{"preliminary_commentary":{"by_channel":{"x_thread":8,"youtube":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT05024318\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"commentary_summary":null,"drugs_tested":[["pembrolizumab"]],"indication":"clear cell renal cell carcinoma","name":"NAPSTER","nct_id":"NCT05024318","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=napster-nct05024318. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"NAPSTER","arms":[{"description":"Stereotactic Ablative Radiotherapy (SABR) will be prescribed to a dose of 42Gy in 3 fractions. All radiotherapy treatment be completed within 3 weeks.Patients will undergo nephrectomy within 9-12 weeks after the first dose of treatment.","label":"SABR plus nephrectomy","type":"ACTIVE_COMPARATOR"},{"description":"Pembrolizumab 200 mg (flat dose) will be administered as a 30 minute IV infusion every 21 days for 3 cycles. Patients will receive 1 cycle of pembolizumab prior to SABR followed by an additional 2 cycles of pembrolizumab (1 cycle is 21 days). Patients will undergo nephrectomy 9-12 weeks after commencement of treatment.","label":"Pembrolizumab followed by SABR after cycle 1 plus nephrectomy","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2025-12","type":"ESTIMATED"},"conditions":["Renal Cell Carcinoma, Clear Cell, Somatic"],"enrollment":{"count":20,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Pembrolizumab","otherNames":["MK-3475"],"type":"DRUG"},{"name":"Stereotactic Ablative Radiotherapy","otherNames":["SABR"],"type":"RADIATION"},{"name":"Nephrectomy","otherNames":["Surgical removal of a kidney"],"type":"PROCEDURE"}],"last_update":"2024-05-16","lead_sponsor":"Peter MacCallum Cancer Centre, Australia","official_title":"NeoAdjuvant Pembrolizumab and STEreotactic Radiotherapy Prior to Nephrectomy for Renal Cell Carcinoma: Investigating Induced Immune Context Changes","overall_status":"UNKNOWN","phases":["PHASE2"],"primary_completion_date":{"date":"2025-12","type":"ESTIMATED"},"primary_outcomes":[{"measure":"mPR post-SABR with or without pembrolizumab","timeFrame":"At nephrectomy performed 9-12 weeks after first dose of pembrolizumab"},{"measure":"CD8+ TRM in baseline biopsy and post-nephrectomy specimen, all measured as a continuous variable.","timeFrame":"Baseline and at nephrectomy performed 9-12 weeks after first dose of pembrolizumab"},{"measure":"TCF-1 + tumour infiltrating lymphocytes (TILs) in baseline biopsy and post-nephrectomy specimen, measured as a continuous variable","timeFrame":"Baseline and at nephrectomy performed 9-12 weeks after first dose of pembrolizumab"}],"references":[],"start_date":{"date":"2022-02-08","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"NeoAdjuvant Pembrolizumab and STEreotactic Radiotherapy Prior to Nephrectomy for Renal Cell Carcinoma","url":"https://clinicaltrials.gov/study/NCT05024318"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/napster-nct05024318"}