Using selinexor as maintenance therapy for advanced endometrial cancer after initial treatment

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

PHASE3 · Karyopharm Therapeutics Inc · NCT05611931

This study is testing if the drug selinexor can help people with advanced endometrial cancer stay healthier for longer after their initial treatment.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment276 (estimated)
Ages18 Years and up
SexAll
SponsorKaryopharm Therapeutics Inc (industry)
Drugs / interventionschemotherapy
Locations217 sites (Birmingham, Alabama and 216 other locations)
Trial IDNCT05611931 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness and safety of selinexor as a maintenance therapy for patients with advanced or recurrent endometrial carcinoma who have a p53 wild-type status. Participants must have achieved a partial or complete response after at least 12 weeks of platinum-based chemotherapy. The study will enroll 220 participants, who will be randomly assigned to receive either selinexor or a matching placebo. The goal is to determine if selinexor can prolong the benefits of initial treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed p53 wild-type advanced or recurrent endometrial carcinoma who have responded to prior platinum-based therapy.

Not a fit: Patients with p53 mutant endometrial carcinoma or those who have not achieved a response to prior therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new maintenance option for patients with advanced endometrial cancer, potentially improving their outcomes.

How similar studies have performed: Previous studies have shown promise with similar maintenance therapies in other cancers, but this specific approach with selinexor is novel.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Birmingham, Alabama and 216 other locations

+167 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Endometrial Cancer, Selinexor, KPT-330, Advanced or Recurrent Endometrial Carcinoma, XPORT-EC, ENGOT-EN20, GOG-3083, XPORT-EC-042

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.