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Pembrolizumab + Lenvatinib for Kidney Cancer
Phase < 1
Recruiting
Led By Vivek Narayan, MD
Research Sponsored by Abramson Cancer Center of the University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequately controlled BP with or without antihypertensive medications
Histologically or cytologically confirmed diagnosis of renal cell carcinoma based on newly obtained renal mass core biopsy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 18-24 months
Awards & highlights
Study Summary
This trial will study how two drugs affect the immune system's response to kidney cancer before & after surgery.
Who is the study for?
Adults with confirmed renal cell carcinoma, eligible for kidney cancer surgery, can join this trial. They must have good organ function and controlled blood pressure, not be pregnant or breastfeeding, use effective contraception if applicable, and have no recent major surgeries or active infections. Those with certain heart conditions, other cancers within 3 years, severe drug allergies or immune diseases are excluded.Check my eligibility
What is being tested?
The study tests pembrolizumab (infusion) alone or combined with lenvatinib (tablet) on the body's immune response to kidney cancer before and after surgical removal of the tumor. The goal is to see how these drugs affect the disease when used as a pre-surgery treatment.See study design
What are the potential side effects?
Pembrolizumab may cause immune-related side effects like inflammation in organs and infusion reactions; lenvatinib might lead to high blood pressure, fatigue, digestive issues such as diarrhea and nausea. Both drugs could potentially increase bleeding risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood pressure is under control, with or without medication.
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My kidney cancer diagnosis was confirmed through a biopsy.
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I am fully active and can carry on all pre-disease activities without restriction.
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My kidney cancer is at a stage where surgery is possible.
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I am 18 or older with a confirmed diagnosis of kidney cancer.
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I agree to avoid sex or use birth control during and after the study.
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I am not pregnant or breastfeeding and will use effective birth control or remain abstinent.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 18-24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 18-24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in frequency of progenitor exhausted CD8 T cells (TEX prog) in peripheral blood during neoadjuvant pembrolizumab +/- lenvatinib and in tumor tissue.
Secondary outcome measures
Brisk TIL
Change in Ki67 expression
Frequency of lenvatinib discontinuation, dose interruption, dose reductions, and dose intensity of lenvatinib during neoadjuvant therapy (observed/expected).
+4 moreOther outcome measures
Disease-free survival (DFS)
Trial Design
2Treatment groups
Experimental Treatment
Group I: B: PembrolizumabExperimental Treatment1 Intervention
Subject will receive Pembrolizumab 200 mg or 400 mg will be administered as a 30-minute IV infusion every 3 weeks.
Group II: A: Pembrolizumab + LenvatinibExperimental Treatment2 Interventions
Subjects will receive Pembrolizumab + Lenvatinib. Pembrolizumab 200 mg or 400 mg will be administered as a 30-minute IV infusion every 3 weeks. Lenvatinib 20 mg daily will be self-administered PO by subject for 28 consecutive days, beginning Day -7.
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Who is running the clinical trial?
Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
105,014 Total Patients Enrolled
Abramson Cancer Center at Penn MedicineLead Sponsor
387 Previous Clinical Trials
145,614 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,061,116 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My organs are working well.I have a history of Hepatitis B or an active Hepatitis C infection.I have been treated with cancer-fighting drugs before.My blood pressure is under control, with or without medication.I have an immune system disorder or I am on long-term steroids.I don't have any health issues that could affect the study's results.I haven't had serious heart problems in the last year.I have been diagnosed with HIV.My kidney cancer diagnosis was confirmed through a biopsy.You have a history of mental health or drug problems.I am fully active and can carry on all pre-disease activities without restriction.My kidney cancer is at a stage where surgery is possible.I have received an organ or tissue transplant from another person.I am 18 or older with a confirmed diagnosis of kidney cancer.I need surgery urgently.I have or had lung inflammation that needed steroids.I do not have conditions affecting medication absorption.I haven't had cancer treatment in the last 4 weeks.I agree to avoid sex or use birth control during and after the study.Your heart takes longer than usual to recharge between beats.You have an autoimmune disease that needed medication to treat in the last 2 years.I am currently on medication for an infection.I am not pregnant or breastfeeding and will use effective birth control or remain abstinent.I have not had major surgery in the last 3 weeks.My scans show cancer has spread to distant parts of my body.I have not received a live vaccine in the last 30 days.I have a severe fistula.I am a woman and my pregnancy test is positive.You have protein in your urine at a level higher than 1+ on a urine dipstick test.My heart's pumping ability is reduced.You have a severe allergic reaction (Grade 3 or higher) to pembrolizumab or lenvatinib, or any of the substances used to make them.I have not coughed up blood in the last 3 weeks.I have another cancer that is getting worse or was treated in the last 3 years.
Research Study Groups:
This trial has the following groups:- Group 1: A: Pembrolizumab + Lenvatinib
- Group 2: B: Pembrolizumab
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 vacancies available in the trial for prospective participants?
"As per clinicaltrials.gov, this specific trial is no longer recruiting participants at present; the posting was initially made on March 1st 2023 and its latest update occurred February 8th of the same year. Nonetheless, there are currently 2559 other studies that require patient enrollment."
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