National Clinical Trial Number:NCT04269200
Clinical Trial Protocol Description:
Clinical Trial Title: A Randomised, Multi-centre, Double-blind, Placebo-controlled, Phase III Study of First-line Carboplatin and Paclitaxel in Combination with Durvalumab, Followed by Maintenance Durvalumab with or without Olaparib in Patients with Newly Diagnosed Advanced or Recurrent Endometrial Cancer
The purpose of this study is to learn more about how the drugs durvalumab and olaparib, when combined with standard of care chemotherapy, could improve outcomes for women with endometrial cancer. This study will also help us better understand endometrial cancer and related health problems. Durvalumab and olaparib are still in the development stage for the treatment of endometrial cancer, and they are not approved for the treatment of endometrial cancer, except for use in research studies like this. Therefore, both these medicines are considered as investigational treatments for patients with endometrial cancer. “Investigational” means that it is not approved by the U.S. Food and Drug Administration (FDA), and that it must be tested to see if it is a safe and effective treatment for the disease or condition being studied.
Study participation may last about 2 years, but participants will receive treatment until the endometrial cancer no longer responds, so it may be longer or shorter than that. Participants will have a clinic visit every 3 weeks for the first 18 weeks (chemotherapy induction period), and then every 4 weeks while participants are receiving study treatment (maintenance period). Each visit may not take the same amount of time.
More information can be found on the website clinicaltrials.gov by searching for NCT04269200.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are at least 18 years of age at time of screening and female.
- Have histologically confirmed diagnosis of epithelial endometrial carcinoma. Sarcomas will not be allowed.
- Have postmenopausal or evidence of non-childbearing status.
- Have endometrial cancer in one of the following categories:
- Newly diagnosed Stage III disease (measurable disease per RECIST 1.1 following surgery or diagnostic biopsy).
- Newly diagnosed Stage IV disease .
- Recurrence of disease where the potential for cure by surgery alone or in combination is poor.
You will be excluded from the study if any of the following criteria apply to you:
- Have any history of, or currently active, brain or leptomeningeal metastases.
- Have had prior treatment with PARP inhibitors.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.