A Study of Pembrolizumab With Lenvatinib in Women With Advanced Uterine Carcinosarcoma (NCT05147558) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study of Pembrolizumab With Lenvatinib in Women With Advanced Uterine Carcinosarcoma
United States40 participantsStarted 2021-12-23
Plain-language 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
Who can participate
Age range18 Years
SexFEMALE
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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.
* participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditio…