Study on Pembrolizumab and Lenvatinib for Patients with Brain Metastases from Melanoma or Kidney Cancer

Sponsor: Yale University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04955743

Provider View

This clinical trial is exploring the effects of combining two drugs, pembrolizumab and lenvatinib, in patients with melanoma or kidney cancer that has spread to the brain. The study aims to determine if this combination can effectively treat brain metastases in patients who have previously received similar treatments.

Patient Parameters

Program Overview

This study is testing a combination of two drugs, pembrolizumab and lenvatinib, in patients with melanoma or kidney cancer (renal cell carcinoma) that has spread to the brain. The main goal is to see how well these drugs work together to treat brain metastases in patients who have already been treated with similar drugs. The study will also look at overall response, survival rates, and any side effects. Researchers will collect and analyze tumor samples and blood to understand how the treatment works and identify markers that may predict response.

Description

This clinical trial involves patients with melanoma or kidney cancer that has spread to the brain and who have previously been treated with anti-PD-1/PD-L1 drugs. The study will test the effectiveness of pembrolizumab and lenvatinib in treating brain metastases. Patients will receive pembrolizumab through an IV every three weeks and lenvatinib as a daily pill for up to two years. The study will monitor the response of brain and body tumors through regular imaging scans.

Participants must have at least one untreated brain tumor between 5 mm and 3 cm in size. They should have previously received at least two doses of anti-PD-1/PD-L1 drugs and show progression in brain tumors. Tumor samples will be collected for analysis, and patients will undergo regular assessments to track the treatment's effectiveness and any side effects. The study will enroll up to 62 patients and will last approximately five years, including follow-up.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older with melanoma or kidney cancer that has spread to the brain.
  • Must agree to use contraception during the study and for 120 days after the last treatment.
  • Must provide written informed consent.
  • Must have a confirmed diagnosis of melanoma or kidney cancer.
  • Must have at least one untreated brain tumor between 5 mm and 3 cm in size.
  • Must have received at least two doses of anti-PD-1/PD-L1 drugs previously.
  • Must have a life expectancy of at least three months.
  • Must have good overall health with an ECOG performance status of 0 or 1.
  • Must have controlled blood pressure and adequate organ function.

Exclusion Criteria

  • Symptomatic brain metastases or active use of steroids for brain symptoms.
  • Recent bleeding from brain tumors or presence of leptomeningeal disease.
  • Inability to undergo MRI scans.
  • Positive pregnancy test or breastfeeding.
  • Recent anti-cancer therapy or major surgery without adequate recovery.
  • Recent CNS radiotherapy or live vaccine within 30 days.
  • Participation in another clinical trial within four weeks.
  • History of severe autoimmune disease or immunodeficiency.
  • Significant cardiovascular disease or uncontrolled hypertension.
  • Active infection or history of HIV or Hepatitis B/C.
  • Any condition that may interfere with study participation or results.

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