A Phase 3, randomized, open-label, multicenter study designed to evaluate GSK5733584 compared with chemotherapy in patients with recurrent endometrial cancer.
Principal Investigator
Dott.ssa Mariastella Bungaro
Contact Information for Access
Phase
FASE III
Status
IN ATTIVAZIONE
Objective of the study
To evaluate the clinical efficacy of Mo-Rez compared with the investigator’s choice of chemotherapy (doxorubicin monotherapy or weekly paclitaxel) in participants with advanced or recurrent endometrial cancer.
Recurrent endometrial cancer.
ClinicalTrials.gov ID: NCT07286331
Sponsor: GlaxoSmithKline
Pathologies
Gynecologic cancers (gynecological tumors)
Medication
GSK5733584 vs. Chemotherapy
Who is eligible to participate in the study?
Patients aged ≥ 18 years with recurrent endometrial cancer who meet the following criteria are eligible to participate in this study:
- 1–2 prior lines of systemic therapy (up to 3 if 1 was adjuvant/neoadjuvant).
- Prior treatment with platinum and immunotherapy (anti-PD-1/PD-L1), unless there are contraindications to the latter.
- PFI < 12 months if platinum was administered only as adjuvant therapy (no limit if used in combination with immunotherapy, in cases of metastatic disease, or due to intolerance).
- Availability of an FFPE tumor tissue sample for central evaluation of B7-H4 expression prior to randomization.
- At least one measurable target lesion according to RECIST 1.1 criteria, confirmed by central review.
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