The EndoBARR Trial: Testing a New Combination of Drugs for Recurrent Endometrial Cancer

Sponsor: Medical College of Wisconsin

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03694262

Provider View

This clinical trial is exploring a new treatment combination of rucaparib, bevacizumab, and atezolizumab to see if it can effectively and safely treat endometrial cancer that has returned or is not responding to other treatments.

Patient Parameters

Program Overview

The EndoBARR Trial is investigating whether a combination of three drugs—rucaparib, bevacizumab, and atezolizumab—can work together to treat endometrial cancer that has come back or is not responding to current treatments. The study aims to see if these drugs can work together to enhance the body's immune response against cancer cells and improve treatment outcomes for patients with this type of cancer.

Description

This study is testing a new combination of drugs to treat endometrial cancer that has returned or is not responding to other treatments. The drugs being tested are rucaparib, bevacizumab, and atezolizumab. Researchers believe that these drugs might work well together to boost the immune system's ability to fight cancer and improve treatment results. The study will look at how safe and effective this combination is for patients with endometrial cancer.

The trial will include patients who have had at least one previous chemotherapy treatment for endometrial cancer. Participants must have measurable cancer that can be tracked with scans. The study will also require participants to stop any hormonal treatments at least one week before starting the trial and any other cancer treatments at least three weeks before. Participants must be in good overall health, with specific blood and organ function levels, and must agree to use effective birth control during the study and for six months after the last dose of the study drug.

The study will not include patients who have had other types of cancer within the last two years, except for certain skin cancers. Patients who have previously been treated with bevacizumab, PARP inhibitors, or immunotherapy are not eligible. The study also excludes patients with certain health conditions, such as uncontrolled high blood pressure, recent heart problems, or active infections.

Eligibility Criteria

Inclusion Criteria

  • Have recurrent or progressive endometrial cancer that is not responding to other treatments.
  • Have a confirmed diagnosis of endometrial cancer with specific types of cancer cells.
  • Have had at least one previous chemotherapy treatment for endometrial cancer.
  • Have measurable cancer that can be tracked with scans.
  • Be in good overall health with a performance status of 0 or 1.
  • Have recovered from any recent surgery, radiation, or chemotherapy.
  • Be free of active infections requiring antibiotics.
  • Have stopped any hormonal cancer treatments at least one week before starting the trial.
  • Have stopped any other cancer treatments at least three weeks before starting the trial.
  • Have completed any previous radiation therapy at least four weeks before starting the trial.
  • Have a urine protein level within specified limits.
  • Be willing to provide a tissue sample from the primary cancer surgery.
  • Have specific blood and organ function levels within specified ranges.
  • Be 18 years or older.
  • Agree to use effective non-hormonal birth control during the study and for six months after the last dose of the study drug.

Exclusion Criteria

  • Have had another type of invasive cancer within the last two years, except for certain skin cancers.
  • Have previously been treated with bevacizumab, PARP inhibitors, or immunotherapy.
  • Have had radiation or chemotherapy for other abdominal or pelvic tumors within the last three years.
  • Cannot tolerate oral medications.
  • Are pregnant or breastfeeding.
  • Have a complete bowel obstruction or recent history of certain abdominal issues.
  • Have a current diagnosis of immunodeficiency or are taking immunosuppressive medications.
  • Have significant heart problems or uncontrolled high blood pressure.
  • Have had major surgery within the last 28 days or have a major surgery planned during the study.
  • Have any condition that makes participation in the study unsuitable, according to the investigator.
  • Are not available for follow-up assessments.
  • Have known sensitivity to any of the study drugs.

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