Study on Lenvatinib and Pembrolizumab Before Surgery for Locally Advanced Kidney Cancer

Sponsor: Emory University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04393350

Provider View

This clinical trial is testing how well the combination of lenvatinib and pembrolizumab works when given before surgery to treat kidney cancer that has spread to nearby tissues or lymph nodes but not to other parts of the body.

Patient Parameters

Program Overview

This study is exploring the effectiveness of using lenvatinib and pembrolizumab before surgery in patients with locally advanced kidney cancer that has not spread to distant parts of the body. Lenvatinib may help stop cancer cells from growing by blocking certain enzymes, while pembrolizumab, an immunotherapy drug, may help the immune system attack cancer cells. The goal is to see if this combination can kill more cancer cells before surgery.

Description

The main goal of this study is to see how well lenvatinib and pembrolizumab work together in shrinking kidney tumors before surgery. Patients will receive these medications for 12 weeks, divided into four cycles, before undergoing surgery to remove the tumor.

Secondary goals include assessing the safety of this treatment combination before surgery and the safety of pembrolizumab after surgery. The study will also look at how long patients remain free of cancer and their overall survival rates. Researchers will evaluate any surgery-related complications and changes in the tumor environment and patients' quality of life before and after treatment.

Participants will take lenvatinib by mouth daily and receive pembrolizumab through an IV every three weeks for up to four cycles, as long as the cancer does not progress or cause unacceptable side effects. After completing the treatment, patients will have follow-up visits within 14 days and then every 12 weeks.

Eligibility Criteria

Inclusion Criteria

  • Have a kidney mass that is locally advanced and not spread to other parts of the body, as determined by a doctor.
  • Have clear cell renal cell carcinoma confirmed by a biopsy.
  • Be willing to provide written consent and follow the study requirements.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Meet specific blood count and organ function criteria, including:
    • Neutrophil count of at least 1500/uL.
    • Platelet count of at least 100,000/uL.
    • Hemoglobin level of at least 9.0 g/dL.
    • Adequate kidney and liver function as indicated by specific blood tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 120 days after.
  • Men must use a condom and ensure their partners use effective contraception during the study and for 120 days after.

Exclusion Criteria

  • Have evidence of cancer spread to other parts of the body.
  • Have received any previous treatment for kidney cancer.
  • Have participated in another clinical trial within 28 days before starting this study.
  • Have another active cancer within the past 24 months, except for certain non-threatening cancers.
  • Have previously been treated with lenvatinib or similar drugs.
  • Be pregnant or breastfeeding, or planning to conceive or father a child during the study.
  • Have significant protein in the urine or conditions affecting the absorption of lenvatinib.
  • Have uncontrolled high blood pressure or significant heart problems.
  • Have a history of significant bleeding or non-healing wounds.
  • Have received a live vaccine within 30 days before starting the study.
  • Have an active infection or a history of certain lung diseases.
  • Have uncontrolled HIV or active hepatitis B or C infections.
  • Have any condition or treatment that might interfere with the study results or participation.

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