NCT05147558

A Study of Pembrolizumab With Lenvatinib in Women With Advanced Uterine Carcinosarcoma

Active, enrolled Phase 2 Last updated 27 February 2026

What this trial tests

Phase 2 trial testing Pembrolizumab in Uterine Carcinosarcoma in 40 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

23 December 2021

Primary endpoint
23 December 2026

23 December 2026

Quick facts

Lead sponsor	Memorial Sloan Kettering Cancer Center
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	23 December 2021
Primary completion	23 December 2026
Estimated completion	23 December 2026
Sites	7 locations across United States

Drugs / interventions tested

• Pembrolizumab (pembrolizumab) — full drug profile →
• Lenvatinib (LENVATINIB) — full drug profile →

Conditions studied

• Uterine Carcinosarcoma — all drugs for Uterine Carcinosarcoma →
• Advanced Uterine Carcinosarcoma — all drugs for Advanced Uterine Carcinosarcoma →

Sponsor

Memorial Sloan Kettering Cancer Center — full company profile →

Who can join

18 and older, female only, with Uterine Carcinosarcoma or Advanced Uterine Carcinosarcoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study to find out whether the combination of lenvatinib and pembrolizumab is an effective treatment for advanced uterine carcinosarcoma. The researchers will also do tests to find out whether biomarkers in the blood can predict the cancer's response to the study treatment. A biomarker is a biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease. A biomarker may be used to see how well the body responds to a treatment for a disease or condition

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Biomarkers for immune checkpoint inhibition in sarcomas - are we close to clinical implementation?
   Yiong CS, Lin TP, Lim VY, Toh TB, et al · · 2023 · cited 26× · PMID 37612756 · DOI 10.1186/s40364-023-00513-5
2. Trial Watch: combination of tyrosine kinase inhibitors (TKIs) and immunotherapy.
   Petrazzuolo A, Maiuri MC, Zitvogel L, Kroemer G, et al · · 2022 · cited 23× · PMID 35655707 · DOI 10.1080/2162402x.2022.2077898
3. Molecular Characterizations of Gynecologic Carcinosarcomas: A Focus on the Immune Microenvironment.
   Nakad Borrego S, Lengyel E, Kurnit KC. · · 2022 · cited 6× · PMID 36139624 · DOI 10.3390/cancers14184465
4. Updates and controversies in the management of uterine serous carcinoma and uterine carcinosarcoma.
   Toboni M, Kurnit K, Erickson B, Powell M, et al · · 2025 · cited 5× · PMID 40056788 · DOI 10.1016/j.ijgc.2025.101672
5. Platinum free interval and clinical benefit of the second-line chemotherapy in recurrent uterine and ovarian carcinosarcoma: a retrospective cohort analysis.
   Berthet J, Kime A, Borghese B, De Percin S, et al · · 2025 · cited 1× · PMID 40223552 · DOI 10.3802/jgo.2025.36.e64
6. Elucidating divergent biology in uterine carcinosarcoma.
   Garg V, Prokopec SD, Stone SC, Pakbaz S, et al · · 2025 · PMID 40850250 · DOI 10.1016/j.tranon.2025.102506