Study on Pembrolizumab and Lenvatinib for Clear Cell Ovarian Cancer

Sponsor: Elizabeth K. Lee MD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05296512

Provider View

This clinical trial is testing the safety and effectiveness of combining two drugs, pembrolizumab and lenvatinib, to treat patients with clear cell ovarian cancer.

Patient Parameters

Program Overview

The purpose of this study is to see if the combination of pembrolizumab and lenvatinib can help treat clear cell ovarian cancer. These drugs are being tested together to find out if they are safe and effective for this type of cancer. Pembrolizumab and lenvatinib are not yet approved by the FDA for clear cell ovarian cancer, but they are approved for other uses.

Description

This study is a Phase II clinical trial, which means it is testing the safety and effectiveness of a new treatment. Participants with clear cell ovarian cancer that has come back or is not responding to treatment will receive pembrolizumab and lenvatinib. The study will continue until the cancer progresses or side effects become too severe. About 31 people are expected to participate. Participants will be monitored for 36 months after treatment to see how they respond. The study involves regular check-ups and tests to ensure the treatment is working and to monitor for any side effects.

Eligibility Criteria

Inclusion Criteria

  • Must have clear cell ovarian cancer that has come back or is not responding to treatment.
  • Must have at least one tumor that can be measured by scans.
  • Must have had at least one previous treatment with platinum-based chemotherapy.
  • Previous treatment with bevacizumab is allowed.
  • Previous use of immune checkpoint inhibitors is allowed for up to 30% of participants.
  • No limit on the number of previous treatments for recurrent or persistent cancer.
  • Must be 18 years or older.
  • Must be in good overall health with a performance status score of 0 or 1.
  • Must have adequate organ and bone marrow function based on specific blood tests.
  • Must have controlled blood pressure.
  • If there are brain metastases, they must be treated and stable.
  • Must provide a tumor tissue sample.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception during the study and for 30 days after.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Previous treatment with lenvatinib.
  • Use of immunosuppressive therapy within 2 weeks before starting the study.
  • Recent cancer treatment within 4 weeks before starting the study.
  • Recent radiation therapy within 2 weeks before starting the study.
  • Use of certain herbal supplements within 1 week before starting the study.
  • Unresolved side effects from previous cancer treatments.
  • Recent live vaccines within 30 days before starting the study.
  • Major surgery within 4 weeks before starting the study.
  • Significant protein in urine.
  • Gastrointestinal disorders affecting medication absorption.
  • Significant heart problems or recent heart attack.
  • Long QT interval on an ECG.
  • Recent significant bleeding.
  • Active autoimmune disease requiring treatment.
  • Immunodeficiency or positive for HIV, Hepatitis B, or untreated Hepatitis C.
  • History of organ transplant.
  • History of lung disease requiring steroids.
  • Uncontrolled illness or psychiatric conditions.
  • Allergic reactions to similar drugs.
  • Pregnant or breastfeeding women.

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