{"preliminary_commentary":{"by_channel":{"x_thread":12,"youtube":2,"podcast":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\": \"NCT02314169\", \"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":[["nivolumab"],["nivolumab","ipilimumab"]],"indication":"refractory metastatic anal canal squamous cell carcinoma","name":"NCI9673","nct_id":"NCT02314169","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nci9673-nct02314169. 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":1250,"size":"standard","size_rule":"Standard: 151–300 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Patients receive nivolumab IV over 60 minutes once every two weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI and blood sample collection throughout the study.","label":"Part A (nivolumab)","type":"EXPERIMENTAL"},{"description":"Patients receive nivolumab IV over 30 minutes once every 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI and blood sample collection throughout the study.","label":"Part B Arm I (nivolumab)","type":"EXPERIMENTAL"},{"description":"Patients receive nivolumab as in Arm I. Patients also receive ipilimumab IV over 30 minutes once every 8 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI and blood sample collection throughout the study.","label":"Part B Arm II (nivolumab, ipilimumab)","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2027-03-20","type":"ESTIMATED"},"conditions":["Anal Canal Squamous Cell Carcinoma","Metastatic Anal Canal Carcinoma","Stage IV Anal Cancer AJCC v8"],"enrollment":{"count":143,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Biospecimen Collection","otherNames":["Biological Sample Collection","Biospecimen Collected","Sample Collection","Specimen Collection"],"type":"PROCEDURE"},{"name":"Computed Tomography","otherNames":["CAT","CAT Scan","Computed Axial Tomography","Computerized Axial Tomography","Computerized axial tomography (procedure)","Computerized Tomography","Computerized Tomography (CT) scan","CT","CT Scan","Diagnostic CAT Scan","Diagnostic CAT Scan Service Type","tomography"],"type":"PROCEDURE"},{"name":"Ipilimumab","otherNames":["Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody","BMS 734016","BMS-734016","BMS734016","Ipilimumab Biosimilar CS1002","MDX 010","MDX-010","MDX-CTLA4","MDX010","Yervoy"],"type":"BIOLOGICAL"},{"name":"Magnetic Resonance Imaging","otherNames":["Magnetic Resonance","Magnetic Resonance Imaging (MRI)","Magnetic resonance imaging (procedure)","Magnetic Resonance Imaging Scan","Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance","MR","MR Imaging","MRI","MRI Scan","MRIs","NMR Imaging","NMRI","Nuclear Magnetic Resonance Imaging","sMRI","Structural MRI"],"type":"PROCEDURE"},{"name":"Nivolumab","otherNames":["ABP 206","BCD-263","BMS 936558","BMS-936558","BMS936558","CMAB819","MDX 1106","MDX-1106","MDX1106","NIVO","Nivolumab Biosimilar ABP 206","Nivolumab Biosimilar BCD-263","Nivolumab Biosimilar CMAB819","ONO 4538","ONO-4538","ONO4538","Opdivo"],"type":"BIOLOGICAL"}],"last_update":"2026-09-22","lead_sponsor":"National Cancer Institute (NCI)","official_title":"A Multi-Institutional Phase 2 Study of Nivolumab or Nivolumab in Combination With Ipilimumab in Refractory Metastatic Squamous Cell Carcinoma of the Anal Canal","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE2"],"primary_completion_date":{"date":"2025-02-15","type":"ACTUAL"},"primary_outcomes":[{"measure":"Overall Response Rate: Number of Participants With Response (Part A)","timeFrame":"Up to 2 years"},{"measure":"Progression-free Survival (PFS) (Part B)","timeFrame":"Time period from the date of randomization to the date of PD or death whichever occurred first, assessed up to 2 years"}],"references":[{"citation":"Morris VK, Ciombor KK, Xiao L, Ochieng JK, Marmonti E, Polite B, Weinberg BA, Krauss JC, Hays J, Mukherjee S, Aranha O, Iqbal S, Shields T, Benson AB, Kazmi S, Lieu C, Hochster H, Whisenant J, Haymaker C, Eng C. NCI9673 (Part B): ETCTN Randomized Phase II Study of Nivolumab With or Without Ipilimumab in Refractory, Metastatic Squamous Cell Carcinoma of the Anal Canal. J Clin Oncol. 2026 Feb 20;44(6):497-507. doi: 10.1200/JCO-25-00929. Epub 2026 Jan 7.","pmid":"41499716","type":"DERIVED"},{"citation":"Morris VK, Salem ME, Nimeiri H, Iqbal S, Singh P, Ciombor K, Polite B, Deming D, Chan E, Wade JL, Xiao L, Bekaii-Saab T, Vence L, Blando J, Mahvash A, Foo WC, Ohaji C, Pasia M, Bland G, Ohinata A, Rogers J, Mehdizadeh A, Banks K, Lanman R, Wolff RA, Streicher H, Allison J, Sharma P, Eng C. Nivolumab for previously treated unresectable metastatic anal cancer (NCI9673): a multicentre, single-arm, phase 2 study. Lancet Oncol. 2017 Apr;18(4):446-453. doi: 10.1016/S1470-2045(17)30104-3. Epub 2017 Feb 18.","pmid":"28223062","type":"DERIVED"}],"start_date":{"date":"2015-05-13","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Nivolumab With or Without Ipilimumab in Treating Patients With Refractory Metastatic Anal Canal Cancer","url":"https://clinicaltrials.gov/study/NCT02314169"},"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/nci9673-nct02314169"}