Selinexor in Maintenance Therapy After Systemic Therapy for Participants With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma (XPORT-EC-042)

NCT 05611931

Brief Summary

Inclusion Criteria

• At least 18 years of age at the time of signing informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment..
• Histologically confirmed EC including: endometrioid, serous, undifferentiated, and carcinosarcoma.
• TP53 wt assessed by next generation sequencing (NGS), evaluated by a central vendor.
• Completed a single line, at least 12 weeks of platinum-based therapy (not including adjuvant or neoadjuvant therapy for Stage I-III disease) and achieved confirmed partial or complete response (PR or CR) by imagingtests that create detailed images of areas inside the body, according to RECIST version 1.1. The participants should have received treatment for:

Primary Stage IV disease, defined as:

• had a primary or later debulkingremoval of as much of the tumour as possible when complete tumour removal is not possible, also known as cytoreduction surgerytreatment involving removal of cancerous tissue and/or tumours and a margin of healthy tissue around it to reduce recurrence during first-line platinum-based therapy with R0 resectionsurgical removal of tissue or part/all of an organ (R0 resection indicates a macroscopic complete resection of all visible tumor) and achieved CR after at least 12 weeks platinum-based therapy, OR
• had a primary or later debulking surgery during first-line platinum-based therapy with R1 resection (R1 resection indicates incomplete removal of all macroscopic disease) and achieved PR or CR after at least 12 weeks platinum-based chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells, OR
• had no surgery and achieved PR or CR after at least 12 weeks platinum-based chemotherapy

OR

At first relapsethe return of disease (i.e., relapse after primary therapy including surgery and/or chemotherapy and/or immunotherapya treatment that uses a person's immune system to fight cancer for Stage I-IV disease), defined as:

• had Stage I – III disease at diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results and received, at initial diagnosis, adjuvant chemotherapychemotherapy given after primary treatment, such as surgery, to reduce the risk of your cancer coming back and relapsed later. Participants should have PR or CR after at least 12 weeks of platinum-based chemotherapy compared with the start of this chemotherapy at the time of relapse,
• had Stage I-III disease at diagnosis and did not receive adjuvant chemotherapy at initial diagnosis and relapsed later. Participants should have PR or CR after at least 12 weeks of platinum-based chemotherapy compared with the start of this chemotherapy at the time of relapse, OR
• had Stage IV disease at diagnosis and received initially chemotherapy with or without surgery and relapsed later. At the time of relapse, participants should have PR or CR after at least 12 weeks of platinum-based chemotherapy compared with the start of this chemotherapy at the time of relapse.
  • Previous treatment with anti-programmed cell death protein 1(PD-1) or anti-programmed death-ligand 1(PD-L1) monoclonal antibodya protein made by the immune system to fight against harmful substances (antigens), such as bacteria or viruses and concomitant biologic agents (e.g., bevacizumab, trastuzumab) is allowed.
  • Must be able to initiate study drug 3 to 8 weeks after completion of their final dosethe amount of medication taken of chemotherapy.
  • Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status of 0-1.
  • Participants must have adequate bone marrowsoft, spongy tissue found in bones that makes blood cells function and organ function within 2 weeks before starting study drug as defined by the following laboratory criteria:
• Hepatic function: total bilirubin up to less than (<) 3*upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to (<=) 2.5*ULN in participants without liver metastasiswhen the cancer has spread to other parts of the body, also known as mets. For participants with known liver involvement of their tumor: AST and ALT (<=) 5*ULN
• Hematopoietic function within 1 week: Absolute neutrophil count (ANC) greater than or equal to (>=) 1.5*10^9/liter (L); platelet count >= 100*10^9/L; hemoglobin >= 9.0 gram per deciliter (g/dL) per local laboratory results
• Renal function: estimated creatinine clearance (CrCl) of >= 20 milliliter per minute (mL/min), calculated using the standard local formula, as applicable- In the opinion of the Investigator, the participant must:
• Have a life expectancy of at least 12 weeks, and
• Be fit to receive investigational therapy
  • Premenopausal females of childbearing potential must have a negative pregnancy test (serum β-human chorionic gonadotropin test) prior to the first dose of study drug. Female participants of childbearing potential must agree to use highly effective methods of contraception throughout the study and for 90 days following the last dose of study drug.
  • Written informed consent signed in accordance with federal, local, and institutional guidelines prior to the first screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening procedure.