Authorised Therapeutic confirmatory (Phase III) Endometrial Cancer

A study to assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent cancer in the lining of the uterus or womb.

EU CTIS ID: 2022-502746-27-00

What this study is testing

To demonstrate the efficacy of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab (Arm B) or durvalumab with olaparib (Arm C) when compared to platinum-based chemotherapy alone (Arm A) by assessment of progression free survival (PFS), in patients with newly diagnosed advanced or recurrent endometrial cancer

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Age ≥18 years at the time of screening and female.
  • Histologically confirmed diagnosis of epithelial endometrial carcinoma. All histologies, including carcinosarcomas, will be allowed. Sarcomas will not be allowed.
  • Patient must have endometrial cancer in one of the following categories: a) Newly diagnosed Stage III disease (measurable disease per RECIST 1.1 following surgery or diagnostic biopsy), b) Newly diagnosed Stage IV disease (with or without disease following surgery or diagnostic biopsy) c) Recurrence of disease (measurable or non-measurable disease per RECIST 1.1) where the potential for cure by surgery alone or in combination is poor.
  • Naïve to first line systemic anti-cancer treatment. For patients with recurrent disease only, prior systemic anti-cancer treatment is allowed only if it was administered in the adjuvant setting (as part of the upfront/adjuvant anti-cancer treatment, which may be concurrent or followed with chemoradiation) and there is at least 12 months from date of last dose of chemotherapy administered to date of subsequent relapse.
  • FPPE tumor sample must be available for MMR evaluation.
  • Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days of starting study treatment.

You likely can't join if

  • History of leptomeningeal carcinomatosis
  • Brain metastases or spinal cord compression.
  • Prior treatment with PARP inhibitors.
  • Prior immune-mediated therapy including other anti-CTLA-4, anti-PD-1, anti-PD-L1 or anti-PD-L2 antibodies, excluding therapeutic anticancer vaccines"

The study team makes the final eligibility decision.

Where it's taking place

  • China
  • Australia
  • Japan
  • Mexico
  • Canada
  • Israel
  • Russian Federation
  • Colombia
  • Korea, Republic of
  • Singapore
  • Hong Kong
  • United States
  • Brazil

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include China; Australia; Japan; Mexico; Canada; Israel and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.