{"preliminary_commentary":{"by_channel":{"x_thread":8},"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\": \"NCT05239533\", \"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,"name":"STARLITE 2","nct_id":"NCT05239533","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=starlite-2-nct05239533. 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":null,"arms":[{"description":"Participants have Advanced or Metastatic Clear Cell Renal Cell Carcinoma/RCC. The protocol will start with a safety-lead in phase using a 3+3 design to establish the maximal tolerated dose (MTD) of 177Lu-labeled-girentuximab in combination with standard-dose nivolumab. The initial starting dose of 177Lu-labeled-girentuximab is 1804 MBq/m2 which is 75% of the single agent dose established in prior studies and will proceed as shown in the schema below. Once the MTD is established, a Simon two-stage optimal design will commence. 10 patients will be enrolled in the first stage and if no responses are observed, the study will be terminated. If 1 or more responses are observed in the first 10 patients, we will extend enrollment to a total of 29 patients (19 additional patients) in the second stage.","label":"Safety lead-in Phase: Participants with Advanced or Metastatic Clear Cell Renal Cell Carcinoma/RCC","type":"EXPERIMENTAL"},{"description":"Participants have Advanced or Metastatic Clear Cell Renal Cell Carcinoma/RCC. If 1 or more responses are observed in the first 10 patients, we will extend enrollment to a total of 29 patients (19 additional patients) in the second stage.","label":"Phase 2 Participants","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2027-03","type":"ESTIMATED"},"conditions":["Clear Cell Renal Cell Carcinoma","Kidney Cancer","Advanced Renal Cell Carcinoma"],"enrollment":{"count":9,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"177Lu-labeled-girentuximab","otherNames":[],"type":"DRUG"},{"name":"Nivolumab","otherNames":[],"type":"DRUG"},{"name":"89Zr-girentuximab PET/CT","otherNames":[],"type":"DIAGNOSTIC_TEST"},{"name":"177Lu whole body (WB) planar and SPECT/CT scans","otherNames":[],"type":"DIAGNOSTIC_TEST"}],"last_update":"2026-01-14","lead_sponsor":"Memorial Sloan Kettering Cancer Center","official_title":"A Phase 2 Open-label Study of Nivolumab Combined With Lutetium 177-Labeled Anti-Carbonic Anhydrase IX Monoclonal Antibody Girentuximab in Patients With Clear Cell Advanced Renal Cell Carcinoma","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE2"],"primary_completion_date":{"date":"2027-03","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Maximal tolerated dose (MTD) of 177Lu-girentuximab","timeFrame":"24 (+/- 2) weeks"},{"measure":"Overall Response Rate/ORR","timeFrame":"24 (+/- 2) weeks"}],"references":[],"start_date":{"date":"2022-02-16","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study of Nivolumab in Combination With 177Lu-girentuximab for Kidney Cancer","url":"https://clinicaltrials.gov/study/NCT05239533"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/starlite-2-nct05239533"}