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A Study of Pembrolizumab With Lenvatinib in Women With Advanced Uterine Carcinosarcoma | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

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

NCT05147558•Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Histologically confirmed persistent/recurrent uterine or ovarian carcinosarcomas. For this study, a histological diagnosis of carcinosarcoma must include identifying high grade malignant epithelial and mesenchymal components. The mesenchymal component can be homologous or heterologous.
•Patients with known microsatellite stable (MSS), microsatellite instability high (MSI-H), mismatch repair proficient (pMMR) and mismatch repair deficient (dMMR) uterine or ovarian carcinosarcoma are eligible.
•Patients must have had 1 prior platinum-based chemotherapy regimen and could have received up to 3 prior lines of systemic therapy.
•* All chemotherapy must have been completed at least 3 weeks prior to the start of study therapy
•* Hormonal Therapy will NOT count as prior treatment line.
•* All hormonal therapy for treatment of endometrial or ovarian carcinosarcomas must be discontinued at least one week prior to start of study therapy.
•* Prior Bevacizumab also allowed and must be at least 3 weeks prior to the start of study therapy.
•* Prior Parp-inhibitors also allowed and must be at least 3 weeks prior to the start of study therapy.
•Age ≥18 years at the time of informed consent
•HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial.
+31 more criteria

Exclusion Criteria

•Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
•Has received prior therapy with a VEGF TKI to include but not limited to: lenvatinib, lucitinib, cederinib, and cabozantonib
•Has participated in a study of an investigational agent and received cancer directed study therapy within 4 weeks prior to start of study treatment.
•Note: Participants must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline. Participants with ≤Grade 2 neuropathy may be eligible.
•Note: If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.
•Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
•Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
•Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
•Steroids as CT scan contrast premedication is allowed
•The use of inhaled or topical corticosteroids is allowed
+7 more criteria

Locations (7)

Memorial Sloan Kettering Basking Ridge (Limited protocol activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited protocol activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited protocol activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited protocol activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited protocol activities)

Rockville Centre, New York, United States

Key Dates

Start Date

December 23, 2021

Primary Completion Date

December 23, 2026

Completion Date

December 23, 2026

Last Updated

February 27, 2026

Enrollment

ESTIMATED participants

Conditions

Uterine CarcinosarcomaAdvanced Uterine Carcinosarcoma

Interventions

Pembrolizumab

DRUG

Lenvatinib

DRUG

A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors

NCT07029399

HR+ Breast CancerTriple Negative Breast Cancer (TNBC)+5 more

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COMPLETEDPHASE2

Thalidomide in Treating Patients With Recurrent or Persistent Carcinosarcoma of the Uterus

NCT00025506

Recurrent Uterine Corpus SarcomaUterine Carcinosarcoma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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