Revealing Engagement Patterns Among Endometrial Cancer Patients

NCT05998798NOT_YET_RECRUITINGOBSERVATIONAL

Summary

Key Facts

Lead Sponsor

Power Life Sciences Inc.

Enrollment

500

Start Date

2024-09-01

Completion Date

2025-09-01

Study Type

OBSERVATIONAL

Official Title

A Journey Endometrial Cancer Clinical Trials - Revealing Engagement Patterns Among Individuals Affected by Endometrial Cancer

Conditions

Endometrial Cancer

Eligibility

Age Range

18 Years+

Sex

ALL

Inclusion Criteria:

* Patients diagnosed with endometrial cancer
* Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
* Subjects willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examination.

Exclusion Criteria:

* Refusal of consent
* Women of childbearing potential without a negative pregnancy test; or women who are lactating.
* Any serious and/or unstable pre-existing medical disorders

Outcome Measures

Primary Outcomes

Number of patients who decide to enroll in an endometrial cancer clinical research

Time frame: 3 months

Rate of patients who remain in an endometrial cancer clinical trial to trial completion

Time frame: 12 months

Locations

Power Life Sciences, San Francisco, United States

Linked Papers

2021-11-19

Phase 3, randomized, open-label study of pembrolizumab plus lenvatinib versus chemotherapy for first-line treatment of advanced or recurrent endometrial cancer: ENGOT-en9/LEAP-001

Pembrolizumab plus lenvatinib is a novel combination with promising efficacy in patients with advanced and recurrent endometrial cancer. This combination demonstrated high objective response rates in a single-arm phase 1b/2 trial of lenvatinib plus pembrolizumab in patients with advanced endometrial cancer (KEYNOTE-146/Study 111) after ≤2 previous lines of therapy. In a randomized phase 3 trial of lenvatinib in combination with pembrolizumab versus treatment of physician's choice in patients with advanced endometrial cancer (KEYNOTE-775/Study 309), after 1‒2 previous lines of therapy (including neoadjuvant/adjuvant), this combination improved objective response rates, progression-free survival, and overall survival compared with chemotherapy. To compare the efficacy and safety of first-line pembrolizumab plus lenvatinib versus paclitaxel plus carboplatin in patients with newly diagnosed stage III/IV or recurrent endometrial cancer, with measurable or radiographically apparent disease. Pembrolizumab plus lenvatinib is superior to chemotherapy with respect to progression-free survival and overall survival in patients with mismatch repair-proficient tumors and all patients (all-comers). Phase 3, randomized (1:1), open-label, active-controlled trial. Patients will receive pembrolizumab intravenously every 3 weeks plus lenvatinib orally daily or paclitaxel plus carboplatin intravenously every 3 weeks, stratified by mismatch repair status (proficient vs deficient). Patients with mismatch repair-proficient tumors will be further stratified by Eastern Cooperative Oncology Group performance status (0/1), measurable disease (yes/no), and prior chemotherapy and/or chemoradiation (yes/no). Adults with stage III/IV/recurrent histologically confirmed endometrial cancer that is measurable or radiographically apparent per blinded independent central review. Patients may have received previous chemotherapy only as neoadjuvant/adjuvant therapy and/or concurrently with radiation. Patients with carcinosarcoma (malignant mixed Müllerian tumor), endometrial leiomyosarcoma, or other high grade sarcomas, or endometrial stromal sarcomas were excluded. Progression-free and overall survival (dual primary endpoints). About 875 patients. Enrollment is expected to take approximately 24 months, with presentation of results in 2022. ClinicalTrials.gov, NCT03884101.

Linked Investigators

Revealing Engagement Patterns Among Endometrial Cancer Patients