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

STATUS

Recruiting
days left to enroll

2
participants needed

699
sponsor

AstraZeneca

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Updated on 19 February 2024

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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 Identifier	NCT04269200
Sponsor	AstraZeneca
Last Modified on	19 February 2024

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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

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Study Definition

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