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Tyrosine Kinase Inhibitor
Pembrolizumab + Lenvatinib for Uterine Cancer
Phase 2
Recruiting
Led By Vicky Makker, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed persistent/recurrent uterine or ovarian carcinosarcomas with high grade malignant epithelial and mesenchymal components
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.
Must not have
Diagnosis of immunodeficiency or receiving immunosuppressive therapy within 7 days prior to study drug
LVEF below institutional normal range
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new combination therapy for uterine carcinosarcoma and will also look for biomarkers that could predict how well patients will respond to the treatment.
Who is the study for?
This trial is for women over 18 with advanced uterine carcinosarcoma who've had one platinum-based chemo and up to three systemic therapies. They must have measurable cancer lesions, stable blood pressure, and adequate organ function. Excluded are those with recent investigational drugs, active autoimmune diseases or pneumonitis, other cancers within two years, CNS metastases, significant liver disease or cardiovascular issues.
What is being tested?
Researchers are testing the effectiveness of combining Pembrolizumab (an immunotherapy drug) with Lenvatinib (a targeted therapy) in treating advanced uterine carcinosarcoma. The study also aims to identify biomarkers that could predict how well these treatments work against this type of cancer.
What are the potential side effects?
Potential side effects include high blood pressure, fatigue, nausea, decreased appetite, thyroid dysfunction from Lenvatinib; immune-related adverse effects like inflammation in organs from Pembrolizumab; plus common risks such as bleeding or infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is a specific type that affects the uterus or ovaries and has come back or not gone away.
Select...
My uterine or ovarian cancer is classified as MSS, MSI-H, pMMR, or dMMR.
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I am fully active or can carry out light work.
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My uterine or ovarian cancer has a specific genetic feature.
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I am 18 years old or older.
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I've had one platinum-based chemotherapy and up to three other treatments.
Select...
I finished my chemotherapy more than 3 weeks ago.
Select...
I have had one platinum-based chemotherapy and up to three treatments in total.
Select...
My cancer is a confirmed carcinosarcoma of the uterus or ovary.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have an immune system disorder or have been on immune-weakening drugs recently.
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My heart's pumping ability is below the normal range.
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I have been treated for an autoimmune disease in the last 2 years.
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I have a condition that affects how my body absorbs nutrients.
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I have been treated with medications targeting the immune system.
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I have received a transplant from a donor.
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I have a severe fistula.
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I have not been treated for another cancer in the last 2 years.
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I haven't had major heart problems in the last year.
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I have had pneumonitis treated with steroids or have it now.
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I do not have any unmanaged ongoing illnesses.
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I have a serious liver condition.
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I have active brain metastases or cancer in the lining of my brain.
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I have active tuberculosis.
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I have been treated with VEGF TKI before.
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I have not had radiotherapy in the last 2 weeks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
overall response rate (ORR)
progression free survival (PFS)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Pembrolizumab With LenvatinibExperimental Treatment2 Interventions
Lenvatinib (20mg once daily orally) in combination with Pembrolizumab (200mg every 3 weeks, intravenously)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2810
Lenvatinib
2017
Completed Phase 4
~2070
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,968 Previous Clinical Trials
597,085 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
4,004 Previous Clinical Trials
5,185,360 Total Patients Enrolled
1 Trials studying Uterine Carcinosarcoma
30 Patients Enrolled for Uterine Carcinosarcoma
Vicky Makker, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
4 Previous Clinical Trials
150 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an immune system disorder or have been on immune-weakening drugs recently.My heart's pumping ability is below the normal range.I have been treated for an autoimmune disease in the last 2 years.I have not had significant coughing up of blood or tumor bleeding in the last 2 weeks.I stopped my hormonal therapy for carcinosarcoma at least a week ago.I am 18 years old or older.My cancer is a specific type that affects the uterus or ovaries and has come back or not gone away.I have a condition that affects how my body absorbs nutrients.My uterine or ovarian cancer is classified as MSS, MSI-H, pMMR, or dMMR.I last took PARP inhibitors more than 3 weeks ago.I have been treated with medications targeting the immune system.I am fully active or can carry out light work.I have received a transplant from a donor.I have a severe fistula.I took Bevacizumab, but it was over 3 weeks ago.My uterine or ovarian cancer has a specific genetic feature.I finished my chemotherapy more than 3 weeks ago.I took Parp-inhibitors, but it's been over 3 weeks since my last dose.I have not received a live vaccine in the last 30 days.I have not been treated for another cancer in the last 2 years.I haven't had major heart problems in the last year.I've had one platinum-based chemotherapy and up to three other treatments.I took Bevacizumab, but it was over 3 weeks ago.I have had pneumonitis treated with steroids or have it now.I do not have any unmanaged ongoing illnesses.I have a serious liver condition.I am 18 years old or older.My blood pressure is under control and I haven't changed my blood pressure medication in the last week.You cannot have participated in another experimental drug study within the last 4 weeks before starting this study.I finished my chemotherapy more than 3 weeks ago.I have had one platinum-based chemotherapy and up to three treatments in total.I am HIV-positive, on treatment, and my viral load is undetectable.I have active brain metastases or cancer in the lining of my brain.I am HIV-positive, on effective treatment, and my viral load has been undetectable for the last 6 months.My organs are functioning well, as tested within the last week.I have active tuberculosis.I have been treated with VEGF TKI before.My previous hormone therapy doesn't count as a treatment line.My cancer is a confirmed carcinosarcoma of the uterus or ovary.My previous hormonal therapy doesn't count as a treatment line.I stopped my hormonal therapy for cancer at least a week ago.I have not had radiotherapy in the last 2 weeks.You cannot tolerate the study treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab With Lenvatinib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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