Lenvatinib + Pembrolizumab and Hypofractionated Pelvic Radiation

Lenvatinib will be self-administered orally (PO) by participants in a 3+3 escalation/de-escalation design. Participants will receive one of the following four dose levels: * Dose level 1: 4 mg * Dose level 2: 8 mg * Dose level 3: 12 mg (Starting dose) * Dose level 4: 16 mg

Pembrolizumab 200 mg will be administered intravenously (IV) once on Days 1, 22 and 43.

The purpose of this research study is to see if it is feasible to combine a fixed dose of pembrolizumab and a daily dose of oral lenvatinib, along with daily treatments of an abbreviated course of pelvic external beam radiation therapy, to support cancer cells in multiplying and spreading to other body sites.

Registro actualizado en ClinicalTrials.gov →

• Biopsy-proven recurrent pMMR EC following surgery alone or de novo unresectable pMMR EC for whom EBRT has been determined as an appropriate therapeutic approach. Eligible tumor histologies include the following: endometrioid adenocarcinoma, adenocarcinoma with squamous differentiation, mucinous, mixed carcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, serous adenocarcinoma, and uterine carcinosarcoma histologies as determined by tissue from an archival sample or newly obtained core or excisional biopsy of a tumor lesion. For patients with recurrent disease greater than 12 months (>12 months), a fresh biopsy must be obtained.
• Measurable disease of at least 1.0 cm in size defined by RECIST 1.1 on imaging studies with at least one (1) site located in the pelvis and/or vagina without any foci of extra-pelvic disease (including the para-aortic region or inguinal-femoral lymph nodes).
• Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (Karnofsky score ≥50).
• Patients must have pMMR tumor subtype(s).
• Absolute neutrophil count (ANC) ≥1,500 cells/mm³

Criterios de inclusión tal como figuran en el registro, recortados. La lista completa, con las exclusiones, está en el registro actualizado.