Title
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

Description
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 220 participants will be enrolled in the study and randomized in a 1:1 ratio to maintenance therapy with either selinexor or placebo.

Objective
To evaluate the efficacy of selinexor compared to placebo as maintenance therapy
To compare overall OS in selinexor and placebo arms
Secondary:
To evaluate the safety and tolerability of selinexor
To compare selinexor and placebo for time to first subsequent therapy
To compare selinexor and placebo for time to second subsequent therapy
To compare selinexor and placebo for time until second progression
To assess the efficacy of selinexor compared to placebo, as assessed by a blinded independent central review (BICR)
To evaluate health-related quality of life (HR-QoL) outcomes

Treatment Experimental: 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.
Drug: Selinexor
Dose: 60 mg (3 tablets); Dosage form: film-coated, immediate-release tablet of 20 mg each; Route of administration: oral
Other Name: KPT-330

Placebo Comparator: Placebo
Participants will receive matching placebo for selinexor oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle.
Drug: Matching Placebo for selinexor
Dose:60 mg (3 tablets); Dosage form: film-coated, immediate-release tablet of 20 mg each; Route of administration: oral

Key Eligibility For full study eligibility, see this study's clinicaltrials.gov record.

Applicable Disease Sites
Uterus

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital