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Neoadjuvant Lenvatinib + Pembrolizumab for Kidney Cancer
Phase 2
Recruiting
Led By Vitaly Margulis, MD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trialwill study a new cancer treatment to see if it is safe and effective for treating kidney cancer with blockage in the veins.
Who is the study for?
Adults with advanced kidney cancer and blood clots in the inferior vena cava who are fit for surgery. They must have good organ function, not be pregnant or breastfeeding, agree to use contraception, and can't have had recent transfusions or certain treatments. Excluded if they have heart issues, high protein in urine, active infections, severe allergies to trial drugs, uncontrolled blood pressure or other conditions that could affect results.Check my eligibility
What is being tested?
The trial tests a combination of Lenvatinib and Pembrolizumab before surgery (neoadjuvant therapy) followed by kidney removal and clot extraction from the inferior vena cava. Afterward, patients receive additional Pembrolizumab treatment (adjuvant therapy). The goal is to assess how safe and effective this approach is for treating renal cell carcinoma with IVC tumor thrombus.See study design
What are the potential side effects?
Possible side effects include high blood pressure, fatigue, loss of appetite, nausea, inflammation of organs like the liver or lungs which might cause symptoms such as jaundice or coughing respectively; also risks associated with immune system reactions leading to skin rashes or hormone gland problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have provided a sample of my tumor that has not been treated with radiation.
Select...
I am fully active or can carry out light work.
Select...
My kidney cancer is advanced, affecting nearby veins but not beyond.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
90 Day Post-Operative Complications
Disease Control Rate
Local and Metastatic Progression Rate
Secondary outcome measures
Estimated blood loss
Intra-operative complications
Length of stay
+3 moreOther outcome measures
Exploratory Outcomes
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment ArmExperimental Treatment4 Interventions
Patients receive neoadjuvant lenvatinib (20 mg PO daily) for 12 weeks and pembrolizumab (200 mg IV every 3 weeks for four doses) prior to surgical resection of locally advanced RCC with IVC tumor thrombus. Following surgery, patients will receive adjuvant pembrolizumab (200 mg IV every 3 weeks for up to thirteen doses).
Find a Location
Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,048 Previous Clinical Trials
1,053,745 Total Patients Enrolled
Vitaly Margulis, MDPrincipal InvestigatorUniversity of Texas Southwestern Medical Center
2 Previous Clinical Trials
700 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had radiotherapy less than 2 weeks before starting the study treatment.Your heart takes too long to recharge between beats.I am a male and agree to use approved birth control methods for 90 days after my last treatment dose and not donate sperm.I have not received a live vaccine in the last 30 days.I am highly allergic to pembrolizumab, lenvatinib, or their ingredients.My organs are functioning well.I have had serious heart problems in the last year.I have received an organ or tissue transplant from another person.You have more than 1 gram of protein in your urine over a 24-hour period.I have no health issues that could affect the study's results.I have been treated for an autoimmune disease in the last 2 years.My doctor thinks my tumor and related blood clot can or cannot be surgically removed.I have provided a sample of my tumor that has not been treated with radiation.I have had cancer treatment, including experimental drugs, before.You have a disease that can be measured using a specific medical guideline.I am fully active or can carry out light work.My kidney cancer has spread to more than three places.I have active brain metastases or cancer in the lining of my brain.Your kidney function needs to be checked as per the hospital's usual method.Your heart's pumping ability is below the normal range.I have an immune system disorder or have been on steroids or other immune-weakening drugs in the last week.I have another cancer that is getting worse or was treated in the last year.I have had or currently have lung inflammation treated with steroids.I am currently being treated for an infection.My blood pressure is high despite taking medication.My kidney cancer is advanced, affecting nearby veins but not beyond.I am 18 years old or older.I haven't had a blood transfusion or needed erythropoietin in the last 2 weeks.I am not pregnant, not breastfeeding, and follow specific birth control methods.I have been treated with specific medications before.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Arm
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any risks associated with Treatment Arm for participants?
"As this experimental arm is only in Phase 2 with limited data on efficacy, its safety rating stands at a 2."
Answered by AI
What is the primary goal of this scientific experiment?
"This clinical trial intends to measure Disease Control Rate across 12 weeks. Additionally, the evaluation of Intra-operative complications, Estimated blood loss and Survival Outcomes will be used as secondary objectives for this study."
Answered by AI
Are there any vacancies within this trial for individuals to join?
"Affirmative, the information on clinicaltrials.gov suggests that this medical trial is presently searching for eligible candidates. This study was initially revealed on January 6th 2023 and underwent its most recent update February 6th of the same year. The team requires 30 individuals to be enrolled at one site."
Answered by AI
How many individuals are currently enrolled in this clinical experiment?
"Affirmative. Clinicaltrials.gov's data implies that this clinical trial is currently recruiting individuals. The study was initially posted on June 1st 2023 and had its most recent update on June 2nd 2023, with the objective of enrolling thirty patients at one site."
Answered by AI
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