Rationale for the Study Population Sample Clauses

Rationale for the Study Population. The study population included in this study was initially based on clinical observations from a Phase 1 study of MIRV (Study IMGN853-0401), which showed promising clinical activity in patients with PROC. Results from that study suggested that higher FRα levels correlated with response to treatment (▇▇▇▇▇▇ 2015). Based on those results, a large, randomized Phase 3 study in patients with platinum-resistant advanced high-grade EOC, primary peritoneal, or fallopian tube cancers was initiated. Eligible patients were required to have tumors expressing what was considered a medium or high level FRα expression per the Ventana IHC assay using a newly implemented “10x” scoring method. Results from this study showed that while the study did not meet the primary endpoint per ▇▇▇▇▇▇▇▇ procedure, MIRV showed consistently favorable efficacy when compared to IC Chemo in measures of PFS, ▇▇▇, OS, DOR, PFS2, CA-125, and PRO endpoints in patients high FRα expression. Subsequent review demonstrated that the “10x” scoring method for the FOLR1 IHC assay misclassified a significant percentage of patients, and thus further impacted the study results. Ad hoc analyses of the PS2+ high FRα patients revealed enhanced benefit from MIRV for ▇▇▇, PFS and OS compared to IC Chemo controls. These findings warranted a follow-up study focusing solely on patients with high FRα expression using the original “PS2+” scoring method. Thus, the present study will enroll a similar PROC population to the prior Phase 3 study, with the exception that patients are required to have high FRα expression by PS2+ scoring as determined by the Ventana FOLR1 (FOLR-2.1) CDx assay. Please refer to the Investigator ▇▇▇▇▇▇▇▇ for more details on the Ventana FOLR1 assay and the FRα expression threshold selected for this study.
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Related to Rationale for the Study Population

  • Study Population ‌ Infants who underwent creation of an enterostomy receiving postoperative care and awaiting enterostomy closure: to be assessed for eligibility: n = 201 to be assigned to the study: n = 106 to be analysed: n = 106 Duration of intervention per patient of the intervention group: 6 weeks between enterostomy creation and enterostomy closure Follow-up per patient: 3 months, 6 months and 12 months post enterostomy closure, following enterostomy closure (12-month follow-up only applicable for patients that are recruited early enough to complete this follow-up within the 48 month of overall study duration).

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