after surgery (hysterectomy and bilateralsalpingo-oophorectomy, Patients with a histological diagnosis of mismatch- repair deficient high risk endometrial cancer (MMRd HREC; no POLEmut; all histology including carcinosarcoma), Stage IB/II with LVSI or stage IIIA-C. Patients are treated with curative intent, with or without lymphadenectomy or sentinel node biopsy), without signs of residual disease or distant metastases.
Conditions
Brief summary
3 year recurrence free survival (RFS) in patients with MMRd EC. RFS is defined as time from randomization until date of any recurrence (local or distant) or date of death due to any cause.
Detailed description
Investigator assessed 5 yr RFS, OS (median, 3yr, 5yr), Vaginal RFS, pelvic RFS, distant metastasis free-survival (median, 3-year, 5-year), Disease-specific survival (median, 3-year, 5-year), HRQoL (EORTC QLQC30 and EORTC QLQEN24), Safety & tolerability, grade 3-5 according to NCI-CTC version 5.0., Exploratory TR, including PD-L1 testing using SP263 assay and TIP algorithm (>1% and 5%) on biopsy or resections of ECsamples
Interventions
DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.
Sponsors
Leiden University Medical Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3 year recurrence free survival (RFS) in patients with MMRd EC. RFS is defined as time from randomization until date of any recurrence (local or distant) or date of death due to any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| Investigator assessed 5 yr RFS, OS (median, 3yr, 5yr), Vaginal RFS, pelvic RFS, distant metastasis free-survival (median, 3-year, 5-year), Disease-specific survival (median, 3-year, 5-year), HRQoL (EORTC QLQC30 and EORTC QLQEN24), Safety & tolerability, grade 3-5 according to NCI-CTC version 5.0., Exploratory TR, including PD-L1 testing using SP263 assay and TIP algorithm (>1% and 5%) on biopsy or resections of ECsamples | — |
Countries
Belgium, Czechia, France, Germany, Italy, Netherlands
Outcome results
None listed