Study on Pembrolizumab and Lenvatinib for Treating Serous Ovarian Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT05114421

Provider View

This clinical trial is exploring the effects of combining pembrolizumab, an immunotherapy drug, with lenvatinib, an enzyme inhibitor, to treat patients with high-grade serous ovarian cancer. The study aims to see if this combination can help control the disease by boosting the immune system and blocking cancer cell growth.

Patient Parameters

Program Overview

This study is testing a new treatment for high-grade serous ovarian cancer using two drugs: pembrolizumab and lenvatinib. Pembrolizumab is an immunotherapy that helps the immune system attack cancer cells, while lenvatinib blocks enzymes that cancer cells need to grow. The goal is to see if these drugs can work together to control the cancer and offer a new treatment option.

Description

The main goal of this study is to see how pembrolizumab and lenvatinib affect immune cells in the area around the tumor in patients with high-grade serous ovarian cancer that has spread to the peritoneal area. Researchers want to understand how these drugs work individually and together to improve immune cell function and memory.

The study also aims to measure how well the combination of pembrolizumab and lenvatinib works in shrinking tumors in patients whose cancer has not responded to platinum-based chemotherapy.

Additionally, the study will explore changes in immune cells and other cells in the tumor environment to identify which cells are linked to resistance or response to the treatment.

Participants will be randomly assigned to one of two groups:

  • Group A: Starts with pembrolizumab given through an IV on the first day of the cycle. From the second cycle, lenvatinib is taken orally every day for 21 days. This cycle repeats every 21 days for up to 35 cycles unless the cancer progresses or side effects become unacceptable.

  • Group B: Starts with lenvatinib taken orally every day for 21 days. From the second cycle, pembrolizumab is given through an IV on the first day. This cycle repeats every 21 days for up to 35 cycles unless the cancer progresses or side effects become unacceptable.

After finishing the treatment, patients will have follow-up visits 30 days later, every 6 weeks for a year, and then every 9 weeks. If the cancer progresses, follow-ups will be every 12 weeks.

Eligibility Criteria

Inclusion Criteria

  • Women aged 18 or older.
  • Must have signed a consent form.
  • Diagnosed with high-grade serous ovarian, peritoneal, or fallopian tube cancer that is resistant to platinum-based chemotherapy.
  • Must not be able to become pregnant or agree to use birth control during the study and for 5 months after.
  • Must have measurable cancer in the peritoneal area or retroperitoneal lymph nodes.
  • Blood pressure must be controlled, with or without medication.
  • Must be in good general health with an ECOG performance status of 0 or 1.
  • Must agree to have a port placed for fluid and blood draws.
  • Must meet specific blood count and organ function criteria.
  • Must not have received certain treatments or have certain medical conditions that would interfere with the study.

Exclusion Criteria

  • Pregnant or breastfeeding women.
  • Previous treatment with lenvatinib.
  • Recent treatment with certain cancer therapies or investigational drugs.
  • Unresolved side effects from previous treatments.
  • Recent major surgery or radiation therapy.
  • Recent live vaccination.
  • Participation in another clinical trial within the last 4 weeks.
  • Certain immune system disorders or treatments.
  • History of another cancer unless treated and in remission for 2 years.
  • Active brain metastases or certain autoimmune diseases.
  • Active infections or certain viral infections.
  • History of severe lung disease or heart conditions.
  • Certain blood disorders or risk of severe bleeding.
  • Tumor involvement with major blood vessels or certain gastrointestinal conditions.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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