RecruitingEarly Phase 1NCT05733715

Neoadjuvant Pembrolizumab and Lenvatinib for Renal Cell Carcinoma

Randomized Pilot Clinical Trial of Neoadjuvant Pembrolizumab +/- Lenvatinib for High Risk Renal Cell Carcinoma


Sponsor

Abramson Cancer Center at Penn Medicine

Enrollment

30 participants

Start Date

May 3, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This study will evaluate the effect of investigational drugs, pembrolizumab alone or pembrolizumab with lenvatinib, on the immune systems response to kidney cancer when given before and after surgery to remove kidney cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether giving two cancer drugs — pembrolizumab (an immunotherapy) and lenvatinib (a targeted therapy) — before surgery (called neoadjuvant treatment) can shrink kidney cancer tumours and improve outcomes. The study is for people with larger kidney cancers that haven't spread widely and are planned for surgical removal. **You may be eligible if...** - You are 18 or older - You have been diagnosed with renal cell carcinoma (kidney cancer) confirmed by biopsy - Your tumour is large (clinical stage T2 to T4) but eligible for surgery - You are in good health overall (ECOG 0 or 1) with controlled blood pressure - You have adequate organ function **You may NOT be eligible if...** - You have already received immunotherapy or targeted cancer drugs for this cancer - Your cancer has spread to distant organs (beyond the kidney and nearby lymph nodes) - You need urgent surgery - You have had a recent heart attack, severe heart failure, or stroke within the past 12 months - You have active autoimmune disease requiring systemic treatment - You have active hepatitis B or C, or HIV - You are pregnant or breastfeeding - You have had an organ transplant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPembrolizumab infusion

100 mg/ 4mL on Day 1 of each 3- or 6- week cycle (one 3 wk cycle; up to eight 6 wk cycles)

DRUGLenvatinib tablet

10mg and 4mg daily for 21 days


Locations(1)

Abramson Cancer Center at University of Pennsylvania

Philadelphia, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

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NCT05733715


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