Study of Lenvatinib w/ Pembro in Black Participants w/Mismatch Repair-Prof Recurrent Endometrial … (NCT05263492) | Clinical Trial Compass
TerminatedPhase 2
Study of Lenvatinib w/ Pembro in Black Participants w/Mismatch Repair-Prof Recurrent Endometrial Cancer
Stopped: Closed early due to low enrollment rates
United States4 participantsStarted 2022-04-01
Plain-language summary
Determine the efficacy of the combination of lenvatinib and pembrolizumab in Black participants
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically and/or cytologically confirmed endometrioid, serous, clear cell, carcinosarcoma, or de-differentiated or undifferentiated endometrial cancer with radiographic and/or clinical evidence of disease progression
* Documented microsatellite stable disease as tested by either microsatellite instability polymerase chain reaction (MSI PCR) or deoxyribonucleic acid (DNA) mismatch repair (MMR) by immunohistochemistry (IHC)
* Self-identify as being of predominantly (\>50%) Black race, inclusive of Black, African-American, Black Hispanic (Afro-Latinx), African, or Afro-Caribbean ancestry
* Received, ineligible for (by investigator determination), or declined platinum containing chemotherapy
* Received no greater than two prior lines of therapy. Maintenance therapies and hormonal therapies will NOT count as a line of therapy.
* Measurable disease as determined by RECIST v1.1:
* At least one lesion of ≥10 mm in the longest diameter for a non-lymph node, or ≥15 mm in the short-axis diameter for a lymph node that is serially measurable using computerized tomography/magnetic resonance imaging (CT/MRI)
* Target lesions limited to a radiated field must show evidence of substantial size increase according to previous scans to be deemed a target lesion
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Ability to swallow oral medications
* Patients who are not postmenopausal or have not undergone hysterectomy must have a documented nega…
What they're measuring
1
Determine the Objective Response Rate (ORR) at 24 Weeks in Black Patients With Recurrent Endometrial Cancer Treated With Lenvatinib 20 mg Orally Daily in Combination With Pembrolizumab 200 mg IV Every 3 Weeks