{"preliminary_commentary":{"by_channel":{"x_thread":5},"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":[["mosunetuzumab","polatuzumab vedotin"]],"indication":"relapsed or refractory B-cell non-Hodgkin lymphoma","name":"NCT03671018","nct_id":"NCT03671018","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct03671018. 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":"Participants will receive mosunetuzumab in combination with polatuzumab vedotin. Dose finding will be guided by the observed incidence of dose-limiting toxicities (DLTs) at each dose level.","label":"Dose Finding","type":"EXPERIMENTAL"},{"description":"Participants with at least one line of prior therapy (2L+) and that have relapsed or refractory (R/R) follicular lymphoma (FL) will receive mosunetuzumab + polatuzumab vedotin.","label":"Mosunetuzumab + Polatuzumab Vedotin 2L+ R/R FL","type":"EXPERIMENTAL"},{"description":"2L+ participants with R/R diffuse large B-cell lymphoma will receive mosunetuzumab + polatuzumab vedotin.","label":"Mosunetuzumab + Polatuzumab Vedotin 2L+R/R DLBCL","type":"EXPERIMENTAL"},{"description":"Participants with at least 2 lines of prior therapy (3L+) will receive subcutaneous (SC) mosunetuzumab + polatuzumab vedotin.","label":"Mosunetuzumab SC + Polatuzumab Vedotin 3L+R/R MCL","type":"EXPERIMENTAL"},{"description":"2L+ participants with R/R DLBCL will receive SC mosunetuzumab and polatuzumab vedotin.","label":"Mosunetuzumab SC + Polatuzumab Vedotin 2L+R/R DLBCL","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2025-07-20","type":"ESTIMATED"},"conditions":["B-cell Non-Hodgkin Lymphoma"],"enrollment":{"count":422,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Mosunetuzumab (IV)","otherNames":["BTCT4465A"],"type":"DRUG"},{"name":"Mosunetuzumab (SC)","otherNames":[],"type":"DRUG"},{"name":"Polatuzumab vedotin","otherNames":[],"type":"DRUG"},{"name":"Tocilizumab","otherNames":[],"type":"DRUG"},{"name":"Rituximab","otherNames":[],"type":"DRUG"}],"last_update":"2024-11-29","lead_sponsor":"Hoffmann-La Roche","official_title":"An Open-Label, Randomized, Multicenter, Phase Ib/II Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With Polatuzumab Vedotin in Patients With B-Cell Non-Hodgkin Lymphoma","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2024-01-30","type":"ACTUAL"},"primary_outcomes":[{"measure":"Maximum Tolerated Dose (MTD) of Mosunetuzumab in Combination with Polatuzumab Vedotin","timeFrame":"Cycle 1 to Cycle 2 (cycle length = 21 days)"},{"measure":"Recommended Phase II Dose of Mosunetuzumab in Combination with Polatuzumab Vedotin","timeFrame":"Cycle 1 to Cycle 2 (cycle length = 21 days)"},{"measure":"Percentage of Participants with Adverse Events (AE)","timeFrame":"Baseline through approximately 90 days after last study treatment"},{"measure":"Best Objective Response Rate (ORR), Defined as CR or Partial Response (PR) at any Time, Based on PET-CT and/or CT Scan, as Determined by the Independent Review Committee (IRC) using Standard Criteria for NHL","timeFrame":"Baseline up to approximately 60 months (assessed at screening and then every 3 months for the first year, then every 6 months until disease progression, start of new anti-cancer therapy, or withdrawal)"}],"references":[{"citation":"Chavez JC, Bastos-Oreiro M, Diefenbach C, Lossos IS, Shah N, Assouline S, Olszewski AJ, Naik S, Ghosh N, Pham S, Wei MC, Batlevi C, To I, Ead W, Makadia S, Penuel E, Jing J, Budde LE. A Randomized Phase II Study of Subcutaneous Mosunetuzumab in Combination With Polatuzumab Vedotin Compared With Rituximab Plus Polatuzumab Vedotin in Patients With Relapsed or Refractory Large B-Cell Lymphoma. Am J Hematol. 2026 Sep;101(9):2177-2189. doi: 10.1002/ajh.70403. Epub 2026 Jun 12.","pmid":"42283231","type":"DERIVED"},{"citation":"Budde LE, Kamdar M, Assouline SE, Chavez JC, Ghosh N, Ollila TA, Hodson DJ, Modi D, Bastos-Oreiro M, Naik SG, Nakhoda SK, Lee Batlevi C, Wang J, Makadia S, Kwan A, Penuel E, Jing J, Wu H, Ead W, Pham S, To I, Wei MC, Wang ML. Mosunetuzumab plus polatuzumab vedotin for relapsed/refractory MCL after BTK inhibitor therapy: a phase 2 study. Blood. 2026 Aug 6;148(6):682-692. doi: 10.1182/blood.2025032422.","pmid":"42013019","type":"DERIVED"},{"citation":"Budde LE, Olszewski AJ, Assouline S, Lossos IS, Diefenbach C, Kamdar M, Ghosh N, Modi D, Sabry W, Naik S, Mehta A, Nakhoda SK, Smith SD, Dorritie K, Jia T, Pham S, Huw LY, Jing J, Wu H, Ead WS, To I, Batlevi CL, Wei MC, Chavez JC. Mosunetuzumab with polatuzumab vedotin in relapsed or refractory aggressive large B cell lymphoma: a phase 1b/2 trial. Nat Med. 2024 Jan;30(1):229-239. doi: 10.1038/s41591-023-02726-5. Epub 2023 Dec 10.","pmid":"38072960","type":"DERIVED"}],"start_date":{"date":"2018-09-25","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study to Evaluate the Safety and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With Polatuzumab Vedotin in B-Cell Non-Hodgkin Lymphoma","url":"https://clinicaltrials.gov/study/NCT03671018"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct03671018"}