Study on Lenvatinib, Pembrolizumab, and Paclitaxel for Treating Recurrent Endometrial, Ovarian, Fallopian Tube, or Peritoneal Cancer

Sponsor: Floor Backes, MD

Sponsor score: 0

ClinicalTrials ID:NCT04781088

Provider View

This clinical trial is exploring a new combination of three drugs—lenvatinib, pembrolizumab, and paclitaxel—to treat women with certain types of cancer that have returned after treatment. The study aims to see how well these drugs work together and what side effects they might cause.

Patient Parameters

Program Overview

This phase II study is testing a combination of three drugs—lenvatinib, pembrolizumab, and paclitaxel—to treat women with recurrent endometrial, ovarian, fallopian tube, or primary peritoneal cancer. While each drug is approved by the FDA, this specific combination has not been studied before. Researchers believe that adding pembrolizumab to the other two drugs could be effective and safe for treating these cancers. The study will look at how well the drugs work together and what side effects patients might experience.

Description

The main goal of this study is to see how well the combination of lenvatinib, pembrolizumab, and paclitaxel can shrink tumors in women with recurrent endometrial and platinum-resistant ovarian cancer. Researchers will also evaluate the safety and side effects of this treatment, as well as how long patients live without the cancer getting worse and their overall survival.

Participants will receive lenvatinib daily by mouth, pembrolizumab through an IV on the first day of each cycle, and paclitaxel through an IV on days 1, 8, and 15 of a 21-day cycle. This will continue as long as the cancer does not progress and side effects are manageable.

Eligibility Criteria

Inclusion Criteria

  • Women aged 18 or older.
  • Diagnosed with endometrial, ovarian, fallopian tube, or primary peritoneal cancer.
  • Previously treated with a platinum-based chemotherapy regimen.
  • For ovarian, fallopian tube, or peritoneal cancer, the cancer must be resistant to platinum treatment (returned within 6 months after treatment).
  • Can have had up to three previous treatment regimens.
  • Can have had prior treatments targeting PD-1/PD-L1 or angiogenesis, as long as they were not the most recent treatment and were not stopped due to side effects.
  • Must have measurable cancer based on specific criteria.
  • Not pregnant or breastfeeding, and willing to use contraception if of childbearing potential.
  • Able to provide a tumor tissue sample for analysis.
  • In good overall health with specific blood counts and organ function levels.

Exclusion Criteria

  • Pregnant or breastfeeding women.
  • Recent treatment with other cancer therapies or participation in another clinical trial.
  • Recent radiotherapy or live vaccines.
  • Active infections or immune system deficiencies.
  • Other active cancers requiring treatment in the past 3 years.
  • Severe allergies to the study drugs.
  • Active autoimmune diseases requiring treatment.
  • History of lung inflammation or current lung issues.
  • History of hepatitis B, C, or tuberculosis.
  • Significant heart disease or recent major surgery.
  • Severe nerve damage or gastrointestinal issues affecting drug absorption.
  • Blood clotting disorders or recent serious infections.
  • Unable to swallow pills or have conditions affecting drug absorption.
  • Psychiatric or substance abuse issues affecting study participation.

Locations

FACILITYZIPCITYSTATE
Ohio State University Comprehensive Cancer Center43210ColumbusOhio
Allegheny Health Network15224PittsburghPennsylvania

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.