{"preliminary_commentary":{"by_channel":{"youtube":2,"x_thread":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":false},"commentary_summary":null,"name":"QUILT-3.055","nct_id":"NCT03228667","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=quilt-3-055-nct03228667. 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":"Patients with any of the cancers listed below who have progressed on or after single-agent checkpoint inhibitor therapy after experiencing an initial complete response (CR) or partial response (PR) while taking a checkpoint inhibitor.\n\n1a - Non-small cell lung cancer\n\n1b - Small cell lung cancer\n\n1c - Urothelial carcinoma\n\n1d - Head and neck squamous cell carcinoma\n\n1e - Merkel cell carcinoma\n\n1f - Melanoma\n\n1g - Renal cell carcinoma\n\n1h - Gastric cancer\n\n1i - Cervical cancer\n\n1j - Hepatocellular carcinoma\n\n1k - Microsatellite instability-high or mismatch repair deficient solid tumor cancer or colorectal cancer","label":"Cohort 1","type":"OTHER"},{"description":"Patients with NSCLC whose tumors have high PD-L1 expression (TPS ≥ 50%) and who relapsed on a PD-1 checkpoint inhibitor after experiencing an initial CR or PR when they received checkpoint inhibitor as a single-agent for first-line treatment.","label":"Cohort 2","type":"OTHER"},{"description":"Patients with NSCLC who had an initial CR or PR but subsequently relapsed on maintenance PD-1 checkpoint inhibitor therapy when they initially received checkpoint inhibitor therapy in combination with chemotherapy as first-line treatment.","label":"Cohort 3","type":"OTHER"},{"description":"Patients who are currently receiving PD-1/PD-L1 checkpoint inhibitor therapy and have disease progression after experiencing stable disease (SD) for at least 6 months during their previous treatment with PD-1/PD-L1 checkpoint inhibitor therapy.","label":"Cohort 4","type":"EXPERIMENTAL"},{"description":"Patients that have experienced disease progression by Investigator-assessment per irRECIST while receiving treatment in Cohorts 1-4.","label":"Cohort 5","type":"EXPERIMENTAL"},{"description":"Patients who have progressed after an initial response (CR or PR) to a PD-1/PD-L1 checkpoint inhibitor but now exhibit acquired resistance. They have received exactly one line of anti-PD-1 or anti-PD-L1 therapy (either pembrolizumab or nivolumab) for advanced NSCLC (Stage IV or recurrent).","label":"Cohort 6","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2030-12-31","type":"ESTIMATED"},"conditions":["Non-Small Cell Lung Cancer","Small Cell Lung Cancer","Urothelial Carcinoma","Head and Neck Squamous Cell Carcinoma","Merkel Cell Carcinoma","Melanoma","Renal Cell Carcinoma","Gastric Cancer","Cervical Cancer","Hepatocellular Carcinoma","Microsatellite Instability","Mismatch Repair Deficiency","Colorectal Cancer"],"enrollment":{"count":40,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"N-803 + Pembrolizumab","otherNames":[],"type":"DRUG"},{"name":"N-803 + Nivolumab","otherNames":[],"type":"DRUG"},{"name":"N-803 + Atezolizumab","otherNames":[],"type":"DRUG"},{"name":"N-803 + Avelumab","otherNames":[],"type":"DRUG"},{"name":"N-803 + Durvalumab","otherNames":[],"type":"DRUG"},{"name":"N-803 + Pembrolizumab + PD-L1 t-haNK","otherNames":[],"type":"DRUG"},{"name":"N-803 + Nivolumab + PD-L1 t-haNK","otherNames":[],"type":"DRUG"},{"name":"N-803 + Atezolizumab + PD-L1 t-haNK","otherNames":[],"type":"DRUG"},{"name":"N-803 + Avelumab + PD-L1 t-haNK","otherNames":[],"type":"DRUG"},{"name":"N-803 + Durvalumab + PD-L1 t-haNK","otherNames":[],"type":"DRUG"},{"name":"N-803 + Docetaxel + Pembrolizumab","otherNames":[],"type":"DRUG"},{"name":"N-803 + Docetaxel + Nivolumab","otherNames":[],"type":"DRUG"}],"last_update":"2026-01-14","lead_sponsor":"ImmunityBio, Inc.","official_title":"QUILT-3.055: A Phase IIb, Multicohort, Open-Label Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment With PD-1/PD-L1 Immune Checkpoint Inhibitors","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE2"],"primary_completion_date":{"date":"2029-08-31","type":"ESTIMATED"},"primary_outcomes":[{"measure":"ORR, defined as Investigator-assessed CR + PR per RECIST v1.1.","timeFrame":"Evaluated from the first dose of study drug and repeated at each scheduled disease-assessment visit for up to 24 months (or until progression/death), with the time-to-response summarized using Kaplan-Meier methods"},{"measure":"Prolongation of OS with NAI therapy by ALC response, where: - OS is defined as the time from first study drug administration to death resulting from any cause. - ALC response is defined as achievement or maintenance of an on-treatment ALC ≥ 1,000 cells/μ","timeFrame":"Measured from the date of the first study-drug administration to the date of death (any cause) and followed for up to 24 months after the last dose (or until death), allowing the correlation with on-treatment ALC changes"}],"references":[],"start_date":{"date":"2018-12-11","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"QUILT-3.055: A Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment With Immune Checkpoint Inhibitors","url":"https://clinicaltrials.gov/study/NCT03228667"},"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/quilt-3-055-nct03228667"}