Study on Pembrolizumab and Lenvatinib for Advanced or Metastatic Neuroendocrine Prostate Cancer

Sponsor: University of Michigan Rogel Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04848337

Provider View

This clinical trial is testing a combination of two drugs, pembrolizumab and lenvatinib, to see if they can help treat advanced or metastatic neuroendocrine prostate cancer. The treatment cycles last 21 days, and patients can receive up to 35 cycles unless the cancer progresses, side effects become too severe, or the patient or doctor decides to stop.

Patient Parameters

Program Overview

Eligible patients will receive a combination of the drugs lenvatinib and pembrolizumab. Each treatment cycle lasts 21 days, and the therapy will continue until the cancer shows signs of worsening, the side effects become too severe, or the patient or doctor decides to stop. Patients can receive a maximum of 35 cycles. On the first day of each cycle, both pembrolizumab and lenvatinib are given, and patients should take lenvatinib as part of their regular routine.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent and authorization to release health information.
  • Must be 18 years or older.
  • Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Must have prostate cancer that has spread, with specific characteristics such as small-cell or neuroendocrine features, or high levels of certain markers.
  • Must have adequate organ function based on specific blood tests.
  • Must agree to use contraception during treatment and for 120 days after the last dose.
  • Must have a life expectancy of at least 6 months.
  • Must be able to understand and comply with study procedures.

Exclusion Criteria

  • Have received certain prior cancer treatments, including specific immune therapies or more than two chemotherapy regimens for metastatic prostate cancer.
  • Have uncontrolled high blood pressure.
  • Have non-healing wounds after surgery.
  • Have active brain metastases or certain other medical conditions.
  • Have received a live vaccine within 30 days before starting the study.
  • Have significant heart problems or bleeding disorders.
  • Have severe allergies to pembrolizumab or lenvatinib.
  • Have active autoimmune diseases requiring treatment in the past 2 years.
  • Have active infections or other cancers requiring treatment in the past 3 years.
  • Have a history of HIV, active hepatitis B or C, or tuberculosis.

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