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

Phase 3

Recruiting

• Conditions: Endometrial Cancer
• Interventions: Drug: Matching Placebo for selinexor; Drug: Selinexor

• Registration Number: NCT05611931
• Lead Sponsor: Karyopharm Therapeutics Inc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-03
• Study First Submitted QC: 2022-11-03
• Study First Posted: 2022-11-10
• Study Start: 2023-04-18
• Status Verified: 2025-09
• Last Update Submitted: 2025-10-16
• Last Update Posted: 2025-10-20
• Primary Completion: 2026-08
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 276

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Matching Placebo for selinexor	Participants will receive matching placebo for selinexor oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle.
Selinexor	Selinexor	Participants will receive a fixed dose of selinexor 60 milligrams (mg) oral tablets once weekly (QW) on Days 1, 8, 15, and 22 of each 28-day cycle.

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Up to 34 months	Time from randomization to death due to any cause
Safety and tolerability of study drug (selinexor and placebo)	From start of study drug administration up to 34 months	The safety and tolerability of study drug (selinexor and placebo) will be evaluated based on adverse event (AE) reports, physical examination results (including vital signs), and clinical laboratory results, by means of the occurrence, nature, and severity of AEs via Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0.
Time to First Subsequent Therapy (TFST)	From randomization until date of initiation of first therapy after discontinuation of study drug or death, whichever occurs first (up to 34 months)	Time from randomization until date of initiation of first therapy after discontinuation of study drug or death, whichever occurs first
Time to Second Subsequent Therapy (TSST)	From randomization until date of initiation of second therapy after discontinuation of study drug or death, whichever occurs first (up to 34 months)	Time from randomization until date of initiation of second therapy after discontinuation of study drug or death, whichever occurs first
Progression-free survival after initiating a next-line treatment (PFS2)	From randomization until the next-line progression event or death due to any cause, up to 34 months	Time from randomization until the progression event after initiating a next-line treatment or death due to any cause, whichever occurs first
Progression-free Survival (PFS) as assessed by a Blinded Independent Central Review (BICR), per RECIST v1.1	From randomization until disease progression (PD) or death, whichever occurs first (up to 34 months)
EuroQol-5 Dimensions-5 Levels Quality of Life Questionnaire (EQ-5D-5L)	From baseline and at specified timepoints up to 34 months	EQ-5D-5L is a generic questionnaire that assesses health status as perceived by the patient across 5 categories (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and overall.

Trial Locations

Locations (220)

UC DAVIS; 🇺🇸 Davis, California, United States

Intermountain Health St. Vincent Regional Hospital; 🇺🇸 Billings, Montana, United States

Northwell Health - Zuckerberg Cancer Center; 🇺🇸 New Hyde Park, New York, United States

Lenox Hill Hospital; 🇺🇸 New York, New York, United States

Northwell Health - Queens Cancer Center; 🇺🇸 Rego Park, New York, United States

Swedish Cancer Institute; 🇺🇸 Seattle, Washington, United States

Border Medical Oncology & Haematology; 🇦🇺 Albury, New South Wales, Australia

Alexandra Hospital; 🇬🇷 Athens, Greece

St. Vincent's University Hospital; 🇮🇪 Dublin, Elm Park, Ireland

Ankara Baskent Hospital; Çankaya, Ankara, Turkey (Türkiye)

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