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

Memorial Sloan Kettering Cancer Center7 sites in 1 country40 target enrollmentDecember 23, 2021

ConditionsUterine Carcinosarcoma Advanced Uterine Carcinosarcoma

InterventionsPembrolizumab Lenvatinib

DrugsPembrolizumab Lenvatinib

Overview

Phase: Phase 2
Intervention: Pembrolizumab
Conditions: Uterine Carcinosarcoma
Sponsor: Memorial Sloan Kettering Cancer Center
Enrollment: 40
Locations: 7
Primary Endpoint: overall response rate (ORR)
Status: Active, not recruiting
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

December 23, 2021

End Date

December 23, 2026

Last Updated

3 months ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Memorial Sloan Kettering Cancer Center

Responsible Party

Sponsor

Eligibility Criteria

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.

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

Arms & Interventions

Pembrolizumab With Lenvatinib

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

Intervention: Pembrolizumab

Pembrolizumab With Lenvatinib

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

Intervention: Lenvatinib

Outcomes

Primary Outcomes

overall response rate (ORR)

Time Frame: 1 year

RECIST v 1.1 assessments

progression free survival (PFS)

Time Frame: week 27

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.