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Tyrosine Kinase Inhibitor

Lenvatinib + Pembrolizumab for Endometrial Cancer

Phase 3
Waitlist Available
Research Sponsored by Eisai Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has at least 1 measurable target lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 and confirmed by Blinded Independent Central Review BICR
Has a histologically confirmed diagnosis of endometrial carcinoma (EC)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the first dose of study drug up to data cutoff date 26 october 2020 (up to approximately 2 years 5 months)
Awards & highlights

Study Summary

This trial will study whether pembrolizumab and lenvatinib prolongs progression free survival and overall survival for endometrial cancer patients when compared to standard treatment.

Who is the study for?
This trial is for adults with advanced endometrial cancer who've had one prior platinum-based chemotherapy. They must not be pregnant or breastfeeding and agree to use contraception. Excluded are those with certain other cancers, heart conditions, active infections, HIV/Hepatitis B/C, recent major surgery complications, autoimmune diseases requiring treatment in the past 2 years, or previous treatments that overlap with the study drugs.Check my eligibility
What is being tested?
The trial tests pembrolizumab combined with lenvatinib against a physician's choice of doxorubicin or paclitaxel in treating advanced endometrial cancer. The goal is to see if the combination improves survival without disease progression compared to standard treatments.See study design
What are the potential side effects?
Potential side effects include fatigue, nausea, increased blood pressure from lenvatinib; immune-related reactions like skin rash or thyroid issues from pembrolizumab; and hair loss (alopecia), heart toxicity from doxorubicin; nerve damage and allergic reactions from paclitaxel.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a tumor that can be measured and has been confirmed by a review.
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I have been diagnosed with endometrial carcinoma.
Select...
My cancer has come back or spread from its original site.
Select...
I have a tumor biopsy for MMR status testing.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization up to first documentation of pd or date of death, whichever occurred first up to data cutoff date 26 october 2020 (up to approximately 2 years 5 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization up to first documentation of pd or date of death, whichever occurred first up to data cutoff date 26 october 2020 (up to approximately 2 years 5 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival (OS)
Progression-free Survival (PFS)
Secondary outcome measures
Health-Related Quality of Life (HRQoL) Assessed by European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQC30) Score
Model Predicted Apparent Total Clearance (CL/F) for Lenvatinib
Model Predicted Area Under the Plasma Drug Concentration-time Curve (AUC) for Lenvatinib
+4 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Lenvatinib 20 mg + Pembrolizumab 200 mgExperimental Treatment2 Interventions
Participants will receive pembrolizumab 200 milligram (mg) administered by intravenous (IV) infusion on Day 1 of each 21-day cycle plus lenvatinib 20 mg administered orally (PO) once daily (QD) during each 21-day cycle for up to 35 cycles.
Group II: Treatment of Physician's ChoiceActive Control2 Interventions
Participants will receive either of the following treatments: doxorubicin 60 milligram per square meter (mg/m^2) administered by IV on Day 1 of each 21-day cycle for up to a maximum cumulative dose of 500 mg/m^2 OR paclitaxel 80 mg/m^2 administered by IV on a 28-day cycle: 3 weeks receiving paclitaxel once a week and 1 week not receiving paclitaxel.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~1950
Lenvatinib
2005
Completed Phase 4
~2690

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,862 Previous Clinical Trials
5,048,873 Total Patients Enrolled
20 Trials studying Endometrial Cancer
4,143 Patients Enrolled for Endometrial Cancer
Eisai Inc.Lead Sponsor
515 Previous Clinical Trials
153,272 Total Patients Enrolled
1 Trials studying Endometrial Cancer
133 Patients Enrolled for Endometrial Cancer
Medical DirectorStudy DirectorEisai Inc.
2,769 Previous Clinical Trials
8,061,373 Total Patients Enrolled
7 Trials studying Endometrial Cancer
3,131 Patients Enrolled for Endometrial Cancer

Media Library

Lenvatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03517449 — Phase 3
Endometrial Cancer Research Study Groups: Lenvatinib 20 mg + Pembrolizumab 200 mg, Treatment of Physician's Choice
Endometrial Cancer Clinical Trial 2023: Lenvatinib Highlights & Side Effects. Trial Name: NCT03517449 — Phase 3
Lenvatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03517449 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Pembrolizumab has received FDA approval, correct?

"Pembrolizumab is considered safe by our team at Power, who gave it a score of 3. This is due to this being a Phase 3 trial, which means that there is not just some data supporting efficacy, but multiple rounds of data supporting safety."

Answered by AI

Can people with certain medical conditions participate in this research project?

"This trial is no longer recruiting patients. According to the study's clinicaltrials.gov page, it was first posted on 6/11/2018 and was last updated on 9/23/2022. However, there are presently 291 clinical trials actively enrolling participants with endometrial neoplasms and 2147 trials for Pembrolizumab actively recruiting participants."

Answered by AI

How many people are being signed up to participate in this test?

"This study is not recruiting patients at this time, as the last update was on September 23rd, 2022. Out of the 291 clinical trials for endometrial neoplasms and 2147 trials for Pembrolizumab, this study is not the only one looking for patients."

Answered by AI

What are some of the more common reasons that Pembrolizumab is prescribed?

"Pembrolizumab is often used to melanoma that cannot be surgically removed. It is also useful for treating microsatellite instability high, neuroblastoma (nb), and high risk of recurrence."

Answered by AI

Could you please tell me more about other Pembrolizumab research projects?

"Pembrolizumab was first studied in 1997 at Spectrum Health Hospital - Butterworth Campus. So far, there have been 1980 completed trials. Out of the 2147 active trials, many are based in San Antonio, Texas."

Answered by AI

Where are the medical facilities that are hosting this clinical trial?

"This trial is being hosted at 36 different locations, some of which include Texas Oncology-San Antonio Medical Center, Utah Cancer Specialists, and Duke University Medical Center."

Answered by AI

What other similar trials have been conducted in the past?

"Pembrolizumab has been the focus of 2147 clinical trials in 82 countries and 4095 cities. The first Pembrolizumab trial began in 1997 and completed Phase 3 in 300 patients. Between 1997 and now, there have been 1980 more trials."

Answered by AI
~123 spots leftby Mar 2025