Study on Pembrolizumab and Lenvatinib for Advanced Cervical Cancer

Sponsor: Georgetown University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04865887

Provider View

This clinical trial is testing a combination of two drugs, pembrolizumab and lenvatinib, to see if they can help treat cervical cancer that has spread or not responded to initial treatments. The study aims to find out if these drugs can improve the body's immune response against the cancer.

Patient Parameters

Program Overview

This phase II study is exploring whether a combination of pembrolizumab and lenvatinib can help treat cervical cancer that has spread or is locally advanced and has not responded to first-line treatments. Researchers believe that these drugs together might help the immune system fight the cancer more effectively by overcoming certain barriers that usually suppress the immune response.

Description

The main goal of this study is to see how many patients with advanced cervical cancer respond to the combination of pembrolizumab and lenvatinib. The study will be conducted in two stages. In the first stage, 11 patients will be treated. If at least 2 patients show a positive response, the study will continue to the second stage, where an additional 24 patients will be treated, making a total of 35 patients. If 9 or more patients respond positively in total, the treatment will be considered for further research. The study will also use special tests to check early on if the treatment is working or not.

Eligibility Criteria

Inclusion Criteria

  • Women aged 18 or older with advanced cervical cancer that has not responded to at least one previous treatment.
  • Not pregnant or breastfeeding, and willing to use birth control during the study and for 120 days after the last dose.
  • Able to provide a tumor sample for testing.
  • Have measurable cancer that can be tracked during the study.
  • In good overall health with a performance status score of 0 or 1.
  • Have adequate organ function based on specific blood tests.

Exclusion Criteria

  • Pregnant or breastfeeding women.
  • Previous treatment with similar drugs (anti-PD-1, anti-PD-L1, or anti-PD-L2).
  • Recent cancer treatments or surgeries that have not fully healed.
  • Recent use of live vaccines.
  • Participation in another clinical trial within the last 4 weeks.
  • Immune system disorders or use of immunosuppressive drugs.
  • Other active cancers or untreated brain metastases.
  • Severe allergies to the study drugs.
  • Active autoimmune diseases or lung diseases.
  • Active infections or history of HIV or hepatitis.
  • Uncontrolled high blood pressure or heart problems.
  • Bleeding disorders or risk of severe bleeding.
  • Conditions affecting drug absorption.
  • Prolonged QT interval on heart tests.

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