{"commentary":{"count":3,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":3},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":false},"name":"NCT03829111","nct_id":"NCT03829111","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct03829111. The price is fixed at order. We build the report after 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: 1–12 commentary sources"},"registry":{"acronym":null,"arms":[{"description":"Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning in cycle 5, patients receive nivolumab IV over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.","label":"Arm I (nivolumab, ipilimumab)","type":"ACTIVE_COMPARATOR"},{"description":"Patients receive clostridium butyricum CBM 588 probiotic strain PO BID, nivolumab IV over 30 minutes on day 1, and ipilimumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning in cycle 5, treatment with clostridium butyricum CBM 588 probiotic strain and nivolumab repeats every 28 days in the absence of disease progression or unacceptable toxicity.","label":"Arm II (CBM588, nivolumab, ipilimumab)","type":"EXPERIMENTAL"}],"collaborators":["National Cancer Institute (NCI)"],"completion_date":{"date":"2023-12-13","type":"ACTUAL"},"conditions":["Advanced Renal Cell Carcinoma","Clear Cell Renal Cell Carcinoma","Metastatic Renal Cell Carcinoma","Stage III Renal Cell Cancer AJCC v8","Stage IV Renal Cell Cancer AJCC v8","Unresectable Renal Cell Carcinoma"],"enrollment":{"count":30,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Clostridium butyricum CBM 588 Probiotic Strain","type":"DRUG"},{"name":"Ipilimumab","type":"BIOLOGICAL"},{"name":"Nivolumab","type":"BIOLOGICAL"}],"last_update":"2024-07-03","lead_sponsor":"City of Hope Medical Center","official_title":"Pilot Study to Evaluate the Biologic Effect of CBM588 in Combination With Nivolumab/Ipilimumab for Patients With Metastatic Renal Cell Carcinoma","overall_status":"COMPLETED","phases":["PHASE1"],"primary_completion_date":{"date":"2023-12-13","type":"ACTUAL"},"primary_outcomes":[{"measure":"Change in Bifidobacterium composition of stool","timeFrame":"Baseline up to week 12"}],"references":[{"citation":"Villemin C, Six A, Neville BA, Lawley TD, Robinson MJ, Bakdash G. The heightened importance of the microbiome in cancer immunotherapy. Trends Immunol. 2023 Jan;44(1):44-59. doi: 10.1016/j.it.2022.11.002. Epub 2022 Dec 1.","pmid":"36464584","type":"DERIVED"},{"citation":"Dizman N, Meza L, Bergerot P, Alcantara M, Dorff T, Lyou Y, Frankel P, Cui Y, Mira V, Llamas M, Hsu J, Zengin Z, Salgia N, Salgia S, Malhotra J, Chawla N, Chehrazi-Raffle A, Muddasani R, Gillece J, Reining L, Trent J, Takahashi M, Oka K, Higashi S, Kortylewski M, Highlander SK, Pal SK. Nivolumab plus ipilimumab with or without live bacterial supplementation in metastatic renal cell carcinoma: a randomized phase 1 trial. Nat Med. 2022 Apr;28(4):704-712. doi: 10.1038/s41591-022-01694-6. Epub 2022 Feb 28.","pmid":"35228755","type":"DERIVED"}],"start_date":{"date":"2019-05-14","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"CBM588, Nivolumab, and Ipilimumab in Treating Patients With Stage IV or Advanced Kidney Cancer","url":"https://clinicaltrials.gov/study/NCT03829111"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct03829111"}