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Pembrolizumab and Lenvatinib for Kidney Cancer Before Surgery

This study is looking at how two drugs, pembrolizumab and lenvatinib, affect the immune system's response to kidney cancer (renal cell carcinoma) when given before and after surgery. You would receive pembrolizumab alone or pembrolizumab with lenvatinib. The study aims to see how these treatments change certain immune cells in your blood and tumor tissue. This will help researchers understand if these changes are linked to how well you do after surgery. To join, you must be at least 18 years old and have been diagnosed with kidney cancer. The study plans to enroll about 30 participants. The current recruitment status is unclear.

Study design
This is a randomized, single-center, unblinded pilot study. It will involve about 30 participants to evaluate pembrolizumab with or without lenvatinib as treatment before surgery.
What's involved
You would go through screening, receive treatment before surgery, have surgery, potentially receive more pembrolizumab after surgery, and then have follow-up appointments. The total study duration, including follow-up, will be approximately 60 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for approximately 60 months after treatment. The primary endpoint, changes in immune cells, will be measured at approximately 18-24 months.

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NCT05733715

Neoadjuvant Pembrolizumab and Lenvatinib for Renal Cell Carcinoma

Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatment
Abramson Cancer Center at Penn Medicine
~30 participants
Updated 2026-08-13 on ClinicalTrials.gov
What's tested:Pembrolizumab infusionLenvatinib tablet

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in frequency of progenitor exhausted CD8 T cells (TEX prog) in peripheral blood during neoadjuvant pembrolizumab +/- lenvatinib and in tumor tissue.
Measured over Approximately 18-24 months

Conditions

Renal Cell Carcinoma

Explore related trials

Renal Cell Carcinoma

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Vivek Narayan, MD · PRINCIPAL_INVESTIGATOR · Abramson Cancer Center at Penn Medicine

Who to contact

Matt Doyle
[email protected]
215-662-7383
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR
Must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause o Agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a woman of child-bearing potential (WOCBP) who is not currently pregnant. Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile-vaginal penetration. 3. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
Is not a WOCBP OR
Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \<1% per year), with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) during the intervention period and for at least 120 days post pembrolizumab or 30 days post lenvatinib, whichever occurs last. 4. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial. 5. Histologically or cytologically confirmed diagnosis of renal cell carcinoma based on newly obtained renal mass core biopsy performed during study screening procedures. 6. Renal cell carcinoma with clinical stage cT2 to cT4 based on screening CT or MRI imaging assessment and eligible for surgical resection.

What this trial measures

  • Change in frequency of progenitor exhausted CD8 T cells (TEX prog) in peripheral blood during neoadjuvant pembrolizumab +/- lenvatinib and in tumor tissue.Approximately 18-24 months

    We will apply two 32-parameter spectral flow cytometry panels for phenotypic characterization of paired blood and tumor specimens over the course of multiple timepoints during three distinct treatment periods (Figure 1: Study Schema): 1) before and after neoadjuvant pembrolizumab + lenvatinib (Arm A), and pembrolizumab alone (Arm B); 2) the initial post-operative adjuvant pembrolizumab period; and 3) upon any tumor recurrence.