Durvalumab With or Without Olaparib as Maintenance Therapy After First-Line Treatment of Advanced and Recurrent Endometrial Cancer

  • STATUS
    Recruiting
  • End date
    Mar 5, 2025
  • participants needed
    699
  • sponsor
    AstraZeneca
Updated on 13 June 2021
Investigator
AstraZeneca Clinical Study Information Center
Primary Contact
Research Site (4.9 mi away) Contact
+192 other location
paclitaxel
cancer
measurable disease
carcinoma
maintenance therapy
carboplatin
durvalumab
recurrent disease
olaparib
sarcoma
platinum-based chemotherapy
endometrial carcinoma
recurrent endometrial cancer
carcinosarcoma

Summary

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 endometrial cancer.

Description

This Phase III study will 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 endometrial cancer.

Target patient population: Adult female patients with histologically confirmed diagnosis of epithelial endometrial carcinoma (excluding sarcomas): newly diagnosed Stage III, newly diagnosed Stage IV, or recurrent endometrial cancer

Details
Condition Endometrial Carcinoma, Uterine Cancer, Endometrial Cancer
Treatment carboplatin, Paclitaxel, durvalumab, olaparib, Durvalumab placebo, olaparib placebo
Clinical Study IdentifierNCT04269200
SponsorAstraZeneca
Last Modified on13 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
Newly diagnosed Stage III disease (measurable disease per RECIST 1.1 following surgery or diagnostic biopsy)
Newly diagnosed Stage IV disease (with or without disease following surgery or diagnostic biopsy)
Recurrence of disease where the potential for cure by surgery alone or in combination is poor
Nave to first line systemic anti-cancer treatment. For patients with recurrent disease only, prior chemotherapy is allowed only if it was administered in the adjuvant setting 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

Exclusion Criteria

History of leptomeningeal carcinomatosis
Brain metastases or spinal cord compression
Prior treatment with PARP inhibitors
Prior immune checkpoint inhibitors or prior treatment with an agent directed to a
stimulatory or co-inhibitor T-cell receptor other than anti-PD-1, anti-PD-L1
or anti-PD-L2 agent
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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