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

  • STATUS
    Recruiting
  • participants needed
    699
  • sponsor
    AstraZeneca
Updated on 19 February 2024
cancer
immunomodulator
measurable disease
platinum-based chemotherapy
carboplatin
paclitaxel
sarcoma
durvalumab
endometrial carcinoma
cancer treatment
carcinoma
immunomodulators
olaparib
maintenance therapy
cancer therapy
recurrent disease
carcinosarcoma
recurrent endometrial cancer
carboplatin paclitaxel
adjuvant
endometrial cancer

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, Uterine Cancer
Age 18years - 150years
Treatment Carboplatin, Paclitaxel, Durvalumab, Olaparib, durvalumab placebo, olaparib placebo
Clinical Study IdentifierNCT04269200
SponsorAstraZeneca
Last Modified on19 February 2024

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

How to participate?

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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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