{"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":[["pegilodecakin"]],"indication":"second-line metastatic pancreatic cancer","name":"SEQUOIA","nct_id":"NCT02923921","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=sequoia-nct02923921. 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":"Sequoia","arms":[{"description":"Pegilodecakin 5 microgram per kilogram (μg/kg) dosed as one of the following 2 fixed doses: 0.4 milligram (mg) for participants weighing ≤80 kg or 0.8 mg for participants weighing\\>80 kg on Days 1-5 and Days 8-12 subcutaneously (SC) plus FOLFOX \\[dl-Leucovorin (dl-LV) 400 milligram per meter square (mg/m2) and oxaliplatin 85 mg/m2 followed by bolus 5-fluorouracil (5-FU) 400 mg/m2 and a 46 to 48 hour infusion of 5- FU 2400 mg/m2\\] initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression. After discontinuation of FOLFOX in the absence of tumor progression \\[that is (i.e., completion of the planned 12 cycles or unacceptable FOLFOX related toxicity\\], Pegilodecakin 10µg/kg maintenance treatment administered as one of the 2 fixed doses, either 0.8 mg for participants weighing ≤80 kg or 1.6 mg for participants weighing\\>80 kg.","label":"Pegilodecakin + FOLFOX","type":"EXPERIMENTAL"},{"description":"FOLFOX (dl-LV 400 mg/m2 and oxaliplatin 85 mg/m2 followed by bolus 5-FU 400 mg/m2 and a 46-hour infusion of 5-FU 2400 mg/m2) initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression.","label":"FOLFOX","type":"ACTIVE_COMPARATOR"}],"collaborators":["ARMO BioSciences"],"completion_date":{"date":"2020-03-05","type":"ACTUAL"},"conditions":["Pancreatic Cancer"],"enrollment":{"count":567,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Pegilodecakin","otherNames":["LY3500518","AM0010"],"type":"BIOLOGICAL"},{"name":"FOLFOX","otherNames":["oxaliplatin","5-FU","leucovorin"],"type":"DRUG"}],"last_update":"2020-10-19","lead_sponsor":"Eli Lilly and Company","official_title":"Randomized Study of AM0010 in Combination With FOLFOX Compared to FOLFOX Alone as Second-line Tx in Pts With Metastatic Pancreatic Cancer That Has Progressed During or Following a First-Line Gemcitabine Containing Regimen","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2019-09-09","type":"ACTUAL"},"primary_outcomes":[{"measure":"Overall Survival","timeFrame":"Randomization to date of death from any cause (Up To 30 Months)"}],"references":[{"citation":"Hecht JR, Lonardi S, Bendell J, Sim HW, Macarulla T, Lopez CD, Van Cutsem E, Munoz Martin AJ, Park JO, Greil R, Wang H, Hozak RR, Gueorguieva I, Lin Y, Rao S, Ryoo BY. Randomized Phase III Study of FOLFOX Alone or With Pegilodecakin as Second-Line Therapy in Patients With Metastatic Pancreatic Cancer That Progressed After Gemcitabine (SEQUOIA). J Clin Oncol. 2021 Apr 1;39(10):1108-1118. doi: 10.1200/JCO.20.02232. Epub 2021 Feb 8.","pmid":"33555926","type":"DERIVED"}],"start_date":{"date":"2017-03-01","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study of Pegilodecakin (LY3500518) With FOLFOX Compared to FOLFOX Alone Second-line Tx in Participants With Metastatic Pancreatic Cancer","url":"https://clinicaltrials.gov/study/NCT02923921"},"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/sequoia-nct02923921"}