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Selinexor in Maintenance Therapy After Systemic Therapy for Participants With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma
Trial Status: active
The purpose of this study is to evaluate the efficacy and safety of selinexor as a
maintenance treatment in patients with p53 wt endometrial carcinoma (EC), who have
achieved a partial response (PR) or complete response (CR) (per Response Evaluation
Criteria in Solid Tumors version 1.1 [RECIST v 1.1]) after completing at least 12 weeks
of platinum-based therapy. A total of 276 participants will be enrolled in the study and
randomized in a 1:1 ratio to maintenance therapy with either selinexor or placebo.
Inclusion Criteria
Inclusion Criteria: Patients must meet all of the following inclusion criteria in order
to be eligible to participate in this study:
- Adults (Aged ≥ 18 years)
- Histologically confirmed endometrial cancer (endometrioid, serous, undifferentiated,
or carcinosarcoma sub-types) that is TP53 wild type by central NGSHistologically
confirmed EC including endometrioid, serous, undifferentiated, and carcinosarcoma
- Must have completed at least 12 weeks of platinum-based chemotherapy (with or
without immune checkpoint inhibitors), with a confirmed partial or complete response
according to RECIST v1.1
- Must be able to initiate C1D1 within 3-8 weeks after last platinum dose
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate bone marrow function and organ function
Exclusion Criteria: Patients meeting any of the following exclusion criteria are not
eligible to participate in this study:
- Uterine sarcomas, clear cell or small cell carcinoma with neuroendocrine
differentiation
- Palliative radiotherapy administered within 14 days of intended C1D1
- Any gastrointestinal dysfunction that could interfere with the absorption of oral
study therapy
- Serious psychiatric or medical conditions that could interfere with study
participation or would make study involvement unreasonably hazardous
- Previous treatment with an XPO1 inhibitor
- Stable disease or disease progression after platinum-based chemotherapy
- Pregnancy, breastfeeding, or other legal/ethical restrictions to trial participation
- Known dMMR/MSI-H EC tumors that are medically eligible to receive an immune
checkpoint inhibitor
Additional locations may be listed on ClinicalTrials.gov for NCT05611931.
