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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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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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.
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I have been treated with cancer-fighting drugs before.
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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.
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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.
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My scans show cancer has spread to distant parts of my body.
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I have a severe fistula.
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I am a woman and my pregnancy test is positive.
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My heart's pumping ability is reduced.
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I have another cancer that is getting worse or was treated in the last 3 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 18-24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 18-24 months for reporting.

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 more
Other 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.

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

A: Pembrolizumab + Lenvatinib Clinical Trial Eligibility Overview. Trial Name: NCT05733715 — Phase < 1
Kidney Cancer Research Study Groups: A: Pembrolizumab + Lenvatinib, B: Pembrolizumab
Kidney Cancer Clinical Trial 2023: A: Pembrolizumab + Lenvatinib Highlights & Side Effects. Trial Name: NCT05733715 — Phase < 1
A: Pembrolizumab + Lenvatinib 2023 Treatment Timeline for Medical Study. Trial Name: NCT05733715 — Phase < 1
~2 spots leftby Jan 2025