Phase II Study of Pembrolizumab and Lenvatinib for Patients with Brain Metastases from TNBC, NSCLC, and Other Tumors

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05064280

Provider View

This clinical trial is testing a combination of two drugs, pembrolizumab and lenvatinib, to see if they are safe and effective in treating patients with certain types of cancer that have spread to the brain. The study includes patients with triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), and other solid tumors.

Patient Parameters

Program Overview

The study aims to evaluate how well the combination of pembrolizumab and lenvatinib works in shrinking brain tumors in patients with TNBC, NSCLC, and other solid tumors. It will also assess the safety of this treatment. The trial is divided into three groups based on the type of cancer, and about 87 patients will participate. Researchers will measure the response of brain tumors to the treatment using specific criteria.

Description

This study is focused on understanding how effective and safe the combination of pembrolizumab and lenvatinib is for treating brain metastases in patients with certain cancers. The primary goal is to see how well the treatment can shrink brain tumors in patients with triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), and other solid tumors.

Secondary goals include evaluating the safety of the treatment, how long patients can live without the cancer worsening, and overall survival rates. The study will also explore how the treatment affects the use of steroids for managing symptoms, neurological function, and the need for pain medication or radiation.

Patients will be divided into three groups based on their type of cancer, and the study will follow a specific design to ensure accurate results. The trial will involve regular assessments to monitor the response of brain tumors and any side effects experienced by the participants.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older with confirmed TNBC, NSCLC, or other solid tumors with brain metastases.
  • Must have at least one measurable brain tumor that can be accurately assessed.
  • Previous treatment of up to 5 brain metastases is allowed if done at least 3 weeks before starting the study.
  • Can have asymptomatic or minimally symptomatic brain metastases.
  • Extracranial disease is not required but can be present.
  • Women must not be pregnant or breastfeeding and must agree to use contraception.
  • Men must agree to use contraception and not donate sperm during the study.
  • Must provide written informed consent.
  • Must have a performance status of 0 or 1, indicating good overall health.
  • Must have a life expectancy of at least 12 weeks.
  • Must have adequate organ function as determined by specific blood tests.
  • Blood pressure must be controlled with no more than one medication.
  • Hepatitis B and C tests are required only if there is a known history of infection.

Exclusion Criteria

  • Patients with NSCLC with specific genetic mutations.
  • Patients with hepatocellular carcinoma.
  • Patients with untreated or symptomatic spinal cord compression.
  • Previous treatment with lenvatinib or similar drugs.
  • Recent systemic cancer therapy or radiation therapy.
  • Recent live vaccines.
  • Participation in another investigational study recently.
  • Contraindications to MRI or MRI contrast.
  • Pregnant or breastfeeding women.
  • Patients with immunodeficiency or on high-dose steroids.
  • Recent active treatment for another cancer.
  • Severe allergies to study drugs.
  • History of lung disease requiring steroids.
  • Active infections or known HIV.
  • Active hepatitis B or C.
  • Active tuberculosis.
  • Conditions that may interfere with study results.
  • Psychiatric or substance abuse disorders.
  • Unable to take oral medications.
  • Significant heart problems.
  • Recent gastrointestinal bleeding.
  • Bleeding disorders or on certain blood thinners.
  • Electrolyte imbalances not corrected.
  • Recent organ transplant.
  • Tumors involving major blood vessels.

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