 (unless specified):\n\nAn individual who meets any of the following criteria will be excluded from participation in the study:\n\n1. Subjects that are not eligible for surgery as SOC.\n2. Patients with a prior history of invasive squamous cell carcinoma (Arm 1 only)\n3. Tumors involving the marginal gingiva (Arm 1 only)\n4. Squamous cell carcinoma (SCC) of the oral cavity that received previous radiotherapy.(Arm 1 only)\n5. Systemic chemotherapy for the treatment of SCC of the head and neck less than 2 years prior to Screening (Arm 1 only)\n6. Concurrent documented malignancy, with the exception of localized SCCs and basal cell carcinoma of the skin Exposure to any investigational agent within 3 months prior to Screening\n7. Known allergy or hypersensitivity to platinum-containing agents, or known intolerance to a prior platinum- containing agent, or to any of the excipients, which, in the judgement of the physician will preclude re- exposure to platinum-containing agent\n8. Active, uncontrolled infection requiring systemic therapy, such as but not limited to HIV, Syphilis, Hepatitis B, or Hepatitis C\n9. Uncontrolled intercurrent illness that would risk subject safety, interfere with the objectives of the Protocol, or limit subject compliance with study requirements, as determined by the Investigator\n10. Known or suspected pregnancy, planned pregnancy, or lactation\n11. Any medical or psychiatric condition that may compromise the ability to give written informed consent\n12. Known diagnosis of oral submucous fibrosis (Arm 1 only)\n13. Known diagnosis of trismus (Arm 1 only)\n\nArm 3a:\n\nInclusion Criteria\n\nParticipants must meet all the following criteria to be eligible for the study:\n\n1. Age: 18 years or older at the time of screening.\n2. Diagnosis: Histologically confirmed squamous cell carcinoma (SCC) of the oral cavity, classified as clinical stage T1-T3, N0-N1, M0. This includes SCC of the lip with a significant mucosal component.\n3. Tumor Accessibility: Tumor must be accessible for intratumoral injection, with no evidence of active infection.\n4. Measurable Disease: Presence of clinically and\u002For radiologically measurable tumor.\n5. Performance Status: Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.\n6. Life Expectancy: Estimated life expectancy of at least 3 months.\n7. Informed Consent: Ability and willingness to provide written informed consent.\n8. Compliance: Ability to return to the study site for treatment visits as defined in the protocol.\n9. Contraception: For participants of childbearing potential, agreement to use two effective methods of contraception during the study period.\n\nExclusion Criteria\n\nParticipants meeting any of the following criteria will be excluded from the study:\n\n1. Surgical Eligibility: Not eligible for standard-of-care (SOC) surgery.\n2. Renal and Hepatic Function: Abnormal renal and hepatic functions as determined by the investigator.\n3. Cardiac Function: Corrected QT interval (QTc) \\> 470 ms for women and \\> 450 ms for men.\n4. Bone Involvement: Known bone involvement by the tumor (Stage T4).\n5. Other Cancers: Diagnosis of salivary gland cancer.\n6. Prior Treatments: History of oral cancers that were nonresponsive to radiation or platinum-based chemotherapy within the past 12 months.\n7. Multifocal Disease: Presence of multifocal invasive oral squamous cell carcinoma (OSCC).\n8. Investigational Agents: Exposure to any investigational agent within 3 months prior to screening.\n9. Allergies: Known allergy or hypersensitivity to platinum-containing agents or any excipients in the study drug, or known intolerance to prior platinum-based therapy that would preclude re-exposure.\n10. Infections: Active, uncontrolled infections requiring systemic therapy, including but not limited to HIV, syphilis, hepatitis B, or hepatitis C.\n11. Comorbid Conditions: Uncontrolled intercurrent illness that would pose a risk to subject safety, interfere with study objectives, or limit compliance, as determined by the investigator.\n12. Pregnancy and Lactation: Known or suspected pregnancy, planned pregnancy, or current lactation.\n13. Consent Capacity: Any medical or psychiatric condition that may compromise the ability to provide written informed consent.\n\n3b: Inclusion Criteria\n\nParticipants must meet all the following criteria to be eligible for the study:\n\n1. Age: 18 years or older at the time of screening.\n2. Diagnosis: Histologically confirmed malignant tumor in the lungs (primary or secondary), classified as clinical stage T1-T2, N0, M0.\n3. Tumor Accessibility: Tumor must be accessible for intratumoral injections via a bronchoscope, with no evidence of active infection.\n4. Measurable Disease: Presence of clinically and\u002For radiologically measurable tumor.\n5. Performance Status: Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.\n6. Life Expectancy: Estimated life expectancy of at least 3 months.\n7. Informed Consent: Ability and willingness to provide written informed consent.\n8. Compliance: Ability to return to the study site for treatment visits as defined in the protocol.\n9. Contraception: For participants of childbearing potential, agreement to use two effective methods of contraception during the study period.\n\nExclusion Criteria\n\nParticipants meeting any of the following criteria will be excluded from the study:\n\n1. Surgical Eligibility: Not eligible for standard-of-care (SOC) surgery.\n2. Renal and Hepatic Function: Abnormal renal and hepatic functions as determined by the investigator.\n3. Cardiac Function: Corrected QT interval (QTc) \\> 470 ms for women and \\> 450 ms for men.\n4. Bone Involvement: Known bone involvement by the tumor (Stage T4).\n5. Other Cancers: Active concurrent malignancies that require systemic therapy.\n6. Prior Treatments: History of cancers in the lung that were nonresponsive to radiation or platinum-based chemotherapy within the past 12 months.\n7. Investigational Agents: Exposure to any investigational agent within 3 months prior to screening.\n8. Allergies: Known allergy or hypersensitivity to platinum-containing agents or any excipients in the study drug or known intolerance to prior platinum-based therapy that would preclude re-exposure.\n9. Infections: Active, uncontrolled infections requiring systemic therapy, including but not limited to HIV, syphilis, hepatitis B, or hepatitis C.\n10. Comorbid Conditions: Uncontrolled intercurrent illness that would pose a risk to subject safety, interfere with study objectives, or limit compliance, as determined by the investigator.\n11. Pregnancy and Lactation: Known or suspected pregnancy, planned pregnancy, or current lactation.\n12. Consent Capacity: Any medical or psychiatric condition that may compromise the ability to provide written informed consent.","ALL","18 Years","100 Years",{"count":129,"type":130},40,"ESTIMATED","INTERVENTIONAL",[133,134],"PHASE2","PHASE3","Arm 1 ( Phase 2\u002F3 Run in ):\n\nPRV111: Topical Locoregional Delivery Placed Over the Tumor Region Primary Endpoint: Overall Response Rate (ORR) Primary Objective: Demonstrate the safety and efficacy of PRV111 in patients with Carcinoma in Situ (CIS) (WHO 2017)\n\nArm 2 (Phase 1) PRV211: Intraoperative Locoregional Delivery Placed into the Resected Tumor Bed Primary Endpoint: Safety Primary Objective: Determine Safety of PRV211 in intraoperative setting\n\nArm 3 (Phase 1\u002F2) PRV131: Intratumoral Injectable delivery into the Tumor Primary Endpoint: Safety and Objective Response Rate (ORR) Primary objective: Determine a safe and effective dose for PRV131 intratumoral injectable\n\nSubject Assignment: Subjects will be assigned to Arm 1, Arm 2, or Arm 3 of this study based on disease staging Arm 1: Pathologically proven and clinically confirmed Tis\u002FCIS of the lip or oral cavity Arm 2: Pathologically proven and clinically confirmed T1-T3, Nx, M0 of the lip or oral cavity Arm 3a: Histologically confirmed squamous cell carcinoma (SCC) of the oral cavity, classified as clinical stage T1-T3, N0-1, M0 Arm 3b: Histologically confirmed malignant tumor in the lungs (primary or secondary), classified as clinical stage T1-2, N0, M0",[137],"Oral Squamous Cell Carcinoma","2026-04-20",{"date":140,"type":141},"2026-04-23","ACTUAL",{"date":143,"type":141},"2024-11-07",{"date":145,"type":130},"2027-05-31",{"name":5,"class":6},4]