Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinosarcoma

Mixed Tumor, Mullerian

Adenoma, Pleomorphic

Uterine Neoplasms

Neoplasms by Histologic Type

Sarcoma

Neoplasms, Connective and Soft Tissue

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Malignant Mixed Mullerian Tumor

Ovarian Carcinosarcoma

Uterine Carcinosarcoma

Soft Tissue Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Lenvatinib

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Lenvatinib (20mg once daily orally) in combination with Pembrolizumab (200mg every 3 weeks, intravenously)

Pembrolizumab (200mg every 3 weeks, intravenously)

Vicky Makker, MD

Maria Rubinstein, MD

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

This is an open label, single institution, phase II study

Women With Advanced Uterine Carcinosarcoma.

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

A Phase II Trial of Pembrolizumab Plus Lenvatinib for the Treatment of Patients With Advanced Uterine and Ovarian Carcinosarcomas

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

is defined as the duration of time from start of treatment until progression or death whichever occurs first. Patients without documented progression or death will be censored at last follow up date.

Merck Sharp & Dohme LLC

Memorial Sloan Kettering Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of Pembrolizumab With Lenvatinib in Women With Advanced Uterine Carcinosarcoma	NCT05147558	Uterine Carcino... Advanced Uterin...	Pembrolizumab Lenvatinib	18 Years -	Memorial Sloan Kettering Cancer Center
A Study of Pembrolizumab With Lenvatinib in Women With Advanced Uterine Carcinosarcoma	NCT05147558	Uterine Carcino... Advanced Uterin...	Pembrolizumab Lenvatinib	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for advanced uterine carcinosarcoma