Study of Pembrolizumab and Lenvatinib for Advanced Cervical Cancer

Sponsor: University of Texas Southwestern Medical Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06266338

Provider View

This clinical trial is exploring a new treatment combination of pembrolizumab and lenvatinib to see if it can help slow down the growth of cervical cancer tumors that have spread or returned after treatment.

Patient Parameters

Program Overview

The main goal of this study is to find out if a combination of two drugs, pembrolizumab and lenvatinib, can help control cervical cancer that has spread or come back after treatment. Researchers want to see if this combination can slow down the growth of cancer tumors.

Description

In this study, participants will receive pembrolizumab at a dose of 200 mg every three weeks, for up to 35 cycles. If the cancer progresses after two years of treatment, participants may be eligible for an additional year of pembrolizumab. Lenvatinib will be given at a dose of 20 mg per day, alongside pembrolizumab.

Participants must meet certain criteria to join the study, including being at least 18 years old, having a confirmed diagnosis of specific types of cervical cancer that have spread or returned, and having received certain prior treatments. Women who can become pregnant must use effective birth control during the study and for a period after the last dose of the study drugs.

The study will also require participants to have a test to check for a specific marker (PD-L1) on their cancer cells. Participants who have previously been treated with similar drugs and have shown disease progression may still be eligible to join the study.

Participants will need to provide a tumor sample for testing and have adequate organ function as determined by specific medical tests. They must also be able to understand and sign a consent form to participate in the study.

Eligibility Criteria

Inclusion Criteria

  • Women aged 18 or older.
  • Diagnosed with specific types of cervical cancer that have spread or returned.
  • May have had up to two previous chemotherapy treatments for advanced cancer.
  • May have received certain other cancer treatments, including radiation.
  • Must not be pregnant or breastfeeding and must use effective birth control if of childbearing potential.
  • Must have a specific test (PD-L1) on their cancer cells.
  • Must have measurable cancer based on specific criteria.
  • Must provide a tumor sample for testing.
  • Must have good organ function and overall health.
  • Must not have active hepatitis B or C unless under control.
  • Must have controlled blood pressure.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Positive pregnancy test for women of childbearing potential.
  • Recent cancer treatment or investigational drug use.
  • Recent radiation therapy or live vaccine.
  • Immunodeficiency or use of immunosuppressive drugs.
  • Other active cancers requiring treatment.
  • Active brain metastases or meningitis.
  • Severe allergies to study drugs.
  • Active autoimmune diseases requiring treatment.
  • Active infections or HIV.
  • Recent major surgery.
  • Psychiatric or substance abuse issues affecting participation.
  • Pregnant or breastfeeding women.
  • Recent organ transplant.
  • Significant heart or blood vessel issues.
  • Conditions affecting drug absorption.

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