{"preliminary_commentary":{"by_channel":{"x_thread":3},"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":false},"commentary_summary":null,"drugs_tested":null,"indication":null,"name":"NCT05122546","nct_id":"NCT05122546","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct05122546. The price is an estimate of verified statements from the commentary indexed so far. Final coverage is set when the report is built. You never pay more than quoted: if the report is delivered at a smaller size, you pay that size's price, and anything paid above it is refunded. 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_rule":"Never more than quoted: the buyer pays the smaller of price_usd and the price the delivered edition is sold at.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Patients receive CBM588 PO BID, nivolumab IV over 30 minutes on day 1, and cabozantinib S-malate PO QD. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.","label":"Arm 2 (CBM588, nivolumab, cabozantinib S-malate)","type":"EXPERIMENTAL"},{"description":"Patients receive nivolumab IV over 30 minutes on day 1 and cabozantinib S-malate PO QD. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.","label":"Arm I (nivolumab, cabozantinib S-malate)","type":"ACTIVE_COMPARATOR"}],"collaborators":["National Cancer Institute (NCI)"],"completion_date":{"date":"2027-01-12","type":"ESTIMATED"},"conditions":["Advanced Clear Cell Renal Cell Carcinoma","Advanced Papillary Renal Cell Carcinoma","Advanced Renal Cell Carcinoma","Advanced Sarcomatoid Renal Cell Carcinoma","Metastatic Clear Cell Renal Cell Carcinoma","Metastatic Papillary Renal Cell Carcinoma","Metastatic Renal Cell Carcinoma","Metastatic Sarcomatoid Renal Cell Carcinoma","Stage III Renal Cell Cancer AJCC v8","Stage IV Renal Cell Cancer AJCC v8","Unresectable Clear Cell Renal Cell Carcinoma","Unresectable Renal Cell Carcinoma"],"enrollment":{"count":31,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Cabozantinib S-malate","otherNames":["BMS-907351","Cabometyx","Cometriq","XL-184","XL184"],"type":"DRUG"},{"name":"Clostridium butyricum CBM 588 Probiotic Strain","otherNames":["C. butyricum CBM 588 Probiotic Strain","C. butyricum MIYAIRI Strain","C. butyricum Strain MIYAIRI 588","CBM 588","CBM588","Clostridium butyricum MIYAIRI 588","Clostridium butyricum MIYAIRI 588 Probiotic Strain","MIYAIRI 588","MIYAIRI 588 Strain of C. butyricum"],"type":"DRUG"},{"name":"Nivolumab","otherNames":["BMS-936558","CMAB819","MDX-1106","NIVO","Nivolumab Biosimilar CMAB819","ONO-4538","Opdivo"],"type":"BIOLOGICAL"}],"last_update":"2026-03-05","lead_sponsor":"City of Hope Medical Center","official_title":"Pilot Study to Evaluate the Biologic Effect of CBM588 in Combination With Cabozantinib/Nivolumab for Patients With Metastatic Renal Cell Carcinoma","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE1"],"primary_completion_date":{"date":"2027-01-12","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Change in Bifidobacterium composition of stool","timeFrame":"Baseline to week 12 of therapy"}],"references":[{"citation":"Ebrahimi H, Dizman N, Meza L, Malhotra J, Li X, Dorff T, Frankel P, Llamas-Quitiquit M, Hsu J, Zengin ZB, Alcantara M, Castro D, Mercier B, Chawla N, Chehrazi-Raffle A, Barragan-Carrillo R, Jaime-Casas S, Govindarajan A, Gillece J, Trent J, Lee PP, Parks TP, Takahashi M, Hayashi A, Kortylewski M, Caporaso JG, Lee K, Tripathi A, Pal SK. Cabozantinib and nivolumab with or without live bacterial supplementation in metastatic renal cell carcinoma: a randomized phase 1 trial. Nat Med. 2024 Sep;30(9):2576-2585. doi: 10.1038/s41591-024-03086-4. Epub 2024 Jun 28.","pmid":"38942995","type":"DERIVED"}],"start_date":{"date":"2021-11-01","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"CBM588 in Combination With Nivolumab and Cabozantinib for the Treatment of Advanced or Metastatic Kidney Cancer","url":"https://clinicaltrials.gov/study/NCT05122546"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.2","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct05122546"}