7 JCI-accredited hospitals 17 hospitals with oncology 65 oncology specialists 19 clinical trials recruiting
Oncology & Cancer Care
Active, closed to enrolmentPhase 3NCT05611931

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

After chemotherapy shrinks advanced endometrial cancer, this study tests whether taking the oral drug selinexor as maintenance therapy delays the cancer from coming back. It is for people whose tumors have a normal (wild-type) p53 gene.

SponsorKaryopharm Therapeutics Inc
Study typeInterventional
Started2023-04-18
Primary completion2026-08
Planned enrolment257
Sites1 Acıbadem · 198 other

A Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial of Selinexor in Maintenance Therapy After Systemic Therapy for Patients With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma

What this study is about

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.

Conditions
  • Endometrial Cancer
Interventions
  • Selinexor
  • Matching Placebo for selinexor
Primary outcome measures
  • Investigator assessed Progression Free Survival (PFS) per RECIST v1.1 — From randomization until disease progression (PD) or death, whichever occurs first (up to 34 months)
Who can take part
SexAllAge18 Years to no upper limitHealthy volunteersNo
Inclusion
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 NGS * 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
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

Criteria are written for physicians. Do not rule yourself out: send your reports and the study team will check.

Acıbadem study sites
  • Acıbadem Atakent Hospital, Istanbul

Also running at 198 other sites in 17 countries.

Source: ClinicalTrials.gov NCT05611931 · last updated 2026-08-27 · View registry record ↗