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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
Must not have
Clinically significant cardiovascular disease within 12 months from first dose of study intervention
Known history of Hepatitis B or known active Hepatitis C virus infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 18-24 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new treatment alone or in combination with another treatment in kidney cancer patients to see if these treatments improve the body's defense system against cancer around the time of surgery. The treatments help the body attack cancer and stop its growth. These treatments have shown promising results in various cancers, especially kidney cancer.
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.
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.
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.
Select...
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.
Select...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't had serious heart problems in the last year.
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I have a history of Hepatitis B or an active Hepatitis C infection.
Select...
I have been treated with cancer-fighting drugs before.
Select...
I have an immune system disorder or I am on long-term steroids.
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I have been diagnosed with HIV.
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I have received an organ or tissue transplant from another person.
Select...
I need surgery urgently.
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I have or had lung inflammation that needed steroids.
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I am currently on medication for an infection.
Select...
My scans show cancer has spread to distant parts of my body.
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I have a severe fistula.
Select...
I am a woman and my pregnancy test is positive.
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My heart's pumping ability is reduced.
Select...
I have another cancer that is getting worse or was treated in the last 3 years.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in frequency of progenitor exhausted CD8 T cells (TEX prog) in peripheral blood during neoadjuvant pembrolizumab +/- lenvatinib and in tumor tissue.
Secondary study objectives
Brisk TIL
Change in Ki67 expression
Immune-Related Pathologic Response (irPR)
+2 moreOther study objectives
Disease-free survival (DFS)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Pembrolizumab is a PD-1 inhibitor that enhances the immune system's ability to recognize and attack cancer cells by blocking the PD-1 pathway, which tumors use to evade immune detection. Lenvatinib is a tyrosine kinase inhibitor that targets multiple receptors involved in tumor growth and angiogenesis, such as VEGFR, FGFR, and PDGFR.
The combination of Pembrolizumab and Lenvatinib provides a dual approach by both stimulating the immune response and inhibiting tumor growth pathways. This multifaceted mechanism is crucial for kidney cancer patients as it can lead to higher response rates and improved outcomes compared to single-agent therapies.
Health-related quality-of-life outcomes in patients with advanced renal cell carcinoma treated with lenvatinib plus pembrolizumab or everolimus versus sunitinib (CLEAR): a randomised, phase 3 study.
Health-related quality-of-life outcomes in patients with advanced renal cell carcinoma treated with lenvatinib plus pembrolizumab or everolimus versus sunitinib (CLEAR): a randomised, phase 3 study.
Find a Location
Who is running the clinical trial?
Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
108,474 Total Patients Enrolled
Abramson Cancer Center at Penn MedicineLead Sponsor
413 Previous Clinical Trials
164,601 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
4,005 Previous Clinical Trials
5,185,391 Total Patients Enrolled
Media Library
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.
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