[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06601296":3,"trial-entities:NCT06601296":106,"trial-summary:NCT06601296":110},{"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":21,"study_type":33,"primary_purpose":34,"phases":35,"enrollment_info":37,"interventions":40,"primary_outcomes":47,"secondary_outcomes":52,"sex":53,"minimum_age":54,"maximum_age":55,"healthy_volunteers":56,"eligibility_criteria":57,"std_ages":70,"locations":73,"central_contacts":95,"overall_officials":102,"references":104,"see_also_links":105},"NCT06601296","2024-0919","Radiotherapy in Combination With Checkpoint Inhibition for Patients With Metastatic Kidney Cancer","STING Agonist and Personalized Ultra-fractionated Stereotactic Adaptive Radiotherapy in Combination With Checkpoint Inhibition for Patients With Metastatic Kidney Cancer.","RECRUITING","2028-10","2025-11","2025-11-12","2025-04-01","University of Texas Southwestern Medical Center","OTHER",true,"To evaluate the impact of combining innate immune system activation (with IMSA101) with antigen release (through SAbR\u002FPULSAR) on limited progressing lesions during ongoing adaptive immune system activation (with maintenance Nivo).","The study expects to accrue the 15 patients over a 3-4 year period.\n\nPatients with oligoprogressive disease (≤5 lesions) after treatment with Anti-PD1 \u002F Anti-CTLA-4 will continue Anti-PD1 (nivolumab). All patients will have a mandatory PD-L1 PET (Pre-treatment and Week 12). All patients will undergo baseline biopsy (just before the administration of IMSA101 of the same lesion to be injected). SAbR will be delivered in 3 fractions at 12 Gy every 4 weeks (PULSAR regimen) to all progressing lesions. One lesion will also receive 3 intratumoral injections of IMSA101 (C1D1, C1D8, C1D15, C2D1, C3D1) immediately after radiation either on the same day or within 72 hours after the PULSE.\n\nSelected Phase 2 dosing of IMSA101 (1200mcg) will be utilized.\n\nAt disease progression, patients have the option to undergo additional imaging and tissue\u002Fblood collections.",[19,20],"Metastatic Renal Cell Carcinoma ( mRCC)","OligoProgressive Metastatic Disease",[22,23,24,25,26,27,28,29,30,31,32],"renal","kidney","mrcc","metastatic","cancer","STING","PULSAR","SABr","SPARK","nivolumab","IMSA 101","INTERVENTIONAL","TREATMENT",[36],"PHASE2",{"count":38,"type":39},15,"ESTIMATED",[41],{"type":42,"name":43,"description":44,"armGroupLabels":45},"DRUG","IMSA101","All enrolled patients to undergo the following treatment:\n\nSOC treatment: Nivolumab 480mg monthly PULSAR: 36 Gy in 3 fractions, Q4weeks IMSA101: three intra-tumoral injections of one of the progressive lesions at 1200 mcg (C1D1, C2D1, C3D1)",[46],"SAbR with Intratumoral STING agonist IMSA101 and IO with Anti-PD1",[48],{"measure":49,"description":50,"timeFrame":51},"To evaluate the PFS rate associated with the therapeutic intervention. PFS is defined as the duration of time from initiation of PULSAR\u002FIMSA101 to disease progression as defined by RECIST1.1 or death.","Exact binomial test will be used to test if the lower limit of the 95% confidence interval of the probability of postponing systemic therapy \\>9 months will be greater than 30%.","Time from initiation of PULSAR\u002FIMSA101 until death from any cause. Follow-up visits to be done every 12 weeks (+\u002F- 1 week) for study duration until patient has progressed. Afterward, subjects to be contacted every 6 months for survival data up to 5 years",[],"ALL","18 Years",null,false,{"inclusion":58,"exclusion":67,"raw_text":69},[59,60,61,62,63,64,65,66],"Patients must have metastatic ccRCC.","Patients must have oligoprogression defined as progression in ≤5 lesions.","All oligoprogression lesions must be suitable for radiation.","Patients must have at least one site of disease that can be safely injected with IMSA101.","Karnofsky Performance Status (KPS) of at least 50%.","Age ≥ 18 years.","Patients must have adequate organ and marrow function within 14 days prior to study entry.","All IMDC risk categories are allowed.",[68],"Patients with progressive ultracentral\u002Fcentral chest lesions will be excluded","Inclusion Criteria:\n\n* Patients must have metastatic ccRCC.\n* Patients must have oligoprogression defined as progression in ≤5 lesions.\n* All oligoprogression lesions must be suitable for radiation.\n* Patients must have at least one site of disease that can be safely injected with IMSA101.\n* Karnofsky Performance Status (KPS) of at least 50%.\n* Age ≥ 18 years.\n* Patients must have adequate organ and marrow function within 14 days prior to study entry.\n* All IMDC risk categories are allowed.\n\nExclusion Criteria:\n\n* Patients with progressive ultracentral\u002Fcentral chest lesions will be excluded",[71,72],"ADULT","OLDER_ADULT",[74],{"facility":13,"status":8,"city":75,"state":76,"zip":77,"country":78,"contacts":79,"geoPoint":92},"Dallas","Texas","75390","United States",[80,85,89],{"name":81,"role":82,"phone":83,"email":84},"BUSAYO ADEFALUJO, CLINICAL RESEARCH COORDINATOR","CONTACT","214 648 1873","Busayo.Adefalujo@UTSouthwestern.edu",{"name":86,"role":82,"phone":87,"email":88},"SARAH NEUFELD SUPERVISOR OF CLINICAL RESEARCH, MS, MBA","214 648 1836","Sarah.Hardee@UTSouthwestern.edu",{"name":90,"role":91},"RAQUIBUL HANNAN, MD","PRINCIPAL_INVESTIGATOR",{"lat":93,"lon":94},32.78306,-96.80667,[96,98],{"name":97,"role":82,"phone":87,"email":88},"SARAH NEUFELD, MANAGER OF CLINICAL RESEARCH, MS, MBA",{"name":99,"role":82,"phone":100,"email":101},"RAQUIBUL HANNAN, MD, PhD.","214 645 7696","Raquibul.Hannan@UTSouthwestern.edu",[103],{"name":90,"affiliation":13,"role":91},[],[],{"nct_id":4,"conditions":107,"biomarkers":109},[108],"Clear Cell Renal Cell Carcinoma",[],{"nct_id":4,"found":15,"summary":111,"prompt_version":121},{"design":112,"status":113,"heading":114,"summary":115,"follow_up":116,"word_count":117,"commitments":118,"compensation":119,"drugs_mentioned":120},"This is an interventional study planning to enroll 15 participants. All participants will receive the study treatments.","completed","Radiotherapy and IMSA101 for Metastatic Kidney Cancer","This study is looking at a new way to treat metastatic kidney cancer (renal cell carcinoma) that has spread to other parts of the body and is progressing in a limited number of spots (oligoprogressive disease). It combines your current treatment, nivolumab, with radiation therapy (PULSAR) and a drug called IMSA101. Researchers want to see if this combination can stop the cancer from growing for longer. To join, you must have metastatic kidney cancer with progression in 5 or fewer lesions, and these lesions must be suitable for radiation and injection. The study will measure how long patients live without their disease getting worse. The current status of this study is unclear.","Participants will be followed for survival data every 6 months for up to 5 years after their disease progresses.",112,"You will receive nivolumab monthly, radiation therapy (PULSAR) every 4 weeks to progressing lesions, and three injections of IMSA101 into one lesion. You will have follow-up visits every 12 weeks until your disease progresses, and then every 6 months for survival data for up to 5 years.","Not stated in the trial record.",[43],"v2"]