Selinexor in Maintenance Therapy After Systemic Therapy for Participants With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma

About

Brief Summary

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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 3

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

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